July 22, 2022Out of Spoons / Public HealthPhoto by Glen Carrie on Unsplash
This blog post is part of a series focusing on what heath care was like during the Biden-Harris administration. It was a month where the main focus was on the COVID-19 pandemic. In addition, other health related topics were addressed. Some of the information about COVID-19 in this blog may be outdated information now.
March 1, 2021 – March 31, 2021
March 1, 2021: President Biden issued “A Proclamation on American Red Cross Month, 2021“. From the proclamation:
…For 140 years, the American Red Cross has been synonymous with the prevention and alleviation of human suffering across the globe. Founded by Clara Barton in 1881, the organization’s mission lives on in the dedication of Red Cross workers – more than 90 percent of whom are volunteers – and the generosity of the American people in moments of crisis.
We saw unmistakable evidence that spirit through the challenges of this past year. In 2020, more than 70,000 people became new Red Cross volunteers and stepped up on behalf of those in need – as disaster shelter workers, health workers, blood donor ambassadors, and transportation specialists. And when our country faced a severe blood shortage, with more than a half-million of our friends and neighbors donating blood with the Red Cross for the first time.
In a year like no other, people made a lifesaving difference. As months of relentless hurricanes, wildfires, and other extreme weather events battered communities, families spent more nights in emergency lodging than in any other year over the past decade – thanks to the hard work and generosity of Red Cross volunteers and partners who provided more than 1.3 million people with overnight stays last year.
When the pandemic strained emergency services, Red Cross workers adapted to help fulfill urgent needs. They responded to increased emergency calls from military families, aided hundreds of thousands of home fire survivors, supported international health and hygiene services, and safely provided health and safety courses to essential workers and others to help them manage the COVID-19 threat. In recent days, as harsh winter storms left many Americans without power and water across the South and Midwest, the Red Cross and its partners have worked to help people recover and restore access to safe water.
This month, we renew our commitment to Clara Barton’s remarkable vision and join together, as one Nation, to recommit ourselves to a foundational American principle: the duty of care we owe to one another when times get tough. I urge all Americans to take part in that tradition through our own everyday acts of compassion – helping a neighbor, a stranger, or a community in need.
NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America and Honorary Chairman of the American Red Cross, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim March 2021 as American Red Cross Month. I encourage all Americans to observe this month with appropriate programs, ceremonies and activities, and by supporting the work of service and relief organizations…
March 1: U.S. Food and Drug Administration posted a Statement titled: “Coronavirus (COVID-19) Update: FDA issues Authorization for Quidel QuickVue At-Home COVID-19 Test”. From the Statement:
Today, the Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.
The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
“The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”
In addition to this new prescription home test, Quidel also was issued a EUA in December 2020 for their QuickView SARS Antigen Test which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIS) to perform high, moderate, or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waver.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
March 1: National Institutes of Health (NIH) posted a news release titled: “NIH to evaluate COVID-19 at-home testing system”. From the news release:
Newly authorized COVID-19 diagnostic kit is paired with smartphone app.
A research team funded by the National Institutes of Health has launched a study to assess performance and usability of a smartphone app paired with the Quidel QuickVue At-Home COVID-19 Test, which just received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for use with a prescription. The home test was supported by NIH through the Rapid Acceleration of Diagnostics (RADx) initiative, which has spurred the development and commercial availability of millions of COVID-19 tests over the past year.
More than 200 participants have already enrolled in the study that involves daily testing for a two-week period. An app called MyDataHelps, developed by CareEvolution, LLC provides step-by-step instructions for taking the test and important tools such as timers to ensure that the steps of the test are performed at the correct time intervals. Although users can interpret the test result on their own, the app also provides an independent confirmation of the results when the user photographs the test strip with the smartphone camera.
Understanding how individuals interact with these apps and where they find value in them will inform future efforts to advance at-home COVID-19 testing.
The antigen test gives results in just 10 minutes using a nasal swab sample that is placed in a test tube followed by addition of a test strip. The visually read, colored lines that appear on the test strip indicate a positive or negative result – similar to a pregnancy test.
As rapid, at-home COVID-19 tests like QuickVue become more widely available, companion smartphone apps are expected to play an important role in their successful use. Apps offer great potential to assist individuals with administering tests, tracking symptoms, and interpreting results – ultimately resulting in improved test performance and ease-of-use. In addition to providing valuable guidance, apps can also make it straightforward to report results to public health authorities and health care providers.
These technologies are supported by the National Institute for Biomedical Imaging and Bioengineering (NIBIB), part of the NIH. Quidel intends to apply for an additional EUA from the FDA for sale of this test over the counter, without a prescription.
Bruce J. Tromberg, Ph.D, director of NIBIB and lead for the RADx Tech program, can comment on COVID-19 testing technology…
…About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.
March 1: Centers for Disease Control and Prevention (CDC) posted a Press Release titled: “CDC’s Tips From Former Smokers Campaign Returns With New Ads” From the Press Release:
The Centers for Disease Control and Prevention’s (CDC) Tips From Former Smokers (Tips) campaign enters its 10th year today with new ads that encourage people who smoke to quit. The Tips campaign is the nation’s first federally funded tobacco education campaign that has helped more than 1 million U.S. adults to quit smoking and inspired millions more to try to quit. This year’s Tips campaign features ads that will air on national and cable television, online, and streaming radio.
To coincide with the launch of this year’s Tips campaign CDC is also releasing a special supplement in the American Journal of Preventative Medicine focusing on the role of tobacco quitlines. The studies and articles in the supplement address how quitlines have been able to reach, adapt, tailor, and innovate to serve more than 10 million Americans since 2004.
Research shows that emotionally evocative, evidence-based campaigns, like Tips, are effective in raising awareness about the dangers of smoking and helping people who smoke to quit. These campaigns are even more effective when coupled with quitlines, which provide free, confidential support services to help people quit smoking. Each year when the Tips campaign is aired, there is an immediate and marked spike in calls to 1-800-QUIT-NOW and in visits to the campaign website.
“For nearly a decade the Tips campaign has shown us the impact of living with real-life consequences from smoking,” said CDC Director Rochelle P. Walensky, MD, MPH. “CDC’s longstanding effort to end tobacco use continues to be a public health priority and we remain determined to reduce the number of deaths and prevent chronic diseases that result from tobacco use.”
Emotionally evocative, evidenced-based campaign
Through the campaign, people share compelling stories about their smoking-related diseases and disabilities and the toll these conditions have taken on them and their loved ones. The new 2021 Tips include:
Tonya M. 49, who suffered from heart failure at age 38. Tonya had open-heart surgery and had a battery-operated heart pump installed.Denise H., 66, who cares for her husband, Brian H., 65, who suffers from heart disease, chronic obstructive pulmonary disease (COPD), and lung cancer – all caused by smoking.Assad M., 25, who cares for his mother, Leah M., 52, who suffers from colorectal cancer due to smoking.
In addition to the new ads, we will continue to run existing ads that highlight a variety of health conditions. This includes ads that feature participants who smoked and have COPD, emphasizing the fact that smoking can cause lung illnesses and make them worse.
“We are so thankful to all the brave Tips campaign participants who, through the years, have shared their powerful stories about the toll cigarette smoking has taken on them and their loved ones,” said Karen Hacker, MD, MPH, director of CDC’s National Center for Chronic Disease Prevention and Health Promotion. “Their stories continue to save lives by inspiring people to quit smoking.”
Cost-effective Tips campaign saves lives and dollars
In addition to the harm it causes to people’s lives, cigarette smoking also has a significant impact on the U.S. economy. Smoking costs more than $300 billion a year, including nearly $170 billion in direct medical care for adults and more than $156 billion lost in productivity.
Mass-reach health education campaigns, like , help people quit smoking, improve their health, and reduce healthcare spending. A recently published study showed that during 2012-2018, the Tips campaign prevent an estimated 129,000 early deaths and helped save an estimated $7.3 billion in smoking-related healthcare costs. Every $3,800 spent on the Tips campaign between 2012-2018 prevented an early death.
Cigarette smoking remains the single largest cause of preventable disease and death in the United States, killing more than 480,000 Americans each year. For every American who dies from a smoking-related disease, about 30 more suffer at least one serious illness from smoking.
The adverse effects of smoking are clear and well-documented. Smoking harms nearly every organ in the human body and increases the risk of more serious illnesses from COVID-19 Quitting smoking is beneficial at any age. For more information on the Tips campaign, including profiles of former smokers, other campaign resources and links to the ads, visit CDC.gov/Tips.
March 1: U.S. Food and Drug Administration (FDA) posted a News Release titled: “FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy”. From the News Release:
The U.S. Food and Drug Administration has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. The Hominis Surgical System is intended for benign hysterectomy (removal of the uterus for non-cancerous conditions) with salpingo-oophorectomy (removal of one or both fallopian tubes and ovaries).
“We are providing physicians and patients another minimally invasive gynecologic surgical option for non-cancerous conditions,” said Binita Ashar, M.D., MBA, FACS, director of the Office of Surgical and Infection Control Devices in the FDA’s Center for Devices and Radiological Health. “The FDA continues to support advancements in safe and effective medical devices that can improve patient experiences when undergoing surgical procedures.”
RASD, sometimes referred to as robotic surgical devices or computer-assisted surgical devices, are not actually robots. The devices cannot perform surgery without direct human control. RASD enable a surgeon to use computer and software technology to control and move surgical instruments through one or more tiny ports (incisions or orifices) in the patient’s body and in a variety of surgical procedures or operations. RASD technology facilitates performing minimally-invasive surgery and complex tasks in confined areas inside the body.
To remove the uterus, the Hominis Surgical System uses minimally-invasive surgical instruments inserted through the vagina (transvaginal approach) and a video camera inserted laparoscopically through a small incision on the abdomen for visualization of the instruments inside the patient. The transvaginal approach requires fewer incisions on the abdomen compared to conventional laparoscopic hysterectomy. During the procedure, surgeons in the operating room control the instruments from the Hominis Surgical System console. The FDA will require the manufacturer to develop and provide a comprehensive training program for surgeons and operating room staff to complete before operation of the device.
In addition to its assessment of performance and engineering testing, the FDA evaluated safety and effectiveness in a clinical study of 30 patients undergoing transvaginal total hysterectomy with salpingo-oophorectomy or salpingectomy for benign conditions, using the Hominis Surgical System. Patients has varying characteristics such as ages ranging from 37 to 79 years, body mass index from 17.6 – 40, and 63% of patients had different cormorbidities, such as high cholesterol, osteoporosis or high blood pressure. All 30 procedures with the Hominis Surgical System were successfully completed and there were no conversions to open or other laparoscopic surgical approach. Observed adverse events included minor blood loss, urinary tract infection and delay healing of the closure made at the top of the vagina (vaginal cuff) that is done as part of a hysterectomy.
The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate- risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type.
The FDA granted marketing authorization of the Hominis Surgical System to Memic Innovative Surgery Ltd…
March 1: President Biden posted “A Proclamation on National Colorectal Cancer Awareness Month, 2021“. From the Proclamation:
For my family, for the Vice President’s family, and for millions of families across our Nation, the fight against cancer is personal. Too many of us know the sinking feeling of shock and devastation when a loved one receives a diagnosis of cancer – too many of us know the unspeakable pain when the fight cannot be won. Each year, colorectal cancer claims more than 50,000 American lives, making it the second leading cause of cancer deaths in our Nation. National Colorectal Cancer Awareness Month is a chance to bring greater attention to this terrible disease and to offer what families living through it need most: hope.
In this battle, hope and awareness are intertwined. Because the risk of death from colorectal cancer drops dramatically when the cancer is caught early, we can save lives by calling attention to risk factors and increasing routine screening. This month is our chance to improve public understanding of colorectal cancer risk, inform people about screening recommendations, and set our sights on broadening prevention strategies, improving treatments, and finding a cure.
Colorectal cancer can afflict anyone, but the risk is higher among some Americans than others. When we lost the trailblazing actor Chadwick Boseman to colon cancer last year after a heroic fight, it served as a reminder that this disease disproportionately impacts communities of color – and is particularly fatal among Black Americans. Age, too, is a factor, as the majority of cases occur in people over 50 years old. People with increased risk for developing the disease include certain racial and ethnic minority populations, as well as individuals with inflammatory bowel disease, a family history of colorectal cancer, or other risk factors such as tobacco use. For more information on risk factors, you can visit www.cancer.gov.
As with so many diseases, the best defense against colorectal cancer is early detection. Symptoms can include blood in the stool; stomach pain, aches, or cramps that do not go away; and weight loss without a known cause. But many cases have no symptoms, especially early in the disease, when colorectal cancer is most curable. A recent Government study estimated that if all 50-year-old adults were screened for colorectal cancer, we could prevent approximately 35,000 deaths. That’s why it is so crucial, especially for Americans over 50 or otherwise at increased risk, to receive regular screenings. And although the disease is relatively rare in younger adults, the incidence of colorectal cancer has been rising among this group. No matter your age, every American should take possible colorectal cancer symptoms seriously and bring them to the attention of your health care provider.
I know how hard it is right now to be mindful of preventative care. The COVID-19 pandemic has disrupted so many parts of our lives, including, for far too many, the routine checkups and screenings that are so vital to guarding against disease. I urge every American to take the precautions they need in order to stay vigilant against cancer – don’t delay your treatments. You and your healthcare provider can discuss how to balance the risks and benefits of cancer screening, taking into account medical history, family history, other risk factors, and the time between screenings.
My Administration is strongly committed to improving the prevention and treatment of colorectal cancer, and to giving every American access to quality, affordable health coverage. Because of the Affordable Care Act, most health insurance plans must cover a set of preventative services with no out-of-pocket cost. This includes colorectal cancer screening in adults age 50 and older. In response to the COVID-19 pandemic, my Administration also announced a Special Enrollment Period for the Health Insurance Marketplace now through May 15th, so that millions of uninsured individuals and families can sign up for health coverage and gain these protections. I encourage you to visit www.healthcare.gov to explore your eligibility and get covered.
Above all, I want every family facing this fight – and all those that will in the future – to know that there is hope. As President, I am committed to ending cancer as we know it. That mission motivated me every day when I led the Cancer MoonshotInitiative in 2016 to speed up progress toward prevention, treatment, and cures. Thanks to that effort, researchers, oncologists, care providers, philanthropists, data and tech experts, advocates, patients, and survivors have joined forces to double the rate of progress toward a cure for cancer. One particular program, Accelerating Colorectal Cancer Screening and follow-up through Implementation Science (ACCSIS), has made strides to improve colorectal cancer screening, follow-up, and referral for care among populations that have low screening rates, including communities of color and rural Americans. You can read more about this important work by visiting www.cancer.gov and www.cdc.gov/cancer…
…NOW, THEREFORE, I, JOSEPH R. BIDEN JR., President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim March 2021 as National Colorectal Cancer Awareness Month. I encourage all citizens, government agencies, private businesses, non-profit organizations, and other groups to join in activities that will increase awareness and prevention of colorectal cancer…
March 1, 2021: The White House posted a “Press Briefing by White House COVID-19 Response Team and Public Health Officials“. From the Press Briefing:
MR. ZIENTZ: Good morning. Thank you for joining us. We got very good news over the weekend: The Food and Drug Administration issued an emergency use authorization for a third safe and effective vaccine, the Johnson & Johnson vaccine, which will help us defeat the pandemic.
While we have much work ahead of us on many fronts, this is certainly a very encouraging development.
Today, we’ll get a state-of-the-pandemic update from Dr. Walensky. Dr. Fauci and Dr. Nunez-Smith will discuss the recently authorized J&J vaccine. And I’ll close with an update on our planning, logistics, and distribution of the J&J vaccine. And then we’ll open it up to questions.
DR. WALENSKY: Thank you, Jeff. I’m delighted to be back with you today. Let’s get started with the current state of the pandemic.
I remain deeply concerned about a potential shift in the trajectory of the pandemic. The latest CDC data continue to suggest that recent declines in cases have leveled off at a very high number. The most recent seven-day average of cases – approximately 67,200 – represents an increase of a little over 2 percent compared to the prior seven days.
Similarly, the most recent seven-day average of deaths has also increased more than 2 percent from the previous seven days to nearly 2,000 deaths per day.
These data are evidence that our recent declines appear to be stalling – stalling at over 70,000 cases a day. With these new statistics, I am really worried about reports that more states are rolling back the exact public health measures we have recommended to protect people from COVID-19.
I understand the temptation to do this. Seventy thousand cases a day seemed good compared to where we were just a few months ago. But we cannot be resigned to 70,000 cases a day, 2,000 daily deaths.
Please hear me clearly: At this level of cases, with variants spreading, we stand to completely lose the hard-earned ground we have gained. These variants are a very real threat to our people and our progress. Now is not the time to relax the critical safeguards that we know can stop the spread of COVID-19 in our communities, not when we are so close.
We have the ability to stop a potential fourth surge of cases in this country. Please stay strong in your conviction. Continue wearing you well-fitted mask and taking the other public health prevention actions that we know will work.
Ultimately, vaccination is what will bring us out of this pandemic. To get there, we need to vaccinate many more people. Yesterday, the CDC’s Advisory Committee on Immunization Practices, or ACIP, endorsed the safety and efficacy of Janssen’s COVID-19 vaccine. After that ACIP met, I was heartened to sign their recommendations for use of this vaccine in people 18 or older.
It offers several unique benefits. It’s a single-dose vaccine that provides COVID-19 protection with just one shot. That can help fully vaccinated people who may have difficulty, or who are not interested, in returning for a second dose. For those administrating the vaccine, this vaccine is also easier to store and transport since it does not need to be kept in a freezer. This will make it easier to provide vaccine in community settings and mobile sites as supplies scale up.
Having multiple types of vaccine available, especially ones with different dosing regimes and different storing and handling, offers more flexibility. For example, clinics and mass vaccination sites that do not have freezer capacity may be able to use the Janssen vaccine, increasing access to more communities.
I know that many Americans look forward to rolling up their sleeves with confidence as soon as a COVID-19 vaccine is available to them. We are working hard to get and distribute these vaccines to your communities. I also know that some people may not be there today and may still have questions about those vaccines, including wanting more information about the process for developing and authorizing them. That’s natural. And I know that some people have had experiences that may have diminished their confidence in the health system. That’s also understandable.
I want to emphasize several important facts about these vaccines. We have conducted the largest-scale clinical trials of any vaccine, and what made that possible so quickly was the high amount of disease in the community and the fact that so many people were interested in participating. All of the available data show that these vaccines are safe and highly effective.
Over 100,000 people participated in clinical trials to evaluate the safety and effectiveness of these vaccines, and they have all met rigorous FDA scientific standards. Equally importantly, as of today, nearly 50 million people in the United States have received at least one does of a COVID-19 vaccine. We have put in place the most intensive vaccine safety monitoring systems in U.S. history, and we are actively monitoring for any new safety signals.
CDC’s new V-safe smartphone-based health checker has now enrolled approximately 4.5 million people to capture patient-reporting side effects in real time. These results are all reassuring. Some people have had no side effects after vaccination. Many people reported mild side effects like pain, swelling at the injection site, and headache and chills or fever. These are common with all vaccines and should go away after a day or so. Serious, generally reversible reactions remain exceptionally rare.
For those who have – still have questions about the vaccines, I encourage you to visit the CDC COVID-19 website for more information. Our decisions today as a unified nation, and as individuals, including whether and when to get vaccinated, will determine how quickly we can stop this pandemic and what life will look like in the coming months ahead.
The most important thing you can do is be ready to get the vaccine that is available to you. It will help protect us all from COVID-19.
Thank you. I look forward to your questions. And with that, I’ll turn things over to Dr. Fauci.
DR. FAUCI: Thank you very much, Dr. Walensky. I’m going to talk just a little bit more now about the Janssen COVID-19 vaccine.
If I could have that first slide. Let’s move on to the second slide. We get questions – just move on to the second slide.
We get questions regarding the various percentage numbers that people see. And I know most of you are aware of them, but let me clarify a few things. The 66 percent vaccine efficacy that we have is really against all of the countries involved. You must recall that this vaccine trial was done on three continents – the United States, South America, and South Africa – with varying degrees of infection dynamics, as well as varying strains, variants, or lineages. That is the 66 percent. The 72 percent is the vaccine efficacy against moderate to severe critical infection in the United States.
I want to point out again a question we often get asked. In order to try – we always say: What vaccine is better than the other vaccine? In order to be able to determine that, you would have to compare them head to head. This was not done. We have three highly efficacious vaccines that also, as Dr. Walensky says, have a very good safety profile.
A very important number, but I want to reemphasize, is that there’s 85 percent efficacy against severe COVID-19 globally, including the United States. This is very important because if you look at other countries, such as South Africa – if you go to the next slide – where you have the B1351, you can see that the efficacy against severe critical disease was 82 percent there. That’s really very important, because even though the vaccine itself – the spike protein against wild-type virus, namely the virus that is D613G, not against the B1351. So even through the vaccine itself was not specifically directed against this variants, it did extremely well when it came to preventing critical disease. And as we’ve heard many times now, there were no hospitalizations or deaths in any of those studies.
I want to spend a minute now telling you the difference between mRNA and the Ad26, because we often get asked that question. As we’ve said on previous briefings, the mRNA that’s injected into the muscle codes for the spike protein in the proper configuration. The body sees that and makes an immune response against that, giving you the protection that has been shown with both of the mRNA vaccines.
In contrast, the Janssen COVID-19 vaccine approach is to take a common-cold, harmless, non-replication, competent virus called Adeno26, in which the DNA of the SARS spike insert was given into the genome. That virus is then injected into an individual. The DNA then transcribes the RNA; the RNA then gives you the spike protein.
The ultimate end game is that both of the viruses – excuse me, both of the vaccines ultimately result in a spike protein in the right configuration that gives the body the opportunity to feel that this is the actual virus that it’s seeing when it’s not; it’s the protein.
And so just to put everything in perspective – we’ve shown this slide before – we now have, again, the third vaccine that is highly efficacious, as shown here, which has been granted an EUA, as has been described by Dr. Walensky.
Let me go to the last slide and just make a comment that I think people do not seem to appreciate, and it has to do with what goes into making these vaccines successful.
I have as the title of the slide, “The Role of the NIH and the U.S. Government in the Development and Testing of J&J.”
I think what people don’t appreciate is that there have been decades of investment in basic preclinical and clinical research to actually develop the adenovirus 26 vector. A lot of work was done by Dr. Dan Barouch and his colleagues up at Harvard.
The development of the stabilized prefusion spike protein was done by scientists at the NIAID Vaccine Research Center. The utilization by J&J of the extensive domestic and international clinical trials network, that was established for – actually, for HIV and influenza.
Also, the NIAID-funded CORE lab at the HVTN, at the Fred Hutchinson Cancer Research Center, performed all the immunological testing. The Data and Safety Monitoring Board was established by NIAID, and there as extensive support from BARDA at ASPR of HHS to conduct the trial and to pre-purchase hundreds of millions of dollars’ worth of vaccines by BARDA.
So it’s a complicated process. So even though it looks like it was quick and it was done in a very relatively short period of time, there was a lot of effort, including fundamental, basic preclinical and clinical research that went into that.
I’ll stop there and hand it over to Dr. Nunez-Smith.
Dr. Nunez-Smith: Well, thanks so much, Dr. Fauci. This is all very, very good news. You know, all three vaccines are safe and highly effective at preventing what we care about most, and that’s very serious illness and death.
So all of the authorized vaccines will be distributed across states and jurisdictions and across all of our federal vaccination channels.
That doesn’t mean that every vaccination site will have every vaccine, but it means that all vaccines will reach all communities – so all three authorized vaccines available in the suburbs, all three available in the cities, all three available on the coast and in the Heartland.
So I just want to briefly talk about some of the clinical benefits of the J&J vaccine from a healthcare provider’s perspective. Having these different types of vaccines available for use – you know, ones that have different storage requirements, different handling requirements, different dosing recommendations – that will bring more options and more flexibility to healthcare providers.
You know, it could absolutely allow for expanded availability of vaccine, you know, in some temporary clinics, some pop-up mobile sites, and those locations that do not have cold storage capacity. The overall increased vaccine supply creates greater opportunity for people to get vaccinated.
We also recognize some individuals may have a preference for a single dose vaccine – so those who do not want to return for a second dose or who would have difficulty returning for a second dose. We understand that.
Still, as a physician, I strongly urge everyone in America to get the vaccine that is available to you when it is your turn. If people want to opt for one vaccine over another, you know, they may have to wait. Time is of the essence; getting vaccinated saves lives.
No doubt, communities across the country have been devastated by this pandemic. The vaccines and vaccinations are a critical tool in bringing this unprecedented pandemic to an end. And now we have three.
And so, for that, in addition to the scientist, I want to thank all of the clinical trial participants for their contributions to scientific discovery.
You know, for this vaccination campaign to be successful, vaccines will have to reach everyone. And so kudos to those states and jurisdictions who are already working closely with trusted leaders in the hardest-hit communities to ensure fair and equitable access to vaccinations. This is best practice.
So, again, all three vaccines have been proven safe, highly effective at preventing severe disease, hospitalization, and death from COVID-19 after full immunity.
And if I could leave people with one message, it is this: Get vaccinated with the first vaccine available to you. Protect yourself, your family, and your community from COVID-19.
And with that, I’ll turn it over to you, Jeff.
Mr. Zients: Well, thank you, Dr. Nunez-Smith. I’ll provide an update on our planning, logistics, and distribution of the recently authorized Johnson & Johnson vaccine before we open it up for questions.
For the last several weeks, we’ve been working with governors, state and local health officials, and pharmacies and community health centers to ensure we were ready to roll out the J&J vaccine immediately after FDA approval and CDC recommendations.
Starting yesterday, we began executing on our plans by distributing 3.9 million doses of Johnson & Johnson to states, tribes, and territories, and also to pharmacies and community health centers.
Johnson & Johnson doses will be delivered as early as tomorrow. We’re allocating the J&J vaccine the exact same way we allocate Pfizer and Moderna’s vaccine: proportional to a state, tribe, or territory’s population.
So, for example, if a state represents 2 percent of the U.S. population, it receives approximately 2 percent of the Pfizer allocation, 2 percent of the Moderna allocation, and will now receive 2 percent of the J&J allocation that is made to states, tribes, and territories.
We have directed states to manage distribution of all three vaccines in a fair and equitable way. And we will continue to monitor that closely.
As part of that work, the CDC is tracking distribution of vaccines across a range of equity metrics, including zip codes and Social Vulnerability Index data.
We have very effective vaccines, and all communities should have equitable and even access to each vaccine.
As to the expected supply of Johnson & Johnson vaccine, this week we’ll distribute 3.9 million doses. That is the entirety of Johnson & Johnson’s current inventory. We’re getting these doses out of the door right away to ensure vaccines get into as may arms as quickly as possible.
J&J has communicated that the supply will be limited for the next couple of weeks following this initial distribution of nearly 4 million doses. The company expects to deliver approximately 16 million additional doses by the end of March.
However, as we have discussed with governors and their teams and with federal partners, we know that J&J distribution and delivery will be uneven across these early weeks in March, and the company expects the delivery to be predominantly in the back half of the month.
Overall, in the J&J vaccine, we’ve done the planning, we have the distribution channels in place, and we’re getting doses out the door as quickly as possible to get shots in arms. So we’re focused on execution, and that includes the important work of ensuring that we continue to increase overall vaccine supply, increase the number of vaccinators, and increase the number of places Americans can get vaccinated.
Next, I want to provide an update on the pace of doses being administered. As you can see on our weekly vaccination report, the current seven-day average is 1.7 million shots per day. Given that first couple of days in this seven-day period included the storm impacts, 1.7 million actually understates the current pace.
Over the weekend, we experienced new record levels of daily vaccinations. That said, we have much more to do on all fronts in our war on this pandemic.
There is a path out of this pandemic, but how quickly we exit this crisis depends on all of us. And that’s why I encourage everyone to take the advice of Doctors Walensky, Fauci, and Nunez-Smith.
Follow the public health guidance. Get vaccinated when it’s your turn. And continue to wear masks and social distance to protect yourself and your fellow Americans. We will continue doing everything we can, as a federal government, to defeat this virus, but it’ll take all of us, stepping up to do our part.
With that, let’s open it up to questions.
MODERATOR: Great. And as a reminder to please keep your questions to one question only. First up, we’ll go to Elizabeth Wise at USA Today.
Q: Hi, thank you so much for taking my question. You didn’t say how many doses are being shipped this week. I think, usually, you’ve said that.
My question, however, is: So, appointment systems seem to be the rate limiting factor for getting people vaccinated in a lot of the country, and in some cases this is frustrating people who aren’t coming back because they couldn’t get through. As states move into phase 1B and 1C, and we get tens of millions of more Americans who are eligible, how is the system going to cope? And what are you doing to strengthen it?
Mr. Zeints: So the number of doses is 3.9 million. So that was the entire J&J inventory, and all of those doses are being shipped this week.
You know, I think scheduling an appointment is too difficult and remains too difficult in many places. You know, in some states or in some locales, things have gotten better. The pharmacy systems are often better at scheduling appointments. But overall, too many Americans are suffering frustration, taking up way too much time to schedule an appointment.
We have addressed some of those root causes as we’ve increased the vaccine supply, as we’ve put more vaccinators in the field, as we’ve increased the number of places. But now we really need to make sure the systems can handle not only the current demand, but the projected demand for people being vaccinated.
So we’re working with states to improve their health sites so that they can handle this capacity. We’re also looking at lower-tech solutions that the federal government might be able to provide, whether those are call centers or people to help navigate the system.
So, I think, overall, scheduling remains, for far too many people, too frustrating, and we need to make it better.
MODERATOR: Next we’ll go to William Joy with WFAA Dallas.
Q: Thank you for taking my question. So this has to do with equity, for either Dr. Nunez-Smith or for Jeff. So, at least here in Dallas-Fort Worth, the gap between vaccinations in affluent zip codes versus underserved zip codes is actually getting worse. So how specifically are you grading yourself when it comes to equity? And what’s that grade right now?
Mr. Zeints: Dr. Nunez-Smith?
Dr. Nunes-Smith: Yeah. No, thanks for the question. We’re absolutely 100 percent committed to equitable vaccine access. And, you know, the statistics that you share are very concerning to us. We know that we still have a challenge in term of – in terms of data. The data quality are not exactly where we’d like them to be as far as race, ethnicity. But even the data that we do have do suggest this pattern.
You know, we are already, in the federal programs, prioritizing equity. We have been committed to this from the very beginning, in the launch of those programs, using metrics such as the CDC’s Social Vulnerability Index to help guide where resources should go.
You know, ultimately, we do believe that people should be vaccinated at the rates – and different groups should be vaccinated at the rates in their population. And that’s – that’s our target and our goal.
We’re already working closely with states to provide technical assistance where needed. We will continue to do so.
Mr. Zeints: I think Dr. Nunez-Smith has captured it well. I will add that the President has been crystal clear that, as important as speed and efficiency in vaccinations, equity and fairness are as important, and we need to make sure that we execute on a strategy that ensures equity and fairness.
MODERATOR: Great. Next question will go to Laurie Garrett.
Q: Sorry, had a moment of unmuting. Thank you very much. Yes, I have a question regarding the variants, and this would go to both Doctors Fauci and Walensky. We have this new New York variant that jumped from 0.2 percent of identified viruses in early November to now about 28 percent in New York. And it seems to have arisen in an HIV/AIDS patient, indicating the possibility that we could see variants arising in highly immunosuppressed individuals. And they’re warning that it may be colonizing in nasal cels with very high, like tenfold affinity, for H2 receptors. And that’s a site pretty privileged in terms of IgG neutralizing antibodies.
So, I wonder – my question is: How worried should we be about this particular variant? And is it possible that vaccinated and COVID-surviving individuals could still harbor and colonize and transmit from their noses to other individuals? Thank you.
Mr. Zeints: Let’s start with Dr. Fauci, and then we’ll go to Dr. Walensky.
Dr. Fauci: Well, we certainly are taking the New York variant, the 526, very seriously, Laurie. You know, as you know, it started of in what is likely the Washington Heights section, and then has gone through multiple boroughs, and is now gaining. Work done by David Ho has shown that we really have to keep an eye on that for its ability to evade both monoclonal antibody and, to a certain extent, the vaccine-induced antibodies. So it’s something we take very, very seriously.
Mr. Zeints: Dr. Walensky, anything to add there?
Dr. Walensky: I would just say we know that early studies actually show that these variants could emerge in a single host – in a single immunocompromised host, as well. And it’s our reason to decrease circulating virus everywhere, but in the community, as well as individuals.
Dr. Fauci: What I think is important – because we often get asked the question that’s a reasonable question: “Should people who are immunocompromised get vaccinated?” And the answer is, “Absolutely, yes.” Absolutely, yes. Because that’s not only important for them for their own health, but that could be the breeding ground of the emergence of variants for the simple reason that, if you don’t clear the virus rapidly, you’re going to have immunological selection within a given individual. And as Laurie said correctly, that was probably how this started with 526.
MODERATOR: Next question will go to Jeremy Diamond at CNN.
Q: Hey, thanks for taking the question. Sorry, let me just mute the (inaudible) here. Apologies. I’m hoping you could address some of the concerns that the more easily deployable nature of the Johnson & Johnson vaccine will make the go-to vaccine for marginalized and harder-to-reach communities.
I know you guys have said that, you know, that’s something that you’re monitoring and you want states to distribute these shots equitably. But beyond monitoring, what more can the administration do to not only avoid this perception that, you know, you have different vaccines for different classes of Americans, but also to make sure that you’re getting the most bang for your buck from an epidemiological perspective, given the limited supply?
Mr. Zeints: Dr. Nunez-Smith?
Dr. Nunez-Smith: Absolutely. Thank you for the – for the question. So, you know, we shouldn’t lose sight of the very good news that we have: we have three authorized vaccines. That’s tremendous. We do expect that they be distributed evenly for all communities to benefit.
There are clinical benefits to J&J that we talked about briefly – in terms of the cold storage capacity, the single dose – that might make it very useful for healthcare providers in their toolkit, as they’re thinking about things like some pop-ups.
But overall, you know, we do think that the distribution, again, should be should be even across communities. So, importantly, providing that guidance upfront – we are modeling that within the federal programs. And then, you know, as we said, we will be tracking biometrics, such as zip code and social vulnerability to see where vaccines are going.
And should certain vaccines go consistently to certain communities, we will be able to intervene. And, you know, we’re here to provide support and technical assistance to pivot and intervene and correct, if and when needed.
MODERATOR: Last question will go to Zeke Miller at the Associated Press.
Q: Thank you all for doing the call. Two questions. First, just to follow up on what Dr. Nunez-Smith just said: What would that intervention look like? Would that be a reduction in a state’s allocation?
And then, more broadly, for Doctors Walensky and Dr. Fauci, what is the current timetable in terms of federal guidance on what people who have been vaccinated can and shouldn’t do in this moment? Is it safe for them to go out to dinner right now? Can they start to travel? And are you worried that the delay in getting that sort of guidance is having some – a downward pressure on demand?
Mr. Zeints: So, Zeke, I’ll go first here, and then over to the doctors.
You know, if we were to see that vaccines were going to certain communities, we will take action, as Dr. Nunez-Smith said, to ensure supply is distributed evenly. And first actions would include obviously the communication of our standards and our insistence that people adhere to the standards, and then we would begin by providing technical assistance to the state or other providers.
Second question over to you, Dr. Fauci.
Dr. Fauci: Yes. So this is something that the team – the medical team talks about all the time. Ultimately, the CDC will be coming out within a reasonable period of time; I’ll let Rochelle give you that timeframe in a moment. But, you know, I have been asked and have said publicly that, you know, as we get more and more people vaccinated, the logical that was just asked by Zeke is an important question. And that is: What happens if you get doubly vaccinated people with the Pfizer and Moderna, for example – members of family, people coming in – like, I use the example of a daughter coming in from out of town who is doubly vaccinated, and maybe a next-door neighbor who you know are doubly vaccinated, and a husband and wife doubly vaccinated. Small gatherings in the home of people, I think you can clearly feel that risk – that relative risk is so low that you could have a good social gathering within the home.
Beyond that is going to be based on a combination of data, a combination of modeling, and a combination of good, clinical common sense. And the CDC is working on that right now. And we’ll all be together with a good message hopefully soon.
So, Rochelle, why don’t you take it from there?
Dr. Walensky: Yeah, I don’t have too much to add, except to say we’re actively working on this guidance. We’re looking forward to releasing it soon.
At the same time – and I would agree with all that Dr. Fauci has said – at the same time, I want to really keep our eye on the fact that were are – our cases are increasing right now, slightly and – but they are. And so, you know, the goal is not to sort of open up travel, open up all of, you know, things because people – you know, we’re scaling up vaccination. The goal in those first 100 days has always been to sort of make sure that we are in a place to be out of this pandemic. At 70,000 cases per day, we’re not in that place right now.
So while we may have, you know, guidance at the individual level, as Dr. Fauci has suggested, I think we all need to keep our eye on the fact that we’re not out of the woods here yet.
Dr. Fauci: Yeah, the environment of, as I just mentioned, the setting in a home of a small group of people having dinner together, all of whom are vaccinated, is very different when you step out the door and go into a society that has 70,000 new infections per day. So, amen to what Dr. Walensky just said.
Mr. Zeints: I want to thank everybody for joining today. We’ll be back together on Wednesday. Thank you.
March 2: National Institutes of Health (NIH) posted a news release titled: “NIH invests in next iteration of public-private partnership to advance precision medicine research for Alzheimer’s”. From the news release:
The National Institutes of Health has launched the next version of the Accelerating Medicines Partnership (AMP) Alzheimer’s disease program (AMP AD 2.0) to expand the open science, big data approach for identifying biological targets for therapeutic intervention. AMP AD 2.0 is supporting new technologies, including cutting-edge, single-cell profiling and computational modeling, to enable a precision medicine approach to therapy development. Managed through the Foundation for the NIH (FNIH), AMP AD 2.0 brings together NIH, industry, non-profit and other organizations with a shared goal of using open science practices to accelerate the discovery of new drug targets, biomarkers and disease subtypes.
“Unraveling the complex biological mechanisms that cause Alzheimer’s disease is critical for therapeutic development,” said NIH Director Francis S. Collins, M.D., PhD. “AMP AD 2.0 aims to add greater precision to the molecular maps developed in the first iteration of this program. This will identify biological targets and biomarkers to inform new therapeutic interventions for specific disease subtypes.”
Alzheimer’s, the most common cause of dementia, affects an estimated 2.8 million Americans 65 and older. Because the prevalence of this disease is greater among Black and Latino Americans than among white Americans, AMP AD 2.0 will expand the molecular characterization of Alzheimer’s in brain, blood, and spinal fluid samples collected from these populations. These dataset will allow the AMP AD 2.0 research teams to refine the characterization of new targets, discover new fluid biomarkers, and define disease subtypes and increase the understanding of causative factors and steps in disease progression. The knowledge gained will inform the development of therapies that can be tailored to different stages of the disease and diverse disease risk profiles.
“AMP AD has helped transform the way we learn about the disease process and identify new targets for treatment,” said Richard J. Hodes, M.D., director of the National Institute on Aging (NIA), part of NIH. “By expanding the molecular characterization of Alzheimer’s disease to be more inclusive of diverse populations and by renewing the commitment to open science practices for sharing data, methods and results, we will enable researchers across the globe to approach the development of effective treatments.”
During the first AMP Alzheimer’s program, research teams generated a wealth of high-quality data from human biological samples and animal and cell-based models and discovered more than 500 unique candidate targets through a centralized data infrastructure and data-sharing platform, the AD Knowledge Portal, and the portal-linked, open-source platform Agora. The wide availability of this data has led to many new insights on the role of the genome, proteome, metabolize and microbiome in the disease process. To date, more than 3,000 researchers around the world, representing academic, biotechnology and pharmaceutical industry sectors, have used these data resources for research on Alzheimer’s and related dementias.
NIA will lead research efforts and contribute an estimated total of $61.4 million over five years, pending availability of funds. This includes funding for a data coordinating center at Sage Bionetworks, and six multi-national, cross-disciplinary academic research teams.
AMP AD 2.0 private funding partners include Eisai Inc., Gates Ventures and Takada Pharmaceutical Company Limited. The Alzheimer’s Association and GlaxoSmithKline plc (GSK), who have been partners since the beginning of the AMP Alzheimer’s program, will again participate and continue to provide support towards the program’s goals. The total co-funding contribution from all private partners will be approximately $13.45 million, which will be managed through FNIH.
As before, FNIH will manage a steering committee to provide strategic direction of the partnership’s research plans with representation from public- and private-sector partners. FNIH’s steering committee management will be directed by an AMP AD executive committee made up of leaders from NIA, industry, the U.S. Food and Drug Administration and not-for-profit research, advocacy and care organizations.
“This partnership offers real hope to the tens of millions of people affected by Alzheimer’s disease,” said Maria C. Freire, Ph.D., president and executive director of the FNIH. “Collaboration through the first round of AMP AD has already enabled breakthrough advances in researchers’ understanding of how Alzheimer’s disease progresses, uncovering numerous potential targets for drug therapy in a field where treatment options are severely limited.”…
March 2: The Centers for Disease Control and Prevention (CDC) posted news titled: “CDC to Require Airlines to Collect Contact Information from Passengers from DRC and Guinea”. From the news:
Starting Thursday, March 4, 2021, airlines and other aircraft operators will be required to collect and transmit contact information to Centers for Disease Control and Prevention (CDC) for appropriate public health follow-up and intervention for all passengers boarding a flight to the United States who were in the Democratic Republic of the Congo (DRC) or the Republic of Guinea within the last 21 days before their arrival in the United States.
There are currently outbreaks of Ebola virus Disease (Ebola) in DRC and Guinea. The ability to identify and locate people in the U.S. who may have been exposed to a communicable disease, such as Ebola, abroad is critical to help prevent the spread of disease within U.S. communities. Having access to travelers’ contact information will allow U.S. federal, state, and local heath departments and agencies to provide health information, monitor travelers for signs and symptoms of Ebola, and ensure travelers who develop symptoms are quickly isolated and receive appropriate medical evaluation and care.
This order follows the February 2020 interim final rule that authorized CDC to require airlines and other aircraft operators to collect certain data from passengers before they board a flight to the United States, and to provide the information to CDC within 24 hours of a CDC order.
“Timely public health follow-up requires health officials to have immediate access to accurate and complete contact information for travelers as they arrive in the United States,” said CDC Director Dr. Rochelle Walensky. “Inaccurate or incomplete contact information reduces the ability of public health authorities to swiftly protect the health of travelers and the public. Any delay in contacting exposed individuals can increase the likelihood of disease spread.”
Air travel has the potential to transport people, some of whom may have been exposed to a communicable disease, anywhere across the globe in less than 24 hours. In certain situations, public health officials may need to follow up with travelers who have arrived from a country where an outbreak is occurring, such as the Ebola outbreaks in DRC and Guinea.
CDC has identified the minimum amount of information needed to locate travelers reliably after they arrive in the United States: full name, address while in the U.S., primary contact phone number, secondary or emergency contact phone number, and email address. Airlines and other aircraft operators will collect this information and submit it electronically, to enable CDC to receive these data in a timely manner.
The U.S. government will also begin to redirect air passengers from DRC and Guinea to six U.S. airports where over 96% of air passengers from these countries already arrive. The six airports include New York (JFK), Chicago (ORD), Atlanta (ATL), Washington D.C. (IAD), Newark (EWR), and Los Angeles (LAX). Passengers can expect their contact information to be verified by U.S. government officials on arrival to ensure it is accurate and complete. CDC will share contact information securely with state and local health departments for passengers’ final destinations in the United States.
For more information on the Order, visit https://www.cdc.gov/quarantine/order-contact-information-ebola.html.
March 2: National Institutes of Health (NIH) posted a news release titled: “NIH effort seeks to understand MIS-C range of SARS-CoV-2 effects on children”. From the news release:
The National Institutes of Health has launched a new research effort to understand how SARS-CoV-2, the virus that causes COVID-19, affects children, who account for roughly 13% of the total cases of COVID-19 in the United States. The effort us called the Collaboration to Assess Risk and Identify Long-term Outcomes for Children with COVID (CARING for Children with COVID). This research program is developing and funding studies to investigate why some children are at greater risk for SARS-CoV-2 infection than others, why symptoms vary among children who are infected, and how to identify children at risk for severe illness from SARA-CoV-2 infection. Research on the latter question is focused particularly on multisystem inflammatory syndrome in children (MIS-C), a life-threatening condition marked by severe inflammation of one or more parts of the body, including the heart, lungs, kidneys, brain, skin, eyes, and gastrointestinal organs.
The program is led by the National Heart, Lung, and Blood Institute (NHLBI) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). Research conducted through CARING for Children with COVID is supported in part by the Coronavirus Aid, Relief, and Economic Security Act.
“This effort stems from NIH’s commitment to understanding the spectrum of risk that SARS-CoV-2 poses for children and to identifying interventions to improve their short- and long-term health outcomes,” said NICHD Director and CARING for Children with COVID co-chair Dana Bianchi, M.D.
Based on current data, most children with SARS-CoV-2 infection do not develop serious illness. However, those who do go on to develop MIS-C can experience prolonged fever and severe abdominal pain and may progress to shock. Although most children with MIS-C survive, its cause and long-term effects remain largely unknown. There is also early evidence that some children with asymptomatic or mild infection may go on to develop such long term symptoms as fatigue, muscle and joint pain, and respiratory problems.
“While much of the devastation wrought by COVID-19 is on older and vulnerable populations, it is affecting children in ways we are just beginning to understand,” said Gary Gibbons, M.D., director of the NHLBI and co-chair of CARING for Children with COVID. “That’s why this research and these networks are so critical.”
Specifically, the program developed new research protocols for three clinical networks with sites across the country, to include children with SARS-CoV-2 infection and related conditions, including MIS-C:
Long-Term Outcomes after the Multisystem Inflammatory Syndrome in Children (MUSIC)
Funded by NHLBI and leveraging the Pediatric Heart Network, this study focuses on cardiovascular complications of MIS-C, but also collects data on all aspects of childhood and adolescent health in affected participants.
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children per Standard of Care (POPS)
Funded by NICHD and leveraging the Pediatric Trials Network, this study focuses on understanding the treatment of children diagnosed with COVID-19 or MIS-C with medicines that have shown promise in adults with COVID-19.
Pediatric Research Immune Network on SARS-Cov-2 and MIS-C (PRISM)
Sponsored and funded by NIAID, the study aims to evaluate the short-and long-term health outcomes of SARS-CoV-2 infection in children, including MIS-C, and to characterize the immunologic pathways associated with different disease presentations and outcomes.
CARING for Children with COVID also includes Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and Artificial Intelligence (PreVAIL kids), a research funding program to encourage the development of approaches that identify children at high risk for developing MIS-C. PreVAIL kids is funded by NIH’s Rapid Acceleration of Diagnostics (RADx) Radical (RADx-rad) program to support new, non-traditional approaches and reimagined uses of existing tools to address gaps in COVID-19 testing and surveillance.
Although the studies supported by CARING for Children with COVID have slightly different goals, all will collect data on a core set of health measures that can later be analyzed across studies. Data from CARING for Children with COVID activities will be made available on multiple NIH web platforms to allow researchers to conduct additional analyses and make more discoveries.
More information on the effort is available on the CARING for Children with COVID website at https://caring4kidswithcovid.nih.gov.
March 2: U.S. Department of Health and Human Services (HHS) posted a Press Release titled: “Biden Administration Announces Historic Manufacturing Collaboration Between Merck and Johnson & Johnson to Expand Production of COVID-19 Vaccines”. From the Press Release:
President Biden Invokes Defense Production Act to Support Measures to Accelerate Vaccine Development
President Biden announced today that his Administration has helped forge a historic manufacturing collaboration between two of the largest U.S. health care and pharmaceutical companies, Merck and Johnson & Johnson (J&J), to expand production of J&J’s COVID-19 vaccine. The collaboration will increase manufacture of vaccine drug substance, as well as its fill-finish capacity – two of the biggest bottleneck facing J&J in the production of its vaccine.
The U.S. Department of Health and Human Services (HHS) will collaborate with Merck to repurpose some of its facilities for rapid large-scale manufacturing of vaccines and therapeutics for use in public health emergencies during the current pandemic. The facilities will be available to private sector partners working with the federal government on the COVID-19 response or to produce Merck products against COVID-19. Janssen Pharmaceuticals, part of Johnson & Johnson, will be the first federal partner to use repurposed Merck facilities to manufacture COVID-19 vaccine. Merck will use two of its facilities to produce drug substance, formulate and fill vials of J&J’s vaccine.
Consistent with the Administration’s mission to ensure that the United States has sufficient long term sustainable capacity to manufacture vaccines, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will leverage the Defense Production Act to provide an initial investment of $105 million in funding for Merck, at the Administration’s request, to convert, upgrade and equip Merck facilities to the standards necessary to safely manufacture the vaccine. The company will address all the necessary qualification and validation activities needed for the facilities to be used for large-scale manufacturing.
To further accelerate production of the J&J vaccine, President Biden also announced he has invoked the Defense Production Act to expedite materials in vaccine production, such as equipment, machinery and supplies like single use bags, and he has directed the Department of Defense (DOD) to provide daily logistical support to strengthen J&J’s efforts. With the urging and assistance of the Administration, J&J’s efforts. With the urging and assistance of the Administration, J&J also will begin operating its manufacturing facilities 24/7 to maximize production output.
These efforts will contribute to J&J’s ability to accelerate delivery of their vaccine doses from 100 million doses by the end of June to at or near 100 million doses by the end of May. In the long term, these actions will ultimately double J&J’s U.S. capacity to produce drug substance and increase the U.S. capacity for fill-finish.
March 2: National Institutes of Health (NIH) posted a news release titled: “NIH halts trial of COVID-19 convalescent plasma in emergency department patients with mild symptoms.” From the news release:
Study shows the treatment is safe, but provides no significant benefit in this group.
The National Institutes of Health has halted a clinical trial evaluating the safety and effectiveness of COVID-19 convalescent plasma in treating emergency department patients who developed mild to moderate symptoms of COVID-19, the disease caused by the coronavirus SARS-CoV-2.
An independent data and safety monitoring board (DSMB) met on Feb. 25, 2021, for the second planned interim analysis of the trial data and determined that while the convalescent plasma intervention caused no harm, it was unlikely to benefit this group of patients. After the meeting, the DSMB recommended that the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, stop enrolling new patients into the study. The NHLBI did so immediately.
Launched in August 2020, the Clinical Trial of COVID-19 Convalescent Plasma of Outpatients (C3PO) was being conducted at 47 hospital emergency departments across the United States and had enrolled 511 of the 900 participant recruitment goal. It was specifically looking at the effectiveness of COVID-19 convalescent plasma – blood plasma derived from patients who have recovered from COVID-19 – in adults who came to an emergency department with mild to moderate symptoms they had for a week or less. These patients also had at least one risk factor associated with COVID-19, such as obesity, hypertension, diabetes, heart disease, or chronic lung disease, but none were ill enough at the time to be hospitalized.
After the study participants received either the COVID-19 convalescent plasma or a placebo, researchers tracked whether the participants needed to seek further emergency or urgent care, had to be hospitalized, or died, within 15 days of entering the trial. The recent data analysis from the study indicated no significant difference in the proportion of participants who experienced any one of these outcomes. Even if enrollment continued, this trial was highly unlikely to demonstrate that COVID-19 convalescent plasma prevents progression from mild to severe illness in at-risk emergency department non-hospitalized participants.
COVID-19 convalescent plasma, also known as “survivor’s plasma,” contains antibodies, or special proteins, generated by the body’s immune system to the novel coronavirus. More than 100,000 people in the United States and many more worldwide have already been treated with it since the pandemic began.
Nahel El Kassar, M.D., Ph.D., program officer for the C3PO trial and a medical officer with NHLBI’s Epidemiology and Clinical Therapeutics branch, or Simone Glynn, M.D., M.P.H., program scientist for the C3PO trial and chief of NHLBI’s Blood Epidemiology and Clinical Therapeutics branch, are available for interviews.
March 2: U.S. Food and Drug Administration (FDA) posted a News Release titled: “Coronavirus (COVID-19) Update: March 2, 2021”. From the News Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA’s response efforts.
The agency issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription at-home with a self collected nasal swab sample by people 14 years and older or people age 8 years and older, with the nasal swab sample is collected by an adult, within the first six days of the onset of COVID-19 symptoms.
A new FDA Voices entitled National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams, by Judy McMeekin, Pharm. D., explains that the FDA is on the lookout for charlatans seeking to profit from the pandemic. Vaccine distribution is underway throughout the country and schemes to mislead and scam the American public are prevalent. Public health protection for consumers is the hallmark of our mission and the FDA remains vigilant to ensure that consumers are shielded from seedy efforts and can have confidence in COVID-19 vaccines.
As part of the FDA’s efforts to protect customers, the agency issued a warning letter jointly with the Federal Trade Commission to Ageless Global, LLC for selling unapproved products with fraudulent COVID-19 claims. The company sells products, including “Immunoral,” “Immune Plus,” “MD Immune Support Spray,” and “MD CVK-365 Mouth Spray,” and misleadingly represents the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested Ageless Global, Inc., take immediate action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
As part of the FDA’s efforts to protect consumers, the agency issued a warning letter to KDunn and Associates, P.A. dab HealthQuilt and Kimberly Dunn, M.D., Ph.D., for not complying with federal laws and regulations, including laws and registrations to protect people participating in clinical trials, during the clinical investigation of an investigational drug to treat, cure and prevent COVID-19. Sponsors seeking to develop new drugs to treat or prevent any disease, including COVID-19, must comply with the FDA’s laws and regulations governing the drug approval process.
Testing updates: As of today, 335 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUA’s). These include 249 molecular tests and sample collection devices, 71 antibody tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test and one over-the-counter (OTC) at-home antigen test.
March 3: The White House posted “Remarks by President Biden in a Bipartisan Meeting on Cancer”. From the Remarks:
The President: Hey, everyone. Thanks. Thanks for coming in. These are members of the House, Senate – Democrat, Republican – who all have an extremely keen interest in doing what – what I said once before: that I’d live to be the President to preside over the end of cancer as we know it. These are the folks in the House and Senate who would love to preside over cancer – the end of cancer as we know it. And they were – all were critical in the CARES Act, which put about $9 billion into NIH to deal with cancer and cancer research.
And the Vice President and I are in the view that we can make significant strides in fighting cancer and Alzheimer’s and other diseases, if we take a slightly different approach. And what I want to talk with them about today is how we go about taking advantage of the work they’ve done to get us where we are today, because I think we’re on the cusp of some real breakthroughs across the board on cancer. And that’s what we’re going to talk about.
And probably to all of you, like all of us, cancer is personal for almost everybody. It’s probably the one word that is the most frightening word in the English language to people. When they hear that “C word,” cancer, it is – it is just devastating.
And I always ask at – when I talk about cancer, I ask the audience if they – to raise their hand, if any of them were suffering from cancer as I spoke, and/or they lost someone, and virtually 70 percent of every audience – whether or not its 4,000 people or 400 people. And a lot of folks in this room have, like many of you maybe have been victims of cancer and overcame it.
But there’s so much hope that that’s what I want to talk about with these folks – about what we do, from a legislative and a substance point of view, to make the kind of inroads I think we can make. That’s what we’re talking about today.
Thank you for coming in. And we’re – I’m optimistic we’re going to get something done here.
…Q: Do you have a response to Texas relaxing its COVID restrictions?
The President: I didn’t hear the question.
Q: Message to Texas and Mississippi – Texas and Mississippi?
Q: (inaudible) COVID-restrictions?
The President: Texas – I think it’s a big mistake. Look, I hope everybody has realized by now: These masks make a difference.
We are on the cusp of being able to fundamentally change the nature of this disease because of the way in which we’re able to get vaccines in people’s arms. We’ve been able to move that all the way up to the end of May to have enough for every American to get – every adult American to get a shot. And the last thing – the last thing we need is Neanderthal thinking that, in the meantime, everything is fine, take off your mask.
Forget it. It still matters.
I carry a card with me – I don’t have it. I put it on my desk. As of last – as of yesterday, we had lost 511,874 Americans. We’re going to lose thousands more. This will not occur – we’ll not have everybody vaccinated until sometime in the summer. We have the vaccine to do it. Getting a shot in someone’s arm and getting the second shot are going to take time. And its critical – critical, critical, critical – that they follow the science: Wash your hands – hot water; do it frequently. Wear a mask. And stay socially distanced.
And I know you all know that. I wish to heck some of our elected officials knew it.
So thank you very much.
March 3: The White House posted “Press Briefing by Press Secretary Jen Psaki, March 3, 2021”. From the Press Briefing.
Ms. Psaki: Okay. I have a couple of items for all of you at the top. Yesterday, I discussed the President’s announcement about the historic partnership between Merck and Johnson & Johnson to produce more COVID-19 vaccines. And, of course, he laid our more details yesterday afternoon.
He also directed states to prioritize teachers for vaccinations in an effort to treat in-person learning, like essential – the essential service it is. He challenged all 50 states to get teachers, school staff, and childcare workers their first shot by the end of this month.
To help states do that, starting next week, we will be using the federal pharmacy program to prioritize vaccinating teachers, school staff, and childcare workers during the month of March. This is a part of the President’s efforts to urge states to prioritize vaccines for all essential workers.
The Special Enrollment Period, which we have talked about a couple of weeks ago – I have an update on that and the number of people who have enrolled. On February 15th, the Biden-Harries administration opened HealthCare.gov for three months to provide all Americans the opportunity to sign up for health insurance through a Special Enrollment Period. In the two weeks since, more than 200,000 Americans have gotten covered. These numbers are encouraging, but we can’t slow down until every American has health coverage.
There is plenty of time left to sign up. And, of course, people who need health insurance can go to HealthCare.gov to sign up before May 15th….
…This afternoon, the President and Vice President will also meet with members of Congress, which we announced last night, to begin working in a bipartisan way to end cancer as we know it.
Defeating cancer is of significant personal importance to the President, the First Lady, and the Vice President. And cancer is, of course, a disease that impacts – affects many Americans, no matter their political affiliation. This has been a priority of the President’s, as we all know, for many, many years. And this is his first engagement with members of Congress in the Oval Office about it…
…Q: If I can, quickly, a little homework around here as it relates to the COVID relief bill. If know we’ll see you speaking – the President speaking to the House Democratic Caucus later today. Can you confirm that the President has signed off on these reduced income thresholds as it relates to those direct payments?
Ms. Psaki: Well, let me – let me provide a little context here, because some of the reporting – it’s all coming out, so some of the reporting is aligned with accuracy and some is not; no one’s fault.
Q: That’s the true story.
Ms. Psaki: First – (laughs) – so, one – I talked to the President about this this morning – he’s pleased with the progress that is being made on the rescue plan. As someone who served for 36 years in the Senate, he is certainly familiar with the journey that it takes from a proposal to a bill being signed. And in every instance, in the final stage, which we feel we are in – we are in now, there are suggestions, there are changes, there are negotiations between even different member – different parts of one party. That’s what – that’s what’s happening now. And he is open to – has always been open to good ideas and to proposals that will strengthen the package.
What he has been firm on is that the package needs to be large enough to meet the scope of the twin crises we’re facing: COVID and the economic downturn. He has been firm on the importance of the $1,400 checks going out to Americans, and that – and that he has fought for that tooth and nail and is – that is a – that is a bar for him. And he’s also been firm on the thresholds at which Americans should receive those checks.
So, as we’ve seen in the reporting, its 75K and 150K. He has been clear that those are important thresholds to him. What we’re talking about here – and I realize you didn’t actually ask this, but just for clarity for everyone – is where the – where is the – is the ramp-up and how far the ramp-up goes.
Q: Where it ends.
Ms. Psaki: Where it ends, I should say. Where it ends. And he has been open from the beginning for those – that being more targeted and for there to be a steeper – steeper cliff at which that ramp down ends.
Q: So for clarity, is he – does he support – I know he’s okay with – what you just said out there – is he okay with it ending at $80,000 for individuals, $160,000 for couples, and $120,000 for heads of households?
Ms. Psaki: He is comfortable with where the negotiations stand. And of course, there are going to be ongoing discussions. We don’t have a final bill, as you know. There will be ongoing discussions. He is comfortable and knows there will be tweaks at the margin. What his firm viewpoint is, is that it needs to meet the scope of the challenge, it needs to be the size he’s proposed, it needs to have the core components in order to have the impact on the American people.
Q: And he’s confident that he’ll have 50 Democrats that’ll all support where it stands based on those changes to which you just referred?
Ms. Psaki: He is – he is certainly. That’s one of the reasons why he’s meeting with members of Congress. You can – you can define them any way you like – moderates, progressives, Republicans – because he’s not taking anything for granted, as we work to get past the finish line…
…Q: Let me ask one last question, given the news that came out last night about Texas and Mississippi. The President was in Texas, met with Governor Abbott just a matter of days ago. They have now, in both of those states, removed their mask mandates, and they’re reopening at 100 percent, even as this White House says, “Now is not the time for that.” How do you characterize those decisions? And what do you say to the governors of those two states that are making them?
Ms. Psaki: Well, first, the President’s position on mask wearing is based on the recommendations of health and medical experts and their views that it could save 50,000 lives. That is why he asked the American people to wear masks for 100 days.
For nearly a year, we’ve been dealing and navigating and coping with this pandemic across the country. And this entire country has paid the price for political leaders who ignored the science when it comes to the pandemic.
We talked a little bit yesterday about how people are starting to feel a little bit better in some cases. You go to the grocery store, and there’s Clorox wipes available. And a year into this that feels better, but there’s still more work that needs to be done. We need to remain vigilant and he believes that, and he’s hopeful, that people in these states will continue to follow the guidelines that have been set our and the recommendations made by health and medical experts.
Q: Jen, thank you. I have several questions about teachers getting vaccinated, but to follow up on Peter first: Does President Biden plan to speak to the governors, to have them reconsider their orders? And secondly, what are people in those states supposed to do if they’re confused about whether to listen to their governor or the President?
Ms. Psaki: Well, first, I would say we’re not asking people just to listen to the President. Of course, we recommend that, but we’re asking people to listen to health experts, medical experts, the CDC, to Dr. Fauci, to others who are basing their recommendations on how to save people’s lives. That’s what we’re asking people to do.
The President’s view is well known – we all know it quite well – about why mask wearing is important – again, based on health and medical experts. He speaks with governors of both parties on a regular basis. He obviously traveled with the governor last Friday, and I’m sure he will raise this at the next opportunity he has.
Q: And on the President’s goal to vaccinate educators by the end of this month: Last month, he made it very clear that, as you well know, it’s up to states to determine how to prioritize vaccines. And you reminded us that even though there are federal recommendations, the process is not to mandate the states to prioritize anyone.
What has changed between then and now? And what power does President Biden have to direct states to prioritize teachers?
Ms. Psaki: Well, first, 30 states are already doing this. So that is the majority of states in the country who are treating teachers as essential workers, and that’s what the President is asking, what he is recommending.
We, of course – right now, the teachers will have access through pharmacies. That is – the supply that goes to pharmacies is through the federal supply. And so that is a – you know, an area where we can work through a program that we have instituted to ensure that teachers are prioritized.
Q: So, today you’ve said that he is challenging states, he’s asking states, he’s urging states, but yesterday the President said he’s directing states. So is it just a firm request, or is he using some mechanism and authority to direct them?
Ms. Psaki: Well, again, he is using a federal program that is – works – that is distributing vaccines to pharmacies across the country to ensure that teachers are prioritized. It is not – it remains – it does not – it remains the same case it’s been, where it is not a prerequisite for schools to open; it is just a – it is one of the mitigation steps that can be taken for teachers to be vaccinated. But he believes that teachers should be treated as essential workers.
There is, of course, the power of the bully pulpit; there is the power of the pharmacy program that the federal government is instituting. And certainly, as the President of the United States, the leader of the country, he is conveying, “This is important.” It’s not a Republican or Democratic issue whether or not our kids are behind. We have all seen the impact on mental health. We’ve seen the impact on kids being – doing Zoom from their kitchen tables and kitchen counters.
And everybody wants – the President wants kids to be back in school. This is part of the effort to east that.
Q: And one last question on the effort. You’re using the federal pharmacy program, which was supposed to establish more equity, especially for communities of color. Dr. Celine Gounder has called the move to prioritize teachers “anti-equity,” since most teachers are white, and it’s taking away from those people who are underserved.
So what is the administration doing to make sure teachers, and these people who are underserved, will have the same access to vaccines?
Ms. Psaki: Well, first, we simply disagree, and not just me or the President, but the head of our Equity Task Force and our health and medical team, for a couple of reasons.
One is it’s critical to remember that the program is beyond teachers; it includes bus drivers, janitorial workers, childcare workers – a workforce that is broadly, incredibly, diverse.
Second, getting kids back to school is one of the most equitable steps we can take, because what we’ve seen statistically is that black and Latino students are disproportionately experiencing learning loss for a variety of reasons – Internet interconnectivity, parents who are disproportionately frontline workers – and this compounds the damaging effects of policies that already leaves students of color with lower-equity resources.
So our view is actually that this step is one that is meant to help communities of color, help students who are already being disproportionately disadvantaged by schools being closed.
Q: Thanks. Following up on this, you know, you said again that the CDC’s recommendations were clear and that educators don’t have to be vaccinated to safely reopen schools, but we’re hearing this big push, this prioritization with the White House through the pharmacy program. So what do you say to critics who say this just isn’t about science; it’s about politics and appeasing the unions?
Ms. Psaki: I would say that our actions have been clear, that we’ve basing our recommendations to school – our work with school districts to reopen on science, on the recommendations of CDC guidelines; and that we’ve been clear that it’s not a prerequisite. It is not a requirement for teachers to be vaccinated.
However, we also – the President has also been clear he believes they should be prioritized, as many other frontline workers are, because – because they are playing a vital role – a role as essential workers, teaching our kids, educating the future of the country.
So, you know, this is a challenging issue, but this is a step where the President could take, using his ability, his authority of federal government program, to ensure he’s sending the message that teachers should be prioritized because of the value of their work, the essential role they play teaching the next generation – schools across the country, many of which keep reopening every single week. As you know, Dr. Biden and our new Secretary of Education are visiting a few today.
We’ll continue to work with them and push for them. It’s not a prerequisite, and nothing has changed on that front.
...Q: What’s your message then to other essential workers? Are teachers really more at risk in the classroom than Americans who are working at a meatpacking plant?
Ms. Psaki: Well, look, certainly the President has taken a number of steps over the last couple of days to expedite the availability and the access of vaccines to Americans across the country. And we – it’s very clear that, you know, it’s important for schools to be reopened. It’s not a political issue or a partisan issue; we all – we all agree with that.
…Q: I have two questions on two different subjects.
Ms. Psaki: Okay.
Q: First, you know, this agreement to, you know, change the eligibility rules around the stimulus checks was something that got moderate Democrats on board. Are you concerned at all about the left on this – that, you know, they see this as negotiating against yourself and, you know, maybe not living up to the promise that even the President was making in campaigning with the Georgia runoff candidates?
Are you concerned that, you know, by cutting some people out of eligibility, that you’re actually giving people – there are people who are going – who are not going to get checks who did get checks during the Trump administration, and that in some way is not living up to his political promises?
Ms. Psaki: What the President promised and committed to was ensuring that the American people receive $2,000 in checks. This $1,400 is part of delivering on that promise.
He also proposed, of course, a higher threshold, as you know, in his own proposal, in his joint session speech that he delivered a couple of weeks ago.
He has also been clear that he is open to changes on the margins of this package. While he is firm on the $1,400 – and, as you know, there have been negotiations about trying to lower that to $1,000 or change the size of the check – he’s unmovable on that; repeated that to me again this morning. And he has been very clear that the threshold should be at 75K and 150K for families.
But he also knows that the sausage-making machine sometimes spits our a different package – almost always it spits out a different package than what is proposed initially. These are negotiations primarily through Democrats in Congress with each other, but he’s a part of – you know, he rolls up his sleeves; he gets involved in them too.
And, you know, he’s confident that this is a package, with all of the components included that – and he’s hopeful that Democrats of all political backgrounds can get behind…
…Go ahead, Hans.
Q: Given the clear importance you’re placing on vaccinating teachers, I’m wondering if there’s been any discussion on holding back some of the federal stockpile outside of this, sort of, federal pharmacy program and going directly and having some sort of program to vaccinate teachers?
Ms. Psaki: I think this is the step that we feel is most effective and immediately impactful in terms of ensuring that teachers can go to their local pharmacies – pharmacies that are already functioning, already distributing the vaccine.
We’ve seen, I think, in some New England states, there was some reporting about it already being underway, or about to be underway. So this was the step that our team that oversees the operational components, as well as the health components, felt was most effective.
You know, we always reserve a range of options. We understand we’re still at the height of a pandemic, but I don’t have anything to preview, nor am I aware of that being under consideration….
…Q: I have a couple of questions –
Ms. Psaki: Okay.
Q: – on several different topics. Going back to the issue of vaccines, when is this administration expecting herd immunity? And I ask that because there are still populations in this nation that are not running to this vaccine, even though you’re – or these vaccines, even though you’re flooding the home. Is there a concern that herd immunity will not be reached by at the time that you are hoping for because of this mindset in certain communities?
Ms. Psaki: Well, I’m not going to make a prediction about herd immunity, but I will say that you’re touching on an incredibly important point in that, now that we’re at the state where the President just announced we’ll have enough vaccines to vaccinate all of the American people by the end of May, we will eventually reach a point – to your point, April, where we will have more vaccines than people who want vaccines. That feels hard to believe at this moment in time, but we are focused on – we are concerned about the level of vaccine hesitancy in a range of communities across the country. And certainly communities of color are communities where there’s been a higher level of vaccine hesitancy.
Now, we are working to take a number of steps. Of course, we have an Equity Task Force, led by Dr. Marcella Nunez-Smith, to look closely, take the appropriate steps, do planning – you know, plan communication, plan outreach that is going to be effective. But this will be a focus. We are, of course, concerned because we know we will reach a point, which we’re already seeing – but we’ll reach a point where we have more vaccines than we have people who want to take them.
Q: So – but at some point, understanding, if you listen to the science – if you have a majority in one community taking it and not a majority in another, it’s all for not. We won’t reach herd immunity, and we still have a problem. Is there still a concern?
Ms. Psaki: There’s absolutely a concern about swaths of the population not taking – not feeling that the vaccine is safe or effective, and certainly relying on a problematic and tragic history that has contributed to vaccine hesitancy.
So this is a significant concern of ours and one that we’ve been focused on from the beginning, and we will be focused on direct outreach, direct communications, and a range of efforts to help address this and reaffirm how safe and effective the vaccines are…
…Q: And another issue is in-house issue. We know today there’s new COVID test rules that have been implemented in the White House. Some suggested that if the White House can provide vaccinations to the White House journalists and cameramen, this daily test issue could be resolved. Does the White House have any plan to do so?
Ms. Psaki: Well, let me first say the good news is that we now have enough vaccines to – we will by the end of May – to ensure every American is vaccinated – well, a little bit after that, once they are all in place – including journalists, of course. And many of you may be eligible before that.
We put in place new policies. One, our objective is to protect all of you, to protect the people in the White House, and to abide by COVID-safe protocols. As you know – and just for full clarity – anyone who is in the briefing room as a part of the briefing room pool is not paying – is not charged for tests. We cover those tests. Anyone who is in the pool for the President, we cover the cost of the tests. And same for the Vice President.
And our objective is certainly bringing an end to the pandemic and having this tool full again without masks, and doing that in a safe way. So we’ll look forward to that.
Thank you so much, everyone. Have a good afternoon. Or I’ll see many of you…
March 3: The White House posted a Statement by President Biden titled “Statement by President Joseph R. Biden, Jr. on 2021 Special Health Insurance Enrollment Period Coverage Progress”. From the statement.
Health care is a right, not a privilege – and ensuring that every single American has access to quality, affordable health care they need is a national imperative. Never has that been more important than today, in the midst of a deadly pandemic that has infected nearly 30 million Americans.
On February 15, my administration opened HealthCare.gov for three months to provide all Americans the opportunity to sign up for health insurance through a special enrollment period. In the two weeks since, more than 200,000 Americans have gotten covered. These numbers are an encouraging sign – but we can’t slow down until every American has the security and peace of mind that quality, affordable health coverage provides.
There is plenty of time to sign up, and I encourage everyone who needs health insurance to go to HealthCare.gov before May 15. If you already have coverage, you can help family members and friends who are uninsured get themselves covered.
Getting more Americans covered is an important part of the equation – but we also need to lower health costs. Last week, the House of Representatives passed my American Rescue Plan, which includes big steps to drive down people’s premiums and expand access to care for all Americans, including those who have lost their employer plans. This plan will increase federal subsidies and decrease premiums in order to ensure that no one ever pays more than 8.5 percent of their income on health coverage – though most Americans will pay far less. And it incentivizes states to expand coverage to an additional four million people with low incomes, and extend coverage for a year to low-income women who have recently given birth.
The American Rescue Plan is essential to defeating the pandemic – allowing us to ramp up testing, tracing, and our national vaccination program to get shots into as many arms as possible as quickly as we can. But it also lays an important foundation for better health, a stronger economy, and peace of mind for more Americans as we come out of the crisis and build back better. The American people have united historic numbers around this plan – Democrats, Republicans, and independents alike. Now, it is up to the Senate to hear them, and act quickly to pass the bill.
March 3: Centers for Disease Control and Prevention posted a press release titled: Allyson Felix, track and field star, joins Hear Her campaign to raise awareness about maternal mortality”. From the press release:
CDC is pleased to announce that Allyson Felix, an elite track and field athlete and U.S. Olympian, has joined the Hear Her campaign to share her story and raise awareness about urgent warning signs that could indicate life-threatening complications during and in the year after pregnancy.
Ms. Felix was diagnosed with severe preeclampsia when she was 32 weeks pregnant. During a routine prenatal visit, test results alarmed her doctor and she was immediately admitted to the hospital. She had an emergency c-section to deliver her daughter, who spent the first month of life in the neonatal intensive care unit. Her doctor’s diagnosis and fast actions may have saved Allyson’s life.
Given her level of fitness and training, Ms. Felix felt prepared for the birth of her daughter and never imagined she would have a serious problem during pregnancy. While she experienced some symptoms, like swelling, she thought they were a normal part of pregnancy.
“Looking back, I wish I would have been better informed about potential warning signs and talked to the doctor about those symptoms,” Ms. Felix said. “I really want women to have information, to know if they’re at risk, to have a plan in place, not to be intimidated in doctor’s offices, and to feel empowered to speak up when they have concerns.”
While Ms. Felix fortunately survived her experience, not every woman does. About 700 women die in the United States each year do to complications in pregnancy. Black women are three times more likely to die from these complications than White women. Through her involvement, Ms. Felix also seeks to raise awareness of the higher burden of poor pregnancy outcomes among Black women in hopes of generating change.
“We are delighted Allyson Felix has joined us to encourage women to speak up and ask those who support them to listen and act quickly if they raise concerns,” said Wanda Barfield, MD, director, CDC’s Division of Reproductive Health. “Allyson’s passion and dedication to improving maternal health, particularly among Black women, makes her a strong partner in this effort.”
Ms. Felix’s video story and a 30 second public service announcement are available for broadcast distribution. Graphics for social media are also available. Ms Felix is one of several women featured in the campaign who share their story about severe pregnancy-related complications. With her involvement, CDC hopes to increase the reach and impact of the campaign’s important messages.
This campaign is supported through a partnership with the CDC Foundation and by funding from Merck, known as MSD outside the United States and Canada, through its Merck for Mothers program…
March 3: The White House posted “Remarks By Vice President Harris In Press Gaggle”. From the remarks:
The Vice President: Well, I’m glad to be in Jacksonville. And we’re here – just been talking with the Mayor, the Commissioner, and the Congressmen about the good work that’s happening here on the ground. And they have expressed their appreciation for, of course, what we’ve been able to do with the ARP, with our American Rescue Plan, getting more shots in arms, helping out folks.
A lot of our conversation today is also going to be about food insecurity, which we all know to be about hunger in America and the crisis – the hunger crisis in America. So we’ll be talking about that today.
But it’s good to be here. And, of course, you will see that part of the day is to emphasize a number of things, including – look, regardless of who somebody voted for in the last election, we’re all in this together.
Q: Madame Vice President, we’re in Florida today. There’s a variant of coronavirus spreading throughout the state. Parts of the state of largely open for business. There’s a spring break issue with people having to abide by curfews. What’s the administration’s message to local officials who are just keeping the state open and not, sort of, observing the fact that there is a pandemic going on?
The Vice President: Well, I’m here to emphasize the importance of vaccinations and getting the vaccine. You know, when it’s your turn, you got to get it.
And regardless of what we’re talking about in terms of the various – the variants, one thing is for sure: if you get vaccinated when it’s your turn, you are much more likely to avoid contracting COVID, much less having severe symptoms or hospitalization or death. And, in fact, for all of them, we’re talking about it at almost 100 percent of avoidance of hospitalization and death.
So the state today, we’ve heard, have lowered the age to 50. That’s a good thing. And we’re going to be here visiting a vaccination site, saying, “Look, everybody who – when it’s your turn, go and get vaccinated.” And that’s the message of the day, and that should be the message every day, including reminding folks to wear a mask and wash their hands and social distance.
These are very specific and effective ways that we can avoid whatever the variant is.
Q: Do you plan to visit the border?
The Vice President: Not today. (Laughter.) But I have before, and I’m sure I will again.
Q: On the border, there’s obviously a lot of political pressure coming from Republicans in particular, on this administration, but also some the Democrats who represent some of those border districts. What can the administration do, at least in the short term, to kind of assure people that it’s really taking steps to make sure that the people – children in particular – are being treated humanely, but also that you’re sort of, you know, thinking about the bigger picture weeks and months ahead?
The Vice President: Yeah. I mean, first of all, we were left with a very challenging situation. And, you know, let me start by saying I think we all agree – and Secretary Mayorkas said it a number of times this weekend – let’s get the kids out of CBP custody, get them into HHS custody.
We’ve got to treat this issue in a way that is reflective of our values as Americans and do it in a way that is fair and humane. And – but we have to meet the moment. And there’s a lot of work going into that, and we expect to have success, but it’s going to take a lot of work.
I mean, again, we were presented, when we came in, with some serious challenges. So –
March 4: The White House posted a Press Briefing titled: “Press Briefing by Press Secretary Jen Psaki and Secretary of Veterans Affairs Denis McDonough, March 4, 2021”. From the press briefing:
Ms Psaki: Well, we have another special guest today. Today we are joined by the Secretary of Veterans Affairs, my former boss, Denis McDonough, who is working tirelessly to build and restore trust in the VA.
As you all know, Secretary McDonough served as White House Chief of Staff in the Obama-Biden administration for four years. He also served in several roles on the National Security Council, including as Principal Deputy National Security Advisor. Throughout his service at the White House, Secretary McDonough helped lead the Obama-Biden administration’s work on behalf of military families and veterans.
He has a busy schedule, as all of our Cabinet members do, but he has kindly agreed to take a couple of questions after he speaks. And I will, as always, be the bad cop.
Come on up.
Secretary McDonough: Jen, thanks so much. It’s a – it’s a total joy to be working with you, as it always is. And good afternoon to everybody here. It’s nice to see some old friendly faces.
I want to obviously thank Jen for inviting me to speak about the importance of the American Rescue Plan, particularly as it relates to its support to the VA to provide quality care to our veterans, especially during the very challenging pandemic.
Like other hardworking Americans, veterans have been severely impacted by the coronavirus pandemic. Countless veterans have lost jobs, closed businesses, homeschooled their own children, and faced uncertain prospects while our nation grappled with the pandemic.
And like the rest of the country, many veterans were directly affected by the deadly virus, with more than 230,000 veterans in our care infected by it and, sadly, 10,605 dying from the disease.
At the VA, we’ve risen to the challenge of combating this deadly pandemic. Our integrated healthcare system, the largest in the nation, has been running nonstop since the start of a pandemic to provide much-needed care to infected veterans and vaccines to those most at risk.
To date, more than 1.4 million veterans have been vaccinated with more than half of them having gotten both vaccines. And we’re making sure that equity is at the forefront of where and how we distribute vaccines.
At the same time, we continue to deliver routine care while mitigating the spread of infection. The VA is leading the country in standardizing the use of Telehealth for routine doctor visits. We’re partnering with community and service organizations so that vets do not forego checkups because of broadband limitations.
Last year, for example, in March, VA averaged approximately 2,500 Telehealth visits a day. Last month, February, we averaged nearly 45,000 such visits a day. As you can see, this is a major increase, and we need the funding in the ARP to sustain this up-tempo for our veterans so we can continue to push through the pandemic.
Lastly, before getting into a little bit more detail on the health situation, the Veterans Benefits Administration continues to help veterans cope with economic impact of the pandemic, from helping veterans avoid eviction and foreclosure, to making sure that veterans can continue to rely on their GI Bill to pay for tuition.
We make sure that VA can continue to adapt to these challenging times, and the President’s American Rescue Plan will do just that. It will provide $17 billion in additional funding to the VA, to include at least $13.5 billion to improve our ability to provide medical service to veterans affected by COVID; $272 million to cut through the backlog of disability claims and help us manage the compensation exams the have worse – – access to which have worsened as a result of the pandemic; and $386 million to develop a rapid retraining program for veterans unemployed as a result of a pandemic.
Now, let me just give you one other figure for you to consider. Since the start of the pandemic, 19 million appointments have been changed, cancelled, or deferred as a result of the pandemic – 19 million. What we believe is – obviously we’ve been able to cut to compensate for those through the Telehealth platforms, but not for all of them. And as a result of deferred care – which were actually seeing across the healthcare system, not just in the VA – we’re going to see increased cost. And the ARP is critical to our ability to make sure that we can keep up with those demands of increased cost.
So our department remains fully committed, obviously, to fulfilling the sacred obligation that President Biden has made clear we have to those who serve in uniform. The Rescue Plan helps us deliver on that promise, especially in this unanticipated and significant time of crisis.
We urge the Senate to pass the much-needed plan as soon as possible. And I thank you again, Jen, for the opportunity to be here with you.
Ms. Psaki: Absolutely. All right, go ahead, Jeff.
Q: Mr. Secretary, can you explain how veterans should go about looking for where to sign up for vaccinations? Should they be going to the VA, or should they be going to their states and localities? It’s certainly been one of the trickiest parts of the vaccination process to figure out information on that.
Secretary McDonough: Yeah, so I want to – I want to start by telling, I think, what is a very positive story. Oftentimes you don’t – at least we’ve not in the past been focused on good-news stories about our scheduling process. Our scheduling process is actually working pretty well.
And what – so the first answer, Jeff, is: Those veterans in our care currently in the 75 and older and 65 and older who are particular focus at the moment should be hearing from our schedulers, and our schedulers are in contact with them. And if you just take an example of the VA here in D.C., they’re moving through something – on some days – something like 80 veterans vaccinated an hour.
Now, that’s obviously because of the vaccinators, it’s because of the pharmacists, it’s because of the nurses, but it’s also because of the schedulers. And they’re doing an amazing bit of work.
So the first thing is, they should be hearing from our schedulers. The second thing is, we have a bunch of information on our website at VA.gov, including how to get access to opportunities. And then we’re working also with VSO partners and directly with veterans through even my office, whom we’re hearing from, to make sure that they have the most recent information.
Are there examples of frustrations? Absolutely. But we’re staying, obviously, on top of this, Jeff, trying to be as transparent as possible, and in the first instance, reaching veterans directly to schedule them.
Q: Are there examples of overlap, too, where veterans may be going to the VA but also hearing from their local – or going to their state or local facilities as well?
Secretary McDonough: Definitely. And many of our veterans are obviously – this is the beauty of the integrated system, which is we provide care across a range of services. And so we’re – many of our, you know, the 6 – the over 6 million vets who are with us, rely on us for care across the board, are very sophisticated consumers of care. But then we have up to 9 million who are enrolled in the VA system, and they have choices, and we’re seeing them make choices.
But again, we are trying to be as affirmative and on the front foot as we can be so that we’re providing that kind of information.
Q: I guess what I’m getting at – and sorry to ask one more – is: Isn’t there some inefficiency there that would be a problem? Like, if veterans just knew “we can get our shots from the VA,” that will clear past at these other facilities for other people and it would ideally give them priority at the VA.
Secretary McDonough: Yeah. And I guess my answer isn’t that there’s not overlap and that their’s not competition; there obviously is. But I think what we’re seeing, Jeff, is that we are very efficiently moving veterans who qualify through the system, and we’re hearing very positive feedback on that.
There inevitably is going to be some overlap, and that’s what we’re trying to get ahead of with forward contracting and also providing information as clearly as we can about dates and times for vaccinations, how those clinics are going to function, but also not have it just be a jump ball – actually have it be scheduled so we can get – efficiently get that through the system.
Ms. Psaki: (Inaudible.)
Q: Thank you. Thank you, Mr. Secretary. Can you talk about what the biggest challenges are in getting as many veterans vaccinated as possible? And secondly, is a part of that hesitancy at all? Because I know Pentagon officials have said about a third of troops have not opted to get the vaccine.
Secretary McDonough: Yeah.
Q: So what are the challenges? And does that include hesitancy?
Secretary McDonough: Well, the biggest challenge is supply, and that’s why we really need the American Rescue Plan. You’ve heard the President say this, you’ve heard Jeff Zeints say this, you’ve heard Jen say this.
We have more demand right now than there is supply. And that’s notwithstanding the fact that the COVID Coordinator, the President have really – really cranked up the supply, week on week, including with this – these several innovative actions, even over the last several days, with Johnson & Johnson and enhancing the manufacturing supply.
So the big challenge is supply. From what I hear from our docs is: From the moment we get it, our allotments are in arms within two to three days. Okay? So I think that’s a pretty remarkable throughput.
Now, on hesitancy: You know, our lead doc on this testified last week to Congress that, in fact, we’re surprised that hesitancy is less than we feared. Now, that doesn’t mean we’re not going to confront it. But right now, we’re seeing significant demand – that demand outstripping supply, and that demand consistent across categories. In fact, our performance among black vets, Latino vets, and white vets is pretty consistent, if not outperforming, in black and Latino vets’, white vets’ uptake.
Nevertheless, this is going to be a problem going forward, so we’re working closely with our VSOs, very closely with Congress, and then very closely to tell the story of the more than 1.4 million vets who have gotten vaccinated to date. We’ve – we’re talking about what that experience has been, which is overwhelmingly positive.
But we need the funding from ARP to get this done.
Q: A quick follow on the supply. Is there a set amount that you’re getting every week from the administration? And have you asked Jeff Zeints to increase that?
Secretary McDonough: We – there is a process – a well-established process that’s run through the interagency. So we get our allotment every week out of that process. We then channel it out to what we call our “VISNs,” which are our regional setups across the country based on their population of the target populations. So we have a very straightforward, transparent process by which we get our allotment and dish it out.
Now the – I think the question over time is: We’re trying to demonstrate at VA that we’re very efficient at moving it through in the hopes that, as their’s extra, that it comes our way. So, for example, about three weeks ago there was 200,000 doses that was additive to our allotment. And we – as with everything else we’re getting, we moved that quickly through the system into vets’ arms on a very clear, efficient process.
Ms. Psaki: Mary.
Q: On another topic: As the Capitol is on alert today, I wanted to ask you about the veterans who played a role in the January 6th attack. We’ve seen 30-plus veterans be arrested for participating. We see these militia groups that are actively trying to recruit veterans. What, if anything can the VA do, are you considering doing to try and combat some of this?
Secretary McDonough: Yeah, so I also – just to fill out the story, I also saw veterans on that day, including members of Congress, who were veterans doing remarkable things, including members of the DCPD and the Capitol PD – veterans doing remarkable things. And so I think it’s a full picture there that underscores that, basically, veterans continue to play a critical role in the country even after they retire from active duty. And we’re proud of that.
As to the questions you raised: We’ll take a look at that. We don’t have anything specific to announce now.
But again, I want to make sure that we have a full picture of things like remarkable members in the House – Mr. Gallego is one who comes to mind; you know, Senator Cotton in the Senate. These people are taking concrete action in support of democracy on the ground that day. They’re vets too.
Ms. Psaki: Phil.
Q: Thank you, Mr. Secretary. Two, if you don’t mind. The first one is COVID-related. You talked about missed appointments and, kind of, the – what COVID has taken away. When it comes to suicide, what is the VA doing right now tangibly to reach out the veterans proactively, not just messaging campaigns – though I know these are important – but to proactively reach out to veterans to ensure that needs in that general area are being met?
Secretary McDonough: Yeah, it’s a major – it’s a major priority for obvious reasons, and it’s heartbreaking every – any individual suicide is absolutely heartbreaking, and we’re very focused on reducing these.
The most important set of sessions I think we have to draw from is the availability of telehealth platform. Demand for mental health services is up. I think that’s a good sign because it speaks to the fact that stigma is being reduced. However, there’s still too much. And that is part of – that’s the first have of the answer to your question, which is, we’re not just passive, waiting for vets to come to us.
We’re also then working with our providers and with local communities to ensure that we have a good sense of at-risk vets and that we’re establishing contact and ways to be in contact with them affirmatively.
Lastly, Congress has given us additional authorities on this, and we’re going to use them. The Hannon Act was just enacted – in fact, I was just speaking with Senator Boozman from Arkansas about this earlier this week; he and Senator Tester spent a lot of time on this question – giving us new authority to make grants in local communities, using local providers who know their communities best to ensure that we’re providing assistance to those vets – at-risk vets, and making sure that we’re doing things like reducing the stigma.
So that’s what we’re – that’s what we’re doing, Phil.
Q: And then just real quick, from a policy question. I know this came up during your confirmation hearing, but do you have a plan right now to either reverse or significantly revise the comment access standard through the VA MISSION Act?
Secretary McDonough: I don’t have a specific plan on that. I’m very – in active discussion with people like Senator Moran, Senator Tester, Senator Sanders about what we’re seeing. We’re also beginning to get data about last fiscal year, what happened in the community. This is – the data we’re getting now is pre-COVID – so, basically, first quarter and a half of FY20. And what we’re seeing there is a pretty significant uptake in the community.
And se we got to, A, be a good partner with that, ensure that we’re paying those bills on time to local providers. We’re keeping vibrant networks so our people have places that they can find care. But we also have to be really careful that we’re also maintaining investment in the integrated system of the VA itself. We have to recapitalize that and make sure that these institutions – many of them over 50 years old – are brought up to speed.
The ARP will be important to that, too. Things like new HVAC, new air control systems, zero-pressure rooms, so we’re not moving that virus through the hospital. Those are all things that are going to be enables by the ARP, and that’s why we really need the Senate to get this done.
Ms. Psaki: All right, let’s do the last question. Then we’ll have to have him come back. Go ahead.
Q: Thank you, Mr. Secretary. At the top of your remarks, you mentioned the importance of keeping veterans in their homes. The moratorium on forbearance and foreclosures, of course, was extended through June.
Secretary McDonough: Yes.
Q: Do you think it should be extended further?
Secretary McDonough: Well, we’ll take a look at that. And we’re taking a look at a lot of those – those things. Incidentally, and importantly, in the ARP is additional funding for homelessness programming. We know that this continues to – to bedevil us as a country. It’s an outrage any night that any vet is homeless.
We’re, you know, over the last 10 years, down 50 percent on those numbers, but they’re creeping back up as a result of the pandemic. And 50 percent, while progress, is nowhere near where we need to be. So we need that funding in the ARP.
Ms. Psaki: Thank you so much, Secretary McDonough.
Secretary McDonough: Thank you.
Ms. Psaki: You’ll have to come back.
Secretary McDonough: Yes, thank you very much. It’s great to see everybody.
Q: Thank you. …
…Ms.Psaki: Go ahead, Mary.
Q: The governor of Mississippi has responded to the President’s comments yesterday, and he seems to have taken offense at some of the President’s language. He says, “Mississippians don’t need handlers.” I just think we should trust Americans, not insult them.” He’s making an argument that this is really about personal liberty here. Does the President have any second thoughts about the language used yesterday? And how does comparing someone to a “Neanderthal” help convince them to change course and get on board with your public health message?
Ms. Psaki: The behavior of a Neanderthal, just to be clear. The behavior of.
Look, I think the President – what we – what everybody saw yesterday was a reflection of frustration and exasperation, which I think many American people have, that for almost a year now, people across the country have sacrificed and, many times, they haven’t had the information they need from the federal government. They haven’t had access to a greater understanding of what the public health guidelines should look like. And those include many, many, people in Mississippi, in Texas, in Ohio, Florida, and every state across the country.
And, you know, he believes that with more than half a million Americans’ lives lost, with families that continue to suffer, that it’s imperative that people listen across the country, whether they live in a red state or blue state, to the guidance of public health experts.
At the same time – you’ve watched the President closely for some time, Mary, as you all have – he’s going to engage with and talk with people who disagree with him on a range of issues, including this one. But he believes that if we’re going to get this pandemic under control, we need to follow public health guidelines.
He simply has – was asked – asked the American people to abide by wearing masks for 100 days. We’re at about day 40. Are we at day 40? Around there. Sixty more days. That’s what he’s asking, and he’s certainly hopeful that businesses and people across the country will continue to do that.
Q: Has he reached out to Governors Reeves and Abbott to convince them to try and change course here?
Ms. Psaki: I don’t think his view on mask wearing is a secret. They’re certainly familiar with it. He’s talked about it many, many times. And I’m certain when he speaks with them next, he will convey that directly.
Q: The President said that he hopes – you know, he’s hopeful that by this time next year we may be getting some semblance of normalcy again. Is there a concern that, as we see states like Mississippi and Texas take these actions, if others follow suit, that we could shift the timeline; that a few states could set back the timeline here?
Ms. Psaki: Well, what the President has said publicly and certainly conveyed to all of us is: He can’t do this alone; the federal government cannot do this alone. This is going to require additional sacrifice from the American people. He doesn’t think that’s easy. None of us think that’s easy.
But he has ordered enough vaccines to ensure everybody in the country is vaccinated, and he will have – we will have those vaccines by the end of May, but it will require ongoing social distancing, ongoing mask wearing, as we’ve been talking about, and it will also require the American people getting the vaccine. He can’t force individuals to do that.
So he can just project the recommendations of public health officials. He can take steps, as he has over the last couple of days, to ensure that communities are prioritized, who are playing key roles in society. But he can’t do it on behalf of the public, and it’s going to require the public to play an important and vital role here too.
Q: Just one question on vaccines. You know, the President has been pretty critical of the prior administration’s handling of this pandemic, saying you inherited a mess here. But when it comes to vaccinations, you’re following some of the same playbook here. So does the prior administration deserve some credit for laying the groundwork?
Ms. Psaki: Which ones are we following?
Q: Well, for instance, former Trump HHS Assistant Secretary Admiral Brett Giroir has said that you’re following 99 percent of the playbooks they created on vaccines. He has said that the prior administration deserves more credit here for at least getting the ball rolling on some of these.
Ms. Psaki: I don’t think anyone deserves credit when half a million people in the country have died of this pandemic. So, what our focus is on, and what the President’s focus is on when he came into office just over a month ago, was ensuring that we had enough vaccines. We have – we are going to have them now. We had enough vaccinators, and we had enough vaccine locations to get this pandemic under control.
There’s no question, and all data points to the face that there were not enough of any of those things when he took office. We are open-eyed about the challenges we continue to live under, and that’s why he has been focused every single day and doing everything possible together the pandemic under control.
But those were – there were shortages in all those areas, which were preventing us from moving forward on getting the pandemic under control.
...Q: And then, on the COVID bill: Last night, when the President was speaking to the House Democrats, he said, “I know we’re all making small compromises, as he tried to work everybody to support the bill or thank them for supporting their version of the bill. What exactly has the President asked moderates to compromise on in this process up to this point?
Ms. Psaki: You’d have to ask them that question. You know, the President has been clear that he is unmovable on the size of the package – $1.9 trillion. And as you know from covering the Hill, that is not – that was a size that some expressed concern about.
He has been unmovable about his view that Americans who need help the most should get $1,400 checks. There were some who spoke openly about their concern about that. And he has been very clear that state and local governments need assistance now to keep cops on the beat; to keep teachers; you know, to keep firefighters employed; and to keep state and local governments functioning.
I’m sure there may be other issues that they have concerns about. I’ll let them speak about that. There were some who spoke openly about their concern about that. But he has been insistent that the scope of the challenge requires this size of a package. And in order to adjust – address these twin crises that we’re facing, it needs to have these key components.
Q: And then, last one. Again from the President last night, to House Democrats, he made the point that “this will make everything more possible… to get done” – “get done” – I think I’m quoting properly there –
Ms. Psaki: Mm-hmm.
Q: – passing this now. Is that the kind of theory of the case here: You get this done at this scale, and all of a sudden, some difficulties you may have in the U.S. Senate become less so because people see that you were able to produce? I just want to make sure I understand, kind of, his thought process going forward.
Ms. Psaki: I’m not sure what the context of that comment was. Can you tell me more of the context of it?
Q: Yeah, I don’t have the full thing in front of me. Sorry about that. I was just struck because he said – you know, I will paraphrase – I promise I’m being accurate when I paraphrase this: that the idea being if they get this done, there’ll be more trust in government, and if there’s more trust in government, therefore people will be willing to get behind maybe the priorities that House Democrats have going forward – whether that’s on infrastructure, whether that’s on climate, any of those things. The list goes on.
And so I guess that’s my question, is: Does the administration look at the American Rescue Plan and say, “This is our springboard to doing even more broad-based, more “bold” – in the words of the administration – legislative proposals in the future?
Ms. Psaki: We don’t look at it through a – as political-legislative as a – of a lens as you just outlined. But I will say that the President came into office knowing that getting the pandemic under control, helping address and put people back to work – the millions and millions of Americans who are struggling to make ends meet, the one in seven American families that can’t put food on the table – that he knew those would be his top two priorities – his top one, two, three four: pandemic economic recovery pandemic economic recovery. And that is what this package is meant to address.
And what I’ve heard him say – and this sounds consistent with that, while I don’t know the full context of this – that is, of course, he wants to build on – build his agenda beyond – build his agenda beyond getting the pandemic under control, beyond addressing and stemming the tide of a fina- – of an economic crisis, because he believes that investing in infrastructure is imperative and long overdue. He believes that modernizing our immigration system is long overdue and is good for the American people, good for our economy. He believes there needs to be more done for caregiving. He believes we need to do more to protect our health – to ensure its people – more people have access to healthcare.
So, there’s no question that he views his – the early stage – early part of his presidency as focused on these twin crises, but he is hardly going to be done with his agenda and work once we have this package signed into law…
Go ahead, Mario…
…Q: Gasoline prices are approaching $3 per gallon for the first time since 2014. Americans, as you well know, are cash-strapped. Is the President planning to intervene somehow? OPEC Plus came out this morning and said they were going to limit supply. Does the President plan to intervene somehow – maybe call the Saudi government, Russia – anything in the toolbox to rein in gas prices?
Ms. Psaki: I don’t have anything on that to preview for you. If will say, since you’ve given me, sort of, an opportunity and opening here, is that there’s been a lot of reporting on, kind of, what kind of relief would come out of the American Rescue Plan – something that can help address a range of issues the American people are having, whether it’s the cost of gas or it’s the inability or concern about getting food on the table.
So let me take this opportunity to lay out some of the specific numbers our NEC team – I love number crunchers – crunched for all of you.
So under the Senate version of the bill, 158.5 million households are going to receive direct payments. That’s 98 percent of the households who received them in December. And in the previous round of relief, that 2 percent all received checks smaller than $600; in some cases, as small as $100 – because, as you all know, it was scaled down after a certain income rate.
Under the Rescue Plan, almost all of these 180 – 158.5 million households are going to receive checks that are more than twice the size of the previous round, not to mention the 66 million kids who will benefit from the expanded child tax credit and 17 million adults who ben- – who will benefit from the expanded earned income tax credit. Because, of course, there are many tax companies, as you all know, in addition to the direct checks that are included in this package.
So, I just wanted to give a little number-crunching letdown.
Go ahead, Jeff.
Q: Jen, going back to Texas and Mississippi, is the White House concerned and the COVID team concerned about the loosening or lifting of restrictions in those states will lead to these COIVD variants to spread more?
Ms. Psaki: Well, one of the reasons that our health and medical experts have continue to call for the American people to wear masks, to social distance, to get whatever vaccine they have access to is because many of them have – of these vaccines have shown to be effective in addressing the variants and because we’ve seen a spread of variants, reportedly, in some of these states.
So I would say, Jeff, that, you know, our concern here is on the health, welfare, wellbeing, and survival, frankly, of people across the country. And in states where the guidelines are not – or where the recommendations from leadership is not following health and medical guidelines, we have concerns about the impact on the population.
Q: You know, in Europe, there are – there are travel restrictions between European states. The United States is large and has 50 states. Is there any discussion of restrictions for traveling between states when different states have such different ideas about how to fight COVID? And would you encourage or discourage other Americans from traveling to Texas or Mississippi right now?
Ms. Psaki: I’m not aware of any discussions, and I certainly wouldn’t do that from here. But I would just say, Jeff, that, you know, we are – we are going to continue to use every bully pul- every method of bully pulpit at our disposal to convey directly to people living across the country, including in many of these states, that mask wearing, social distancing, getting access to the vaccine is the path to go back to normal. And that is how we are going to get it done and how the American people can return to – believe me, I’d love to take my kids to birthday parties and to parks and to go to a restaurant. I haven’t been to one in a year. You know, we all want that. This is the pathway to do that, and that’s what we’ll continue to convey.
Q: Just one more quick one on another topic. I’m sorry.
Ms. Psaki: Yeah.
Q: The Capitol is on high alert today because of the potential of an attack related to a conspiracy theory about this date. Is the White House taking any additional security measures? And can you share any intel or readout about what we know about the threat?
Ms. Psaki: Well, let me first say, Jeff, that, on the specifics of today’s threats, the FBI and DHS have warned that the threat from domestic violent extremism, particularly racially motivated and anti-government extremists, did not begin or end on January 6th. And we have been vigilant, day in and day out. Our national security and homeland security team has been since then, in part because we are witnessing a years-long trend of false narratives fueling violence. And the current heightened security environment in the National Capital Region, writ large, is an illustration of that.
I’m not going to outline any security steps from here at any point in time, but I can say the our team is, of course, remain – or our team – the President personally remains deeply engaged in tracking these threats, in receiving regular updates, as he does from his team, about threats, of course, but about incidents happening across the country. It’s something he is personally engaged in. It’s reflected in the comprehensive review he ordered in his first week on the job.
He’s also a diligent and cons- – an eager consumer of intelligence. And as you’d expect, appropriate elements of the intelligence community and law enforcement are providing a stay pace of information and analysis on a regular basis on domestic violent extremism in the country.
Q: Thank you, Jen. As more people are getting vaccinated every day, there’s still a lack of clarity about what they should and shouldn’t do. And we’ve reported that the CDC guidance for them was supposed to release today, but that’s no longer happening. Do you have any guidance about why not and when Americans should expect to see recommendations?
Ms. Psaki: I would certainly point you to the CDC. I believe they said, in your story or maybe another story perhaps, that the CDC’s guidance will not be posted tomorrow – this is a quote from them – “because we have not finalized it here at the CDC. Once it is final, we will publish and disseminate it.”
And certainly, we know people are eager to hear more details about steps they can take once they’re vaccinated. And we certainly think that once people have a sense of that, hopefully – and we’ll see it when we see it – it will hopefully encourage people to get vaccinated, as well. But they’re on their own timeline, and we’ll wait to see when they’re ready to put out that guidelines.
Q: So the White House has not seen them yet?
Ms. Psaki: I’m not aware of the White House reviewing the guidelines, no.
Q: And then, on Texas, Governor Abbott said that “the Biden administration must stop importing COVID into the country” because he claims that COVID-positive migrants are being bussed into Texas and then sent to other places in the country. Do you have a response to that? And can you elaborate on what the government is doing to test migrants, if anything?
Ms. Psaki: Sure. Well, we’re around fact – we’re about facts around here. That is not factual. So let me give you an overview of what happens.
When migrants are placed in alternatives to detention, their COVID-19 testing – our policy for COVID-19 testing its to be done at the state and local level with the help of NGOs and local governments. And that, certainly, is something that our policy is, is to have that be done – concluded – before they are even moved to go stay with family members or others they may know while their cases are being adjudicated.
And, of course, our guidance to anyone – regardless of status – who is testing positive for COVID-19 or experiencing COVID-like symptoms is, you know, to social distance, to wear a mask, and seek medical attention as needed.
But, you know, in general, our approach and our policy is to work with local governments, work with NGOs, to ensure – to have testing – to ensure these migrants are tested. And that can take place, in that steps for isolation, quarantining, and medical care can be taken should that be needed.
Q: Is there a reason why the burden is on the state and local jurisdictions to do the testing and not the federal government?
Ms. Psaki: Well, many of these NGOs are – have stepped in to help ensure these steps can be taken. Many of these NGOs have also, if quarantining or isolf – or isolation is needed, have even reserved hotel blocks in some cases. And you just certainly have to talk to some of them about the steps they take.
But obviously, their assistance is – allows – allows the federal government to, you know, work with local communities to get this done…
…Q: The President has traveled back to Wilmington a couple of times since taking office. The CDC does still urge people not to travel for personal reasons. Obviously, presidential travel is very different than commercial travel, but should the President are doing more of an example about personal travel during a pandemic?
Ms. Psaki: Well, the President lives in Wilmington; it’s his home. That’s where he’s lived for many, many years. And as you know, as any President of the United States does, he takes a private airplane called “Air Force One” to travel there. That is, of course, a unique – unique from most Americans, but I think most Americans would also see that as a unique circumstances….
Q: Thank you, Jen. You mentioned earlier – on masks, you referenced the President’s frustration and exasperation with people who are not following the science. It would appear notwithstanding, there are still millions of Americans out there who are not following the science, certainly in places like Texas, Mississippi, South Carolina, and other places.
So I’m wondering: Why doesn’t the President consider ratcheting up his rhetoric beyond the undertow and personalizing his concerns? Why doesn’t – for example, why doesn’t he think about saying, “Folks, here’s the deal: If you don’t wear your mask, people are going to die because of you”? That would certainly get people’s attention.
Ms. Psaki: We’ll note it. I will say, the President has been clear that if people wear masks for 100 days, 60,000 lives could be saved. And he has been clear – he did a whole PSA during the Super Bowl about it – and about the benefit and impact of mask wearing.
He also, though, does not believe that people of any state or any American should be hurt by the guidance of their leadership. And so that’s why he’s spoken directly to the American people – we all have, or we are all trying to – about the impact of mask wearing, of social distancing, and of taking the vaccine when people can have access to it…
March 4: National Institutes of Health (NIH) posted a news release titled: “NIH scientists discover how DNA fragments can trigger inflammation in sickle cell disease”. From the news release:
Researchers have discovered that DNA from the mitochondria – the cell’s “powerhouses” – acts as a danger signal in the body and triggers inflammation in people with sickle cell disease. A better understanding of mitochondrial DNA, long known to circulate in human blood, may provide vital insight into how to stop the underlying chronic inflammation that marks this inherited red blood cell disorder. It could also lead to new ways to reduce the pain crisis suffered by people living with the life-threatening disease.
The study, published in the journal Blood, was supported by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.
“These study findings suggest that measuring the DNA of mitochondrial origin could help us better understand its role in pain crises, destruction of red blood cells, and other inflammatory events in sickle cell disease,” said Swee Lay Thein, M.B., D.Sc., chief of the Sickle Cell Branch at NHLBI. “It could also serve as a marker of disease progression and a way to measure the effectiveness of therapeutic interventions.”
Normally a red blood cell gets rid of its mitochondria when it matures, because the energy from mitochondria is not needed to carry out the red blood cell’s function of delivering oxygen throughout the body. However, Thein and her team showed that red blood cells from people with sickle cell anemia – the most common and often most severe type of sickle cell disease – abnormally retain the mitochondria, which can lead to a buildup of highly reactive chemical molecules that stresses the cells.
The condition, researchers found, allows damaged mitochondrial DNA to enter circulation with too few of the small molecules, called methyl groups, that typically attach to the DNA to help the cells function. This abnormal amount of molecules on the mitochondrial DNA, in turn, stimulates inflammation, a hallmark of sickle cell disease.
To do the study, Thein and her staff scientist, Laxmianth Tumburu, Ph.D., the study’s main author, analyzed the complete set of DNA extracted from the blood plasma of 34 people with sickle cell anemia, as well as the blood plasma from eight healthy volunteers.
“We were intrigued when we found higher levels of free-floating mitochondrial DNA in the plasma of the patients with sickle cell disease,” Thein said. “These were shorter and more fragmented than free-floating nuclear DNA fragments, which are also known to drift in the patient’s blood.”
The free-floating mitochondrial DNA from patients with sickle cell disease had fewer methyl groups than were found in the blood plasma of the healthy volunteers. As intriguing: the free-floating mitochondrial DNA from seven of those patients had even less of these methyl groups when the patients were having a pain crisis, compared to when they were not.
To examine why this was the case, the researchers looked at how the blood plasma containing high levels of free-floating mitochondrial DNA triggers a specific inflammatory process. Neutrophils are part of the immune system and they form structures called neutrophil extracellular traps, or NETs that are crucial components of the immune response and are typically protective in bacterial or viral infections.
But a negative consequence of these NETs is inflammation that is detrimental and often continual, even in the absence of infection. Knowing this, Thein and her team were able to block the formation of NETs by treating neutrophils with a small molecule inhibitor.
With this improved understanding of the components that contribute to the sickle cell disease process, the researchers said they now want to pursue preclinical testing of drugs that target mitochondrial DNA and the inflammatory process it stimulates…
March 4: U.S. Food and Drug Administration (FDA) posted a News Release titled: “FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally, Offering Thermal Imaging Systems for Sale” From the News Release:
The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature – also known as telethermographic systems, infrared thermographs, thermal cameras, and “fever cameras” that improper use of the systems may provide inaccurate temperature readings due to a variety of factors. Additionally, the FDA issued several Warning Letters to certain firms offering unapproved, uncleared, and unauthorized thermal imaging systems for sale.
“While thermal imaging is not an effective diagnostic device for COVID-19, it can determine if someone has an elevated temperature, which can be an important risk management tool during the pandemic when used properly,” said William Maisel, M.D., M.P.H., Chief Medical Officer and director of the Office of Product Evaluation and Quality in FDA’s Center for Devices and Radiological Health. “But improper use and marketing of thermal imaging systems may lead to inaccurate temperature readings and pose a potential danger to public health. As part of the FDA’s ongoing commitment to transparency to the American public, the agency is providing important information to users about the correct use of these devices and is warning certain firms that the FDA will not tolerate their marketing of misbranded and adulterated products.”
Thermal imaging systems intended to measure a person’s surface skin temperature are regulated as devices by the FDA. Thermal imaging systems detect infrared light emitted from a person’s skin and convert that information into a temperature reading. The FDA is aware that thermal imaging systems can be used in a way to detect temperature as part of a larger approach to COVID-19 risk management, such as in combination with mask wearing, social distancing and hand washing, to provide initial temperature assessments or triage individuals for elevated temperatures in public areas such as airports, grocery stores, offices and schools. When designed and used correctly, thermal imaging systems have been shown to accurately measure someone’s surface skin temperature.
Improper use of thermal imaging systems may lead to inaccurate body temperature measurements which can present potentially serious public health risks. Such risks may include, but are not limited to, the device incorrectly detecting a normal human body temperature when a person has an elevated temperature and incorrectly assessing a person to have an elevated body temperature when they do not. These risks are more likely to be present where thermal imaging systems scan multiple individuals simultaneously. To help mitigate these risks, the FDA is providing important recommendations in the safety communication to consumers, health care providers and other users about the proper and improper use of these system.
The FDA is also aware that some firms are marketing unapproved, uncleared and unauthorized thermal imaging devices intended to measure human body temperature, including measuring multiple individuals’ temperature simultaneously, and has issued Warning Letters to Certify Global Inc., Kogniz Inc., Opgal Optronic Industries Ltd., and Thermavis. The FDA’s position is that Warning Letters are issued only for violations of regulatory significance. Warning Letters that have been issued by the FDA are published on Warning Letters page, and COVID-19 related Warning Letters are published on FDA’s Fraudulent Coronavirus Disease 2019 (COVID-19) Products page.
The FDA may take additional action, as appropriate, to protect consumers.
If you wish to report a problem with a thermal imaging system, you may do so through the MedWatch Voluntary Reporting Form.
March 4: National Institutes of Health (NIH) posted a press release titled: “NIH-Sponsored ACTIV-3 Clinical Trial Closes Enrollment into Two Sub-Studies”. From the press release:
The ACTIV-3 clinical trial, which is evaluating the safety and efficacy of investigational therapeutics for COVID-19 in hospitalized patients, has closed enrollment in two sub-studies: one examining the investigational monoclonal antibody therapy VIR-7831, and another evaluating the investigational combination monoclonal antibody therapy containing BRII-196 and BRII-198. The sub-studies were halted by the trial sponsor, the National Institutes of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, on March 1, 2021, following an interim review and recommendations from the independent Data and Safety Monitoring Board (DSMB).
The DSMB determined that the Brii therapeutic did not meet the inclusion for criteria for further enrollment in the trial, due to futility. The initial analysis of data from the VIR-7831 sub-study indicated that the investigational treatment met the pre-specified criteria for study continuation. However, participants entering the control group had more advanced illness overall than those enrolling in the group receiving the therapeutic, so the data were adjusted to account for this imbalance. Once this difference was taken into account, the DSMB recommended that recruitment in the VIR-7831 sub-study should cease, due to futility.
There were no safety concerns with either therapeutic agent and no indication of harm in the therapeutic arms compared to the placebo arm.
VIR-7831 was developed through a partnership between GlaxoSmithKline (Brentford, United Kingdom), and Vir Biotechnology Inc. (San Francisco). BRII-196 and BRII 198 are manufactured by Brii Biosciences (Durham, North Carolina and Beijing).
ACTIV-3, part of the Accelerating COVID-19 Therapeutic Interventions And Vaccines (ACTIV) public-private partnership, is a master protocol designed to allow for the study of multiple investigational agents compared to placebo in adults hospitalized with COVID-19. All trial participants receive Veklury (remdesivir), a drug approved by the U.S. Food and Drug Administration for the treatment of COVID-19 in hospitalized patients. The trial is divided into sub-studies, each of which evaluates a different candidate therapeutic. After five days, the clinical status of participants is assessed using two seven-point ordinal scales. Each scale ranges from being able to undertake usual activities with minimal or no symptoms, to death. After approximately 150 participants are enrolled in each sub-study and 150 enrolled in the corresponding placebo group, the DSMB conducts a pre-planned interim safety and efficacy review to determine if the sub-study should be expanded to enroll additional participants or if it should be closed.
The DSMB reviewed data on 344 people in the VIR-7831 sub-study and 343 people in the Brii-196 and Brii-198 combination sub-study. Volunteers in both sub-studies will continue to be followed for 18 months. Currently, NIAID and trial coordinating investigators are analyzing the data, and they will provide more information in a forthcoming report.
Participants continue to be enrolled in the ACTIV-3 sub-study evaluating AZD7442, an investigational long-acting antibody combination developed by biopharmaceutical company AstraZeneca (Cambridge, United Kingdom). The DSMB will review the safety and efficacy of this sub-study once approximately 300 participants have been enrolled.
The NIAID-supported ACTIV-2 trial will continue to test the BRII-196 and BRII-198 combination monoclonal antibody therapeutic regimen in people with mild-to-moderate COVID-19 who have not required hospitalization. It is being overseen by the same DSMB that oversees ACTIV-3, and the DSMB does not recommend any changes to ACTIV-2 at this time.
NIAID conducts and supports research – at NIH, throughout the United States, and worldwide – to study the causes of infection and immune-mediated diseases, and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
March 4: U.S. Department of Health and Human Services (HHS) posted News titled: “HHS OCR and the U.S. Attorney’s Office for the Eastern District of Michigan Enter Voluntary Resolution Agreement with Michigan Bariatric Practice to Protect Patients from HIV Discrimination”. From the News:
The U.S. Department of Health and Human Services, Office for Civil Rights (“HHS OCR”) and the U.S. Attorney’s Office for the Eastern District of Michigan have entered into a Voluntary Resolution Agreement with Great Lakes Surgical Associates (“GLSA”) to protect patients from discrimination on the basis of HIV status. The Complainant, an African American man and a Medicare beneficiary, initially filed a complaint with the Department of Justice (DOJ), reporting that his primary care physician referred him to GLSA for bariatric surgery to address his high blood pressure and diabetes. However, GLSA allegedly refused to evaluate him for bariatric surgery or to provide him with the surgery due to the Complainant’s HIV status.
The U.S. Attorney’s Office for the Eastern District of Michigan investigated the allegation that GLSA discriminated against the Complainant based on his disability, in violation of Title III of the Americans with Disabilities Act of 1990 (“Title III of the ADA”). Title III of the ADA prohibits public accommodations from discriminating on the basis of disability in the full and equal enjoyment of their goods, services, facilities, privileges, advantages, or accommodations.
In cooperation with DOJ, HHS OCR initiated a compliance review to determine GLSA’s compliance with Section 504 of the Rehabilitation Act of 1973 (“Section 504”), and Section 1557 of the Patient Protection and Affordable Care Act of 2010 (“Section 1557”). Section 504 prohibits discrimination on the basis of disability (including HIV status) in programs or activities that receive HHS funding, such as hospitals, nursing homes, or physician practice groups. Section 1557 prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs or activities.
The Voluntary Resolution Agreement requires GLSA to:
Post a Notice of Nondiscrimination notifying GLSA personnel, patients, and the public that it does not discriminate on the basis of race, color, national origin, sex, age, or disability, including HIV status, in its health programs or activities;
Provide assurances that, in the future, it will not discriminate on the basis of disability; nor retaliate against any person who has made, or is making, a disability discrimination complaint;
Establish and implement policies and procedures for providing services in a nondiscriminatory manner to individuals with disabilities;
Arrange for training of all personnel on GLSA’s obligations not to discriminate against individuals with disabilities; and
Report on implementation of the Agreement for a three-year term.
In addition, pursuant to DOJ’s authority under Title III of the ADA, GLSA has agreed to compensate the Complainant in the amount of $37,000.
“The HHS Office for Civil Rights is committed to ensuring that all individuals with disabilities are afforded an equal opportunity to participate in and benefit from health care programs and services,” said Acting HHS OCR Director Robinsue Frohboese. “Discrimination against individuals with HIV in health care or human services is unlawful and we will continue to take appropriate steps to remedy discrimination when it occurs and provide consumers with knowledge about their rights and providers with awareness of their obligations.”
A copy of the Voluntary Resolution Agreement may be found at: https://www.hhs.gov/sites/default/files/glsa-joint-vra.pdf – PDF.
March 4: U.S. Food and Drug Administration (FDA) posted a News Release titled: “Federal judge entered permanent injunction against New York-based dietary supplement manufacturer”. From the News Release:
A dietary supplement manufacturer and two of its executives have been ordered by a federal court to stop manufacturing, holding, or distributing any articles of food, including dietary supplements, until they come into compliance with federal dietary supplement current good manufacturing practice regulations and other Federal Food, Drug, and Cosmetic Act (FD&C Act) requirements.
Today, Judge Edward R. Norman, of the U.S. District Court for the Eastern District of New York, entered an order of permanent injunction against Confidence USA Inc., of Long Island, New York, and the company’s president Helen Chian and general manager and founder Jim Chao. The permanent injunction requires the defendants to cease manufacturing, holding, or distributing dietary supplements until the FDA notifies defendants that they may resume operations.
“Consumers deserve access to dietary supplements that are manufactured to assure their quality. If a dietary supplement company repeatedly fails to comply with good manufacturing practice requirements, the public cannot trust that their products are what they say they are,” said Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs. “The FDA will continue to protect American consumers by taking appropriate actions necessary when companies violate the law.”
Confidence USA Inc. has manufactured and distributed more than 50 dietary supplements under brand names that include Confidence USA, American Best, USA Natural, and The Herbal Store. Confidence USA Inc. currently manufactures and distributes the above-mentioned dietary supplement products through Amazon, Walmart, and its own online store at www.confidenceusa.com.
The court found that defendants violated the FD&C Act because their products were prepared, packed or held in violation of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements. Multiple FDA inspections showed that the defendants repeatedly failed to verify the identity of each dietary ingredient used in the manufacture of their supplements. The defendants also failed to verify that their products met specifications for purity, strength, composition, and contamination limits.
The court order prohibits defendants from receiving, processing, manufacturing, preparing, packing, holding and distributing any article of food, including dietary supplements, until they hire an independent expert to ensure that they are following the CGMP regulations, and, following an inspection, receive the FDA’s approval to resume operations. Following the court order, once defendants resume operations, they must retain an independent auditor to ensure that they continue to follow the CGMP regulations.
March 5: The White House posted a Press Briefing titled: “Press Briefing by White House COVID-19 Response Team and Public Health Officials”. From the Press Briefing:
Acting Administrator Slavitt: Thank you all for joining us. It was an eventful week at the White House and around the country. I want to take a moment to step back and remind people where we’ve come from and where we’re going.
Over the past six weeks, we’ve seen the nation rally together in an unprecedented way. Together we’ve recovered from a storm, kept vaccination sites open late, packed and shipped vaccines throughout the night, seen companies across America make major commitments to masking and vaccinations and to underserved communities.
And just this week, we went from J&J authorization to shots in arms in three days. All that was topped off by an announcement from two rival drug companies, Johnson & Johnson and Merck, of an unprecedented collaboration to increase our vaccination capacity along with the U.S. government.
We have increased vaccine supply to states, tribes, and territories by more than 77 percent, launched programs to get vaccines into thousands of additional convenient and trusted locations, like pharmacies, community vaccination centers, and community health centers. And there are thousands of Americans – from our military servicemen and women, to retired doctors and nurses, to members of the National Guard – all vaccinating Americans across the country.
The nation is coming together on this pandemic response, and we are throwing everything we have at this virus. As much sacrifice as this requires from everyone, we are making progress.
Six weeks ago, only 8 percent of seniors – those most vulnerable to COVID – had received a vaccination. Today, nearly 55 percent of people age 65 or older have received at least one shot. Altogether, we’ve administered more than 82 million shots – more than any country in the world. And we’ve opened or expanded more than 450 community vaccination sites.
Today, we are announcing the addition of two new FEMA-supported high-volume sites. The Atlanta Falcons Stadium in Georgia and the Wolstein Center in Cleveland, Ohio, will turn into FEMA-supported community vaccination sites with the capacity to deliver 6,000 shots per day each. Both of these sites sit in neighborhoods hit hard by the pandemic and are well known in the community.
This brings that total to 18 FEMA-supported sites across seven states with the ability to administer more than 60,000 shots per day.
But I want to be clear: We owe the public straight talk, whether the news is promising or challenging. Progress demonstrates we can defeat COVID-19, but it does not equal success.
It may seem tempting in the face of all this progress to try to rush back to normalcy as if the virus is in the rearview mirror. It’s not. Now, years of watching football on TV has shown me that it’s better to spike the football once you’re safely in the end zone, not after you’ve made a couple of completions.
The CDC and public health officials – locally, at the state level, and nationally – are all clear: Wear a mask – not forever, but for now. Wear a mask now so we can get to a place where you don’t have to.
and this is not just the voice of cautious public health experts. It is what businesses who want to remain open and many public officials of both parties who have lived through the last year are saying.
And as you will hear in a moment from Dr. Walensky, it is also what the data from the last year is telling us.
And with that, I’m going to turn it over to Dr. Walensky.
Dr. Walensky: Thank you so much. It’s a pleasure to be back with you today.
I know there have been many questions about when CDC is going to release its guidance for fully vaccinated persons and activities they can resume. These are complex issues, and the science is rapidly evolving. CDC is working to ensure that the communication we release on this guidance are clear and that the American public can act on them.
Our goal and what is most important is that people who have been vaccinated, and those not yet vaccinated, are able to understand the steps they can take to protect themselves and their loved ones. we are making sure and taking the time to get this right, and we will be releasing this guidance soon.
Now let’s shift to an overview of the pandemic. CDC’s most recent data shows cases continue to fluctuate around 60,000 to 70,000 cases per day, with the most recent seven-day average of 62,000 cases per day. We also continue to see deaths hovering around 2,000 deaths per day with the latest seven-day average of 1,900 deaths per day.
The current numbers remain concerning. Cases and deaths are still too high and have now plateaued for more than a week at levels we saw during the late summer surge following six weeks of steady declines.
This is why I’m asking you to double down on our prevention measures. I know the idea of relaxing our mask wearing and getting back to everyday activities is appealing, but we’re not there yet. And we have been – we have seen this movie before. When prevention measures like mask mandates are rolled back, cases go up.
An article published today in CDC’s Morbidity and Mortality Weekly Report highlights that critical importance of these prevention strategies and the real risks when prevention measures are eased. The study looked at the relationship between COVID-19 cases and deaths, and both state-issued mask mandates and restaurants resuming on-premises dining from March to December of 2020.
The researchers found that increases in both daily death rates and COVID cases and deaths slowed significantly within 20 days of putting masks mandates into place. And protective effect of the mask mandates grew stronger over time. In contrast, increases in daily death rates of COVID-19 cases and deaths grew more quickly within 40 to 80 days following restaurants being allowed to resume on-premises dining.
This report is a critical reminder that with the current levels of COVID-19 in communities, and the continued spread of more transmissible virus variants, which have now been detected in 48 states, strictly following prevention measures remains essential for putting and end to the pandemic. It also serves as a warning about premature lifting these prevention measures.
There’s a light at the end of this tunnel, but we must be prepared for the fact that the road ahead may not be smooth. And that is within our control. But continuing to wear masks and following CDC’s public health recommendations, while we get more people vaccinated, we can bring this pandemic to an end.
Thank you. I look forward to your questions. But first I’ll turn things over to Dr. Fauci.
Dr. Fauci: Thank you very much, Dr. Walensky. I’d like to take up a bit of what Dr. Walensky just said. If I could have the first slide.
I’m going to spend the next couple of minutes talking about the daily trends in the numbers of cases that have been reported and how this relates to both… I’m going to spend the next couple of minutes talking about the daily trending in the numbers of cases that have been reported, and how this relates to both the evolution of variants and how you handle variants.
If you look at the far-left part of the slide, on the area between January and June, you remember – many of us will recall very, very vividly – in the end of the winter and the beginning of the spring, we had a surge that was dominated by the New York Metropolitan Area. After the surge, what we came down to was a baseline of about 20,000 cases per day. That is a very high baseline, relatively speaking. When we tried to open up the country on the second peak, in the middle of the slide, the same thing: After we peaked, we started to come down, but we plateaued again at a very high baseline – in this case 40,000.
We just now recently experienced the worst surge – on the right hand part of the slide – which now, as you see, is starting to come down in a very nice deflection curve.
The issue is – if you look on the very far right of the slide – as Dr. Walensky has said, we are starting to plateau. I’ve blown that up in a little section, which is now sitting in the middle of the slide. That plateau is about 60-70,000 cases a day. When you have that much of a viral activity in a plateau, it almost invariably means you are at risk for another spike.
In fact, as the Washington Post reported yesterday, many countries in Europe have seen just that. They had a decrease in cases over a six-week period. They plateaued. And now, over the past week, they saw an increase in cases by 9 percent, something we desperately want to avoid.
How does that relate to the variants? Let me just go through this. I refer to it as virology 101. What it really is is some fundamental tenets of virology; namely RNA viruses, like SARS-CoV-2, tend to mutate. They have poor proofreading mechanisms. A virus cannot mutate if it doesn’t replicate. And it replicates in infected individuals.
A high baseline level of community spread of virus favors mutations and the evolution of variants. Now, variants get evolved because of selection pressures, namely just fundamental pressure to enhance its own replication and propagate itself, as well as pressure to evade neutralizing antibodies. This has important implications for vaccines, as well as the potential role of immunosuppressed people who get infected, don’t clear the virus very rapidly, and allow it to mutate in the individual.
So a suboptimal immune response favors the generation of variants. That’s very, very clear when your dealing with RNA viruses.
In fact, I had showed you in a previous press briefing what the issue was when you have a first dose of, let’s say, for example, Pfizer vaccine – very similar to the Moderna: you get a response that is protective. In this case, it would be about 52 percent. However, the second dose brings that level of antibodies quite high, which gives it redundancy to prevent the evolution, as well as to protect against viral variants.
Said in a just plain and simple way: Suboptimal immune responses to wild-type virus promotes the generation of variants, and the lack of potency or redundancy of an immune response to protect and suppress variants is another issue of concern.
And so, how do you address these threat – which we clearly are facing – of a number of viral variants? On the one hand, vaccination: Maximize the immune response against the wild-type virus. You can do the by the proper adherence to the regimens shown on the clinical trial, or even plan – as some companies are doing – of, in the distance, giving a booster to the wild type.
Also, as I mentioned in a prior conference, perhaps plan, as we are doing with Moderna, to boost with a very variant-specific vaccine.
But importantly, there’s another tool in our armamentarium, and that is what was emphasized by Dr. Walensky: namely adherence to the public health measures in an arena of a high baseline of infections – with masks, distance, avoiding congregate settings, washing hands.
And on the next and final slide – just yesterday evening, in JAMA, John Moore, a very accomplished virologist, actually gave a nice description and hit upon many of the things that I just described to you. So if you want to look at it in some detail, I recommend you take a look at this article that came out yesterday.
I’ll stop there. And hand back to Andy.
Acting Administrator Slavitt: Thank you. Okay, let’s go to Q&A.
MODERATOR: Great. First question we will go to Sam Whitehead with WABE Atlanta.
Q: Hey, thank you all for taking my question. I’m wondering if you can share some more details on this mass vaccination site you all are going to be setting up here in Atlanta. You know, I have been covering the active mass vaccination effort from our county health department there, and I’ve heard from people in some parts of the south – like the south side of Atlanta, the Mercedes-Benz is still kind of a hard place for them to reach. So is there going to be further outreach to make sure people have access to this site and not just that it’s set up?
Acting Administrator Slavitt: Sam, thank you for the question. So I can’t give you the specifics on this site, on this call. We will be glad to follow up with you.
But I will last that with all of our mass vaccination site efforts, the first week we really see a lot of adjusting to the needs of the local community, including how appointments are reserved, including whether there are mobile vans and clinics that need to be set up, including transportation issues and in arranging transportation.
You may be aware that Uber and Lyft – to pick two – have a donated millions of rides. So we’re going to try to make sure all those things are packaged neatly so that it is easier for people, particularly those who have a more challenging time getting vaccinated, to get there and get vaccinated. So thank you for the question.
MODERATOR: Next we’ll go to Arlene Saenz at CNN.
Q: Hi there. Thanks for taking my question and doing this call. I have a few questions when it comes to the Johnson & Johnson vaccine. You guys have acknowledged that there’s going to be a bit of a break, as far as the shipment and distribution of that. So what are you doing to prepare for the coming lull in the J&J supply? And how is that going to impact places that have already incorporated this into their vaccination operations?
And then, separately, you know, you’ve spent a lot of time stressing that J&J is equal to the other vaccines and that everyone should take it as soon as whichever vaccine is available to them. But we heard Detroit’s Mayor Duggan saying that he’s declining that initial allotment of J&J in part because he believes that Pfizer and Moderna are better vaccines. So what exactly do you guys plan to do to counter this type of messaging, especially if it’s coming form a local official?
Acting Administrator Slavitt: Yeah. So, look, I’m going to actually ask Dr. Fauci to talk about the compatibility of these three very successful vaccines in a second, but I do think it’s important to clarify that that was not actually the mayor’s intent, and that was not the mayor’s comment.
We’ve been in constant dialogue with Mayor Duggan, who said, in fact, that was not what he said or – however it was reported. In fact, he is very eager for the Johnson & Johnson vaccine. And I think we would reiterate the message that, for all of us, the first vaccine we have an opportunity to take makes absolute sense to take. So thank you for allowing us to clarify that.
But, Dr. Fauci, maybe you want to reiterate the guidance around these three vaccines.
Dr. Fauci: Yes. Thank you, Andy. As we’ve said many times and happy to reiterate it right now, we have three highly efficacious vaccines with a very good safety profile. Each of them are very effective in preventing clinically apparent disease. But importantly, all three of them have a important effect of being extraordinarily effective in preventing severe disease, and particularly preventing hospitalizations and deaths. That’s point number one.
We don’t compare one to the other. The only way that you can effectively do that is by having head-to-head comparisons in a clinical trial, which was not done.
And so, as Andy said, and I’ll reiterate, it’s a question – if you go in and a vaccine is available to you, I would take the first vaccine because the most important thing to do is to get vaccinated and not try and figure out what one may be or may not be better than the other.
I’ll stop there, Andy.
Acting Administrator Slavitt: Yeah, thank you. And I realized I didn’t answer one element of your question, which is: How are we preparing states and others in the distribution system for the pattern of vaccines that are coming off the line at Johnson & Johnson?
The same thing is true for Johnson & Johnson as it is for Moderna and Pfizer: Everyone we’re distributing to – all the states and jurisdictions – have a – at least a three-week-forward view as to their vaccinations that are coming. They’re able to plan for them.
And thankfully, to date – even if you just look at the Pfizer and Jo- – Pfizer and Moderna vaccines, we’ve taken them up about 77 percent so far, and we will aim to continue to increase as much as possible.
So next question.
MODERATOR: Next we’ll got to Tamara Keith at NPR.
Q: Great. Can you hear me?
Acting Administrator Slavitt: I can.
Q: Okay, excellent. I am – and you probably don’t have the answer to this – but how soon is “soon” on this guidance for people with vaccines? There are now millions of people who are fully vaccinated and making life choices, like some grandparents I know who are getting on an airplane today. So there is a sense of urgency there.
And then I have one other question.
Acting Administrator Slavitt: So, noting your sense of urgency, maybe – maybe I will – and, look, you’re not alone. Everybody is eager to see what’s next.
The burden that falls on the CDC is not only to get the science right, but to communicate clearly in a way that’s not confusing. But maybe I’ll get – go back to you, Dr. Walensky, for you to reiterate some of your points.
Dr. Walensky: Yeah, I will just reiterate that it’s coming soon. We know that people are interested. I think the anecdote that you raise is one that is exactly why we want to make – to ensure that the communication is crystal clear – and that is because everyone has their specific scenario of what they’re trying and wanting to do. And so we really just want to make sure that it’s very clear and can be easily adapted for individuals, their households, and their loved ones.
Q: And the other question I have is: When do you expect this crossover to happen, where it will go from a scarcity problem to then an administration problem – you know, having enough people to put shots in arms – and then from there, to a hesitancy problem?
And on the hesitancy: Has anyone in this administration tried reaching out to President Trump, who got his vaccine privately, about maybe doing a PSA?
Acting Administrator Slavitt: So, Tamara, thank you for the question. So your question is: When do we go from having a situation where we have a shortage situation, which we have today, to one where we have an oversupply situation?
And I think the best way to answer that question is not with a precise date, but the fact that it’s not a switch that flips, but it’s a sliding scale, and it happens differently in community by community.
And I will tell you that there are some communities we’re already very engaged and very focused on communicating with people about the questions they have about getting off the fence and taking the vaccine. That’s already begun.
This has been a massive week of outreach, led by Dr. Marcella Smith, but with many people across the country participating in that dialogue, and it’s happening increasingly on a local basis.
So, from our view, this is not something that will start at some magical day in the future; it has begun today. And it’s something that we have to make sure we’re addressing.
Did you have another part of your question? U’m sorry, I feel like I forgot one things you asked. Okay, well – yes.
Q: Yes. Here. I’m back. The question was whether anyone in this administration –
Acting Administrator Slavitt: Oh.
Q: – has reached out to President Trump, who quietly and privately got vaccine, but would seem to be a perfect spokesman for a public service announcement to supporters who might be experiencing hesitancy.
Acting Administrator Slavitt: Well, we’re glad that everybody who has taken the vaccine is talking about it, including him. We’ll also note that we have governors of both parties who are – who have taken the vaccine and who are being very public about it, and others as well.
I think many people are, you know, waiting their turn. But we find it helpful for everybody – I particularly like the Dolly Parton song myself. Ev- – that’s one of my favorites.
All right, next.
MODERATOR: Next we’ll go to Yamiche Alcindor with PBS.
Q: Hi. Thanks so much. You guys can hear me?
Acting Administrator Slavitt: Yes.
Q: Great. I – it sounded like you touched on this a bit, but I want to go back to the idea of the Detroit mayor declining this city’s allotted J&J vaccine and saying, in fact, that it’s a good vaccine, but that Moderna and Pfizer are the best. How often is this happening, and what are you doing to try to avoid this? And what else can be said or done to make sure that cities aren’t going to follow in his footsteps? And how problematic, if at all, is that?
And then, I have a second question on the vaccine hesitancy, but I want the first – that – the first one about the Mayor of Detroit.
Acting Administrator Slavitt: Yeah, let me reiterate the mayor’s office has indicated, after we talked to them, that that was a misunderstanding; that was not the intent of those remarks.
So – and thankfully, I think, as Dr. Fauci said, we’re seeing widely across the country, people are grateful and we’re seeing an overwhelmingly positive response to this third vaccine.
And I think people understand the fact that they are not directly comparable, given the time periods with which they were tested, and that they all make – make it past the most important test, which is that they are able to prevent disease, and particularly severe disease and death, and at the 28-day at 100 percent level. And, by the way, that’s including testing in South Africa, where we have one of the most dangerous variants.
Maybe I’ll go back to you, Dr. Fauci, again because I don’t think we can say it enough… And – and I think it – I will tell you that it’s a great question, but the message is getting through.
Dr. Fauci: Yeah, Andy. I – we’ve got to get away from this issue of comparing one with the other, except to say that we have a highly efficacious group of three vaccines. And the critical issue that you said to repeat again, in the important area of preventing very severe disease leading to hospitalization and death: It is virtually 100 percent in that regard. That is really good news.
And, again, people want to get vaccinated. And you go to a place that will have a vaccine – almost all will have one or the other – I would just take the vaccine that is the most readily available to you.
Acting Administrator Slavitt: Thank you.
And did you – did you have a follow up on hesitancy?
Q: Yeah. I had a follow-up on hesitancy. I know there’s been a lot of talk about, obviously, African Americans and hesitancy, but I was also looking at hesitancy among Republican voters, in particular. There was a poll that showed, in Michigan, only about 29 percent of Republicans said they would get the coronavirus vaccine. I’m wondering if there’s a special push for Republican voters, for conservative voters who, according to polling, are showing a big amount of vaccine hesitancy.
Acting Administrator Slavitt: Yeah. You know, the only thing I would say – we’ve seen obviously a lot of the same information. We are engaged with stakeholder groups across racial and ethnic minorities, rural Americans, to reach young Americans. All of these are important. Our whole perspective is: :eave nobody behind.
And, in fact, I just – the only thing I would take slight issue with is we don’t think this decision is a matter of political identity. And I think – and I can tell you, everybody from evangelical leaders to media figures, like Hugh Hewitt and others, reinforced the fact that while there may – there may be different pockets of populations that may, in fact, identify with whether it’s their location or political identity, and so forth, it’s not driven necessarily by their politics. And that’s a good and important thing because we don’t think that this is about political identity.
So we are targeting specific groups with conservations and answering questions that people have. And those questions may differ based on where you live or how you identify. But this is not and nor should it ever become something that is a question of politics.
Do we have another question?
MODERATOR: Last question will go to Kristen Welker at NBC.
Q: Hi, everyone. Thank you for the question. Really appreciate it. I want to follow up with you on the report that you all referenced today: the fact that areas with mask mandates have seen decreases in their daily cases, and yet areas where restaurants were open have seen increases in cases and even deaths. What’s the broader message here? And does this mean that restaurants should close down, or does there just need to be more vigilance?And then just as a quick follow-up: I know that the CDC data shows that a larger share of white – of the white population has been vaccinated as compared to Hispanic, Asian, black populations. What’s being done specifically to address that right now?
Acting Administrator Slavitt: Okay, Dr. Walensky, do you want to take the first? And welcome to obviously talk about the second, if you like, as well.
Dr. Walensky: Yeah. You know, I think the science is now following the messaging that we have, and the messaging has followed the science. We have demonstrated that masks work. We have demonstrated that in-person dining – this is not the first report that demonstrates the impact of in-person dining and how cases and deaths will follow after in-person dining. So I think all of this is very consistent.
I think we’ve known that restaurants have led to cases, have led to clusters, so I think this is yet another report at a population level – at a large population level, over a durable period of time, that has demonstrated that you have decreases in cases and deaths when you wear masks, and you have increases in cases and deaths when you have in-person restaurant dining. And so we would advocate for policies, certainly while we’re at this plateau of a high number of cases that would listen to that public health science.
Acting Administrator Slavitt: So, I’ll just – I’ll just add to that. Number one, we are following the science and we are following the data, and we are following with the work the CDC says. It’s very clear that these interventions work and they save lives. Why somebody wouldn’t take advantage of a small intervention to save people’s lives, that – that would be surprising.
Second, so with – just very clear – we’ll say it – all three of us have said this: We’re not done. We’re not done. We’re making progress, but there are also disturbing signs on the horizon. And every time we’ve gone through this pandemic, we’ve learned that you can look a few weeks ahead, and in the world, you see a few weeks ahead, it will not look like the world you live in today. And the signs of what you will see ahead are with you at the present, if you look at them. And I think Dr. Fauci and Dr. Walensky have been very clear about what we’re seeing today. Very clear. We – and so we – we have to be straight with the public.
In terms of equity, particularly with racial and ethnic minorities, we have been, I think, the first ones – the first ones to come out and say, “This is a challenge, and this is a hard challenge, and this is an important challenge.” It’s – and it’s been a pillar of everything we’ve focused on. It doesn’t mean it’s easy. But I will tell you that there are three major thrusts to this initiative.
The first is we have to meet communities where they are. We have to go to where people are. We have to make sure the transportation, working hours, et cetera, hit people to allow them to get vaccinated. And this is in large part, as we all know now, an occupational disease, and it’s a disease of living conditions.
So we cannot allow just a system where we generically throw out vaccine supply and let whoever comes to get it get it. We have to make these focused efforts. And we have some evidence in the case of our community vaccination centers, in the case of retail pharmacies, in the case of the emerging program on community health centers that these steps are working.
Second, trusted messengers. We are spending a lot of time with people locally who need to hear from and want to hear from to feel comfortable whether they should be taking the vaccine. People have legitimate questions. Let me be clear: A question about whether I should take a vaccine or not is not an illegitimate question. These are legitimate questions, and they need to be answered in a straightforward way with people who they trust. Because the record of these vaccines is just outstanding from an efficacy and safety standpoint.
And third: data, data, data. The more we can look at this, the more we can see the problem, the better we can solve it, the better we can focus on solutions. So we need more states to be contributing data to this effort. We are committed to trying to solve it. It doesn’t mean it’s easy, but we’re committed to trying to solve it.
Thank you for all the questions today, and I hope everyone has a good weekend.
March 5: U.S. Food and Drug Administration (FDA) posted a News Release titled: “Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID-Test”. From the News Release:
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2.
“Today’s authorization further underscores the FDA’s commitment to innovation in test development,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data the deepen our understanding of SARS-CoV-2 remain important keys to get ahead of this global pandemic.”
The test analyzes DNA (deoxyribonucleic acid) sequences from T cells (white blood cells) to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. A positive test result indicates recent or prior infection with SARS-CoV-2, while a negative test result indicates that a patient is unlikely to have been infected with SARS-CoV-2. Negative results do not preclude acute or current SARS-CoV-2 infection. All results from the test should be used in combination with a clinical examination, patient medical history and other findings. The T-Detect COVID Test should not be used to diagnose current SARS-CoV-2 infection.
A T cell response may be detected in blood several days after initial infection; however, it is unknown how long the T cell immune response remains following infection and what level of protection may be provided by the presence of a T cell immune response. The T-Detect COVID test will be a useful tool to help determine if a person previously had COVID-19. This is especially important for people who may have exhibited symptoms previously or believe they have been exposed but have not tested positive for COVID-19 using a molecular or antigen diagnostic test.
The test is indicated for use by qualified healthcare professions on samples from individual who are 15 days or more post-symptom onset. Testing is currently limited to laboratories designated by Adaptive Biotechnologies Corporation that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meet the requirements to perform high complexity tests.
March 8: The White House posted a Press Briefing titled: “White House COVID-19 Response Team and Public Health Officials”. From the Press Briefing:
Acting Administrator Slavitt: Thank you for joining us. It was an important weekend for the President and the American People.
President Biden came into office with two clear, immediate goals: mount a vaccination program to turn the tide on the pandemic and pass a rescue plan to bring the nation through these tough times successfully.
This weekend, we took critical steps on both fronts. On Saturday, the Senate passed the American Rescue Plan. In the face of what is one of the country’s greatest challenges Americans have ever faced, this historic legislation will cut child poverty in half, put $1,400 checks into the pockets of 85 percent of the country, fund our schools so they can reopen safely and so our kids can catch up quickly, and create 7 million jobs. And importantly, it gives America the resources we need to defeat the pandemic. It demonstrates government once again is working for the people.
On that very same Saturday, we set a new record for single-day recorded vaccinations. We are vaccinating a seven-day average of nearly 2.2 million Americans a day, up from about 900,000 when we came into office. Saturday was as high as 2.9 million doses reported administered – a new daily record – and we’re at a pace seen nowhere else around the world. This is a function of everyone executing to their fullest, and it depends on vaccination sites being open late and the tireless efforts of vaccinators.
While all of this is challenging, our message is: Keep going. I know the pace is challenging. This is a war, and we can’t let up.
Last week, the President announced we’d have enough vaccine for every adult in America by the end of May. Turning those vaccine doses into vaccinations requires more vaccinators and more vaccination sites. We must continue to get these vaccinations efficiently and equitably distributed to the public.
We’ve already provided more than $4.1 billion to states, tribes, and territories to support more than 500 community vaccination sites. The American Rescue Plan includes tens of billions more in funding to scale up our vaccination program.
Many states are now running vaccination sites 24 by 7. Slots are being reserved for teachers and people in hard-hit ZIP codes, and we’re getting more vaccinators – from the military to retired doctors and nurses – into the field.
We are in a historic crisis, and we have reason to have confidence that we will prevail. But we are not done, and we must keep up the pace of progress and remain vigilant.
Joining me today is Dr. Walensky, Dr. Fauci, and Dr. Nunez-Smith. And with that, I will turn it over to Dr. Walensky to talk about or next steps on our path back.
Dr. Walensky: Good morning and thank you. I’m glad to be back with you today. Let’s get started with an overview of the pandemic. The most recent seven-day average of cases is about 59,000 cases per day/ Importantly, on the far right of the graph, you can see there is a leveling off the decline. And the most recent seven-day average of deaths is slightly lower than 2,000 deaths per day.
These numbers show us that the pandemic still remains a very serious situation with the most communities continuing to have high levels of COVID-19 transmission. We are watching these data very closely to see where the pandemic will head in the coming days.
But I’m also hopeful. As of today, 59 million people in the United States have received at least one COVID-19 vaccine, and approximately 31 million or 9.2 percent of the U.S. population is fully vaccinated, putting us on a strong path to eventually end this pandemic. And as you just heard, we are now vaccinating more than 2 million people per day.
We’ve been through a lot this past year. And with more and more people getting vaccinated each day, we are starting to turn a corner. And as more Americans are vaccinated, a growing body of evidence now tells us that there are some activities that fully vaccinated people can resume at low risk to themselves.
This is why, today, CDC is releasing initial guidance for the public that, for the first time, lays out some of the activities considered safe for those who are fully vaccinated. When I say “fully vaccinated,” I mean people who are two weeks after their second dose of either the Pfizer or Moderna vaccines, or two weeks after a single dose of the Johnson & Johnson.
Before I talk about specific recommendations, I want to underscore a few important points. First, robust clinical trial data demonstrate that the current COVID-19 vaccines are highly effective at protecting vaccinated people against severe illness, hospitalization, or death from COVID-19. However, there is still a small risk that vaccinated people could become infected with milder or asymptomatic disease, and potentially even transmit the virus to others who are not vaccinated. Understanding the size of this risk in vaccinated people and the risk of transmitting the virus to others who are not vaccinated is an ongoing area of research.
Second, it’s important to note that this is initial guidance. The science of COVID-19 is complex and our understanding of the virus continues to rapidly evolve. The recommendations issued today are just a first step. As more people get vaccinated and the science and evidence expands, and as the disease dynamics of this country change, we will continue to update this guidance.
Importantly, our guidance must balance the risk to people who have been fully vaccinated, the risks to those who have not yet received a vaccine, and the impact on the larger community transmission of COVID-19 with what we all recognize to be the overall benefits of resuming everyday activities and getting back to something – to some of the things we love in life.
It’s against this backdrop and the current state of the pandemic that we have developed these new recommendations. With today’s initial guidance, it’s important to note that we are focusing on activities fully vaccinated people can resume in private settings, such as their homes, under two scenarios.
The first scenario is fully vaccinated people visiting with other fully vaccinated people. In this slide, these individuals are represented by solid green circles. In this scenario, CDC recommends that fully vaccinated people can visit with other fully vaccinated people in small gatherings indoors without wearing masks or physical distancing. Remember, here we are talking about private settings where everyone is vaccinated.
So what does this mean? If you and a friend or you and a family member are both vaccinated, you can have dinner together wearing masks, without distancing. You can visit your grandparents if you have been vaccinated and they have too.
Now I want to talk to you about another more complicated scenario: It involves vaccinated people visiting with unvaccinated people. When fully vaccinated people visit with unvaccinated people, we have to consider the underlying risks of the unvaccinated people and any unvaccinated members of their household. We take this approach because all of our guidance is rooted in making sure we are keeping people safe.
So, CDC recommends that fully vaccinated people can visit with unvaccinated people from one other household, indoors, without wearing masks or physical distancing, as long as the unvaccinated people and any unvaccinated members of their household are not at high risk for severe COVID-19 disease.
In the slide, people who are vaccinated at a low risk for severe COVID-19 are indicated by orange circles. This means that none of the unvaccinated people or any unvaccinated members of their households, for example, are an adult over age 65 or have an underlying condition – such as cancer, heart disease, or diabetes – that could increase their risk of COVID-19 related hospitalization or death.
Here is an example: If grandparents have been vaccinated, they can visit their daughter and her family, even if they have not been vaccinated, so long as the daughter and her family are not at risk for severe disease. They are solid orange circles.
Second, if an unvaccinated individual or any unvaccinated member of their household are at high risk for severe disease, shown here by hollow orange circles, everyone, regardless of vaccination status, should still were a mask and physically distance and choose to meet outdoors or in a well-ventilated space. This is recommended to keep the individuals at high risk who are unvaccinated safe.
Moving on to quarantine, away from visiting. In addition to these new recommendations on visitation in private settings, CDC’s new guidance also recommends that fully vaccinated people do not need quarantine or get tested following a known exposure to someone with COVID-19 as long as they are asymptomatic. At this time, the CDC is not adjusting current guidance on travel.
We believe these new recommendations are an important first step to our – in our efforts to resume everyday activities on our communities. However, we remain in the midst of a serious pandemic and still over 90 percent of our population is not fully vaccinated, though we are working hard to get there. Therefore, everyone, whether vaccinated or not, should continue to avoid medium- and large-sized gatherings, as well as nonessential travel, and, when In public spaces, should continue to wear a well-fitted mask, physically distance, and follow other public health measures to protect themselves and others.
COVID-19 continues to exact a tremendous toll on our nation. Like you, I want to be able to return to everyday activities and engage with our friends, families, and communities. Science and the protection of public health must guide us as we begin to resume these activities.
I know this is complex and I’ve covered a lot of ground this morning, so I want to recap the main points of our initial guidance released today.
In summary, fully vaccinated people can visit with other fully vaccinated people indoors without wearing a mask or physical distancing; visit with unvaccinated people from a single household who are low risk of severe COVID-19 disease, indoors, without wearing masks or physical distancing; and refrain from quarantine and testing following a known COVID-19 exposure if the vaccinated person remains asymptomatic.
For now, we will continue to examine this in the upcoming weeks – and update our guidance accordingly. Fully vaccinated people should continue to take precautions in public like wearing masks and physical distance and adhere to other prevention measures when visiting with unvaccinated people who are at increased risk of severe COVID or who have an unvaccinated family member – household member who has an increased risk of COVID; wear masks, physically distance and practice other prevention measures when visiting with unvaccinated people from multiple households; avoid medium- and large-sized crowds; get tested if experiencing COVID-19 symptoms; follow guidance issued by individual employers; and follow CDC and health department travel recommendations.
As I close, I want to stress that we have – we continue to have high levels of virus around the country, and more readily transmissible variants have now been confirmed in nearly every state. While we work to quickly vaccinate more and more people each day, we have to see this through. Let’s stick together. Please keep wearing a well-fitting mask and taking the other public health actions we know work to help stop the spread of this virus.
Thank you so much for your time today, and I will now turn things over to Dr. Fauci.
Dr. Fauci: Thank you very much, Dr. Walensky. I’d like to just spend a couple of minutes now on a different topic, and that has to do with investigational therapeutics for COVID-19. If I could have the first slide.
On a previous briefing, I had mentioned to the group that there were a number of investigational therapeutics, including monoclonal antibodies, convalescent plasma, immunomudulators, et cetera. What I want to do today for a couple of minutes is talk about the issue of direct-acting antivirals. If I could have the next slide.
The strategy for direct-acting antivirals in the future will be a process that we have done with other infections, which I’ll get to in a moment, and that is the identification of vulnerable targets after study of the replication cycle of the virus – in this case, SARS-CoV-2 – and then, to design drugs to directly inhibit that vulnerable target. Next slide.
We have been extraordinarily successful in this with HIV. Now, targeted drug development, which is the terminology we use for this approach – “targeted drug design” – has occurred before HIV, particularly with the herpes viruses. But it really got into its own frame with HIV.
And the reason I say that is that that was the first of the extraordinarily successful results of targeted drug design. And the reason and the mechanism that we got there – next slide – was to delineate the replication cycle of the virus. In this case, you can see in the upper left, HIV binding to it’s now well-described receptors: the CD4 molecule and one of its core receptors. It fuses, it enters, the RNA reverse transcribes, it integrated its DNA into the cellular DNA, then transcribes out and buds off.
Over the years of intensive study – next slide – each of those vulnerable targets has led to a different class of highly effective antiretroviral drug, including the reverse transcriptase inhibitors, the protease inhibitors, the integrate inhibitors, and the fusion and entry inhibitors.
This has led to now an extraordinary number of drugs which, when used in combinations, have transcribed – has transformed, excuse me, the life of HIV-infected individuals, giving them almost a normal lifespan, although the drug needs to be given, essentially, for the rest of their lives.
That same principle is now being applied to SARS-CoV-2, because here’s a comparable life cycle. Obviously there are differences here. Again, in the upper left, you’ll see SARS-CoV-2, by virtue of its spike protein, binding to its ACE2 receptor, binding to the membrane, fusing, entering, and then a whole bunch of steps that I need to go through that involve a variety of enzymes, which ultimately lead to the virion release – on the lower right-hand part of the slide.
With the same strategy that was used with HIV, we will be screening and then proactively designing entry inhibitors, protease inhibitors, polymerase inhibitors, and others.
And then, if you look at what’s been going on right now and take each of these very briefly, there are early-stage, non-monoclonal antibody candidates in preclinical development, such as peptides and small portions blocking entry.
With regard to polymerase inhibitors, the FDA has already approved remdesivir from Giliad. And just this past week, we’ve heard of molupiravir from Ridgeback Biothearapeutics and Merck, in which they published the preliminary analysis of their phase-two trial that showed a quicker decrease of infectious virus in participants with symptomatic disease. Just two days ago, Atea Pharmaceuticals reported favorable safety and pharmocokenitic data from phase-one trial. And Pfizer now is in a phase-one trial with a protease inhibitors.
I show this to the group because this is really the beginning of the phase of looking in a strategic way for direct-acting antivirals, which are going to be used to prevent people from progressing in their disease, mainly keeping them out of the need for hospitalization.
And on this final slide, for those of you who want to get more detail: Just this past November, the NIH had an NIH SARS-CoV2 Antiviral Therapeutics Summit looking at the state of therapeutics gaps in the field, and a number of our public-private partnerships. You can get this on the NIH website. And I encourage you, for those who have any interest in it, to take a look at that because that is the direction that we will be going over the next few weeks, to months, to two years.
I’ll stop there and hand it over to Dr. Marcella Nunez-Smith.
Dr. Nunez-Smith: Thank you so much, Dr. Fauci, and good morning to everyone. I’m going to talk, of course, about equity. And you’ve heard us describe that equity is the foundation – the center of this administration’s COVID-19 response. You know, over the last month in my time with you, I’ve detailed why that needs to be the case. So we’ve took a – we’ve taken a look at the differences in COVID-19 outcomes, for instance, by race and ethnicity.
And since the beginning of this pandemic, we have all seen that factors, you know, like race, ethnicity, rural versus urban geography, poverty, disability, living situation, and type of employment – they all are exerting tremendous influence on the outcomes we’ve see in COVID-19.
So I want to begin this morning by giving an update on the ongoing inequities related to COVID-19. So, first, let’s take a look at the rates of COVID-19 cases, deaths, and vaccination by race and ethnicity. As you can see here, Latino individuals continue to bear more than their share of COVID-19 cases, while black people continue to bear more than their share of deaths.
Notably, you see the share of vaccinations is significantly – significantly lower for Latino and non-Hispanic black individuals, relative to their share of the general population. And the same is true for Asian individuals.
This all still only tells part of the story as we remain limited by the completeness of our data. We only have race ethnicity data for 53 percent of those who have received their first dose of COVID-19 vaccine. This varies widely among the states, as you can see on the next slide. And we’re not getting from individuals, from providers, and from states the critical information about who has access to these three lifesaving vaccines that need to be equitably distributed across our country.
So I want to emphasize here: It is possible to do better. The final slide shows us the information that providers and states are reporting to us on the age of people who they’re vaccinating. So contrast that with the data on the race and ethnicity of those same individuals.
Again, we have critical ground that we must make up, but we cannot get discouraged or feel like it’s insurmountable. You know, all of the evidence points to one simple truth: We can do this.
So, like many of you, we’ve also seen a lot of conversation about vaccine confidence, about how some communities – due to a range of historical, as well as contemporary factors – are less inclined to believe that these vaccines are safe and effective, less inclined to trust the government asking them to get vaccinated. So we still have some work to do to meet people where they are.
The administration is implementing a comprehensive national public education campaign and we have been hosting roundtables with key constituencies to make sure that we get that effort right. We’re building relationships with trusted messengers all over the country to make sure they have the best information possible to share with their communities. But we cannot and we will not accept that these differences in vaccine confidence are the end all and be all of the differences in vaccine update that we’re already seeing.
In the context of inequitable systems, we must take significant steps at every level of intervention to bend the vaccination process towards justice. Now our success depends on our ability to build a robust and coordinated effort at the local, state, and federal level to overcome all of the dynamics that are in place, and this moment absolutely calls for that kind of effort.
In the context of inequitable systems, we must take significant steps at every level of intervention to bend the vaccination process towards justice. Now our success depends on our ability to build a robust and coordinated effort at the local, state, and federal level to overcome all of the dynamics that are in place, and this moment absolutely calls for that kind of effort.
So in light of everything that we’ve seen in the 84 days since our nation began administering COVID-19 vaccines, we’re turning up the expectations for this vaccine program on all fronts. And we have a series of federal programs that are a key part of our approach to ensuring that all communities have vaccination access.
First, we have our large community vaccination sites all over the country. So far, we have over 580 operational, federally supported sites. And over 170 sites are actively receiving on-site support by federal personnel. We’ve also been able to stand up a series of federally established community vaccination centers. And by the end of this week, we’ll have 18 of those sites running across seven states with the ability to administer 61,000 total shots per week.
And each of our federal sites has been designed with key equity-oriented features – so targeted geographic eligibility, weekend extended hours, reserved slots for registration through faith-based and community-based organizations, as well as deployment alongside mobile vaccination units to help vaccinate surrounding communities.
So we’re going to keep pushing to launch more and more of these sites and dive into the data on each site to make sure they are achieving their goal of improving vaccine equity in those communities.
Second, we have our Federal Retail Pharmacy Program. And this program features chain and independent pharmacies across the country. And as of last week, we’re administrating 2.5 million doses of the Pfizer/Moderna vaccines, plus the additional supply that they received with the Johnson & Johnson vaccine.
We designed this Retail Pharmacy Program to ensure that one third of the pharmacy sites were placed in communities with higher scores on the CDC Social Vulnerability Index. Those are populations at higher risk due to factors like socioeconomic status, the composition of the household, people of color, as well as housing types and transportation dynamics.
So we’re going to press toward this mark to ensure that pharmacies are selecting the communities with the greatest need. And we’re going to prioritize those pharmacies that do a better job addressing equity.
And finally, we rolled out our federal community health centers partnership program. And over the past three weeks, we have been onboarding the first 250 centers. They collectively serve 12.5 million people and span all 50 states. You know, as a whole, these community health centers provide services for large numbers of public housing residents, people of color, and individuals with limited English proficiency.
So, as we look to the next phase of this program we will prioritize filling gaps in our coverage to the highest-hit – I’m sorry – hardest-hit, highest-risk communities, whether they be urban or rural. And as we double down on the reach and impact of our federal programs, we’ll continue increasing our vaccine supply to the states.
And as we move forward, we’re calling on every state to show their work, too. We’re asking our partners in the states to offer clear, transparent equity goals for their residents. And we’re also calling on the states to help us get the data we need to know where we are and to work with us to find creative solutions to the inequitable vaccine uptake that has already emerged in these first months of the vaccination program.
So, I just want to be clear that achieving equity is not an aspirational goal; this is mission critical. Absent equity, we will not be able to stop this pandemic from continuing to claim lives, strain our healthcare system, and weaken our economy. But, but working together, we believe we can hit the mark.
So I think you for your time. And with that, I’ll turn it back over to Andy.
Acting Administrator Slavitt: Thank you. So we’ve covered a lot of ground in our report-outs. Before I turn for questions, I just want to maybe briefly summarize a few things I heard today. Today, I think we’ve begun to describe what a world looks like where we move beyond COVID-19.
Dr. Walensky outlined a first step for those of us who’ve been vaccinated. And I think it’s important to note that, as more and more people get vaccinated, Dr. Walensky will continue to update us and that list of activities will continue to grow.
Dr. Fauci outlined ongoing strategies to allow for a life post-COVID to become safer and safer. And Dr. Nunez-Smith, I think importantly, points out that this recover is not an even picture. And in fact, we cannot fully get back to a place where we are approaching where we were before COVID unless we do an important and good job reaching equity.
So, I think a very hopeful morning, but with some continued warning signs and hope for the future. So with that, let’s take some questions…
…MODERATOR: We’ll go ahead and go to – we’ll go to Zeke at AP.
Q: Thanks, you all, for doing the call. For Dr. Walensky, I was hoping you could clarify why the CDC hasn’t – what the limiting factor is in CDC not, sort of, putting out guidance to the effect of those who have been fully vaccinated not been – not having to wear masks and being able to travel and things like that. You know, what is the limiting factor? Is it the background cases of the virus in the community? Is it the fact that enough – not enough people are vaccinated just yet to get there?And then can you just provide potentially a step, sort of, what the next set of guidance is going to be and what the triggers would be for – you know, for people who are fully vaccinated being advised to be able to remove their masks in public, and, you know, go about a somewhat normal life?
Dr. Walensky: Yeah, thank you for that question. I think it’s important to realize, as we’re working through this, that still over 90 percent of the population is not yet vaccinated and that it is our responsibility to make sure, in the context of 60,000 new cases a day, that we protect those who remain unvaccinated and remain vulnerable. So we’re doing our best to do that.
I think it’s also important to remember that people who are vaccinated – there’s increasing data now that suggests they might get breakthrough infection with lesser amounts of virus, lesser amounts of disease, lesser symptomatic disease – milder disease. However, we’re still waiting for data to emerge about whether they could transmit that virus to other people.
So our next steps, in terms of putting out the guidance, as I mentioned, is really to see a larger swath of the population vaccinated – we’re actively on our way to doing that – as well as to hopefully see further cases decline in the country, as well as waiting for new data to emerge.
So we’re hoping it’s in – you know, a relatively short period of time, but we do need to see some more data as well.
Acting Administrator Slavitt: Next question.
MODERATOR: Next we’ll got to Shira Stein at Bloomberg.
Q: Hi, thanks so much for doing this. Can you explain what the scientific justification is for not changing travel guidance to telling folks who are fully vaccinated that they should not be traveling? And how will this guidance affect folks’ willingness to get vaccinated?
Dr. Walensky: In terms of travel, here’s what we know: Every time that there’s a surge in travel, we have a surge in cases in this country. We know that many of our variants have emerged from international places, and we know that the travel corridor is a place where people are mixing a lot. We are really trying to restrain travel at this current period of time, and we’re hopeful that our next set of guidance will have more science around what vaccinated people can do, perhaps travel being one of them.
Acting Administrator Slavitt: To the second part of your question: Obviously, it will be pure speculation on our part, but we think that this is part of a growing list of reasons why Americans do want to get vaccinated. We are already seeing increasing numbers of people wanting to get vaccinated given the highly effective vaccines and given the very good safety profiles. And this list, which Dr. Walensky pointed out, will continue to grow, we think, are a growing set of reasons why people want to get vaccinated.
Having said that, I think it’s important to note that the CDC makes its decisions based upon what the science and the data tells them are the right decisions, not for any other reasons.
MODERATOR: Okay. I’m going to try Ed one more time. I think he figured it out.
Q: I did. Thank you. And let me follow up on the travel question there because, Director Walensky, you explicitly said grandparents now could go visit their daughter’s house and see the grandkids. But in many cases, that’s going to result in grandparents probably getting on a train or plane to go to a neighboring state or some other state to see them.
If a governor calls you today and says, “Okay, you just said people can gather together in homes, and this is going to cause people to start traveling despite the urge not to,” what guidance would you give governors regarding vaccinated people coming back to their state? Do they still have to quarantine for a certain amount of time? Or, at this point, can they sort of disregard those travel restrictions if they’ve been vaccinated and have been fully vaccinated within those two weeks after their final shot?
Dr. Walensky: Our travel guidance is unchanged, and so we would maintain whatever travel guidance is currently in place. We would like to give the opportunity for vaccinated grandparents to visit their children and grandchildren who are healthy and who are local, but our travel guidance currently has been unchanged.
Acting Administrator Slavitt: Okay, the next question.
MODERATOR: All right. And final question will go to Alice Park at Time.
Q: Hello. Can you hear me?
Acting Administrator Slavitt: We can.
Q: Great. This is a question for Dr. Fauci, and this has to do with the studies you mentioned last week on the third dose. Can you outline for us what the metrics are that you’re going to be looking at in those dose – in those studies, and what thresholds you will set for success or to determine whether a third does might be necessary or not?
Dr. Fauci: Alice, there were two third-dose scenarios. One was one that Pfizer was pursuing, where they’re talking about giving a third dose against the wild-type virus to boost up the level of neutralizing antibodies. The parameter there will be taking a look at what the level of boost of antibody, because we do know from in vitro studies that when you get a high level of antibody against the wild-type, it gives you a cushion of effect against the variant.
And the second third boost is one that we are doing in collaboration with Moderna, where the boost will actually be a boost of a vaccine that is directed specifically against the variant. So there are two issues there. What we’re looking for in the second one is the level of antibody that we will have boosted against, specifically, the variant, as opposed to the level of antibody against wild-type, which you will assume will give you some cross protection against the variant.
Acting Administrator Slavitt: Thank you.
Thank you all for joining. This is a – I hope people view this as a hopeful day in this next steps of the pandemic. And we are here in no small measure because of the safety and protection that many, many Americans have taken with regard to their family, friends, and neighbors. We ask people to continue to do that so we can get there as quickly and as permanently as possible.
Thank you very much, and we’ll be here again on Wednesday.
March 8: Centers for Disease Control and Prevention (CDC) posed a press release titled: “CDC Issues First Set of Guidelines on How Fully Vaccinated People Can Visit Safely with Others”. From the press release:
Today, the Centers for Disease Control and Prevention (CDC) issued its first set of recommendations on activities that people who are fully vaccinated against COVID-19 can safely resume.
The new guidance – which is based on the latest science – includes recommendations for how and when a fully vaccinated individual can visit with other people who are fully vaccinated and with other people who are not vaccinated. The guidance represents a first step toward returning to everyday activities in our communities. CDC will update these recommendations as more people are vaccinated, rates of COVID-19 in the community change, and additional scientific evidence becomes available.
“We know that people want to get vaccinated so they can get back to doing the things they enjoy with the people they love,” said CDC Director Rochelle P. Walensky, MD, MPH. “There are some activities that fully vaccinated people can begin to resume now in their own homes. Everyone – even those who are vaccinated – should continue with all mitigation strategies when in public settings. As the science evolves and more people get vaccinated, we will continue to provide more guidance to help fully vaccinated people safely resume more activities.”
Visit with other fully vaccinated people indoors without wearing masks or staying 6 feet apart.Visit with unvaccinated people from one other household indoors without wearing masks or staying 6 feet apart if everyone in the other household is at low risk for severe disease.Refrain from quarantine and testing if they do not have symptoms of COVID-19 after contact with someone who has COVID-19.
A person is considered fully vaccinated two weeks after receiving the last required dose of vaccine. Although vaccinations are accelerating, CDC estimates that just 9.2% of the U.S. population has been fully vaccinated with a COVID-19 vaccine that the FDA has authorized for emergency use.
While the new guidance is a positive step, the vast majority of people need to be fully vaccinated before COVID-19 precautions can be lifted broadly. Until then, it is important that everyone continues to adhere to public health mitigation measures to protect the large number of people who remain unvaccinated.
CDC recommend that fully vaccinated people continue to take this COVID-19 precautions when in public, when visiting with unvaccinated people from multiple other households, and when around unvaccinated people who are at hight risk of getting severely ill from COVID-19:
Wear a well-fitted maskStay at least 6 feet from people you do not live withAvoid medium- and large-sized in-person gatheringsGet tested if experiencing COVID-19 symptomsFollow guidance issued by individual employersFollow CDC and health department travel requirements and recommendations.
CDC has released resources to help people make informed decisions when they are fully vaccinated.
March 8: National Institutes of Health (NIH) posted a press release titled: “Statement on NIH starting enrollment for third trial of blood clotting treatments for COVID-19”. From the press release:
The National Institutes of Health has launched the last of three Phase 3 clinical trials to evaluate the safety and effectiveness of blood thinners to prevent life-threatening blood clots in adults diagnosed with COVID-19. The first patient in the trial was enrolled on February 15.
Part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) initiative, the trial explores the use of Eliquis (apixaban 2.5 mg), a blood thinner, or anticoagulant, donated by Bristol Myers Squibb/Pfizer, in patients who have been discharged from the hospital following a diagnosis of moderate-to-severe COVID-19, the disease caused by SARS-CoV-2.
The ACTIV-4 Convalescent trial is the third of the ACTIV-4 Antithrombotics master protocol for adapted traits. The other two – one focused on hospitalized COVID-19 patents and the other one on patients with COVID-19 patients who have not been hospitalized – are already underway. The trials are being conducted at more than 100 sites around the world. These trials are overseen by the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH.
Early in the coronavirus pandemic, researcher noticed that many patients who died from COVID-19 had formed blood clots throughout their bodies, including in their smallest blood vessels. This unusual clotting, one of many life-threatening effects of the disease, has caused multiple health complications, from organ damage to heart attack, stroke, and pulmonary embolism.
The ACTIV-4 trials will answer critical questions about the proper use of blood thinners or anticoagulants – called anthithrombotics – in the treatment of patients with COVID-19, particularly those who suffer from life-threatening blood clots.
Recruiting at sites with a significant COVID-19 burden, ACTIV-4 Convalescent is a randomized and placebo-controlled trial. Researchers will assess if, within 45 days of being hospitalized, patients develop any thrombotic complications – heart attack, stroke, blood clots in major veins and arteries, deep vein and pulmonary thrombosis, or death.
Trial planning and development work is being done through a collaborative effort with a number of institutions, including Duke University, Durham, North Carolina, University of Pittsburgh; University of Illinois at Chicago; Brigham and Women’s Hospital, Boston; the Medical College of Wisconsin; the University of California, San Francisco; and the University of Ottawa and the Ottawa Hospital Institute.
COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis https://clinicaltrials.gov/ct2/show/NCT04650087
March 8: U.S. Department of Health and Human Services (HHS) posted News titled: “Biden Administration to Invest $250 Million in Effort to Encourage COVID-19 Safety and Vaccination Among Underserved Populations” From the News:
HHS Office of Minority Health Will Offer Localities Funding to Partner with Community Organizations to Connect Minority, Underserved Populations with Vital Services, Promote Pandemic Safety Measures
As part of President Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness today, the Administration is announcing an effort to invest $250 million to encourage COVID-19 safety and vaccination among underserved populations. The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) will offer the funding as health literacy grants to localities, who will partner with community-based organizations, to reach racial and ethnic minority, rural, and other vulnerable populations. The new initiative – Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19 – is expected to fund approximately 30 projects in urban communities and 43 projects in rural communities for two years. Cities, countries, parishes or other similar subdivisions may apply for the funding.
Recipients are expected to develop a disparity impact statement using local data to identify racial and ethnic minority populations at highest risk for health disparities, low health literacy, and not being engaged or reached through existing public health messages and approaches for promoting COVID-19 public health recommendations. Then they will create and operationalize a health literacy plan, partnering with community-based organizations and adhering to culturally and linguistically appropriate services by racial and ethnic minority populations and others considered vulnerable for not receiving and using COVID-19 public health information.
“Information is power, especially the ability to understand and use information to support better health. Whether it helps us understand where to get tested or the benefits of the COVID-19 vaccine, information is a crucial part of keeping families and communities safe,” said Acting Assistant Secretary for Health RADM Felicia Collins, M.D. “Nowhere is this more important than in communities hit hardest by the pandemic, especially racial and ethnic minority communities and other vulnerable populations.”
Racial and ethnic minority populations experience higher rates of cases, hospitalizations and deaths related to SARS-CoV-2 infection. Social determinants of health, such as housing, education and work conditions, contribute to these disparities. Underlying chronic conditions, such as kidney disease, diabetes and obesity, are more prevalent among minority populations and increase the risk of severe COVID-19 illness.
OMH will be accepting applications for this new initiative through April 20, 2021.
The Office of the Assistant Secretary for Health (OASH), a division of the U.S. Department of Health and Human Services, provides public health and science advice to the Secretary, and oversees the Department’s broad-ranging public health offices, whose missions include minority health, HIV policy, women’s health, disease prevention, human research protections and others. OASH also includes the Office of the Surgeon General and the U.S. Public Health Service Commissioned Corps.
The Office of Minority Health is dedicated to improving the health of racial and ethnic minority populations through the development of health policies and programs that will help eliminate health disparities.
March 9: National Institutes of Health (NIH) posted a Media Advisory titled: “NIH scientists use human cerebral organic to test drug for deadly brain disease”. From the Media Advisory:
Approximately two years after establishing a human cerebral organoid system to study Creutzfeldt-Jakob disease (CJD), National Institutes of Health researchers have further developed the model to screen drugs for potential CJD treatment. The scientists, from NIH’s National Institute of Allergy and Infectious Diseases (NIAID), describe their work in Scientific Reports.
Human cerebral organdies are small balls of human brain cells ranging in size from a poppy seed to a pea; scientists use human skin cells to create them. CJD, a fatal neurodegenerative brain disease of humans caused by infectious prion proteins, affects about 1 in 1 million people each year. It can arise spontaneously, result from a hereditary mutation within the prion gene, or arise due to infection, for example, from eating contaminated meat products. A notable example of this occurred in the United Kingdom in the mid-1990s following an outbreak of bovine spongiform encephalopathy in cattle. There are no preventative or therapeutic treatments for CJD.
The lack of a completely human CJD model has been a considerable barrier hindering the discovery of potential therapies. Studies in mice have failed to identify treatments that were then effective when tried in patients. The human cerebral organoid CJD model holds promise that this barrier can be eliminated. Cerebral organoids have organization, structure, and electrical signaling systems similar to human brain tissue. Because they can survive in a controlled environment for months to years, cerebral organoids also are ideal for studying nervous system diseases over lengthily periods of time. Cerebral organoids have been used as models to study Zika virus infection, Alzheimer’s disease, and Down syndrome.
The CJD study was conducted at NIAID’s Rocky Mountain Laboratories in Hamilton, Montana. Scientists tested pentosan polysulfate (PPS) to determine its potential preventive and therapeutic benefits. In the experiments, PPS treatment reduced the disease indicators by 10-fold or more without causing tissue death. PPS is a benchmark anti-prion compound in laboratory experiments, but it is rarely used clinically because it requires direct administration into the brain.
While it may extend a patient’s life, PPS has not been shown to improve quality of life. However, using the anti-prion properties of PPS with the new human organoid CJD model allowed researchers to assess the value of this model system for drug discovery. The scientists showed that the human organoid model can be used to screen compounds that may be useful for preventative treatment. Such treatment could be used for people carrying genetic mutations that cause the disease, but who have not yet developed symptoms, or for people who may have been exposed to infectious prion proteins that might cause CJD. The model further proved useful for screening drugs against established CJD after a patient is diagnosed and starts showing symptoms of the disease.
The scientists are working to expand the organoid model for screening larger numbers of novel drug candidates. Their goal is to find treatment options for people who are susceptible to CJD because of their genetics or who accidentally are exposed, as well as for those who develop sporadic disease. They are optimistic that with their fully human model of disease, they can now identify compounds with promise for benefitting patients with CJD.
March 9: U.S. Food & Drug Administration (FDS) posted a News Release titled: “Coronavirus (COVID-19) Update: March 9, 2021” From the News Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
On Friday, the FDA issue an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter-at-home diagnostic test for COVID-19 The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to preform the test. Results are available in about 20 minutes.
On Friday, the FDA issued a EUA to Adaptive Biotechnologies for its T-Detect COVID Test. The T-Detect COVID Test analyzes DNA from a patient’s T cells (white blood cells) to aid in identifying people with an adaptive T cell immune response to SARS-CoV-2, indicating recent or previous SARS-CoV-2 infection. The test should be used together with a clinical examination and a patient’s medical history. Negative results do not rule out acute or current SARS-CoV-2 infection.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to CAMA Wellness Center/IodoRios Company, LLC for selling an unapproved product with fraudulent COVID-19 claims. The company sells a hand wipe product, and misleadingly represents the product can prevent or treat COVID-19 in people. The FDA requested that CAMA Wellness Center/IodoRios Company, LLC take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis or cure of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
As of today, 340 tests and sample collection devices are authorized by the FDA under EUAs. These include 253 molecular tests and sample collection devices, 72 antibody and other immune response tests and 15 antigen tests. There are 39 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home tests, one OTC at-home antigen test and one OTC molecular test.
March 9: U.S. Department of Health and Human Services (HHS) posted News titled: “Extension of the Public Comment Period for Proposed Modifications to the HIPAA Privacy Rule” From the News:
Today, the Office for Civil Rights (OCR) and the U.S. Department of Health and Human Services (HHS) announces a 45-day extension of the public comment period for the Notice of Proposed Rulemaking (NPRM) to modify the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.
OCR first released the NPRM to the public on the HHS website on December 10, 2020, and it was published in the Federal Register on January 21, 2021. The 45-day extension moves the current deadline for the public to submit comments from March 22, 2021, to May 6, 2021. The notice of extension of the comment period is available at https://public-inspection.federalregister.gov/2021-05021.pdf – PDF.
The proposed changes to the HIPPA Privacy Rule include strengthening individuals’ rights to access their own health information, including electronic information; improving information sharing for care coordination and case management for individuals; facilitating greater family and caregiver involvement in the care of individuals experiencing emergencies or health crises; enhancing flexibilities for disclosures in emergency or threatening circumstance, such as the Opioid and COVID-19 public health emergencies; and reducing administrative burdens on HIPAA covered health care providers and health plans, while continuing to protect individuals’ health information privacy interests.
OCR encourages and will carefully consider comments from all stakeholders, including patients and their families, consumer advocates, HIPAA covered entities (health plans, health care clearinghouses, and most health care providers) and their business associates, health care professional associations, health information management professionals, health information technology vendors, and government entities.
“OCR anticipates a high degree of public interest in providing input on the proposals because the HIPPA Privacy Rule affects nearly anyone who interacts with a health care system,” said Acting OCR Director Robinsue Frohboese. “The 45-day extension of the comment period to May 6, 2021, will give the public a full opportunity to consider the proposals and submit comments to inform future policy.”
Interested members of the public may submit their comments on the NPRM no later than May 6, 2021. The NPRM is available for review and comment at https://www.federalregister.gov/documents/2021/01/21/2020-27157/proposed-modifications-to-the-hipaa-privacy-rule-to-support-and-remove-barriers-to-coordinated-care.
March 10: National Institutes ofHealth (NIH) posted a News Release titled: “Study of mosquito protein could lead to treatments against life-threatening viruses”. From the News Release:
The mosquito protein AEG12 strongly inhibits the family of viruses that cause yellow fever, dengue, West Nile, and Zika and weakly inhibits coronaviruses, according to scientists at the National Institutes of Health (NIH) and their collaborators. The researchers found that AEG12 works by destabilizing the viral envelope, breaking its protective covering. Although the protein does not affect viruses that do not have an envelope, such as those that cause pink eye and bladder infections, the findings could lead to therapeutics against viruses that affect millions of people around the world. The research was published online in PNAS.
Scientists at the National Institute of Environmental Health Sciences (NIEHS), part of NIH, used X-ray crystallography to solve the structure of AEG12. Senior author Geoffrey Mueller, PH.D., head of NIEHS Nuclear Magnetic Resonance Group, said at the molecular level, AEG12 rips out the lipids, or the fat-like portions of the membrane that holds the virus together.
“It is as if AEG12 is hungry for the lipids that are in the virus membrane, so it gets rid of some of the lipids it has and exchanges them for the ones it really prefers,” Mueller said. “The protein has high affinity for viral lipids and steals them from the virus.”
As a result, Mueller says the AEG12 protein has great killing power over some viruses. While the researchers demonstrated that AEG12 was most effective against flaviviruses, the family of viruses to which Zika, West Nike, and others belong, it is possible AEG12 could be effective against SARS-CoV-2, the coronavirus that causes COVID-19. But, Mueller said it will take years of bioengineering to make AEG12 a viable therapy for COVID-19. Part of the problem is AEG12 also breaks opens red blood cells, so researchers will have to identify compounds that will make the protein target viruses only.
Alexander Foo, Ph.D., an NIEHS visiting fellow and lead author of the paper, explained that mosquitoes produce AEG12 when they take a blood meal or become infected with flaviviruses. Like humans, mosquitos mount a vigorous immune response against these viruses, with AEG12 bursting their viral covering. But, at the beginning of the project, Foo and his colleagues knew little about the function of AEG12.
“The prospect of studying a new protein is exciting, yet daunting,” Foo said. “Thankfully, we had enough clues and access to a wide range of expertise at NIEHS to piece it together.”
Co-author and crystallography expert Lars Pedersen, Ph.D., is leader of the NIEHS Structure Function Group. He routinely uses information about a molecule’s physical makeup in his work and encourages more scientists to consider using this data in their studies. He said, “Our research shows that understanding the structure of a protein can be important in figuring out what it does and how it could help treat disease.”
March 11: National Institutes of Health (NIH) posted a News Release titled: “NIH-led team sets new bar in retinal imaging”. From the News Release:
A team led by scientists at the National Eye Institute (NEI) has noninvasively visualized the light-sensing cells in the back of the eye, known as photoreceptors, in greater detail than ever before. Published in Optica, the researchers report how they improved imaging resolution by a third party by selectively blocking the light used to image the eye. NEI is part of the National Institutes of Health.
The achievement is the latest in an evolving strategy to monitor cell changes in retinal tissue that, in turn, will help identify new ways to treat and prevent vision loss from diseases such as age-related macular degeneration, a leading cause of blindness in people age 65 and older.
“Better imaging resolution will enable tracking of degenerative changes that occur in retinal tissue. The goal of our research is to discern disease-related changes at the cellular level over time, possibly enabling much earlier detection of disease,” said the study’s lead investigator, Johnny Tam, Ph.D., Stadtman Investigator in the Clinical and Translational Imaging Unit at NEI.
Earlier detection would make it possible to treat patients sooner, well before they’ve lost vision. What’s more, detecting cellular changes would enable clinicians to more quickly determine whether a new therapy is working.
The two types of photoreceptors, cones, which enable color vision, and rods, which enable low-light vision, vary in size and density across the retina. Cone photoreceptors, while larger than rods, are trickier to visualize when they’re more tightly packed together as they are in the fovea, the region of the retina responsible for the highest level of visual acuity and color discrimination. The entire landscape of cones and rods is referred to as the photoreceptor mosaic.
Advanced imaging systems are widely used for observing retinal tissue and are essential tools for diagnosing and studying retinal diseases. But even with adaptive optics retinal imaging, a technique that compensates for light distortions using deformable mirrors and computer-driven algorithms, there are still some areas of the photoreceptor mosaic that are challenging to image, according to the first author of the paper, Rongwen Lu, Ph.D., a postdoctoral fellow in the Clinical and translational Imaging Unit at NEI.
“Sometimes rods are hard to image because they are so small,” Lu said. “By eliminating some of the light in the system, it actually makes it easier to see the rods. So, in this case, less is more.”
In this latest report, Tam’s team at NEI, with help from researchers at Stanford University, Palo Alto, California, sought to push the resolution of adaptive optics retinal imaging further by strategically blocking some of the light to image the retina.
By blocking the light that illuminates the eye in the middle of the beam, to create a ring of light (rather than a disk), the NEI-led team improved the transverse resolution (across the mosaic). But that came at the expense of axial resolution (mosaic depth). To compensate, Tam’s team blocked the light coming back from the eye using a super small pinhole, called a sub-Airy disk, which recovers the axial resolution that would have been lost using the ring of light alone.
Combining the ring illumination with the sub-Airy disk imaging results in the best of both worlds, Tam said. The tweaked technique yields about a 33% increase in resolution, which makes it much easier to see rods, as well as sub cellular details within cones.
Their technique also enhanced the visualization of the photoreceptor mosaic with another technique called non-confocal split-detection, which is yet another type of microscopy that provides a complementary view of the photoreceptor mosaic.
The work was supported in part of NEI grants U01 EY025477, and by the Intramural Research Program at NEI, part of the National Institutes of Health.
March 11: U.S Department of Health and Human Services (HHS) posted News titled: “Biden Administration to Expand COVID-19 Vaccine Program to 950 Community Health Centers”. From the News:
As part of President Biden’s commitment to ensure the nation’s underserved communities and those disproportionately affected by COVID-19 are equitably vaccinated, this week the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA) and the Centers for Disease Control and Prevention (CDC), is announcing that an additional 700 HRSA-supported health centers will be invited to join the Health Center COVID-19 Vaccine Program. These health centers will have the opportunity to join the program over the next six weeks, increasing the total number of invited health center partners to 950.
HRSA-funded health centers are community-based and patient-directed organizations that deliver affordable, accessible, quality, and cost-effective primary health care. Over 91% of health center patients are individuals or families living at or below 200% of the Federal Poverty Guidelines and nearly 63% are racial/ethnic minorities. Health centers across the nation are playing vital roles in supporting local community responses to the COVID-19 public health emergency.
The additional 700 centers invited to participate in the next phase of the program include those that serve high proportions of low-income and minority patients, provide services to rural or frontier populations, operate Tribal/Urban Indian Health Programs, and/or utilize mobile vans to deliver services.
250 health centers have already been invited to participate in this program, and include those that serve a large volume of the following disproportionately affected populations: individuals experiencing homelessness, public housing residents, migrant/seasonal agricultural workers, or patients with limited English proficiency.
To view a list of the health centers participating in or invited to join the program please visit: https://www.hrsa.gov/coronavirus/health-center-program.
To locate a HRSA-funded health center, visit: https://findahealthcenter.hrsa.gov/
March 11: National Institutes of Health (NIH) posted a News Release titled: “NIH awards grants to support bacteriophage therapy research”. From the News Release:
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded $2.5 million in grants to 12 institutes around the world to support research on bacteriophage therapy. These awards represent NIAID’s first series of grants focused exclusively on research on this therapy, an emerging field that could yield new ways to fight antimicrobial-resistant bacteria. A 2019 report from CDC found that antibiotic-resistant pathogens cause more than 2.8 million infections in the U.S. each year and more than 35,000 people die.
Bacteriophages (or “phages”) are viruses that can kill or incapacitate specific kinds of bacteria while leaving other bacteria and human cells unharmed. By gathering naturally-occurring phages, or by modifying or engineering phages to display certain properties, researchers hope to create novel anti-bacterial therapeutics. Because phages eliminate bacteria by infecting them, rather than by generating compounds like antibiotics which kill bacteria, phages can be used to treat antibiotic-resistant infections. In addition, some evidence suggests that combination therapy containing both phages and antibiotics could prevent bacteria from becoming drug resistant.
Although scientists have been aware of phages and their ability to kill bacteria since 1917, the first U.S.-based clinical trials of phage therapy have only recently begun. Individual U.S. patients have received phage therapy, but only under emergency investigational new drug protocols. In Eastern Europe, where the use of phage therapy is more prevalent, its efficacy has not been rigorously demonstrated.
“In recent decades, multidrug-resistant bacteria, particularly those that cause potentially deadly diseases like tuberculosis, have become a serious and growing public health concern,” said NIAID Director Anthony S. Fauci, M.D. “With these awards, NIAID is supporting research needed to determine if phage therapy might be used in combination with antibiotics – or replace them altogether – in treating evolving antibiotic-resistant bacterial diseases.”
The new NIAID grants support research to address key knowledge gaps in the development of phages as preventative and therapeutic tools for bacterial infections. Basic research supported by these grants will include a study characterizing different types of phages; a project studying how phages combat sticky, sheet-like colonies of microorganisms called biofilms, which can be difficult to treat with antibiotics; and research to determine how to identify new, potentially useful phages. Some translational research supported by these grants will study how to exploit the interaction between phages and bacteria to create lasting, re-usable therapeutics; and engineering viruses to combat Staphylococcus bacteria.
The recipients of the awards are as follows:
University of Pittsburgh
Principal Investigator: Graham F. Hatfull, Ph.D. – Phage resistance in Mycobacterium tuberculosis
Principal Investigators: Minmin Yen, Ph.D., MPH, and Andrew Camilli, Ph.D. – Targeting antibiotic resistance genes in Vibro cholerae using a phage-encoded CRISPR-Cas system to improve efficacy of phage prophylaxis
University of Connecticut (Storrs)
Principal Investigator: Simon White, Ph.D. – Characterization of long-circulating phages isolated from in vivo mouse studies
Georgia Institute of Technology (Atlanta)
Principal Investigator: Samuel Paul Brown, Ph.D. – Building re-usable phage and antibiotic treatments via exploitation of bacteria-phage co-evolutionary dynamics
University of Wisconsin-Madison
Principal Investigator: Srivatsan Raman, Ph.D. – Understanding molecular rules governing bacteriophage specificity and virulence by high-throughput mutational and metagenomic scanning.
Texas A&M Agrilife Research (College Station)
Principal Investigators: Lanying Zeng, Ph.D., Junjie Zhang, Ph.D. – Reducing virulence through the suppression of retractile pilli
Queens College, City University of New York
Principal Investigator: John Joseph Dennehy, Ph.D. – Novel strategies for treating biofilm-forming pathogens with phage therapy
Harvard School of Public Health (Boston)
Principal Investigator: Eric J. Rubin, M.D., Ph.D. – Using genetics and multi-scale imaging to understand the mechanisms underlying emycobacteriophage host choice
Guild Associates, Inc. (Dublin, Ohio)
Principal Investigator: Ian Fleming, Ph.D. – Optimized methods for isolation and characterization of bacteriophage by VT-FACS
Geneva Foundation (Tacoma, Washington)
Principal Investigator: Yohann Stephane Le Breton, Ph.D. – A platform for genome mining of multidrug-resistant pathogens to develop therapeutic phages using synthetic biology.
University of Alabama at Birmingham
Principal Investigator: Terje Dokland, Ph.D., and Asma Hatoum, Ph.D. – Engineering picoviruses with defined host range to combat drug-resistant staphylococci
Albert Einstein College of Medicine (New York)
Principal Investigator: William Robert Jacob Jr., Ph.D. – TB phage therapy: Optimizing delivery methods of mycobacteriophages to target intracellular Mycobacterium tuberculosis
March 11: National Institutes of Health posted a News Release titled: “Preterm birth, prolonged labor influenced by progesterone balance”. From the News Release:
Novel research in mice sheds light on hormone regulation needed in late pregnancy, opens doors for therapy.
New research by the National Institutes of Health found that unbalanced progesterone signals may cause some pregnant women to experience preterm labor or prolonged labor. The study in mice – published in the Proceedings of the National Academy of Sciences – provides novel insights for developing treatments.
During pregnancy, the hormone progesterone helps to prevent the uterus from contracting and going into labor prematurely. This occurs through molecular signaling involving progesterone receptor types A and B, referred to as PGR-A and PGR-B. In this first-of-its-kind study, the scientists showed how unbalanced PGR-A and PGR-B signaling can affect pregnancy duration.
“We used genetically engineered models to alter the ratio of PGR-A and PGR-B in the muscle compartment of the uterus, called the myometrium,” said senior author Francesco DeMayo, Ph.D., head of the National Institute of Environmental Health Services Reproductive and Developmental Biology Laboratory. “Our team found that PGR-A promotes muscle contraction and PGR-B prevents such contraction, and we identified the biological pathways influenced by both forms.”
Previous research showed that PGR-A regulates processes involved in initiating childbirth and that PGR-B affects molecular pathways related to maintaining the normal course of pregnancy. This study builds on those findings, revealing that the relative abundance of PGR-A and PGR-B may be critical in promoting healthy pregnancy. The public health implications are significant.
Preterm birth affects 10% of all pregnancies and is the primary cause the neonatal morbidity and mortality worldwide, while prolonged labor increases the risks of infection, uterine rupture, and neonatal distress, according to the researchers.
The scientists pointed out that care for preterm deliveries can result in high social and economic costs, with infants born preterm at greater risk for experiencing disorders ranging from blindness to cerebral palsy. Prolonged labor can harm both mother and infant and lead to cesarean delivery.
Progesterone treatment aimed at preventing premature labor can help a subset of patients, but for other individuals, confounding factors may reduce effectiveness, noted Steve Wu, Ph.D., first author on the study and a staff scientist in DeMayo’s lab. Wu said that the research team found novel molecules that control uterine muscle contraction, and they could serve as future therapeutic targets. He added that the current study also may help to advance treatment for labor dystocia – the clinical name for abnormally slow or protracted labor.
“Although labor stimulation by oxytocin infusion is an approved measure to mitigate labor dystocia, serious side effects have been associated with this treatment,” said Wu. “Novel proteins that we identified as being part of progesterone signaling could serve as a key molecular switch of uterine contraction, through drug-dependent regulation of their activities,” he explained.
“Hormone signaling in pregnancy is complicated and involves both the hormone levels and the types of receptors in the uterus that sense the hormones,” said co-first author Mary Peavey, M.D., from the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. “This publication sheds light on how hormones influence labor and can thus be used to help women when the uterus goes into labor too soon for a prolonged period.”
This news release describes a basic research finding. Basic research increases our understanding of human behavior and biology, which is foundational to advancing new and better ways to prevent, diagnose, and treat disease. Science is an unpredictable and incremental process -each research advance builds on past discoveries, often in unexpected ways. Most clinical advances would not be possible without the knowledge of fundamental basic research. To learn more about basic research, visit https://www.nih.gov/news-events/basic-research-digital-media-kit.
March 12: U.S. Department of Health and Human Services (HHS) posted News titled: “Biden Administration Takes Action Through HHS to Increase Number of Vaccinators”. From the News:
HHS amends PREP Act declaration to increase COVID-19 vaccine workforce.
As part of President Biden’s national strategy to defeat the pandemic, and following his speech last night outlining the Administration’s next steps in the war-time effort to speed COVID-19 vaccinations, the U.S. Department of Health and Human Services (HHS) has taken action to expand the pool of qualified professionals able to serve as vaccinators.
HHS has used its authority under the Public Readiness and Emergency Preparedness Act (PREP Act) to add additional categories of qualified people authorized to prescribe, dispense, and administer COVID-19 vaccines authorized by the U.S. Food and Drug Administration, including dentists, EMTs, midwives, optometrists, paramedics, physician assistants, podiatrists, respiratory therapists, and veterinarians.
This action also authorizes medical students, nursing students, and other health care students in the professions listed under the PREP Act with proper training and professional supervision to serve as vaccinators.
“As President Biden said last night, the key to getting us back to our lives is increasing vaccinations, and in order to do that, we need more vaccinators,: said Acting HHS Secretary Norris Cochran. “As vaccine supply ramps up, we want to be sure communities have the help they need to get shots into arms for anyone in the U.S. who wants to be vaccinated against COVID-19.”
As hundreds of millions more vaccine doses are manufactured and distributed throughout the country, today’s announcement provides a pathway for states to expand and support their vaccination workforce if needed. People interested in administering vaccinations should visit PHE.gov/COVIDvaccinators to determine if they are eligible.
More information about the PREP Act can be found at PHE.gov.
March 12: The White House posted a Press Briefing titled: “Press Briefing by White House COVID-19 Response Team and Public Health Officials”. From the Press Briefing:
Mr. Zeints: Thank you everybody for joining us today. Today, we will get a state-of-the-pandemic update from Dr. Walensky, Dr. Fauci will highlight the latest science, and Dr. Nunez-Smith will discuss our focus on equity.
But first, I want to start by giving an overview of the President’s address to the nation. Last night, President Biden announced that all Americans will be eligible for vaccinations no later than May 1. All Americans no later than May 1. And the President put the nation on a path to get closer to normal by the 4th of July.
As many of you remember, on the President’s first full day in office, he outlined a comprehensive strategy to beat this pandemic. We’ve spent every day since then executing against that strategy, and we are making progress.
As you can see on our weekly vaccination progress report, the current seven-day average – the dark bar on the far right – is 2.2 million shots per day. That’s a new record pace that we will continue to build on.
On Inauguration Day, only 8 percent of Americans 65 and over had gotten their first vaccination. Today, that number is nearly 65 percent. This is important because 80 percent of COVID deaths have been individuals 65 and over. So we’re making progress, but there’s more work to do.
Last night, Americans heard the President say that all we – that all of us need to do our part, and that if we do, there’s a good chance that families and friends will be able to safely gather in small groups to celebrate Independence Day.
I want to walk through the key components of our effort moving forward, starting with May 1 eligibility. The President will direct states, tribes, and territories to make all adults eligible for the vaccine no later than May 1st. That’s earlier than expected and reflects our success in working with vaccine manufacturers to increase supply and in securing doses for all adult Americans, and also our progress in increasing both the number of vaccinators and the number of places that people can get vaccinated.
Now, that does not mean that everyone will get a shot immediately, but May 1st is the date every adult will be eligible to sign up to get the shot. And by the end of May, we expect to have enough vaccine supply available for all adults in this country.
To help ensure that we turn vaccine supply into shots and arms, the President announced that we will continue to increase the number of vaccinators in the place – the number of places to get vaccinated. First, over the coming weeks, we will deliver vaccines directly to up to 700 additional community health centers that reach underserved communities, brining the total number of these community health centers participating in our federal vaccination program to 950.
Second, we will work to double the number of pharmacies participating in the Federal Pharmacy Program. We will make the vaccine available at more than 20,000 pharmacies across America.
And the administration is instructing these pharmacies to expand mobile operations into the hardest-hit communities to reach more people.
Third, the administration will more than double the number of federally run mass vaccination centers to ensure that we hit the hardest-hit communities – sorry, to ensure that we reach those hardest-hit communities. Many of these sites will include mobile operations to further reach out to underserved communities and deliver thousands of shots per day.
Today, in fact, I’m pleased to announced the addition of a new FEMA-supported site in Detroit. This site, located at Ford Field, home of the Detroit Lions, has the ability to administer 6,000 shots per day. And last night, President announced the deployment of more than 4,000 active-duty troops to support vaccination efforts, bringing the total troop deployment to over 6,000.
Fourth, we will increase the number of vaccinators – people who can administer shots in arms. Dr. Nunez-Smith will talk about the importance of today’s PREP Act amendment to increase the total number of vaccinators in the field.
Now, we know the work to increase vaccine supply, vaccinations and places to get vaccinated is not enough on its own. We need to make it easier for every American to get vaccinated. Too often, it’s too difficult, too time consuming, and too frustrating for people to identify where vaccines are available and where to schedule an appointment.
That’s why the President, last night, announced steps to make it easier for individuals to find a vaccine near them.
By May 1st, as vaccines are available in more places, the administration will launch a federally supported website that will show the locations near them that have available vaccines.
And because we know that not everyone has Internet access or is comfortable online, we will also launch a call center to provide assistance in finding a vaccine. Since so many Americans use their state and local websites to schedule vaccine appointments, the administration will also deploy technology teams to help improve these systems.
Reopening schools safely is critical to getting closer to normal. Last night, President Biden discussed additional steps in our efforts to reopen schools. Now that the American Rescue Plan is law, $130 billion will help schools pay for critical supplies to implement CDC’s mitigation strategies, hire more staff, and support children’s academic, social, and emotional needs. And we’re getting educators vaccinated.
Last week, the President announced that he’s using the administration’s authority to direct states that haven’t yet prioritized pre-K-through-12 school staff and childcare workers for vaccinations to do so immediately.
As we work to get more people vaccinated, we need to expand testing, diagnostic screening, and genomic sequencing. With the American Rescue’s Plan $1.7 billion investment, we will dramatically expand our ability to sequence to identify, track, and mitigate emerging variants. And the administration will use the nearly $50 billion in testing that comes from the funding in the American Rescue Plan to invest in screening and testing to help schools reopen safely, and also to expand testing in congregate settings, including shelters for individuals experiencing homelessness, prisons, and other settings where individuals live in close quarters.
Across the next several weeks, the CDC will provide health guidance based on the best available science and the pace of vaccinations for people as they travel, participate in small gatherings, and go to work, and in houses of worship.
Also, as we increase the number of people vaccinated, we know some people may have a need to demonstrate that they are vaccinated. The private sector and not-for-profit coalitions are already beginning to work on this. Our role is to help ensure that any solutions in this area should be simple, free, open source, accessible to people both digitally and on paper, and designed from the start to protect people’s privacy.
As the President noted last night, this fight is far from over. We still have a lot of work to do. This is certainly not a time to put down your guard. Mask up and follow the public health standards. We need all Americans to get vaccinated as soon as it’s their turn, and to help your family and friends and neighbors get vaccinated, as well.
Together, unified, we can defeat this pandemic, and we can all celebrate a more normal Fourth of July with our family and friends, gathering in small groups, to celebrate the holiday.
With that, I’ll turn it over to Dr. Walensky. Dr. Walensky?
Dr. Walensky: Thank you, Jeff. It’s good to be back with you all today. We are now officially one year and one day into the COVID-19 pandemic. As I reflect back on the near-impossible clinical decisions we had to make to prioritize scant resource s- ventilators and PPE – I recall those moments, and I’m sure many of you shared them, where I felt powerless and hopeless. And here we are, one very long year later, led by science and propelled by a growing sense of hope that we can and we will get out of this together.
But cases and hospitalizations and deaths remain high, and we’ve been fooled before into being too lax. So now is the time to double down to see this through.
CDC’s most recent data shows cases continue to fluctuate between 50- and 60,000 new cases per day, with the most recent seven-day average being more than 55,500 cases per day. The most recent seven-day average of hospital admonitions continues to decline, down from the previous seven-day period to about 4,900 admissions per day. We also continue to see around 1,500 to 1,800 deaths per day, with the latest seven-day average being just over 1,500 deaths per day.
I’m encouraged by these data, but we much – must remain vigilant to continue in our efforts to get cases, admissions, and deaths down.
We’re making remarkable progress on our vaccination efforts. We now have more than 64 million people who received at least one dose of the vaccine, and we are vaccinating millions more each day. This is our path out of the pandemic. As you heard last night from the President, we are working as quickly as we can to ensure that every American has access to vaccine.
As we get more vaccinations into communities, I am asking everyone to do the right thing: Continue taking public health precautions and be ready to roll up your sleeve when that vaccine is available to you.
Throughout the pandemic, parents and caregivers have faced the challenging task of balancing childcare responsibilities with work responsibilities, often operating in virtual environment, with limited childcare options. We know that childcare programs and early childhood education are essential to healthy childhood development. The services these programs offer are important for working parents and provide a safe, stable, and nurturing environment for kids to get them ready for school and develop critical social and emotional skills.
Like other businesses and community services, many childcare programs have been challenged in their response to the pandemic. Early last year, CDC released initial guidance for childcare programs during COVID-19. As we learned more about the virus, CDC experts updated that guidance several times throughout 2020.
Today, CED is releasing updated guidance based on the most recent science. That science includes additional evidence showing that, when used consistently and correctly, prevention strategies such as mask wearing, staying home while sick, and good hand hygiene can allow childcare programs to operate safely and reduce the spread of COVID-19.
This updated guidance is intended for all types of childcare providers, including childcare centers, family childcare homes, Head Start programs, and pre-kindergarten programs, and is meant to supplement, not to replace, other laws, rules, or regulations that childcare programs must follow.
The guidance includes strategies that childcare programs can use to maintain healthy environments and operations, to lower the risk of COVID-19 clusters in their programs, to prepare for when someone is sick with COVID-19, and to support coping and resilience for their staff and children and parents they serve.
Critically, the updated guidance evidence – emphasizes the importance of mask wearing for all children older than two years old and all staff, except when eating or sleeping. It also highlights strategies such as cohorting, where groups of children are kept together with the same peers and staff to reduce the risk of spread throughout the program. The guidance also provide recommendation on simple, low-cost ventilation strategies, how to adapt the environment for children with disabilities and special needs, and ways to make spaces, such as communal spaces, food service areas, and other – and play areas safer.
Recognizing that guidance can sometimes be complex, we’re also releasing a suite of complementary resources, infographics, and toolkits to help programs with implementation. For example, we have included quick guides and flowcharts to help you know what to do if a child become ill or is showing signs of COVID-19 while in care. All of these resources, along with the guidance, are now available at CDC.gov. I hope that childcare providers will view the guidance as a one-stops shop for strategies they can use to safely provide care and enrichment to our nation’s children.
In addition, I’m excited to note that the American Rescue Plan, signed by the President yesterday, includes $24 billion in emergency funding to help support childcare providers. This funding can be used to pay for rent, utilities, and staff, but also to help childcare providers implement COVID-19 prevention strategies.
I also want to stress that our childcare guidance emphasizes the importance of COVID-19 vaccination as an additional layer of protection for childcare workers. I strongly encourage America’s childcare workers to get vaccinated.
Last week, President Biden directed all states to prioritize childcare workers as well as K-through-12 teachers and school staff for COVID-10 vaccination in March.
CDC is taking a leading role in helping to achieve the President’s goal through our Federal Retail Pharmacy program. We now have over 9,000 pharmacies participating nationwide, while childcare workers are being prioritized for vaccination appointments.
If you are a childcare worker and want to get vaccinated, please visit CDC.gov and check out the pharmacy partners that are participating in your state. Our website also provides information on where to go to schedule your appointment.
And if you are a childcare center whose workers don’t uniformly have access to the web, please work with your center and your community to assist them in making appointments.
Finally, as we’re taking about the impact of this pandemic has had on childrens and family, I want to share with you another concerning way that COVID-19 is affecting the health of our nation: disrupting our ability to vaccinate children against other infectious disease. On-time vaccination throughout childhood is essential because it helps to provide immunity before child – children are exposed to potentially life-threatening disease.
During the pandemic, we have seen substantial declines in pediatrician visits. And because of this, CDC orders for childhood vaccinations dropped by about 11 million doses – a substantial and historic decline.
As we work to get our children back to school, we certainly do not want to encounter other preventable infectious outbreaks such as measles and mumps. When planning for your child’s safe return to childcare programs or to school, please check with your child’s doctor to make sure that they are up to date on their vaccines. As if they did – and if they did fall behind, they can be caught up by following the CDC’s catch-up immunization schedule available on the CDC website.
This pandemic has taken so much from us already. We must work together to protect our children’s health now and in the future.
Thank you. I’ll now turn things over to Dr. Fauci.
Dr. Fauci: Thank you very much, Dr. Walensky. I’d like to spend just a few minutes on updating you from something I spoke about a couple of pressers ago regarding therapy and, in some respects, prevention of COVID-19 disease.
If I could have the next slide.
This is a slide, again, which I had shown previously. And the reason I repeat it is because what I’m going to tell you over the next two or three minutes relates to things that will be very useful if one consults the treatment guidelines, which, as I mentioned, is a living document which is updated on a regular basis as new clinical data come in.
The reason why I point this out is that, recently, there has been a considerable amount of information regarding some of the monoclonal antibodies that are used in the prevention and treatment of COVID-19.
Recall, a week or so ago, I spoke to you about the direct antiviral agents the we are pursuing in a very proactive way. What we’re going to be talking about in the next minute or two are the monoclonal antibodies.
So just to orient you, there are a number of monoclonal antibodies, not all of the, directed against the virus itself. For example, toclizumab is an anti-IL-6 receptor antibody from Genentech. I’ll get to that in a moment.
The monoclonal antibodies that are directed against the SARS-CoV-2 spike protein – usually the receptor-binding domain – are bamlanivimab from Lilly, estesevimab from Lilly, the VIR-7831 by VIR-GSK, and a cocktail from Regeneron called casirivimab and imdevimab – again, from Regeneron.
So let’s just go to the next slide.
We’ll talk about monoclonal antibodies for COVID-19 treatment.
I had mentioned that tocilzumab – there was a recent guideline alert from the NIH, which showed that this particular monoclonal antibody in combination with dexamethasone, for certain advanced hospitalized patients, namely patients who were exhibiting rapid respiratory decompensation, showed that it was useful in the treatment of these individuals who are exhibiting this rapid progression of disease.
Now getting to the monoclonal antibodies against the virus itself, the combination of bamlanivimab and etesevimab recently – literally a couple of days ago at the CROI Conference, which is the Conference on Retroviruses and Opportunistic Infections. I point that out to you – is that many of the researchers who had previously devoted their careers to studying HIV have now pivoted because of the emergency nature of COVID-19. In this study reported at CROL, in individuals who were ambulatory – with the question being asked, “Can we keep them out of the hospital?” – it showed a 70 percent reduction in COVID-related hospitalizations and deaths, by any cause, by day 29 in people who received this combination as opposed to placebo.
There was another study by Vir – which is a combination of the Vir Biotechnology Company and GSK – who announced that their product, VIR-7831 – again, in ambulatory patients – reduced hospitalization and risk of death with an 85 percent reduction when you look at this compared to placebo.
Very quickly now, looking at monoclonal antibodies for COVID-19 prevention, as opposed to treatment: In this study reported a couple of days ago, bamlanivimab prevented COVID-19 morbidity and mortality in the nursing home setting. What does that mean? It meant that in an individual where you have infection in a nursing home, and you looked at the groups – be they staff or residents – who were randomized to placebo versus bamlanivimab, there was an 80 percent reduction in the incidence of moderate or worse COVID-19 at eight weeks.
Here again is the Regeneron COV antibody cocktail that I mentioned just previously. In this situation, it was within a household setting – in other words, where there is a infection in the household setting – and you’re looking at the results of randomized – the family members, either to take this cocktail or to placebo, to determine if you can prevent, namely, a post-exposure prophylaxis, or if you can treat early disease.
The results were really dramatic. There was 100 percent protection against symptomatic infection in the group, compared with placebo. And it reduced the overall infection rate by 50 percent. And importantly, those who were infected had 100-fold lower viral load and shorter duration of the detectable viral RNA.
Now, the reason I show you the slide on the NIH treatment guidelines is that this is a very fluid area of research, particularly since , as I mentioned on a previous presser, that these monoclonal antibodies can be knocked out, particularly when given as mono therapy, by different variants – which is the reason why, as we go on – and I will report to you at future meetings – you’ll see mostly combinations of these antibodies, as opposed to single ones, because the single ones are most vulnerable the variants that can knock them out easily.
I’ll stop there and turn it over to Dr. Nunez-Smith.
Dr. Nunez-Smith: Thank you so much, Dr. Fauci. It’s great to be here. I’m just going to return us to vaccines for a moment. So, you know, a doctor, as a frontline worker myself, I am very excited to see that more of my healthcare colleagues now have the chance to further expand their participation in the response.
You know, as Jeff said, expanding the number of places people can get vaccinated, as well as a number of vaccinators – that’s going to be critical for us as we drive an equitable response.
You know, we are faces with this reality that marginalized and minoritized communities are often the first to be forgotten, especially when resources are in short supply. And so we remain very committed to disrupting that narrative.
You know, with today’s announcement, up to 700 new community health centers coming online, a doubling of pharmacy locations, and a surge in vaccinators, we’re ensuring that equity remains at the center of our response.
So I want to just take a minute to touch on the newly eligible vaccinators. You know, to help meet the demand for more shots in arms once everybody is eligible for vaccines come May 1, the administration is expanding the pool of qualified professionals who will be able to administer shots. And so this list now includes dentists, optometrist, paramedics, physician assistance, and many more, including trained medical and healthcare students.
You know, alongside this effort, the Department of Health and Human Services will launch a new portal to help individuals determine where they can sign up to volunteer to administer shots.
We know a person’s zip code is a stronger driver of health than their genetic code, so we will continue to prioritize getting the necessary resources to those areas and communities that have been hit hardest and are at highest risk.
As we fight against centuries of structural inequities, we must be intentional about making vaccination easy and convenient for everyone, and key to that effort is having enough vaccinators to deliver shots in arms. So I encourage my fellow healthcare colleagues to visit the new portal at PHE.gov. Check your status and sign up to help.
So, thanks so much in advance. And with that, I’ll turn it back over to you, Jeff.
Mr. Zeints: Well, thank you. Let’s open it up for questions.
MODERATOR: All right, we’ll start doing questions now. Just a reminder to please keep your question to one question so we can get through as many as possible.
First we’ll got to Carl O’Donnell at Reuters.
Q: Hey, one things I wanted to ask you: So there’s been, you know, some commentary lately from a number of different – from a number of different groups about the impact of U.S. export controls on, you know, both efforts in places like India to scale up the global supply and also, you know, AstraZeneca’s ability to get shots to the EU, where it’s already been authorized.
Just wondering if you can sort of share any views that you guys have on that and whether, you know, there’s any reassessment for, you know, how to make sure that the global supply chain is streamlined.
Mr. Zeints: So, you know, the President has been very focused on fulfilling his responsibility to the American people. And we as a country have suffered over a half million deaths – more than any country in the world – so we’re rightly focused on getting Americans vaccinated as soon as possible. And, you know, as we’ve talked about, we’re pleased with the progress, and there’s yet a long road ahead.
However, we know this is a global pandemic and that the virus has no borders. That’s why the President is providing – the United States is providing the most funding or any country to COVAX – over $4 billion. It’s why we – the President, on his first day in office reengaged with the WHO. And that’s why just today, this morning, I participated in the Quad meeting with the President, and it was announced that we’re working to achieve expanded manufacturing of sale and effective COVID-19 vaccines at facilities in India. And we also believe that the historic partnership between J&J and Merck will help expand capacity and ultimately benefit the world.
So we will continue to prioritize getting all Americans vaccinated as quickly as possible while at the same time understanding this is a global pandemic and making as big a contribution as we possibly can to worldwide efforts to get everyone else vaccinated.
MODERATOR: Next question will go to Kaitlan Collins at CNN.
Q: Thanks very much. I have two questions – one super quick. One is: How many people do you actually want to see vaccinate by July 4th in order to meet that goal of having those small gatherings that the President was talking about?
And secondly – I think this is probably best for Jeff, but you all have said we’ll have enough vaccine for everyone by the end of May – not that everyone will get it by then. But if we’re looking at these numbers, it looks like Moderna will have 200 million by then, Pfizer 200 million, and Johnson & Johnson 20 million. So, that’s enough, based on my math, for about 220 million people. So where are those other vaccines coming from in order to have enough for all eligible Americans by the end of May?
Mr. Zients: So, Kaitlan, I think your 20 million is the figure that Johnson & Johnson has talked about in terms of their cumulative doses by the end of the month. The work that we did, working with Johnson & Johnson and Merck to accelerate their manufacturing process – particularly the fill-finish piece, which is relevant in this timeframe – has it so that Johnson & Johnson is now delivering at or near its 100 million by the end of May.
So if you take the 200 million doses by the end of May, of Moderna, plus the 200 million doses of Pfizer, plus the at or near 100 million completion of the Johnson & Johnson first contract, that is more than enough supply to vaccinated – vaccine supply to vaccinate all Americans by the end of May.
Now, we need to ramp up the number of vaccinators, as we’ve been talking about, and the number of places where Americans can get vaccinated so that when all adults are – Americans are eligible on May 1st, we can accelerate and move very quickly to get as many Americans vaccinated as soon as possible.
Dr. Walensky: Maybe I’ll just address the second – the first question, and that is: We’re still not looking at a single metric of a fraction of people vaccinated in a vacuum. We’re looking at it in the context of what’s going on with the pandemic, as well. So I don’t think we can put a single metric on that, as well as what’s happening in – what science has emerged with regard to vaccinated people. So, it’s hard to put a metric on a single number.
MODERATOR: Great. Next question will go to Chyenne Haslett at ABC.
Q: Hi. Thanks for taking my question. How likely do you think it will be that states can open up to every adult before May, when it comes to that vaccine supply? And when should states really be expecting the floodgates to open on vaccines?Mr. Zeints: Well, I think that the key here is that May 1 is a date that the President will direct using his authorities. There, hopefully, will be states – and we already have one in Alaska – that open up before then, and we’re doing everything we can to encourage states to get as many needles in arms as fast and efficiently as possible.
And this is where increasing the number of vaccinators, the number of laces, the can community vaccination centers, the federal pharmacy channel, the community health centers – as we welcome those efforts, we can accelerate from the 2.2 million rate that we’re having on average per day now – hopefully, we can accelerate that further. And there will be states that open before May 1, but May 1 is an absolute deadline for all Americans to be eligible to receive the vaccine.
MODERATOR: Next question will go to Sean Sullivan at The Washington Post.
Q: Thanks very much. Can you talk a little bit about why the President felt the need to set out specific dates in his speech last night, and also how you intend to manage the public’s expectation of what will happen by those dates? As you’ve pointed out and as the President pointed out, you know, things could change, the situation could change. But how do you manage expectations from a public that might not always be paying attention to some of those developments, caveats that could make things change?
Mr. Zeints: So I think it’s – I think we all would agree that it’s important to have deadlines and goals, and we spent a lot of time working through the supply, the number of places, the number of vaccinators, and we believe May 1st is the right deadline. No later than May 1st.
So we will have enough supply, as we talked about, by the end of May, given all the President’s work and leadership to bring forward the supply and create enough supply for all adult Americans by May 31st. We will have enough vaccinators and enough places for people to get vaccinated.
And the funding from the American Rescue Plan really helps to ensure that we will have that capacity to do the 2.2 million shots per day that we’re currently doing, and hopefully to accelerate off of the pace as we add more places and vaccinators.
MODERATOR: All right. We got time for one more question. We’ll go to Zeke at AP.
Q: Thank you all for doing this. First, for Jeff, can you speak to – with the expansion in the retail pharmacy program and as well as the community health center program, how many doses are you starting to divert into that – into that stream – that fairly controlled stream? I know you’ve told the governors that their allocation will remain largely static for the coming weeks.
And then, just another one on the AstraZeneca, in particular: With the stockpile of millions of doses here in the United States that aren’t approved here but they can be used overseas, with that EUA still up in flux, why not just send those vaccines oversees right now to help out and save some lives, with American allies in particular?
Mr. Zeints: Well, the allocation that we’ll make on a going-forward basis will be based on performance of the different channels. And performance is a function of speed and efficiency, but as Dr. Nunez-Smith talked about, as importantly, equity and fairness. The next couple of weeks of supply overall are relatively flat before supply really starts to accelerate towards the end of the month, and then into April and May.
Now when I say “relatively flat” – at a level that’s more than twice what it was six or seven weeks ago. So allocation will be based on performance, and we believe that community health centers are particularly important in order to reach hard-to-reach communities and to ensure fairness and equity. The pharmacy program is also structured around fairness and equity. So we’ll make future allocations based on performance.
As to AstraZeneca, we’re following the exact same process that we did with the other three now-approved vaccines – Moderna, Pfizer, and J&J. And just as we did with those vaccines, as we awaited for the completing of the clinical trial – and right now, my understanding of when they submit the data from the clinical trial, we have a small inventory of AstraZeneca so that, if approved, we can get that inventory out to the American people as quickly as possible, as we just did with J&J. So, AstraZeneca, we’re awaiting the clinical trial and then the decision by the FDA and CDC.
I think that’s it on questions. I want to thank everybody for joining today, and we look forward to seeing you on Monday. Thank you.
March 12: U.S.Department of Health and Human Services (HHS) posted News titled: “HHS and DHS Joint Statement on Termination of 2018 Agreement”. From the News:
Today, the U.S. Department of Health and Human Services (HHS) and the U.S. Department of Homeland Security (DHS) announced the termination of a 2018 agreement that undermined the interests of children and had a chilling effect on potential sponsors (usually a parent or close relative) from stepping up to sponsor an unaccompanied child placed in the care of HHS. In its place, DHS and HHS signed a new Memorandum of Agreement that promotes the safe and timely transfer of children. The new agreement does not change the safeguards designed to ensure unaccompanied children are unified with properly vetted sponsors who can safely care for them while they await immigration proceedings.
March 12: U.S. Food and Drug Administration (FDA) posted a News Release titled: “Coronavirus (COVID-19) Update: March 12, 2021” From the News Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
As part of the FDA’s effort to protect consumers, the agency issued a warning latter to Cannafyl for selling unapproved products with fraudulent COVID-19 claims. The company sells CBD-containing products, including “Balance CBD Drops”, “Relief CBD Drops”, “Relax CBD Drops” and “Relief CBD Salve,” and misleadingly represents the products can mitigate, prevent, treat, or diagnose or cure COVID-19 in people. The FDA requested that Cannafyl take immediate action to cease the sale of any unapproved and unauthorized products for the treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
Today, the FDA issued a Letter to Clinical Staff, Point-of-Care Facility Staff and Health Care Providers to alert them that false positive results can occur with the Roche Molecular Systems, Inc. cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System.
Today, the FDA issued an Emergency Use Authorization (EUA) for Propofol-Lipuro 1% injective emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved propofol drugs; providers should consult the Health Care Provider Fact Sheet for more information before administering it.
As of today, 341 tests and sample collection devices are authorize by the FDA under EUAs. These include 254 molecular tests and sample collection devices, 72 antibody and other immune response tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, one OTC at-home antigen test and one OTC molecular test.
March 12: U.S. Department of Health and Human Services (HHS) posted News titled: “Fact Sheet: The American Rescue Plan: Reduces Health Care Costs, Expands Access to Insurance Coverage and Addresses Health Care Disparities”. From the News:
The Biden-Harris Administration is reducing health care costs, expanding access to coverage, and ensuring nearly everyone who buys their own individual or family health insurance through a Marketplace can receive a tax credit to reduce their premiums. The American Rescue Plan (ARP) not only provides the resources for America to beat this pandemic, but it also expands access to health insurance coverage, lowers costs, and ensures that health care is truly a right for all Americans.
It’s Working: After the Biden-Harris Administration made available a Special Enrollment Period through the Federal Marketplace from February 15 to May 15 for people who needed health care coverage during the pandemic, more than 200,000 people signed up for Marketplace coverage through HealthCare.gov in the first two weeks – a three-fold year over year increase. Now following the passage of the ARP more than 14.9 million Americans who currently lack health insurance and many current enrollees will receive additional financial support to find the coverage that best meets their needs at a price they can afford.
More Affordable Options are Available: Many people who enroll in health coverage through HealthCare.gov will qualify to save money on their premiums. Premiums after advance payment of these increased tax credits will decrease, on average, by $50 per person per month and $85 per policy per month. Four out of five enrollees (up from 69% pre-ARP) will be able to find a plan for $10 or less per month after tax credits, and over 50% (up from 14% pre-ARP) will be able to find a Silver plan for $10 or less per month.
Making it Easier for Consumers: Starting on April 1, consumers will be able to take advantage of increased premium tax credits on high quality health care plans when they enroll in coverage through HealthCare.gov. Every day, we’re going to make the consumer experience even better, streamlining HealthCare.gov and providing the help and support consumers want in order to understand their options and pick the right plan for their families.
The American Rescue Plan:
Reduces the cost of health care coverage for 9 million consumers currently receiving financial assistance by ensuring consumers eligible for premium tax credits have at least a couple of plans to choose from that won’t cost more than 8.5% of their household income on their Marketplace plan premium per year.
Many premiums will decrease, on average, by 50% per person per month and $85 per policy per month.Four out of five enrollees (up from 69% pre-ARP) will be able to find a plan for $10 or less per month after tax credits, and over 50% (up from 14% pre-ARP) will be able to find a Silver plan for $10 or less per month.1 out of 4 enrollees on Healthcare.gov will be able to upgrade to a higher plan category that offers better out of pocket costs at the same or lower premium compared to what they’re paying today (excludes enrollees already at the highest health plan category available, including certain enrollees eligible for cost sharing reductions).For example:
Uninsured couples earning over $70,000 could save more than $1,000 per month on their monthly premium.
A family of four making $90,000 will see their premiums decrease by $200 per month.
An individual making $19,000 will be able to find health insurance coverage with no monthly premium, saving roughly $66 per month on average.
Expands the number of people eligible to save money on their health care coverage.
About 14.9 million Americans who currently lack health insurance will be able to save money on their premiums to find the coverage they need at a price they can afford:
3.6 million uninsured people are estimated to be newly eligible for health care coverage savings (See state level data in table 1)
1.8 million uninsured people are estimated to be eligible for zero-dollar benchmark Marketplace coverage, since PTC-eligible individuals with incomes 150% of the FPL will now qualify for a 100% premium subsidy for the benchmark Marketplace plan (See state data in table 1.)
An additional 9.5 million uninsured people with incomes between 150% and 400% of the FPL are estimated to potentially qualify for additional financial support to reduce out-of-pocket costs for Marketplace premiums.
Addresses racial health inequities by expanding coverage and reducing costs. Increased affordability and health insurance coverage expansion will allow historically uninsured communities – especially those who have faced significant disparities – to access coverage, thereby improving opportunities for health care during and beyond the COVID-19 pandemic.
The Covid-19 pandemic has exacerbated stark health disparities among certain racial and ethnic minority populations in several areas, including infections, hospitalizations, death rates, and vaccination rates. Many of these same populations have experienced job loss or loss of health insurance coverage at disproportionately high rates.
48,000 uninsured American Indians and Alaska Natives will be newly eligible to save money on health care coverage and 21,000 will be eligible for zero-dollar benchmark Marketplace plans.
730,000 uninsured Latinos will be newly eligible to save money on health care coverage and 328,000 will be eligible for zero-dollar benchmark Marketplace plans.
197,000 uninsured Asian, Native-Hawaiian and Pacific Islander will be newly eligible to save money on health care coverage, and 50,000 will be eligible for zero-dollar benchmark Marketplace plans
The Biden-Harris administration is further expanding access to health insurance coverage and improving access to mental health services and community-based programs that addresses social determinants of health.
(NOTE: The HHS website includes a large box that breaks into three parts: State, Uninsured Population Newly Eligible for Tax Credits, and Uninsured population now eligible for $0 dollar benchmark Marketplace coverage <(150% FPL). You can find that box by clicking the link above.)
March 15, 2021: The White House posted a “Press Briefing by White House COVID-19 Response Team and Public Health Officials”. From the Press Briefing:
Acting Administrator Slavitt: Good morning. Thank you for joining us.
As President Biden said, recovering from a devastating pandemic will require all of us doing our part. We are not out of the woods, but we know what we need to do as a country. The President has now laid down some markers about steps to move our country back to normal activities with a fully vaccinated population, provided we all work together.
President Biden has directed the administration to deliver the two things that will most hasten our ability to recover: checks and shots. And as he said, “Help is on the way.”
With the American Recovery Act signed into law last week, Americans will finally get the support they need – most immediately, in the form of checks to American households and relief to Americans and small businesses under so much pressure from the pandemic.
Nearly 30 percent of adults and nearly two thirds of seniors have now received their first vaccination shot. And we are accelerating vaccinations in anticipation of meeting the President’s goal of being ready to be – open up all vaccinations to all adults by May 1st at the latest.
Over the last seven days, we’re now averaging 2.4 million shots per day. For those who pay extremely close attention, there was a delay in data synching over the weekend, which resulted in a reporting cut-off time of 11:00 a.m. instead of 6:00 a.m. Eastern time on Saturday. I’m sure you’re all following that.
So, for the record, there were 3.2 million shots reported administered on Saturday and 2.7 million on Sunday. This is an enormously complex effort, and it’s a result of the work of tens of thousands of people who are going above and beyond the call of duty.
Healthcare providers across the country are doing everything they can to protect Americans from getting this infectious disease. Doctors, nurses, and pharmacists are working around the clock and vaccinating people with a modest reimbursement. This is exactly what our medical professionals have shown the country throughout this pandemic.
Now, today, we are doing more than saying thank you to all the people we call heroes. We’re announcing that the Biden Administration will nearly double Medicare’s reimbursement rates for administering COVID vaccines, from about $23 per shot to $40 per shot. That’s $80 total for a two-dose vaccine.
Now, this will make it easier for more healthcare providers to get out into communities and give more COVID shots to people in need. We need this heroic team in particular to make sure that our highest-risk and underserved populations are cared for.
Second, thanks to the American Rescue Plan, the administration will now be covering 100 percent of the cost for Medicaid and children’s health insurance beneficiaries to get vaccinated. This protects states from bearing any costs associated with the increased Medicare reimbursement rates. And the Biden administration stands ready to work with states who are interested in increasing their Medicaid reimbursement rates for vaccinations so that we can make sure that we have most effectively reached vulnerable communities. This is an important health equity step, as working and lower-income Americans have faced the brunt of this crisis and must receive the resources to protect them.
What do these changes mean for people across the country? Well, first it means that vaccines will continue to be free to you. You do not need insurance to get vaccinated. You do not need cash or a credit card, or worry about a co-payment or deductible. You will not get a bill. The vaccines are free, they’re safe, and they’re effective.
It also means doctors, nurses and healthcare providers you trust will be out in your communities administering vaccines because the federal government will now pay them more for each shot they deliver.
Now, with that, I will turn it over to Dr. Walensky and then to Dr. Fauci, and then we’ll take your questions.
Dr. Walensky: Thank you, Andy. I’m glad to be back with all of you today. Let’s begin with the data. CDC’s most recent data show cases continue to fluctuate somewhere between 50,000 and 60,000 per day, with the most recent seven-day average approximately 52,500 cases per day. The most recent seven-day average of hospital admissions has also declined to just over 4,700 per day.
We also continue to see decline in deaths, with the latest seven-day average just over 1,200 deaths per day. We have come a long way from where we were in early January, but we still have much work to do.
In some parts of the country, the weather has started to warm up. And with the clocks change this weekend, our days have seen a little bit more sunshine And with the coming warmer weather, I know it’s tempting to want to relax and to let our guard down, particularly after a hard winter that sadly saw the highest level of cases and deaths during the pandemic so far.
This past Friday, we saw more travelers pass through our airports: over 1.3 million. This is the most travelers that we’ve had in a single day since last March, before the WHO declared the global pandemic. We have seen footage of people enjoying spring break festivities maskless. This is all in the context of still 50,000 cases per day.
Equally concerning are the resurgence we are now seeing in some European countries – countries that have had strikingly similar trends and surges during the pandemic as the United States. Each of these countries has had nadirs like we are having now, and each took an upward trend after they disregarded known mitigation strategies. They simply took their eye off the ball.
I’m pleading with you, for the sake of our nation’s health. These should be warning signs for all of us. Cases climbed last spring. They claimed again in the summer. They will climb now if we stop taking precautions when we continue to get more and more people vaccinated.
Please follow our recommend public health prevention precautions and be ready to get your vaccine when it is available to you. We are just starting to turn the corner. The data are moving in the right direction, but where this goes is dependent on whether we all do what must be done to protect ourselves and others.
We continue to see positive information emerge from our vaccines. A new CDC MMWR published today, looking at data from mid-December to mid-February, found that the vast majority of people getting both doses of these vaccines within the recommended timeframes. Based on the report, only about 3 percent missed their second dose, and systems were in place to make sure that those missed doses were not wasted – a very encouraging finding.
We also found that 96 percent of people who got both doses did so within the recommended timeframe: on or within four days of the 21 days for the Pfizer vaccine and 28 days for the Moderna vaccine.
These findings are incredibly reassuring as we continue to scale up our vaccination efforts. They show that our systems are working and that people are taking vaccination seriously, even when it means taking time to show up for their second appointment. It is remarkable what we can do as a nation when we are united against the virus.
This report also shows that a small percentage of people did miss their second dose. It may be hard for some people to get back for their second dose, but it’s essential for everyone who receives a two-dose vaccine to get both shots and get the full protection of these vaccine offers – this vaccine offers.
CDC is working across the government and with state and local partners to identify and address barriers to getting both doses. Some strategies include working with trusted messengers and communities to spread science-based messages on the importance of getting fully vaccinated; partnering with jurisdictions and vaccination providers to schedule both vaccination appointments upfront or schedule the second appointment when you get the first shot; and having systems in place to send appointment reminders to patients, reschedule canceled appointments, and repurpose missed second doses to avoid vaccine wastage; and finally, making available the second – the single-dose vaccine, Johnson & Johnson, as a terrific option for individuals who may prefer a one-dose vaccine.
Importantly, we have a role to play. I encourage those who can help others to get vaccinated. This can be as simple as helping family members and other loved ones with scheduling their appointments, reminding them about their appointments, reminding them about their appointments, and driving or accompanying them to their appointments. These small acts will go a long way toward protecting health and helping to end the pandemic.
Finally, I want to briefly discuss a technical update to our vaccination data on the CDC website. I know many of you watch our data closely, and when something changes, it can prompt questions.
Last Friday, CDC implemented an improvement to how we calculate the age of people who have received vaccinations. This was done to correct for differences in how states report date of birth to CDC and to more accurately determine the age of people getting vaccinated. As a result, there was a slight change in our age distribution of those vaccinated, with the percentages in all age groups under 75 increasing slightly, and those 75 and older decreasing slightly.
This largest shift occurred among people aged exactly 75 when more than 1 million individuals previously classified as 75 were reclassified as age 74. This should not be concerning as we’re vaccinating exactly the right cohorts, and those people will be 75 sometime in the next 12 months.
As CDC Director, a key principle is leading with transparency. And reflecting this principal, I believed it was important for me to clarify this new approach to our public-facing data.
Thank you. I look forward to your questions. And with that, I’ll turn things to Dr. Fauci.
Dr. Fauci: Thank you very much, Dr. Walensky. I’m just going to give a brief what we’ll call “science update” on something that is being asked much more consistently, is that: How do we approach the entire issue of pandemic preparedness currently and for future pandemics?
If I have the first slide.
There are three components that have been pursued now for some years. The first is, priority pathogens pick out a pathogen that you think might be risky in the future. That could be Nipah, that could be Ebola, that could be any of a number. The other is to develop platform technologies. We’ve already spooled about the, really advances that have been made with messenger RNA technology.
And the third one is one I want to send just a couple of minutes on, and that’s called prototype pathogens. What do we mean by how prototype pathogen approach helps us for future pandemics? Next slide.
This slide looks complicated but it’s simple, because it really tells you that this is all of the phylogenetic tree of the coronaviruses. And in red are the human coronaviruses, but, noticeably, in the yellow boxes are the four coronaviruses that each year cause about 15 to 30 percent of all the common colds that we all experience repetitively usually during the winter months.
So we’ve been studying these viruses now for decades and decades. if you go to the next slide, then in 2002, with the appearance of SARS – which we all remember – and then in 2012, with the appearance of MERS – which we all remember – we’ve gotten more and more experienced within this group of coronaviruses.
And then next slide, – nope, go back one. Yeah, next slide comes the SARS-coronavirus-2, which is the current virus that we’re dealing with. And in the next minute or so, I want to show you how previous experience has allowed us to make the kind of advances that have been so successful in COVID-19 vaccine.
This is a slide from 2017, when we were attempting to make a vaccine for MERS – the Middle East Respiratory Syndrome coronavirus. We had found, interestingly, that that spike protein that we talked about was unstable in its perfusion form, namely the one that we really wanted to vaccinate people with. She we made a bunch of mutations to stabilize it and to have what would be a successful MERS-CoV-2 vaccine. But, however, given the fact that MERS is smoldering right now, and even though we’re pursuing the vaccine for MERS, we use that same knowledge gained from the prototype pathogen of coronaviruses.
And on the next slide, what you see is what we’re dealing with now: That squiggly structure on the right-hand part of the slide is the spike protein that the messenger RNA codes for, that the adenovirus vectors express, and that the soluble portions that we have using in the Sanofi and the Novavax all use the same sort of structure.
And the point I want to makes is that we didn’t start doing this in January of 2020. This was literally decades of fundamental research on the broad prototype pathogens of coronavirus. And these are the kinds of things that we’re going to be doing with other viruses that could, in fact, pose risks as future pandemics.
So, let me stop there and go back to Andy. Thank you.
Acting Administrator Slavitt: Thank you, Dr. Fauci. Okay, let’s take questions.
MODERATOR: All right. We have time for a few questions. First question will go to Tamara Keith at NPR.
Q: Thank you very much. A question about the variants. CDC had predicted that the UK variant would be dominant in the U.S. by March. Is it yet? Is it dominant in certain states? Which ones? And what effect is that having on the trajectory?
Acting Administrator Slavitt: Dr. Walensky, would you like to start?
Dr. Walensky: I can start with that. Yeah, thank you. You know, it’s not evenly distributed across the United States. We do have B117 reported in 50 jurisdictions, over 4,700 cases reported so far, and that’s just based on what we’re evaluating and sequencing.
In some states, Florida and California, it’s up to 25 percent. In other states, it’s lower. Our current models still project, by the end of March, early April, B117 will be the dominant variant.
Acting Administrator Slavitt: Okay, next question.
MODERATOR: Next question will go to April Ryan at TheGrio.
Q: Thanks for doing this call. A couple of questions. Doctors, do you by any chance have solid numbers at this point on how many people have been vaccinated successfully with both vaccines, as well as the one from Johnson & Johnson? And do you have adequate numbers of the breakdown on minority numbers? Because there is now a report form Brilliant Corners that talks about the reason why black people have not gotten it. It’s not what the original thought was about Tuskegee or Henrietta Lacks; it was basically – the hesitancy was basically about misinformation or no information. Can you expand, please?
Acting Administrator Slavitt: Dr. Walensky?
Dr. Walensky: So, you know, we keep updated numbers on our CDC website. They’re updated every day. I can tell you that 37.45 million people have received two doses of – are fully vaccinated, and that 107.6 million people have been – have received at least one dose of a vaccine. I don’t have, off the top of my head, the racial breakdown this morning, but that is available on the CDC website.
I think we still have a lot to learn with regard to why, you know, some communities are not choosing to be vaccinated. Some communities are more hesitant. And I would be reluctant to say that it’s the same reason for every community. I think we have to meet people where they are as we try and get all communities vaccinated. And we have to understand that there’s not a singular underlying reason, but many reasons.
Dr. Fauci: Yeah, let me just, maybe, extend that for a minute. We also are very, very much involved in trying to get better access for the minority populations. It is, you know, not just the idea of hesitancy, but the fact that we have been in – and you’ve heard the President, himself, say very clearly that with the community vaccine centers; with the community health centers; with the pharmacies that we’re giving vaccine to, particularly in areas where minorities are represented; as well as the mobile units that are going out – so we are right now being very actively – in going out in a proactive way to make sure that any inequities that exist we can then, essentially, eliminate them. And that will be one of the things that are now, going forward, we’re putting a lot of effort into.
Acting Administrator Slavitt: It’s critical. Okay, next question.
MODERATOR: Next, we’ll go to Elizabeth Weise at USA Today.
Q: Thank you so much for taking my question. We’re hearing so much about other countries requiring some type of vaccination proof to enter those countries. Is there anything under discussion at the federal level to provide some type of vaccine, for want of a better word, “passport”?
Acting Administrator Slavitt: Yeah, let me take this, Elizabeth. It’s an important question as more people get vaccinated. Americans are asking the question: How will I be able to demonstrate, reliably, that I’ve been vaccinated?
And, you know, we have a couple of core beliefs about that. One is that it’s not the role of government to hold that data and to do that. But we do believe that when that gets done, there is a right way and a way that’s not as good. And the right way is: It needs to be private; the data should be secure; the access to it should be free; it should be available both digitally and in paper, and in multiple languages; and it should be open source.
So, those are the right kind of principles for someone to be able to have – be able to demonstrate that they have had a vaccine. And we know that there are – there are efforts that are underway, led by nonprofit collaboratives and the private sector, all working on exactly that type of thing.
MODERATOR: Next, we’ll go to Anne Flaherty at ABC.
Q: Hi, thanks for taking my question. I wanted to ask about this study that found that three feet in schools might be safe, as long as they’re masked. Dr. Walensky, are you revisiting the CDC guidance on this? And also, can you tell us where the six feet came from? Was it ever studied with masks?
Dr. Walensky: Thank you for your question. Yes, we’re looking at this carefully. The six feet data came from early studies, with and without masks, from all other – from respiratory viruses, flu viruses, as well as SARS, and other coronaviruses – the MERS virus that Dr. Fauci just spoke about – and how distant air – how far aerosols and droplets can travel in that context.
As soon as we put out our guidance, among the biggest challenges that we were aware of was the fact that schools were having a hard time with the six foot guidance, and that, of course, prompted more studies to say: Is six feet necessary on the context of mask wearing?
The study that you’re remarking on is the first study that has been published that looked at there feet versus six feet. It was in Massachusetts schools where there was 100 percent mask wearing. And it demonstrated that students, when there was 100 percent mask wearing, had similar infection rates when it – at six feet versus three feet, as well as staff had similar infection rates at six feet versus six feet when they were masked.
We are looking at these data carefully. The question actually prompted more studies to be done, so we know more are forthcoming. We’re taking all of those data carefully and revisiting our guidances in that context.
Acting Administrator Slavitt: Great. Next question.
MODERATOR: Next we’ll go to Shira Stein at Bloomberg.
Acting Administrator Slavitt: Shira, are you with us? Kevin, maybe we should take the next question and come back.
MODERATOR: We’ll come back to you, Shira. We’ll go to Zeke at AP.
Q: Thanks all for doing the call. I was hoping you might be able to explain what your assessment is of the early rollout of the J&J vaccine. The CDC tracker right now show – it’s showing under 1.3 million doses administered, with 3.7 million distributed, but obviously, those doses have been distributed now for a couple of weeks. Are you seeing any vaccine hesitancy with the update in the shot versus the two-dose regimens? Thank you.
Acting Administrator Slavitt: Well, let’s start this way: Let me ask Dr. Fauci if – for people who haven’t heard our review before – for you to talk about the Johnson & Johnson vaccine and how people should view it relative to the two other vaccines, the Moderna and Pfizer. Then I’ll more specifically go into your question.
Dr. Fauci: Yeah. Thanks, Andy. You know, just to reiterate what we’ve said multiple times on these briefings: that we have three highly efficacious, safe vaccines that are now available to the American public. They have not been compared one to the other, which is the only way you could effectively do that would be in head-to-head comparisons.
So that’s the reason why you’ll hear all of us always say continuously that the way to look at it is that there are three vaccines that are highly efficacious. If you go into a place and you have a certain vaccine available to you, take that vaccine rather than waiting for another vaccine because all three of them are highly efficacious.
Acting Administrator Slavitt: Yeah, and I’ll – let me address the other part of your question. So, look, we watch this data, as you can imagine, incredibly closely, and we don’t have reason for concern at this point.
To remind everybody the Johnson & Johnson vaccine came out with a – it’s no secret – a relatively small amount of doses. Given that, we know that states are metering the – you know, how they’re putting out the doses to be a little bit more straight line. And then, third, that, you know, we are seeing it continue to ramp. There was a day this weekend where we say 300,000 Johnson & Johnson doses.
So I think it continues to climb. We’re – I think the key operative word in your question is “early.” When we get – by the time we get to the end of the month, I think we will see the ramp pattern where we expect it to be.
Next question. Kevin –
Q: Thanks, all.
MODERATOR: Making sure you were there. Great.
Q: Yep, there we go. Sorry about that earlier. Can you tell me why you decided to change the – change the reimbursement number for the Medicare administration of vaccines? And then, can you also talk – it looks like you’re going to be doing some more public service announcements to provoke vaccination. What’s the budget of that?
Acting Administrator Slavitt: Well, look, I think CMS – who focuses on making sure that our nation’s seniors and our nation’s – people who live on low and fixed incomes are getting access to the same high-quality care that they deserve and that others in the country should get – determined that an additional level of reimbursement was going to increase vaccination rates, particularly in hard-to-reach communities. So asking people to do, as Dr. Fauci indicated, mobile vans, reach out into communities, and make the extra effort to meet people where they are to reimburse them.
You know , we believe that the medical professionals that are on the frontlines of this vaccination effort – by the way, the same people that ore on the frontlines of this entire pandemic – need to be taken care of. And we think that’s going to do a job of both increasing vaccinations as well as improving equity. And that’s – that’s the reason behind it.
Your second question was about education campaigns? Is that – was that what it was?
Acting Administrator Slavitt: Yeah. So, look, let me say this: Today I think the latest data shows – from, I believe, Pew – that 69 percent of Americans are definitive in saying that they either have taken – have had a vaccine or plan to take a vaccine. That’s significantly higher. It’s at least 10 points higher than it was a short while ago and more significant than from when the Biden administration began.
We think this is for a number of reasons. These are very good vaccines with an incredible track record – large clinical trials; years, as Dr. Fauci has indicated, of research into them.
And many Americans got vaccinated early. And the people who I think have been watching this and seeing the process and seeing how it has had an impact on them and in their communities, that it increasingly makes them want to take the vaccination.
So we believe this is edu- in some respects, the easiest education effort ever is if we let people see the truth and not get information on, say, Facebook, or somewhere where there’s less reliable information. People are capable of making these decisions for themselves. We know that people are not looking to be convinced by the government or by some other entity; they want to have conversations with people in their local community; whether it’s a doctor, their pharmacist, or other people that they trust. And our job – and I think the CDC had been doing a marvelous job at this – is to get reliable information out to people. These briefings are another example of this – very clear scientific information, the good and the bad.
Now, we will – we will be supporting that effort with all kinds of additional education efforts, including some paid efforts, including other types of conversations. But it’s most important that the people who are the local, trusted people continue to have the reliable information about these vaccines. And we believe that will continue the pattern that’s already begun, which is that more and more people will be comfortable taking the vaccine.
Kevin, is that –
MODERATOR: All right, we’re going to squeeze one more question in from Brian Karem at The Bulwark.
Q: Thanks. I’ll be brief. I want to follow up on April Ryan’s question about the number of people – the millions that have already been fully vaccinated. Today we heard that 30 percent of the adults, or 20 percent of the seniors, had received some vaccination. Is that – you know, are the 20 percent seniors a 20 percent of the Total number, or is that a subset of adults? First.
And secondly, if we use the number of shots that we are getting on a daily basis, the number of new cases, and the number of people who have been fully vaccinated, can you all – using those metrics – give us a better idea of when we’ll either reach herd immunity or be in the clear? And thus, when we can start sharing our dosage of our vaccines with our allies and neighbors internationally?
Acting Administrator Slavitt: It sounds like an SAT math question. So let me clarify the basic of the numbers, because I think they may not have come through clearly.
We are talking about close to two thirds of seniors and close to 30 percent of all adults that have now received their first shot. And I think its important – for reasons that I think both Doctors Walensky and Fauci can articulate – that people get their second shot, largely because of the durability and the variants.
So as we report these numbers out, this is to report on the progress and the very hard work of tens of thousands of people, but it’s – by no means should be perceived as declaring victory. There’s much more – much more work to do.
I think the question that you’re asking in some sense is: “When will we reach herd immunity? When will we have enough doses, et cetera?” And what I will tell you is that, as the President articulated last week, we believe that we will have enough for the adult population – produced by the end of May. And with some time after that, those vaccinations will have – will have occurred. And it is with that the President indicated that if we all do our part, by the 4th of July, we should be able to take the really important step to brining the things to people – the events in our lives – back into our lives. That’s an “if”. That’s – that’s really on all of us.
So no mater what math you use, we will have enough vaccine doses. We do need people to actually get vaccinated. We do need everybody that’s been doing this enormously important work to keep doing it. And if we do that, we should be in a position right around then, when the adult population will have the vaccines they need.
Now, if you’re asking questions about our supply, we have indicated that there are other pieces of our supply;y that are important to us, and Dr. Fauci has mentioned this several times : teenagers, adolescence, children, potential booster shots down the road, other things.
So it’s a very big equation with a lot of scenarios in it, and our job is to be prepared for every scenario.
Now, having said all of that, I think there was a part of your question about the world, about the globe, and so many I can ask Dr. Fauci to talk about the efforts that we have undertaken already, even as we vaccinate our country, to make sure we’re playing a leadership role in the globe.
Dr. Fauci: Yes. Thank you, Andy. So, as you well know, on the first day of the President’s presidency – his tenure – he had me go out early in the morning and make a speech to the executive board of WHO, saying we’re going to rejoin WHO and we’re going to be part of COVAX, which means, A, that we’ve made a commitment of $4 billion that the United States will be giving to COVAX – which is a multi-organization, multi-country effort to help those countries that do not have the resources to be able to vaccinate their people to get them vaccinated.
In addition, it’s become clear that after we get our people in the United States vaccinated – and remember, we’ve suffered terribly with over 530,000 deaths thus far, so our responsibility of getting all people vaccinated first, before we start giving doses to other countries – which, we will be doing that if and when we do have a surplus, which it looks very much like we will. But that will not occur until we actually have our people vaccinated.
But the $4 billion has already been implements. Part of it, $2 billion, and then $2 billion to come. So we’re very actively involved in thinking about and caring about the plight of other countries.
Andy, if I might just make one comment that was made part of the question. We should not get so fixated on this elusive number of herd immunity. We should just be concerned about getting as many people vaccinated as quickly as we possibly can because herd immunity is still somewhat of an elusive number. We made a projection of what it would likely be – I’ve said many times – somewhere between 70 and 85 percent, but we don’t know that for sure. So rather than fixating on that, why don’t we just say, get as many people vaccinated as quickly as you possibly can. And every day that goes by now, with more than 2 million doses going into people, we’re getting closer and closer to control of this pandemic.
Acting Administrator Slavitt: Great, thank you. And thank you all for listening in. And I really want to thank again the doctors, nurses, physicians, vaccinators, people around the country who have been – and continue to be a part of this extraordinary effort that we need to keep going.
We will be her Wednesday to do this once again. Thank you.
March 16: U.S. Food and Drug Administration (FDA) posted an FDA Statement titled: “Coronavirus (COVID-19) Update: FDA takes steps to streamline path for COVID-19 screening tools, provides information to help groups establishing testing programs”. From the Statement:
The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Team Stenzel, M.D., Ph.D., director of the Office of In Metro Diagnostics in the Center for Devices and Radiological Health
Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomatic individuals who do not have known or suspected exposure to COVID-19 in order to make individual decisions such as whether an individual should participate in an activity, based on test results.
Today, we are providing information for test developers about a streamlined path to emergency use authorization for these important screening tools as well as information to help these groups as they set up testing programs. Our actions complement those taken by the Centers for Disease Control and Prevention (CDC) and are not intended to replace CDC’s testing or other public guidance.
First, the FDA issued a new supplemental template for test developers seeking emergency use authorization (EUA) of certain tests for screening with serial testing. Serial testing involves testing the same individual multiple times within a few days, and can increase chances of detecting asymptomatic infection that might not always show up with a single test. CDC recommends serial testing at least once per seek, along with mitigation measures, such as masking and social distancing, to reduce disease transmission.
This template applies to developers of molecular and antigen tests, for use in serial testing programs, as well as at-home tests for use in a serial manner outside of a testing program, intended to detect SARS-CoV-2 from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This includes tests conducted in any location, including a laboratory, at the point-of-care (POC), or even places such as a person’s home or certain non-traditional sites such as offices, sporting venues, airports, schools, etc.
We believe this effort will pave the way for further expanding the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs and increase consumer access to testing.
As part of this new template for test developers, the agency provided recommendations aimed to streamline the authorization of screening tests with serial testing. The recommendation apply to test developers who seek a EUA from the FDA for certain screening tests prior to conducting certain performance evaluations with asymptomatic individuals. For example, in certain circumstances, a POC test or an at-home test could be authorized for over-the-counter (OTC) use without the need for validating its use in asymptomatic individuals prior to authorization. The FDA believes that evidence of a test’s strong performance in symptomatic patients combined with serial testing can mitigate the risk of false results when testing asymptomatic individuals.
Additionally, today the FDA issued a fact sheet that outlines considerations for selecting a test for use in a screening testing program. The fact sheet will help schools, workplaces, communities, and other locations as they are selecting a test for screening and help them understand the difference between tests used for diagnosis of suspected COVID-19 compared to those used for screening asymptomatic individuals.
This information we’re providing will be helpful to groups as they set up testing programs. We believe these combined efforts will further expand the availability of tests authorized for screening asymptomatic individuals, including OTC use, help bolster existing and new testing programs and increase consumer access to testing.
March 16: U.S. Food & Drug Administration (FDA) posted a News Release titled: “Coronavirus (COVID-19) Update: March 16, 2021”. From the News Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
On March 15, 2021, the FDA launched the COVID-19 EUA FDA Adverse Events Reporting System (FAERS) Public Dashboard providing weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biological products used under an EUA during the COVID-19 public health emergency.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Ravenscroft Apothecary, Inc., DBA Raenscroft Escentials for selling unapproved products with fraudulent COVID-19 claims. The company sells products, including “AIR PURIFY AROMAMIST” “HEALER’s CHAI AROMATEA & BREATH DROPS,” “ELEVATION OF MIND AROMAMIST” AND “ROSE FREQUENCY TONGUE TINCTURE,” and misleadingly represents the products as safe and/or effective to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. The FDA requested that Ravenscroft Apothecary, Inc. take immediate action to cease the sale of any unapproved and unauthorized products for the treatment of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
The FDA has posted translations of the Janssen COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Burmese, Chinese, French, Hindi and Russian. We will post additional language translations of the fact sheet for recipients and caregivers as they become available.
As of today, 341 tests and sample collection devices are authorized by the FDA under emergency use authorization (EUAs). These include 254 molecular tests and sample collection devices, 72 antibody and other immune response tests and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen test and one OTC molecular test.
March 17: U.S. Department of Health and Human Services (HHS) posted News titled: “Biden Administration to Invest More Than $12 Billion to Expand COVID-19 Testing”. From the News:
$10 Billion in Funding for School Screenings to Help Reopening
$2.25 Billion in Screenings to Address Disparities and Advance Equity
New CDC Guidance to Provide Clarity on Screening Testing Approaches
As part of President Biden’s National Strategy for the COVID-19 Resource and Pandemic Preparedness – PDF the U.S. Department of Health and Human Services (HHS) will invest $10 billion from the American Rescue Plan to ramp up screening testing to help schools reopen, $2.25 billion to scale up testing in underserved populations, and provide new guidance on asymptomatic screening testing in schools, workplaces, and congregate settings. These measures are part of President Biden’s strategy to increase COVID-19 testing nationwide as vaccinations increase.
“COVID-19 testing is critical to saving lives and restoring economic activity,” said HHS Acting Secretary Norris Cochran. “As part of the Biden Administration’s National Strategy, HHS will continue to expand our capacity to get testing to the individuals and the places that need it most, so we can prevent transmission of the virus and defeat the pandemic.”
Todays announcement includes funding or guidance to:
Support COVID-19 screening testing to help schools reopen: Consistent with the American Rescue Plan (P.L 117-2), the Centers for Disease Control and Prevention (CDC) will provide $10 billion to states to support COVID-19 screening testing for teachers, staff and students to assist schools in reopening safely for in-person instruction. CDC’s Operational Strategy for K-12 Schools through Phased Mitigation, released in February 2021, makes clear that screening testing is a tool schools can utilize to help reopen safely as part of a comprehensive COVID-19 mitigation approach. Using existing funding mechanisms, this funding will be able to be deployed quickly as part of a strategy to help get schools open in the remaining months of this school year.
In addition to ensuring diagnostic testing of symptomatic and exposed individuals, serial screening testing will help schools identify infected individuals without symptoms who may be contagious so that prompt action can be taken to prevent further transmission. With this ARP funding, states can support the critical testing and testing supports schools need to implement screening testing programs. Recognizing that establishing a testing program is new for many schools, CDC and state and local health departments will support technical assistance to assist states and schools in standing up and implementing these programs. Today, CDC is releasing the state-by-state allocation table with final awards to be made to health departments in early April (The table is available below).
Address disparities and promote equity in COVID-19 testing and mitigation: CDC will invest $2.25 billion to address COVID-19-related health disparities and advance health equity among high-risk and underserved populations, including racial and ethnic minority groups and people living in rural areas. This funding represents CDC’s largest investment to date to support communities affected by COVID-29 -related health disparities. Grants to public health departments will improve testing and contact tracing capabilities; develop innovative mitigation and prevention resources and services; and, improve data collection and reporting to advance health equity and address social determinants of health as they relate to COVID-19.
Provide clear guidance for implementation of testing, including screening testing: CDC is releasing updated testing guidance to provide recommendations for how to use screening testing to identify, track and mitigate asymptomatic transmission of COVID-19. The guidance will provide information on the categories of tests used to detect COVID-19 and the intended strategies for use of those tests, including to diagnose infection, to screen in an effort to reduce asymptomatic or pre-symptomatic transmission, and to monitor trends in infection. This guidance also includes considerations for health equity in testing; choosing a test; and guidance for specific settings (e.g. non-healthcare workplaces, correctional facilities, shelters and other settings).
Support asymptomatic screening testing: This week, the Food and Drug Administration (FDA) provided new recommendations and information for test developers to streamline the path to emergency use authorization (EUA) for screening tests. The recommendations apply to test developers who seek an EUA from the FDA for screening tests with serial testing. FDA may authorize certain tests, including those currently authorized for diagnosing COVID-19, for screening with serial testing prior to test developers conducting certain performance evaluations with asymptomatic individuals. This may include authorizing point-of-care and at-home COVID-19 tests for over-the-counter use. FDA also has released a fact sheet to assist schools, workplaces, communities, and others looking to establish testing programs to screen asymptomatic individuals as they are selecting a test for screening. These actions are intended to expand the availability of tests authorized for screening asymptomatic individuals, help bolster existing and new testing programs, and increase consumer access to testing.
Support COVID-19 screening testing in long-term care: The Departments of Health and Human Services and Defense have awarded a $255 million contract for the production and delivery of 50 million Abbott BinaxNOW rapid point-of-care antigen tests for COVID-19 to support continued screening testing in long-term care facilities.
Last month, HHS announced additional actions the Biden Administration is taking to expand COVID-19 testing capacity across the country as part of its national testing strategy. This includes:
Launching a pilot program to expand COVID-19 testing for schools and underserved populations through coordinating centers. HHS, in partnership with the Department of Defense (DOD), is investing $650 million to expand testing opportunities for K-8 schools and underserved congregate settings, such as homeless shelters, directly through new regional coordinating centers. These coordinating centers will organize the distribution of COVID-19 testing supplies and partner with laboratories across the country, including universities and commercial labs, to collect specimens, perform tests, and report results to the relevant public health agencies. These coordinating centers will identify existing testing capacity, match it up to an area of need, and fund that testing.
Increasing domestic manufacturing of testing supplies and raw materials. HHS and DOD are investing $815 million to increase domestic manufacturing of testing supplies and raw materials, including filter pipette tips, nitrocellulose used in antigen point-of-care tests, and specific injected molded plastics needed to house testing reagents. These investments will help create more domestic sources and expand existing facilities to increase production capacity.
Rapidly increasing genomic sequencing of the virus. CDC is investing nearly $200 million to identify, track and mitigate emerging strains of SARS-CoV-2 through genomic sequencing. This investment will expand genomic sequencing capabilities to increase sequencing three-fold per week. Increasing samples will improve the agency’s ability to detect emerging variants and understand their spread with greater precision. Expanded testing is critical to support more genomic sequencing, because sequencing only occurs after a COVID-19 test comes up positive.
The American Rescue Plan, which was signed into law last week, will allow the Biden Administration to further ramp up testing actions to detect, diagnose, trace and monitor COVID-19 and prevent its spread.
March 17: U.S. Food and Drug Administration (FDA) posted a News Release titled: “FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premarket Review Process”. From the News Release:
BioFire Respiratory Panel 2.1 is the First COVID-19 Diagnostic Test Granted Marketing Authorization Using the De Novo Review Pathway
Today, the U.S. Food and Drug Administration granted marketing authorization of the BioFire Respiratory Panel 2.1 (RP2.1), a diagnostic test for the simultaneous qualitative detection and identification of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected by COVID-19 and other respiratory tract infections. The diagnostic test, which had an Emergency Use Authorization (EUA), was granted marketing authorization using De Novo premarket review pathway, a regulatory pathway for low-to-moderate-risk devices of a new type. The grant of this De Novo request marks an important step in FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency.
“Today’s action is a great demonstration of the FDA’s work to protect the public health in emergency response situations and beyond,” said FDA Acting Commissioner Janet Woodcock, M.D. “We ensure there were tests made available quickly under EUA; and we continue to work with diagnostic manufacturers to take the next step of ensuring products are FDA reviewed for safety and effectiveness and authorized for marketing under our traditional premarket authorities. While this is the first authorization for a diagnostic test using a traditional premarket review process, we do not expect this to be the last and look forward to working with developers of medical products to move their products through our traditional review pathways.”
The grant of the De Novo request for this test is based on additional data showing validation beyond what is needed for emergency use authorization. The FDA reviewed data from a clinical study of more than 500 test samples and a variety of analytical studies, which demonstrated a reasonable assurance that the BioFire RP2.1 was safe and effective at identification and differentiation of various respiratory viral and bacterial pathogens.
With granting of the De Novo for the BioFire RP2.1 today, the FDA also revoked the EUA for this device, which was initially authorized for emergency use in May 2020. This EUA revocation and De Novo authorization do not impact the availability other tests under EUA.
“Safety , effectiveness and innovation remain important priorities for CDRH, Today’s action underscores the FDA’s ongoing commitment to expand access to testing while providing important safeguards through both our EUA authority and traditional review pathways,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
The BioFire RP2.1 is for use only in individuals suspected of respiratory tract infections, including COVID-19. The diagnostic test is for the detection and indication of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of respiratory infection and aids in the diagnostic of respiratory infection if used along with other clinical and epidemiological information. Results of the test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Positive results of this test do not rule out confection with other organisms. The agent(s) detected by the BioFire RP2.1 may not be definite cause of disease. Negative BioFire RP2.1 results in the setting of a respiratory illness illness may be due to infection with pathogens that are not detected by this test or lower respiratory tract infection that may not be detected by an NPS specimen. Additional laboratory testing (e.g., bacterial and viral culture, immuoflorescence and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.
Along with this De Novo authorization, the FDA is establishing criteria called special controls that define the requirements related to labeling and performance testing. When met, the special controls, in combination with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway, whereby devices can obtain a clearance by demonstrating substantial equivalence to a predicate device.
The FDA granted the marketing authorization to BioFire Diagnostics LLC.
March 17: The White House posted a press briefing titled: “Press Briefing by White House COVID-19 Response Team and Public Health Officials”. From the press release:
Acting Administrator Slavitt: Thank you for joining us today. You can see we have a full house.
Just this morning, following the President’s direction, the Department of Health and Human Services issued the order to formally direct states, tribes, and territories to make all adults eligible for COVID vaccines no later than May 1st. Even as we take steps to expand eligibility for vaccines in advance of May 1st, we continue to emphasize to states the importance of prioritizing vaccinations for higher-risk populations.
Two areas states can focus on in particular are, first, vaccination programs for congregate settings an homebound populations; and, second, creating priority scheduling pathways and dedicated shots for higher-risk populations.
Today, our team is going to highlight aggressive actions we are taking to use diagnostic testing to help defeat the pandemic and all people to safely return to normal activities. We’ve recently discussed investments in at-home and point-of-care testing, which can contribute significantly to our ability to safely get back to normal life.
Today, we’re releasing details about how our testing strategy can be advanced in three additional critical ways.
First – first is how we can reduce the disparities in health outcomes by investing more testing resources in underserved communities. We will also discuss how we will get critical therapies to underserved communities.
Second, our investments we are making in testing to increase screening and surveillance.
And third is how we can strategically invest in testing to ramp up the safety of schools and get them back open.
First you will hear from Dr. Nunez-Smith. She will then introduce Carole Johnson, the White House Testing Coordinator. She will introduce Dr. Walensky and then Dr. Fauci.
Between all of them, you will hear how various elements of our testing strategy come together. And with that, I’ll turn it over to Dr. Nunez-Smith.
Dr. Nunez-Smith: Thanks so much, Andy. And good afternoon, everyone. You know, as Andy said, we are continuing to advance robust efforts to ensure equity in our federal COVID-19 response, you know, making sure there is equitable access to all COVID-19 resources – so whether that is access to PPE or masks, access to vaccines; you know, access to testing, as you will hear much more about in today’s briefing; or access to treatments.
And today I’m here to provide an important update on how this administration is making COVID-19 treatments more accessible and available for the American people, particularly those in the hardest-hit, highest-risk communities.
We are working to improve access to one specific class of therapies, the monoclonal antibodies. And you’ve heard Dr. Fauci discuss the benefits of these therapies previously.
You know, there are currently three monoclonal antibodies that have been authorized by the Food and Drug Administration for emergency use, with the most recent authorization coming just in February.
You know the positive impact of these treatments has become pretty clear. For individuals who are diagnosed early with COVID-19 – that’s early testing – and who, you know, although they’re currently doing okay, are really at risk of getting pretty sick, these treatments can make a huge difference in preventing them from developing severe illness from COVID.
You know, in fact, Eli Lilly’s newest monoclonal antibody combination therapy has shown the ability to reduce COVID-19 related hospitalizations and deaths by up to 87 percent. So the National Institutes of Health, you know, and the Infectious Disease Society of America – that’s an association of over 12,000 physicians, scientists, and public health experts; they specialize in infectious disease – you know, they both formally recommend the use of this treatment in patients with mild or moderate COVID-19 who are at high-risk of progression to severe disease.
So these recommendations by the NIH and by IDSA send a really strong signal to patients as well as providers all over the country – you know, a message that these treatments are efficacious. They show enough promise in clinical studies to recommend their broader use during this pandemic to help us save lives. And we are certainly tracking all the latest science and updating clinical recommendations as needed.
You know, for all Americans, these treatments for COVID-19 are free, and the cost of administering them is covered why Medicare, Medicaid, and most private insurance companies. And these therapies are already available across the country, so that’s hospitals, emergency rooms, urgent care settings, physicians offices, and infusion centers.
But there is still work to do to make sure that these treatments are available and accessible to the highest-risk communities, those communities that have faced high burdens of COVID-19 over this past year.
So today we’re announcing a new $150 million agreement, signed by the Department of Health and Human Services, specifically to help us make sure that any individual and any community who meets the clinical criteria can have access to these important therapeutics. These funds will help us go beyond those existing 5,000 sites to help get these therapies to folks in other settings as well, giving us the ability to continue to meet people where they are.
This new effort is going to speed assistance to hard-hit communities, really increasing the use and administration of the monoclonal antibody therapies, preventing hospitalization and death.
You know, this assistance may include additional staffing, infusion center capacity, in both traditional and non-traditional healthcare settings, and the equipment necessary to administer this intravenous infusion, as well as being sure we increase awareness among healthcare providers and patients about the treatment options that are available, including where and how to access them.
So this is just another example of how we are committed to an equitable COVID-19 response. We’re working absolutely to keep people from getting COVID-19 in the first place. You know, and the vaccines that are currently being administered across the country are key to doing just that.
But for those individuals who get COVID-19, we want to make sure that they too have the benefit of the latest in scientific discovery to help them hope and help toward a safe and speedy recovery.
So you can learn more about these monoclonal antibodies and how to access them by going to CombatCOVID.HHS.gov.
And with that, I’ll turn it over to Carole Johnson, the Testing Coordinator, and the White House COVID-19 Response Team.
Ms. Johnson: Thank you, Dr. Nunez-Smith. When the President announced his national strategy to fight COVID, he outlined a comprehensive plan to scale and expand testing in order to safely reopen schools and society.
Today, thanks to the American Rescue Plan, we’re turning that plan into action. We know that school districts want to reopen, but up to this point, many lack the resources to set up COVID screening programs for students, teachers, and staff to keep COVID out of our schools.
Today, all that changes. Earlier today, the Department of Education announced the state funding allocations for the $122 billion in the American Rescue Plan to help schools invest in mitigation strategies like PPE, additional space, more teachers, and extending their critical learning and enrichment programs.
And today, the Department of Health and Human Services announced plans to distribute $10 billion to support COVID-19 testing in schools across our country. With this funding for testing, every state in America will have access to millions of dollars to set up screening programs to add a layer of protection for schools, teachers, and students. This funding can be used to test teachers and staff, students and others with symptoms of COVID, those who may have been exposed, and to establish sustained regular screening testing programs across the school system.
We recognize that establishing a COVID testing program is new for many schools, and that’s why CDC will work with state and local health departments to support technical assistance to help schools and states in standing up and implementing these programs.
With this critical funding from the American Rescue Plan, we hope more schools will reopen across the country and more kids will be back in the classroom soon.
We know that testing works. We know that it works to identify cases and slow the spread of COVID. And we look forward to working with schools to implement this exciting new program.
Finally, I want to note that this work builds on additional actions the administration has already taken to scale up testing nationwide, like establishing regional coordinating centers to help accelerate testing and make the process easier, increasing domestic manufacturing of testing supplies, and rapidly increasing genomic sequencing.
The American Rescue Plan, which was signed into law last week, will invest nearly $50 billion over all in testing. We believe it was important – we believe it is important to get the first $100 billion out to states for school reopening as quickly as possible.
So with that, I’ll turn it over to Dr. Walensky who will share additional testing news for today. Thank you, Dr. Walensky.
Dr. Walensky: Thank you, Carole. And good afternoon. I’m glad to be back with you today. Let’s start first with an overview of the data.
Cases continue to hover around 50-55,000 cases per day, and the most recent seven-day average is 53,000 cases per day. Hospital admissions continue to fall, with the most recent seven-day average just over 4,700 admissions per day. We continue to see declines in the number of deaths from COVID-19, averaging slightly more than 1,100 deaths per day over the last seven days.
Today, I want to spend a little time discussing COVID-19 testing and why this remains a critical component of our comprehensive approach to ending this epidemic.
Reliable and widely available testing is a crucial part of our efforts to stop the spread of COVID-19. But several factors can make testing strategy decisions complex, including the different kinds of tests available, the changing dynamics of the pandemic in communities, and the increasing proliferation of new variants that are more transmissible.
Having clear, evidence-based recommendations to help state and local public health departments and the medical community make informed decisions about COVID-19 testing is paramount to an overall national testing strategy.
Today, CDC is releasing a suite of five updated guidance documents on COVID-19 testing, building on the latest science, available testing options, and what we have learned about testing during this pandemic.
Our testing overview guidance describes the available tests that are used to detect COVID-19, how to choose a test, and the reasons for using them. They also explain the impact of vaccination on testing.
Importantly, until now, limited test capacity has resulted in our use of tests for largely diagnostic purposes when someone presents with symptoms or has been exposed. Only in selected places have we capitalized on the benefits of how testing can be used as a screening intervention, with frequent tests to identify asymptomatic disease and prevent clusters before they start.
Testing can also be used as a surveillance tool to monitor the burden of disease in communities. Our newly released set of guidances offers a comprehensive approach to testing and helps to prevent the spread of COVID-19 through the rapid identification and isolation of people who are infected, including those who do not know they are infected because they do not have symptoms.
The updated overview also provides new information about how health equity – about health equity issues related to testing. To end this pandemic, everyone must have equal access to affordable and timely testing, with fast turnaround time for results, to identify infections and reduce community spread.
In addition to the overview guidance, we are also releasing four complementary guidance documents that focus on testing in specific settings, including correctional and detention facilities, non-healthcare workplaces, institutions or higher education, and homeless shelters and encampments.
Each of these companion documents – guidance documents provide tailored recommendations that take into account the unique circumstances and risks for COVID-19 spread in the different settings.
Today’s updated guidance is intended to help public health officials, medical providers, school and justice system administrators, and others make decisions about setting up testing programs in their communities.
All five guidance documents are now posted on our website at CDC.gov. And while guidance is critical to informing decisions making for – decision making for COVID-19 testing, its equally important that testing programs and communities are supported with resources to do the work. This requires much-needed and long-overdue resources.
So I’m proud to share that CDC is announcing new funding for $2.25 billion in grants to public health departments – on average, $20 million per grant to more than 100 health departments – to address COVID-19 health disparities and advance health equity among people who are at high risk and underserved, including racial and ethnic minority groups and people living in rural areas.
A large component of this funding will focus on strategies to improve testing and contact tracing, along with funding to support continued implementation and prevention strategies for COVID-19. These funds will provide much-needed funding to states, cities, counties, and rural locations.
I’m so excited to report that this funding represents CDC’s largest investment to date to support communities that are affected by COVID-19-related health disparities, especially those in high-risk and underserved groups.
This is truly a historic investment for CDC and an important step forward to help hard-hit communities turn the corner on this pandemic.
Thank you. And I’ll now turn it over to Dr. Fauci.
Dr. Fauci: Thank you very much, Dr. Walensky. I’m just going to change topics somewhat, just for the next minute or two, to give you an update in the context of vaccines and what we are learning in the longer range as we go from the EUA’s.
This slide is a familiar slide that I’ve shown a couple of times at these briefings. Just to summarize, we have three vaccines that have been proven to be highly efficacious. Namely, within the context of the clinical trial, they work. Now the question is: What happens when you get out into the real world?
We refer to this as the difference between efficacy and effectiveness. Efficacy is what you show in a clinical trial. Effectiveness means what happens when you use that in the real world.
And what we are seeing is that, in fact, these types of vaccines that I just mentioned are working. Let me give you just a couple of quick examples among several.
This is a study from Israel, in which 600,000 newly vaccinated people with the Pfizer-BNT vaccine were matched against 600,000 controls. Look at the right-hand part of the slide: Seven or more days after the second dose, the effectiveness of this vaccine in the community was well within the range of the efficacy of the trial – 92 to 94 percent.
This is a slide from the UK in which regular asymptomatic testing was done among healthcare providers who did the same kind of routine testing that many of us do. It was shown that in an arena and a context in which there was a variant, B117, predominated – in England – again, you had a very high degree of effectiveness seven days after the second dose, as shown here, with 85 percent.
Back to the United States, in the Mayo Clinic: In this study of individuals who went un- – who underwent routine pre-procedural testing – coming into the hospital for a sigmoidoscope, a colonoscopy, dental procedures, or what have you – they were tested, and it was found that after adjustment for confounding factors, there was an 80 percent reduction in the risk of a positive screening test in people who received two doses of an mRNA vaccine.
And then, finally, on this last slide, in Israeli and Spain: The study in Spain showed that a viral load is a proxy for infectivity. And then, in a study in Israel, they found out, when there were breakthrough infections either among vaccinated individuals or those who were not vaccinated, when you look at the viral load in the nasopharynx, it was decreased fourfold for those who actually were within 12 to 28 days of the first dose of vaccine.
Bottom line: The vaccines are effective in the real world. Not only are they efficacious, but they are effective.
Now back to you, Andy.
Acting Administrator Slavitt: Thank you. All right, why don’t we take questions?
MODERATOR: All right. First question we will got to Shannon Pettypiece with NBC.
Q: On the school testing, there’s been concern from schools that they are not able to use the rapid tests for asymptomatic students unless they get one of these CLIA waivers. And they say there’s been a big issue with them being able to use the rapid test. So does this guidelines that you’re putting out today, is that going to open the door for schools to use the rapid tests more easily in asymptomatic students?
Acting Administration Slavitt: Let me ask Carole to take that.
Ms. Johnson: Yeah, so I will say the CDC is putting out guidance today, but there’s more work to do. We’re putting these resources out to help schools plan, but we continue to work on the policy background here. And there continues to be work to do.
We have seen some states do some creative work around CLIA waivers, and we have seen some work from the Department of Health and Human Services to make it easier to access CLIA waivers. And we’re going to continue to work on that issue.
I will also point out that, just yesterday, the FDA made a policy announcement about making it easier for tests to get authorization for asymptomatic screening use. So, again, much more work to do, but we are continuing to move forward on the policy environment here to support screening testing.
Acting Administrator Slavitt: Dr. Walensky, is there anything you want to add to that question? Nothing?
Dr. Walensky: Nothing to add. Thank you.
Acting Administrator Slavitt: Okay. Next question.
MODERATOR: Next we’ll got to Sheryl Stolberg with The New York Times.
Q: Thank you for taking my question. I’m wondering what metrics you’re going to apply to measure the effects of the spending on testing and the other mitigation measures. How much will this hasten the end of the pandemic or bring about the reopening of schools and the economy? How quickly will that happen, and how will you measure it?
Acting Administrator Slavitt: That’s a – it’s a broad question, so I would invite anyone to take that. Carole, is that something you want to start with?
Ms. Johnson: Yeah, let me just start by saying that we – our goal, from the front end, was that – we have heard from folks who work directly with school districts about schools that are anxious to have the resources to be able to do testing to support their reopening. So, as part of our broader goal to – the President’s broader goal to safely reopen schools, we want to make sure there are resources available to do that. And we are continuing to track school reopening with our colleagues at the Department of Education.
But our main message here is that we want schools to have the resources so that they can add this layer of mitigation that the CDC guidance on school reopening has pointed out can be an added protective factor. We know schools want – there are many schools that want that. We know there are schools that have tried to do it and have struggled to have the resources to do it. And so we want the resources out there, and we want to attract school reopening.
Acting Administrator Slavitt: Anybody want to add to that.
Dr. Walensky: Maybe I’ll just add that there a lot of metrics that people are using. We’re looking at wastewater for disease burden in communities. We’re looking at hospitalization rates. We’re looking at clusters and outbreaks in these schools that implement these screening strategies. So I think there are a lot of metrics that we can impose. Of course, there are a lot of moving parts. Not only are we ramping up testing, we’re also ramping up vaccinations.
Acting Administrator Slavitt: I would just add, as a reminder for everyone, that since the President’s call for schools to be open, we have issued a set of guidelines from the CDC to help with a roadmap to do that, prioritize vaccinations for teachers, and now this commitment around testing.
So the question, I think, for the administration and for the schools in the country is not whether they can be open, but how. And I think with this roadmap, with this testing resource, with these vaccinations, there is a clear path there.
MODERATOR: Next we’ll go to April Ryan with TheGrio.
Q: Thank you. I want to get back to the issue of children and vaccinations. What is the current research showing right now as it relates to vaccinating school-aged children? I ask that because I’m hearing from doctors that there is a concern about the possible change in the genetic profile by two of the vaccinations versus the Johnson & Johnson. If you can give me a comment on all of that – all of the above. Thank you.
Acting Administrator Slavitt: Dr. Fauci.
Dr. Fauci: Yeah. Thank you, Andy. Thank you for that question, April. Right now, there are a couple of studies from multiple companies looking at vaccines in children. Just to let everybody know where we are: The vaccine studies that are done right now are looking at both safety and immunogenicity; it’s not looking for vaccine efficacy signals, because you would need tens of thousands of people in those trials. We’re trying to do bridging studies to show comparable immunogenicity at the same time of looking at safety.
We will know answers to that for high school-level individuals by the time we get to the fall. And when you do an age de-escalation in younger children – we just started a study with Moderna, literally this past week, in which we’re going to do age de-escalation from 12 to 9, 9 years to 6 years, 6 years to 2 years, and 6 months to 2 years. We’re going to be looking at multiple aspects of safety.
There is really no biological reason at all to indicate or even predict that you would even see any modification of the genetic profile when you’re dealing with an mRNA, which has no way of integrating into the genome of a cell. So it is a question, April, that gets asked frequently, but there’s no biological mechanism why we can see how that would happen. We’re going to be looking at all aspects of safety, but I really don’t predict you’re going to see anything in that – in that space.
Acting Administrator Slavitt: Next question.
MODERATOR: Next we’ll go to David Lim at Politico.
Q: Hi, thanks for taking my question. I wanted to ask about the testing announcement today, specifically supply tests and what types of tests school districts will have access to, and if CDC is setting up a mechanism for purchasing those tests for distribution. Because it seems that there are still relative limitations, considering the number of students that are in K-through-12 schools.
Acting Administrator Slavitt: All right, why don’t we start with Carole.
Ms. Johnson: Yeah. Thanks, David. We are obviously closely monitoring supply, and expect some of the efforts to onshore supply will start to dovetail with the increases associated with this screening testing. We hope that the President’s commitment to testing, with a nearly $50 billion investment in the American Rescue Plan, is a strong signal to all about our commitment to testing and the importance of continuing to ramp up and expand testing.
Every – we are using those resources to not only expand testing but to address critical supply issues as we announced earlier last month that we were going to invest critical resources in raw materials and other issues that have presented shortage issues in the past.
The awards from CDC – I should let Dr. Walensky and anything that she would like – but these will be awards to state health departments for the purposes of helping to – help schools stand up testing programs. Many schools have – some schools have testing programs, and so the intent is not to disrupt the relationships that they have. Others need help in connecting to programs. And the federal government is continuing to work to build up the Federal Supply Schedule, to ensure that people have easy access and affordable testing.
Dr. Walensky: And maybe I’ll just add that we’re exciting because it’s not just to the state health departments, but this goes to the local health departments; it goes to rural and urban health departments so that we can really facilitate not just the testing, but the contact tracing and other prevention / interventions; the technical support that these local health departments will need to implement this testing.
Acting Administrator Slavitt: Thank you. Next question.
MODERATOR: Next we’ll go to Shira Stein at Bloomberg.
Q: Hi. Thanks. You used to break down all the vaccines that we’re getting by various streams – so one by states, tribes, and territories; then by pharmacies; and then – now we’re seeing community heath centers. Can you break down how many vaccines, specifically for next week? So – basically, so we can better understand where all the vaccines are going.
Acting Administrator Slavitt: Let me give you a rough – this is not a precise answer but I’ll give you a rough approximation: Somewhere in order a third of vaccination – of vaccines are going to retail pharmacies; something in the order of half are going to healthcare systems – the healthcare providers, hospitals, et cetera; then a large piece, after that, going – most of the rest to the big community vaccination centers; and then an increasing share to community health centers, mobile vans, et. cetera.
Now, the reason that can’t be precise is some of their – there’s some overlap in that states are each distributing their vaccinations into a variety of those channels. And so, you know, you can’t really – you can’t really give a complete picture because we’re sending vaccines directly to, say, community health centers and so are states. But that – the numbers are certainly rough in there.
But, Dr. Walensky, anything you want to add or change about that?
Dr. Walensky: No, that’s exactly – you know, the – if the states are distributing to the federal – to pharmacies, but there’s also getting federal supply, it makes it harder to tease apart. But that’s about – that’s exactly what I would have said.
Acting Administrator Slavitt: Okay. Next question.
MODERATOR: Last question will go to Ricardo Alonso-Zaldivar at AP.
Q: Hi, thank you for taking my question. Can you hear me?
Acting Administrator Slavitt: We can.
Q: Okay, thank you. Yeah. My question is for Dr. Walensky. And I was just wondering with the new guidance today, could you please review, underline for us what is the value added from the new guidance when compared to the previous layers of CDC guidance that we’ve had?
Dr. Walensky: Thank you for that question. So, this new guidance actually is really quite extensive compared to prior. It’s an expansion of the description of the kind of tests; how might one choose a test; the addition of the intended use of each of the individual tests; the addition of health equity as how we would use these tests in – to ensure that we have equitable distribution, that there’s a rapid turnaround time in all of these settings; the expanded availability of screening tests and how one might consider using diagnostic tests, as well as screening tests; and then, some discussion about how we would interpret these tests; and then some discussion about how we would interpret these tests in the context of vaccinated individuals; and then, of course, a menu of guidance on specific settings and how you would use the test, both from a diagnostic standpoint, but as well as from a screening and surveillance standpoint.
Acting Administrator Slavitt: We’ll close with one of the comments that President Biden made the other day, which is that “help is here.” It’s not even 60 days into the administration, and I would just like to summarize that your government is acting with urgency – acting even as people are being asked to maintain wearing masks.
The government is moving as quickly as possible, acting with speed of moving checks into the American – to the American public – near 100 million already; speed of vaccinations – near 100 million since January 20th; the speed of testing dollars moving out into the field, as Carole Johnson said today, with over $10 billion getting out the door quickly; and the speed of action on all of the areas needed to support the public from the most recent legislation that was passed.
So I want to thank everybody at the government and who is part of this effort for the great speed with which we’re asked – we’re acting on behalf of the public.
With that, thank you, and we will be here again on Friday.
March 17: Centers for Disease Control and Prevention (CDC) posted a press release titled: “CDC Announces $2.25 Billion to Address COVID-19 Health Disparities in Communities that are High-Risk and Underserved”. From the press release:
The Centers for Disease Control and Prevention (CDC) today announced a plan to invest $2.25 billion over two years to address Coronavirus Disease 2019 (COVID-19)-related health disparities and advance health equity among populations that are high-risk and underserved, including racial and ethnic minority groups and people living in rural areas. This funding represents CDC’s largest investment to date to support communities affected by COVID-19-related health disparities.
CDC’s new National Initiative to Address COVID-19 Health Disparities Among Populations at High-Risk and Underserved Communities, Including Racial and Ethnic Minority Populations and Rural Communities, will offer grants to public health departments to improve testing and contact tracing capabilities; develop innovative mitigation and prevention resources and services; improve data collection and reporting; build, leverage, and expand infrastructure support; and mobilize partners and collaborators to advance health equity and address social determinants of health as they relate to COVID-19.
“Everyone in America should have equal opportunity to be as healthy as possible,” said CDC Director Rochelle P. Walensky, MD, MPH. “This investment will be monumental in anchoring equity at the center of our nation’s COVID-19 response – and is a key step forward in bringing resources and focus to health inequities that have for far too long persisted in our country.”
Data show that COVID-19 has disproportionately affected some populations and placed them at higher risk, including those who are medically underserved, racial and ethnic minority groups, and people living in rural communities. These groups may experience higher risk of exposure, infection, hospitalization, and mortality. In addition, evidence shows that racial and ethnic minority groups and people living in rural communities have disproportionate rates of chronic diseases that can increase the risk of becoming severely ill from COVID-19 and may also encounter barriers to testing, treatment, or vaccination.
To stop the spread of the COVID-19 virus and move toward greater health equity, CDC continues to work with populations at higher risk, underserved, and disproportionately affected to ensure resources are available to maintain and manage physical and mental health, including easy access to information, affordable testing, and mental health care. For more information and community resources, visit: https://www.cdc.gov/coronavirus2019-ncov/community/health-equity/index.html
This initiative is funded through the Coronavirus Response and Relief Supplemental Appropriations Act, 2021, (P.L. 116-260) and is expected to award funding to up to 108 state, local, territorial and freely associated state health departments, or their bona fide agents. CDC will be accepting applications for this initiative through April 30, 2021.
March 17: U.S. Department of Health and Human Services (HHS) posted News titled: “Biden Administration to Invest $150 Million to Expand Access to COVID-19 Treatments in Underserved Communities”. From the News:
As part of the Biden Administration’s ongoing efforts to promote health equity in response to the COVID-19 pandemic, the U.S. Department of Health and Human Services (HHS) is investing $150 million to increase access to COVID-19 monoclonal antibody therapeutic treatments for patients in vulnerable communities across the country.
This new effort will speed assistance to hard-hit communities to increase administration of monoclonal antibody treatments to prevent hospitalizations and deaths. Assistance may include additional staffing, infusion center capacity in traditional and non-traditional health care settings, and equipment to administer the intravenous treatments. The effort will also increase awareness among health care providers and patients about the treatment options available, including where and how to access them.
“This is another example of how the Biden Administration is committed to an equitable COVID-19 response,” said Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force. “We’re working to keep people from getting COVID-19, and the vaccines that are currently being administered across the country are a key to doing just that. But for those individuals who get COVID-19, we want to make sure that they, too, have the benefit of the latest in scientific discovery to give them hope and help toward a safe and speedy recovery.”
This effort will focus on communities that have high levels of COVID-19 and are determined to be particularly vulnerable based on the Centers for Disease Control and Prevention (CDC) social vulnerability index. Social vulnerability refers to the potential negative effects on communities caused by external stresses on human health including disease outbreaks. The index uses 15 U.S. census variables to help local officials identify vulnerable communities.
CDC has found that COVID-19 is affecting underserved communities and ethnic minorities disproportionately largely due to poverty and uneven access to health care in those communities. Also considered are communities in which monoclonal antibody treatments currently are available and equitable access can be increased quickly for underserved populations.
Three monoclonal antibody treatments are available under emergency use authorization from the U.S. Food and Drug Administration (FDA). The monoclonal antibody therapeutics neutralize the virus that causes COVID-19 to prevent progression of disease. Based on the available evidence of safety and efficacy, the National Institutes of Health (NIH) recently updated its guidelines to recommend use of the treatments for those non-hospitalized COVID-19 patients who are at high risk of progressing to severe disease.
As each monoclonal antibody therapeutic received FDA authorization, HHS purchased and began allocating treatment courses, and now health care facilities can order the treatment courses directly from the distributor. Each therapeutic is administered as a single infusion. Since November 2020, more than 900,000 treatment courses have been distributed to more than 5,000 locations across the United States.
To learn more about the monoclonal antibody therapeutics available, visit https://combatcovid.hhs.gov/
March 18: The White House posted “Remarks by President Biden on the 100 Million Shot Goal”. From the speech:
The President: Well, folks, good to see you all.
When I announced in early December that I had goal that I set of administering 100 million shots for the virus in the first 100 days of our office – 100 million shots in 100 days – it was considered ambitious. Some even suggested it was somewhat audacious. Experts said that it was a – the plan was, quote “definitely aggressive,” and distribution would have to be “seamless” for us to be successful. One headline simply put it, quote: “It won’t be easy.” End of quote. Well, it wasn’t.
When I took office, when we took office, there was a lot that had to be done. We needed to vaccine, more vaccinatiors, more places for people to get vaccinated. And we needed a whole-of-government approach.
So, I directed Jeff Zeints, the coordinator of our COVID-19 response, to put us on a war footing – and I meant that in a literal sense – to get us on track to truly beat this virus.
And I’m proud to announce that tomorrow, 58 days into our administration, we will have met my goal of administering 100 million shots to our fellow Americans.
That’s weeks ahead of schedule, and even with the setbacks we faces during the winter storms. And it’s another big step on the path to checking the – putting checks in pockets and shots in people’s arms.
When we crossed the 50 million doses just three weeks ago, I told you that every time we hit the 50 million mark, I’d update you on our progress.
So here is where we are today: Eight weeks ago, only 8 percent of seniors, those most vulnerable to COIVD-19, had received a vaccination. Today, 65 percent of people aged 65 or older have received at least one shot, and 36 percent are fully vaccinated. And that’s key – because this is a population that represents 80 percent of the well over 500,000 COVID-19 deaths that have occurred in America.
We have nearly doubled the amount of vaccine doses that we distribute to states, Tribes, and territories each week. We have gone form 1 million shots a day – that I promised in December, before we were even sworn in – to an average of two and one half million shots a day, outpacing the rest of the world significantly.
And here’s how we accomplished this: Using the power given to a President under the Defense Production Act, we expedited critical materials in vaccine production, such as equipment, machinery, and supplies. We worked with vaccine manufacturers to speed up the delivery of millions more doses and brokered a historic manufacturing partnership between competing companies who put patriotism and public health first.
These steps put us back on track to have enough vaccine – enough vaccine supply for every adult American by the end of May – months – months earlier than anyone expected.
And we stood up or supplied more than 600 community vaccination sites that are administering hundreds of thousands of shots per day.
We launched the Federal Pharmacy Program, which has allowed millions of Americans to get a shot at one of thos- or, excuse me, one of 14,000 local pharmacies in this country, the same way they get their flu shot.
And for folks who aren’t near a pharmacy or mass vaccination center, we’ve supplied more than 500 mobile clinics, like pop-up sites or vans, meeting people where they are – meeting people where they are.
We’ve developed nearly – we’ve developed nearly 6,000 federal personnel, including FEMA, active-duty military, and Department of Health and Human Services to support vaccinations and serve as vaccinators – putting the needle in people’s arms.
We’re also supplying vaccines to community health centers to reach those who have been the hardest hit – the hardest hit – and suffered the most, especially Black, Latino, Native American, and rural communities. This is really important – because we believe that speed and efficiency must be matched with fairness and equity.
Now when President Harris and I took a virtual tour of a vaccination center in Arizona not long ago, one of the nurses on that – on that tour, injecting people, giving vaccinations, said that each shot was like administering a dose of hope. “A dose of hope.” That’s how she phrased it.
Behind these 100 million shots are millions of lives changed when people receive that dose of hope: Grandparents can hug their grandchildren again. Front-line workers who can show up at their jobs without the same fear they used to have. Teachers – with the confidence to head back into the classroom.
These milestones are significant accomplishments, but we have much more to do. Much more to do. And the American Rescue Plan will help us do it.
In addition to cash payments it provides to you and your families, it also provides the funds to add vaccinators, to supply more community vaccination – support more community vaccination centers, and increase testing.
It will help accelerate nationwide efforts to reopen schools safely. And as I told the nation last week, I’ve directed all states, Tribes, and territories to make all adults eligible to be vaccinated no later than May the 1st. I’m glad to see that several states are already taking that step to make more and more Americans eligible, even before May 1st.
Tomorrow, we will hit 100 million doses our administration has administered. But I’ve always said: That’s just the floor. We will not stop until we beat this pandemic. Next week, I will announced our next goal to put shots in arms.
This is a time for optimism, but it’s not a time for relaxation. I need all Americans – I need all of you to do your part: Wash your hands, stay socially distanced, keep masking up as recommended by the CDC, and get vaccinated when it’s your turn. Now is not the time to let down your guard.
In the last week, we’ve seen increases in the number of cases in several states.
Scientists have made clear that things may get worse and new variants of this virus spread. Getting vaccinated is the best thing we can do to fight back against these variants.
While millions of people are vaccinated, we need millions more to be vaccinated. And, again, I need you to get vaccinated when it come – when it’s your turn, when you’re able to do that. I need your help. I need you to help – not just the country, but your family, your friends, your neighbors. Get them vaccinated as well.
If we keep our guard up, stick with the science, we can look forward to a Fourth of July that feels a bit more normal, with small groups able to gather for cookouts in backyards, and when we’ll be – where we begin to declare our independence on Independence Day from the virus.
Look, together – together we’re going to come through this stronger, with renewed faith in each other, in our government that fulfills its most important function: protecting the American people.
Let me be clear again: wearing this mask, in the meantime; making sure you wash your hands; making sure you socially distance and listen to the CDC. We’ve got to reach the point where we have herd immunity – meaning where we have a vast majority of the American people have been vaccinated – before we can stop wearing these.
So, please, please, don’t let what’s happening – you see happening in Europe and you see on television. Keep the faith. Keep wearing the mask, keep washing your hands, and keep socially distanced. We’re going to beat this. We’re way ahead of schedule, but we’ve got a long way to go.
So I just wanted to bring you up to date. And I think you very much. And may God bless America, and may God protect our troops.
Thank you so much.
March 18: National Institutes of Health posted a News Release titled: “NIH leaders on the future of precision medicine, healthcare transformation”. From the News Release:
COVID-19 puts renewed focus on the urgent need to put diverse health data to work to support discoveries and bring more precise prevention and treatment strategies to communities. A new commentary in Cell, co-authored by Director of the National Institutes of Health Frances S. Collins, M.D., Ph.D., and Joshua C. Denny, M.D., M.S., chief executive officer of the All of Us Research Program, highlights seven opportunities to accelerate tailored medicine efforts and create a more equitable health landscape in the future.
The commentary covers key areas including huge cohorts, artificial intelligence, routine inclusion of genomics as part of clinical testing, deeper investigation of the role of phenomics and environment in health and disease, and returning value across diverse populations.
The authors highlight the role of large cohorts, like the All of Us Research Program and the immense potential of such resources that aim to bring together diverse streams of information spanning genomics, social determinants of health, environmental exposures, electronic health record data, and wearable device data. They note that these resources offer tremendous opportunities for discovery across every area of medicine, but that an “open science” approach is needed for researchers to combine data across cohorts to maximize their impact on a global scale.
Another necessary growth area the authors discuss is improving diversity and inclusion in science. As a case in point: a Nature Genetics paper last year reported that people of African or Hispanic/Latin American genetic ancestry make up less than 3% of participants in published, genome-wide associations of studies. Collins and Denny content that such underrepresentation has the potential to worsen current health disparities, while also weakening biological discovery that could benefit all populations. All of Us is working to change this, with more than 80% of its core participant cohort from populations that are historically underrepresented in biomedical research, including more than 50% from racial and ethnic minorities.
The COVID-19 pandemic has only heightened the need for transformative change in health research to meet the needs of communities nationwide, especially communities of color bearing the brunt of the viruses’s impact. With a bold plan in place – including international collaboration, engagement of diverse populations of participants and researchers, and broad access to data – the authors believe more precise medicine is possible for all.
March 18: Centers for Disease Control and Prevention (CDC) posted a press release titled: “CDC Initiative Creates New Water Fluoridation Technology to Support Rural Health Needs”. From the press release:
A Centers for Disease Control and Prevention (CDC) funded research initiative offers access to optimally fluoridated water for up to 19 million people in the U.S. for the first time.
The new fluoridation method is designed to dissolve in a small amount of water, much like the chlorine tablets used in swimming pools. This tablet system could allow nearly 32,000 small public utilities – often in underserved, rural areas – to contribute to the national Healthy People goal of providing access to fluoridated water to 77.1% of the U.S. population by 2030.
Drinking fluoridated water has greatly improved oral health outcomes for over 75 years keeping teeth strong and reducing cavities by about 25% in children and adults. Oral health is critical to overall health, yet oral diseases – ranging from cavities and gum disease to oral cancer – cause significant pain and infections across the globe. Untreated oral diseases can lead to problems eating, speaking, and learning. Over $45 billion is lost in productivity in the United States each year because of untreated oral disease.
“Drinking fluoridated water keeps teeth strong and reduces cavities, resulting in less pain, fewer fillings or teeth pulled, and fewer missed days of work and school,” said Karen Hacker, MD, MPH, Director of CDC’s National Center for Chronic Disease Prevention and Health Promotion. “As we honor World Oral Health Day on March 20, I am proud we could for the first time, make available such an important prevention strategy to so many people.”
Oral Disease Highlights Inequities
The burden of oral diseases highlights disparities in access to dental care and preventative services. In the U.S., children and adults from low-income households are two to three times more likely to have untreated cavities compared to those from higher-income households. Community water fluoridation is the most efficient and cost-effective way to deliver fluoride to everyone in a community, regardless of their age, income, or education.
About 35% of people in the U.S – and most people around the world – do not have access to properly fluoridated water, often because they live in a home not served by a public water system or because their public water system lacks resources to install and maintain cost-effective fluoridation systems.
The CDC recognized some smaller public water systems would need an alternative approach to optimally fluoridate water. In 2013, CDC announced a Small Business Innovation Research (SBIR) funding opportunity to develop a method similar to chlorine tablets used in swimming pools, so small systems could provide fluoridated water to their customers. Through a competitive, objective process, KC Industries (KCI) of Mulberry, Florida, received a CDC Phase 1 SBIR Award in 2014 to test the idea.
Following successful competition for Phase 2 funding, the awardee created a tablet and feeder system that is economical for systems that serve between 50 and 10,000 people. Nearly 19 million people in the United States are serve by these small systems – often in rural areas with less access to school dental sealant programs, healthy foods, and public transportation to get dental appointments.
March 19: The White House posted a Statement titled: “President Biden Announces his Intent to Nominate Assistant Secretary for Preparedness and Response, Department of Health and Human Services”. From the statement:
Today, President Joe Biden announced his intent to nominate Dawn O’Connell to serve as Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
Dawn O’Connell, Nominee for Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
Dawn O’Connell is currently the Senior Counselor to the Secretary for COVID-19. In this role, she coordinates the Department-wide response to the pandemic. Prior to assuming this role, Dawn serve on the Biden Transition Team a the health cluster lead for the Nominations Team. She was also the Director of the Coalition for Epidemic Preparedness and Innovation (CEPI) US Office. As director she was responsible for managing the broad spectrum of CEPI’s US and North American interests, including its relationships with US and North American-based stakeholders, government entities, and industry partners. She also served as the executive director for CEPI’s Joint Coordination Group – a roundtable of institutional partners who all have a vested interest in the successful development of epidemic vaccines.
Prior to joining CEPI in June 2017, she was a Senior Counselor to Secretary Sylvia Burwell at the U.S. Department of Health and Human Services (HHS) during the Obama Administration. As Senior Counselor, O’Connell advised Secretary Burwell on high-priority global health and humanitarian issues, including infectious diseases, unaccompanied children, and refugees. She worked with HHS leaders, the White House, and other federal and international partners, to resolve key policy challenges, lead implementation, and drive progress toward Administration goals. O’Connell received her undergrad degree in literature from Vanderbilt University and her law degree from Tulane University School of Law. She lives in Washington D.C., with her husband and two daughters.
March 19: U.S. Food and Drug Administration (FDA) posted a News Release titled: “Coronavirus (COVID-19) Update: March 19, 2021”. From the News Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
On March 16, the FDA posted a new web page on FDA.gov, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs. This resource is intended for schools, workplaces, communities and others looking to establish testing programs to screen people without symptoms and with no known or suspected exposure to COVID-19. The FDA also posted a new template for test developers to help facilitate submission of an emergency use authorization (EUA) request for certain COVID-19 tests for screening using a serial testing approach.
On March 17, the FDA posted two templates for serology tests with recommendations on what to include in Emergency Use Authorization (EUA) requests or Pre-EUA submissions: Template for Test Developers for Serology Tests that Detect or Correlate to Neutralizing Antibodies (New) and Serology Template for Test Developers (Update). The FDA updated the Serology Template for Test Developers to add clarity throughout and provide recommendations regarding monitoring for and assessing the impact of new SARS-CoV-2 mutations and variants. These templates provide the FDA’s current recommendations concerning what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for SARS-CoV-2 antibody tests. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
On March 17, the FDA granted BioFire Diagnostics LLC marketing authorization for its BioFire Respiratory Panel 2.1 diagnostic test. The grant of this De Novo request marks an important step in the FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. The BioFire Respiratory Panel 2.1 is a multi-analyze molecular test that simultaneously detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab. It is for use only for people suspected of respiratory tract infections, including COVID-19.
On March 17, the FDA approved an abbreviated new drug application for azithromycin tablets USP, 500 mg, which is indicated for specified mild to moderate infections caused by designated, susceptible bacteria. Side effects of azithromycin tablets include hypersensitivity, QT prolongation, diarrhea, nausea, abdominal pain, and vomiting. We remain deeply committed to facilitating access to medical products that are experiencing increased demand.
The FDA authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each monoclonal antibody (mAb) therapy that is available through an Emergency Use Authorization for COVID-19 treatment. The fact sheets contain details regarding specific variants and potential resistance that may make the authorized mAb therapies less effective.
The revised fact sheets are for:
Bamlanivimab and Etesevimab
REGEN-COV (Casirivimab and Imdevimab)
In a March 18 FDA Voices entitled FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic, FDA leaders explain that over the past year, the agency’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The COVID-19 pandemic required us to rework our business operations so that we could carry out our public health mission while protecting our workforce, and the workforces of those we regulate.
As of today, 341 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUA’s). These include 254 molecular tests and sample collection devices, 72 antibody and other immune response tests, and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test.
Coronavirus Disease 2019 (COVID-19)
March 19: The White House posted a “Press Briefing by White House COVID-19 Response Team and Public Officials”. From the press briefing:
Mr. Zeints: Well, thank you for joining us today. Today we’ll get a state-of-the-pandemic update from Dr. Walensky, and Dr. Fauci will highlight the latest science.
But first, I want to start with an important announcement the President made yesterday. We reached our 100 million shots goal in just 58 days, weeks ahead of schedule. Achieving this goal is a direct result of deliberate, aggressive actions guided by the President’s whole-of-government national strategy to end the pandemic.
Now, thanks to the American Rescue Plan, we will have the resources to fully implement this strategy and put the pandemic behind us. I’m currently at a community health center in New York City where I joined Leader Schumer on a tour of the Ryan Health Center to see what’s working, thank the folks on the frontlines, and hear what else we can do to support them.
I also want to thank Leader Schumer for his critical leadership in passing the American Rescue Plan.
Today, I’ll give a brief update on our three-part strategy on vaccinations. First, more vaccine supply. Second, more vaccinators in the field. And third, more places to get vaccinated.
On vaccine supply, the President has taken aggressive action to move up the production timelines for all three vaccines – Pfizer, Moderna, and Johnson & Johnson. As a result, by the end of May, we will have enough vaccine for every adult in the United States.
This week, about 22 million doses went to states, Tribes, and territories, and through the federal channels, including pharmacies and community health center. That’s more than two and a half times the weekly supply that was being distributed when we took office.
On vaccinators in the field, we’ve deployed nearly 6,000 federal personnel to serve as vaccinators and support vaccinations, including over 2,000 active-duty military men and women. At the President’s direction, that number will grow to more than 6,000 active-duty troops over the coming weeks.
On places to get vaccinated, we’ve increased the number of convenient and trusted places for people to get a shot. We’ve provided federal support for more than 600 community vaccination sites. We’ve administered more than 1 million shots at federally run community vaccination sites across the country. And more than 60 percent of those vaccinations have been administered to minority populations. That includes two sites right here in New York City: one in Brooklyn and one in Queens. And the American Rescue Plan will allow us to continue to increase the number of community vaccination centers.
We launched the Federal Pharmacy Program, which has allowed millions of Americans to get a shot in their local pharmacy the same way they get their flu shot. Last week, the President committed to doubling the number of pharmacies participating in the program. Already, people can get vaccinated at one of 14,000 pharmacies around the nation. For Americans who aren’t near a pharmacy or a community vaccination center, we’ve supported more than 500 mobile clinics to meet people where they are.
And today, I’m at the Ryan Health Center. Community health centers like Ryan Health serve 30 million people; 60 percent are people of color, and two-thirds of patients are below the poverty line. The administration is already sending vaccines directly to 250 of these community health centers. By the end of April, we will deliver vaccines to an additional 700 community health centers. This work is a result of the Biden administration’s partnership with state and local officials, federal workers, and the nonprofit and private sectors, and is leading to significant progress.
As you can see in our weekly vaccination progress report, the current seven-day average is 2.5 million shots per day – 2.5 million shots per day. That’s a new record pace that we will continue to build on. Importantly, now two out of three adults age 65 and older have gotten at least their first shot. This is critical because 80 percent of COVID deaths have been individuals 65 and older.
Given our progress on increasing supply, coupled with increasing the number of vaccinators in the field and creating more places to get vaccinated, the President announced last week that all adults in the country will be eligible for vaccinations no later than May 1. All adults eligible no later than May 1.
Finally, I want to provide an update on how we are working with our North American partners on efforts to stop the spread of COVID-19 across the continent. As part of the national strategy to end the pandemic, the United States is committed to engaging with the international community and supporting global efforts to address public health and humanitarian concerns. Under the President’s direction, the U.S. has reengaged with the WHO on day one of his presidency. We committed to providing the most funding to COVAX than any country in the world: $4 billion.
We also announced with our Quad partners last week that we are working to achieve expanded manufacturing of safe and effective COVID-10 vaccines at facilities in India.
And now, given our visibility into vaccine supply in the U.S., we’re able to announce that we’re lending a portion of our releasable AstraZeneca vaccines to Mexico and Canada.
Our approach to this wartime effort is to have as many tools in our toolkit as possible. Right now, we have three effective vaccines that went through a rigorous review process to be authorized by the FDA. We have other vaccines going through that process now, including one from AstraZeneca.
As we await the results of these trials here in the U.S., many countries have already approved AstraZeneca but need more supply. That includes Canada and Mexico.
So balancing the need to let the approval process of the AstraZeneca vaccine take place here in the U.S., with the importance of helping to stop the spread in other countries, we will loan a portion of our releasable AstraZeneca vaccine to Mexico and Canada. This action will allow our neighbors to meet a critical vaccination need in their countries, providing more protection immediately across the North American continent. In total, we will loan Mexico and Canada around 4 million doses.
To be clear: This loan will not reduce the available supply of vaccines to Americans. The doses we are loaning are not approved for use in the United Staes. No American will be without a vaccine because of this action.
And with that, I’ll turn it over to Dr. Walensky. Dr. Walensky?
Dr. Walensky: Thank you, Jeff. I’m glad to be back with you today. Let’s begin with the data.
COVID-19 cases continue to remain between 50- and 60,000 cases per day, with the most recent seven-day average at 53,200 cases per day. The most recent seven-day average of hospital admissions is slightly below 4,700 admissions per day, similar to the seven-day average we had on Monday. Deaths continue to decline with the current seven-day average of 1,025 deaths per day.
Today, I want to talk about a top priority for us at the CDC and for me as a parent: CDC’s efforts to support the safe reopening of schools for in-person instruction. We have frequently said CDC believes schools should be the last place to close and the first place to open.
The benefits of in-person instruction are well recognized. As a mother of three myself, I know all too well the difficulties that arise for our children – and parents and caregivers -when children are not Abel to attend in person for school. These challenges are especially difficult for children and families from low-resourced communities, as well as those from racial and ethnic minority communities and those with disabilities.
Safe in-person instruction gives our children access to the critical, social, and mental health services that prepare them for the future, in addition to the vital educational needs that they need to succeed.
When I became CDC Director, I promised that I would lead with science. To rebuild trust in our public health institutions and to keep people safe, it’s critical to make decisions based on evidence and facts. On February 12th, CDC released our operational strategy for K-12 schools, based on the latest science at the time, to help schools open and remain open for safe in-person learning.
The science told us then, just as it tells us now, that K-12 schools that implement strong, layered prevention strategies can operate safely while protecting teachers, staff and students. We’ve seen data demonstrating that this is safe, even in areas of high community spread.
CDC’s operational strategy focuses on five key layered mitigation measures for schools conducting in-person learning. These include universal and correct use of masks, physical distancing, hand washing and respiratory etiquette, cleaning to maintain healthy facilities, and diagnostic testing with rapid and efficient contact tracing, in combination with isolation and quarantine, and in collaboration with local health departments.
When we released the operational strategy, I said that CDC was going to follow the science and would update our guidelines as new evidence emerged. This is essential since the science of COVID-19 is rapidly changing with new data emerging every week.
Since the initial release, CDC scientists have been actively reviewing the latest science and conducting their own studies to expand the evidence base, and we now have new information to help us refine our recommendations, specifically for physical distancing.
Last week, the Journal of Clinical Infectious Diseases published a study that looked at COVID-19 in 251 Massachusetts school districts over a four-month period of time. It found that physical distancing of at least three feet between students could safely be adopted in school settings where everyone – students and staff – wore a mask at all times. And today, CDC is publishing three new studies in the MMWR that add to this evidence base.
One study looked at data from Utah elementary schools and found that COVID-19 spread was low with students placed less than six feet apart in classrooms, even though levels of virus spread in the community were high.
Another report examined data from kindergarten classrooms in Springfield and St. Louis, Missouri. This study found that transmission occurred at lower rates in classrooms than in the community because the schools used multiple layered prevention strategies together.
And the third study looked at COVID-19 rates among students in Florida and found that 60 percent of cases in students were not related to the spread in schools. It also found that resuming in-person activity was not associated with proportionate increase in COVID-19 cases. Importantly, this study also found that COVID-19 rates were higher among students in school districts that did not have mandatory mask-use policies in place.
Layered mitigation strategies, including strict use of masks among students and a distance of at least three feet between students, were common factors among the schools in these studies that demonstrated decreased transmission from COVID-19. This additional evidence continues to underscore why it is so important for schools to use layered prevention strategies to provide the greatest level of protection.
So, in light of the expanded evidence on physical distancing, today, CDC is pleased to update our recommendations for physical distancing between students and classrooms in our K-12 operational strategy. Specifically, in elementary schools, CDC is now recommending that all students remain at least six feet apart in classrooms where everyone is wearing a mask, regardless of whether community COVID-19 risk is low, medi- intermediate – low, moderate, substantial, or high.
In middle and high schools, CDC is also recommending that students be at least three feet apart in classrooms where everyone is wearing a mask and the community level of risk is low, moderate, or substantial. Because COVID-19 is spread more likely among older students, CDC recommends that middle and high school students should be at least six feet apart in communities where COVID 19 rift is high, unless cohorting is possible.
Cohorting is when groups of students are kept together with the same peers and staff, without close interaction with other groups or cohorts, to reduce the risk of spread throughout the school. We recognize that cohorting is harder in high school students, but the science indicates that these students are also at higher risk of transmitting SARS-CoV-2.
I want to emphasize that these recommendations are specific to students in classrooms with universal mask wearing. CDC continues to recommend at least six feet of distance between teachers and staff and other adults in the school buildings and between the adults and students.
In common areas in the school, where masks cannot be worn – such as when eating, during activities such as singing, band practice, sports, exercise, and other activities that can increase exhalation – these activities should be moved outdoors or to large, well-ventilated spaces when possible. And six feet should also be used in community settings outside the classroom.
Today’s announcement builds on our ongoing efforts to support teachers, school, staff, and students, as well as our work and educational and public health stakeholders to provide the guidance, tools, and resources to get our nation’s schools open as quickly and safely as possible. This includes our plan to invest $10 billion to support COVID-19 diagnostic and screening testing for teachers, staff, and students – which we announced on Wednesday – and our ongoing work to get teachers and school staff vaccinated during the month of March through more than 9,000 pharmacies in our Federal Retail Pharmacy program that are now prioritizing vaccination appointments for teachers and staff who work in K-12 schools.
If you are an eligible educator or school staff member and have not yet been vaccinated, I encourage you to go to CDC.gov to learn more about how you can sign up for an appointment through this program.
I’m hopeful that we are turning a corner on this pandemic. Getting our children back to school, in-person instruction, as soon as possible, is a critical first step in doing so. I’m grateful to all the scientists who have produced the evidence to address the key question, such as a distance required to remain safe, so that we can move quickly to this end.
Thank you. I look forward to your questions, and I’ll now turn things over to Dr. Fauci.
Dr. Fauci: Thank you very much, Dr. Walensky. I’d like to spend the next couple of minutes in addressing an issue which is on the forefront of the minds of many people, and that relates to the threat of a variant of concern, particularly the B117 variant, which, right now, as we know, is causing a significant degree of concern in Europe where the flare and the surge that they are seeing is directly related to the variant 117.
This variant, as you know, is every day getting more and more dominant in our own country. So, very first, let me just take a few seconds to refresh your memory about the variant. It was first detected in the UK in December of 2020. It was reported in over 90 countries. The first U.S. cases were detected in the United States, in Colorado, at the end of December 2020. And since then, it has been detected in 50 jurisdictions in the United States, and likely accounts now for about 20 to 30 percent of the infections in this country, and that number is growing.
So what I want to do, again, is take a look, first, of the concern that we have and then some encouraging news, and then I’ll end with a caveat. Of concern is that there are about 50 percent increase of transmission with this particular variant that has been documented in the UK, and there’s likely an increase in severity of disease if infected with this variant.
This is an example of that. If you look at the daily confirmed cases in certain selected European countries over a period of time – and as you can see, the last date on this slide is March 17th – this is what I referred to previously about the surges that are going on in Europe at a time when we’ve reached this point of plateauing that Dr. Walensky mentioned to you, where we’re now at 53,200 cases per day on a seven-day average. This strongly suggests that there’s an increase in transmissibility in the European countries associated with 117.
What about severity of disease? Next slide. In a couple of UK studies, this one, looking at over 54,000 mashed pairs of participants in the UK, in which one person was infected with the B117 and another one wit the previously circulating variant, there was a 64 percent increased risk of death for those with the B117.
In this similar study in the UK, there was about 5,000 deaths that were analyzed where there was the presence or absence of 117. And again, an estimated 61 percent higher risk of death with B117.
What about some encouraging news? There has been a minimal impact on viral neutralization by EUA monoclonal antibodies. And importantly, for what we are doing in the United States with vaccines, there’s been a minimal impact on viral neutralization either by convalescent plasma or, importantly, by post-vaccination sera.
And so, on this last slide, as you can see with Israeli as an example where the B117 predominates, as their vaccine doses into the arms of individuals increase, you’re seeing a very dramatic and steady diminution of cases, which is underscoring the effect and the capability of the currently utilized vaccines against 117.
With that encouraging note, I want to end with a big caveat. The way we can counter 117, which is a growing threat in our country, is to do two things: to get as many people vaccinated as quickly and expeditiously as possible with the vaccine that we know works against this variant; and finally, to implement the public health measures that we talk about all the time and that was on Dr. Walensky’s slide: masking, physical distancing, and avoiding congregate settings, particularly indoors.
I’ll stop there, and back to Jeff.
Mr. Zeints: Thank you Dr. Fauci. And before we open up it for questions, I spoke at the beginning about reaching the President’s goal to administer 100 million shots in his first 100 days, and we accomplished that in just 58 days.
This week, we’ve also announced a number of steps to help deliver in the President’s goal to get our schools reopened. As Dr. Walensky just discussed, the CDC continues to work to update its guidance for schools, as the science evolves.
Earlier this week, we announced that schools will receive $10 billion in funding for testing program and nearly $130 billion to help schools invest in mitigation strategies, like PPE, additional space, hiring more teachers. And at the President’s direction, we’re also working to get all educators vaccinated.
With that, we’ll open it up for a few questions.
MODERATOR: All right. And I know there’s a lot of questions today, so please keep your questions to one question. First, we’ll got to Anne Flaherty at ABC.
Q: Hi, thanks for taking my question. Dr. Walensky, can you address the criticism by some of the unions that the research that you’re looking at in schools does not address underfunded urban schools?
And on the testing – you’ve encouraged testing but these tests – these rapid tests are not widely available on the market, even with the additional $10 billion. How soon before schools can test?
Dr. Walensky: Yeah, thank you for that question, Anne. You know, we have now increasing evidence for many different school settings that did not control for ventilation, as to demonstrating that it is safe in classrooms, when 100 percent masked, to be at three feet.
And so, you know, what I would say is, you know, we are following the science, and we have done the science, and we’ve seen the science to make – to ensure that this is safe for those schools.
Our strategies for mitigation, when layered with integration strategies that we have demonstrated, talk about distancing, masking, as well as respiratory etiquette, hand washing, and contact tracing. We have added, indeed, layered mitigation strategies – further layers mitigation strategies for both ventilation as well as testing and teacher vaccination.
So while we don’t believe those to be essential, all of those are scaling up simultaneously through the American Rescue Plan.
Mr. Zeints: Next question.
MODERATOR: Next we’ll go to Erin Billups at Spectrum News.
Q: Hi, thanks for taking my question. So a growing number of studies are finding that the second shot of the mRNA vaccines are unnecessary for people previously infected with COVID-19. In France, they’ve changed their policy based on this. Are there any discussions happening to consider a change in dosing policy for the U.S. in light of these findings, particularly because research is showing that second doses are effectively wasted on those with pre-existing immunity?
Mr. Zeints: Let’s go to Dr. Fauci. Dr. Fauci?
Dr. Fauci: Yeah. Yes, there’s no doubt that the preliminary studies that we have seen right now, that vaccination of an individual who has been previously infected has a much greater increment in the level of neutralizing antibodies, compared to an individual who has just been vaccinated an received a second dose.
Now, obviously, the places that are now looking at that are those that have a true paucity of vaccine doses. But as you’ve heard from Jeff, just recently, we are now at a position where we are giving between 2 and 3 million doses a day. If there were a dramatic shortage, I think that’s something that you would want to consider, but that’s not something that we’ll be making a policy about soon.
Mr. Zeints: And, importantly, we have enough doses now, driven by the President’s action, for all adult Americans by the end of May.
MODERATOR: Next we’ll going to Michael Winner at McClatchy.
Q: Thanks, everyone, for doing this. I’d like to ask about these FEMA-run federal mass vaccination sites and clarify some confusion I’m hearing out there. In Florida, we understand that the sites are now transitioning to only administering second doses and will then close up shop.
So two questions, specifically one on Florida. Are those mass sites closing? And then, secondly, and more broadly, are all of these federal mass vaccination sites intended to stand up for only a couple of weeks at a time? Thanks.
Mr. Zeints: You know, I don’t know the specifics on Florida. We can follow up on that. But I can say, across the board, these sites are really an important opportunity to increase the number of places where Americans can get vaccinated.
As I said in my opening comments, we’re now well over a million shots – doses administered at the federal sites. The federal sites are seen as very well run. And, importantly, not only efficiently and effectively delivering vaccines, but doing so in an equitable way.
So, the plan is for the federal sites to continue. We’ll get back to you with any specifics on the Florida site.
MODERATOR: Next we’ll go to Kaitlan Collins at CNN.
Q: Thank you very much. I have a question for Jeff and a question for Dr. Walensky. Jeff, can you just explain what is – what do you mean by “loan,” when you’re saying that we’re loaning vaccines to Mexico and to Canada – these AstraZeneca vaccines? Does that mean that they’re going to reimburse the U.S. for these return this amount of AstraZeneca doses? Could you just explain that/
And then, Dr. Walensky, could you say: Was the CDC pressured by teachers unions to change this guidance to three feet from six feet in school?
Mr. Zeints: So thank you, Kaitlan. The structure of a loan, that’s what makes the most sense, given what we’re balancing here, which is helping our global partners while they have a critical need and we await the results of the clinical trials here in the U.S. and FDA action on AstraZeneca in the next few weeks.
So this arrangement helps Canada and Mexico, in the moment, meet that critical need, while ensuring that they return those does through the company – through AstraZeneca – later in the year.
Dr. Walensky: Great. Yeah, thank you, Kaitlan, for that question. First, let me just acknowledge what the teachers have had to do this year in the context of COVID-19, and how they have had to evolve their thinking and their curricula, and how they teach their students in, truly, an overwhelming and challenging time.
I’ve spoken to the teachers unions. They know that we need to follow the science and to make our guidance based on that science, and they’ve been very respectful of that.
Mr. Zeints: Next question.
MODERATOR: Next we’ll go to Kristen Welker at NBC.
Q: Hi, everyone. Thanks for doing the call. Can you address the fact that there has been an uptick in cases in some states? New Jersey, New York, Rhode Island – to name just a few. Why do you assess this is happening now, given the fact that people are vaccinated? And how concerned are you about it?
And can you be crystal clear why it is ok for kids to be three feet apart but adults in the workplace, for example, still need to be six feet apart? Thank you.
Mr. Zeints: So let’s have Dr. Fauci answer the first question about increases in some states and Dr. Walensky on three versus six feet.
Dr. Fauci: Yeah, thank you very much, Jeff. Yes, that’s an excellent question, and it really relates to what we have been saying on the past few briefings that we’ve given.
We’re at a position right now where we have a plateauing at around 53,000 cases per day. The concern is that throughout the country, there are a number of state, city, regions that are pulling back on some of the mitigation methods that we’ve been talking about: the withdrawal of mask mandates, the pulling back to essentially non-public health measures being implemented. This is something that each of us have express concern about that is really quite risky to declare victory before you have the level of infection in the community to a much, much lower level than 53,000 cases per day.
So it is unfortunate but not surprising to me that you are seeing increases in number of cases per day in areas – cities, states, or regions – even though vaccines are being distributed at a pretty good clip of 2 to 3 million per day. That could be overcome if certain areas pull back prematurely on the mitigation and public health measures that we talk about.
Dr. Walensky: Maybe I’ll chime in – thank you for that question, Kristen – that the evidence shows that the risk of COVID-19 transmission among younger children is much lower than it is among teenagers and adults. And in particular, our school studies have shown that when children – young children – are masked, the distance of three feet is, in fact, safe and has a lower transmission risk.
For adults, we don’t have that evidence, and for older children, so we’re continuing with the six foot guidance.
Mr. Zeints: I just want to reiterate what the President said yesterday, which is consistent with what Dr. Fauci just said, which is: It is a time for optimism but not a time for relaxation. We need to follow the basic public health standards. We need to mask up, and then we need to make sure everyone gets their vaccine when it’s their turn. We cannot let down our guard at this point.
Kevin, one more question.
MODERATOR: One more question. We’ll go to April Ryan with theGrio.
Q: Thank you for letting me ask this question. What are the concerns with the variant and its severity as it relates to school-aged children? We’re understanding that the variants are hitting the children harder than the original strain. And how does this play into these new guidelines for schools and the distancing – three feet apart? Thank you.
Mr. Zeints: Let’s start with Dr. Fauci on the variant in kids and then over to you, Dr. Walensky.
Dr. Fauci: Well, yes. Obviously, as I mentioned in one of the first slides that I showed, that there is an increase in severity, but also, it appears that the likelihood of a child getting infected is greater with this variant. That might relate not to anything specific about children, but that is just, in general, more easily transmitted. So that would explain that.
Regarding the school situation, I’ll hand that back to Dr. Walensky.
Dr. Walensky: And what we can say is that it is, in fact – while these variants are concerning, it is, in fact, the same disease and the same mitigation strategies – the masking, the distancing – work just the same with the variants as they do with the wild-type disease.
Mr. Zeints: Good. Well, thank you, everybody, for joining us. We’ll look forward to Monday’s briefing. Thank you.
March 19: Centers for Disease Control and Prevention (CDC) posted a press release titled: “CDC Updates Operational Strategy for K-12 Schools to Reflect New Evidence on Physical Distance in Classrooms”. From the press release:
The Centers for Disease Control and Prevention (CDC) is updating K-12 school guidance to reflect the latest science on physical distance between students in classrooms. CDC now recommends that, with universal masking, students should maintain a distance of at least 3 feet in classroom settings. CDC has updated its operational strategy to say:
In elementary schools, CDC recommends all students remain at least 3 feet apart in classrooms where mask use is universal – regardless of whether community transmission is low, moderate, substantial, or high.In middle and high schools, CDC also recommends students should be at least 3 feet apart in classrooms where mask use is universal and in communities where transmission is low, moderate, or substantial.Middle school students and high school students should be at least 6 feet apart in communities where transmission is high, if cohorting is not possible. Cohorting is when groups of students are kept together with the same peers and staff throughout the day to reduce the risk for spread throughout the school. This recommendation is because COVID-19 transmission dynamics are different in older and younger students – that is, they are more likely to be exposed to SARS-CoV-2 and spread it than younger children.
The updated Operational Strategy for K-12 Schools through Phased Prevention is part of CDC’s existing resources for K-12 schools to open and remain open for in-person instruction during the COVID-19 pandemic. Since release of the Operational Strategy on February 12, 2021, CDC has continually reviewed the evolving evidence of SARS-CoV-2 transmission in K-12 schools, as well as the latest science on the effectiveness of different prevention strategies within schools. The updated guidance complements CDC’s existing guidance, resources, and tools for K-12 schools.
Three studies, published in today’s Morbidity and Morality Weekly Report (MMWR), also addresses spread of SARS-CoV-2 in schools. Taken together, these studies build on evidence that physical distancing of at least 3 feet between students can safely be adopted in classroom settings where mask use is universal and other prevention measures are taken.
“CDC is committed to leading with science and updating our guidance as new evidence emerges,” said CDC Director Rochelle P. Walensky. “Safe in-person instruction gives our kids access to critical social and mental health services that prepare them for the future, in addition to the education they need to succeed. These updated recommendations provide the evidence-based roadmap to help schools reopen safely, and remain open, for in-person instruction.”
These updated recommendations are specific to students in classrooms with universal mask wearing.
CDC continues to recommend at least 6 feet of distance:
Between adults in the school building and between adults and students.
In common areas, such as school lobbies and auditoriums.
When masks can’t be worn, such as when eating.
During activities when increased exhalation occurs, such as singing, shouting, band practice, sports, or exercise. These activities should be moved outdoors to large, well-ventilated spaces wherever possible.
In community settings outside of the classroom.
Given the crucial services schools offer and the benefits of in-person learning, it is critical for K-12 schools to open and remain open for in-person instruction, as safely and as soon as possible. Schools should be the last settings to close because of COVID-19 and the first to reopen when they can do so safely. Working together, school leaders and community member can take actions to keep schools open for in-person learning by protecting students, teachers, and school staff where they life, learn, and play.
Vaccines are an important tool to help stop the COVID-19 pandemic. Earlier this month, as part of ongoing efforts to reopen K-12 schools, President Biden directed all states to prioritize K-12 teachers, school staff, and childcare workers for COVID-19 vaccination, and he challenged states to give these educators their first shots by the end of March. CDC is taking a leading role in helping to achieve the President’s goal through its Federal Retail Pharmacy Program, which has over 9,000 participating pharmacies nationwide prioritizing K-12 teachers, school staff and childcare workers for vaccination appointments throughout the month of March. Additional information is available on the CDC website.
March 19: U.S. Food & Drug Administration (FDA) posted a News Release titled: “Coronavirus (COVID-19) Update: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection”. From the News Release:
Device may be used to identify biomarkers indicative of SARS-CoV-2 infection among certain asymptomatic individuals following a temperature reading that does not meet criteria for fever
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).
The Tiger Tech COVID Plus Monitor is intended for use by trained personnel to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19. The device identifies certain biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory states (such as severe allergic reactions), in asymptomatic individuals over the age of 5. The Tiger Tech COVID Plus Monitor is designed for use following a temperature reading that does not meet the criteria for fever in settings where temperature check is being conducted in accordance with Centers for Disease Control and Prevention (CDC) and local institutional infection prevention and control guidelines. This device is not a substitute for a COVID-19 diagnostic test and is not intended for use in individuals with symptoms of COVID-19.
“The FDA is committed to support innovative methods to fight the COVID-19 pandemic through new screening tools,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Combining use of this new screening device, that can indicate the presence of certain biomarkers, with temperature checks could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums, and airports.”
The device is an armband with embedded light sensors and a small computer processor. The armband is wrapped around a person’s bare left arm above the elbow during use. The sensors first obtain pulsatile signals from blood flow over a period of three to five minutes. Once the measurement is completed, the processor extracts some key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model that has been trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation in blood. Hypercoagulation is known to be a common abnormality in COVID-19 patients. The result is provided in the form of different colored lights used to indicate if an individual is demonstrating certain biomarkers, or if the result is inconclusive.
The Tiger Tech COVID Plus Monitor is not a diagnostic device and must not be used to diagnose or exclude SARS-CoV-2 infection. The device is intended for use on individuals without a fever. An individual’s underlying condition may interfere with the COVID-19 related performance on the device and could lead to an incorrect screening result.
The FDA issued the EUA to Tiger Tech Solutions, Inc.
March 22: The White House posted a Press Briefing titled: “Press Briefing by White House COVID-19 Response Team and Public Health Officials”. From the press briefing:
Acting Administrator Slavitt: Good morning. Thank you for joining us. We’re now two months into our national strategy to defeat COVID-19. At the heart of our plan are a number of critical activities.
Vaccinations: We’ve had to significantly ramp up vaccine production to a level more than double when we arrived, acquired enough vaccines to vaccinate the population, and have set up a deadline – May 1st – by which all Americans should be eligible to get a vaccine.
We’ve done this not only by increasing vaccine production, but also adding thousands more vaccinators and thousands of additional locations to get vaccinated.
We are now vaccinating about 2.5 million people per day, up from 900,000 when we arrived. This weekend was the first time that the U.S. reported vaccinating more than 3 million people on consecutive days.
There are now a total of 81 million people – or nearly 1 in 3 adults – with at least one vaccine dose in the U.S., and 44 million who are fully vaccinated. Nearly 69 percent of seniors have now received their first vaccination, and 42 percent are fully vaccinated.
A second core element of our plan is to get schools open and open safely. This has meant following the science, dramatically increasing testing, and making it a priority to vaccinate teachers. With $10 billion committed to testing so far, schools have enough resources to properly test their students and staff.
Today, we’re taking another step in building equitable and efficient response. The state of Washington will receive its first federally – federal community vaccination site. The Yakima County CVC will be able to offer up to 1,200 shots per day. Local residents will be able to drive through the Central Washington State Fair Park and get a shot.
Now, this is the 22nd federally run vaccination site we’ve opened. And as you can see from some of the tweets on the screen here, these sites get great reviews as a place to get vaccinated. Combined, they deliver nearly 100,000 shots per day.
All of the sites are in areas defined by the CDC as having a high social vulnerability rating. In fact, against the backdrop of inequity in vaccine distribution generally, and the severe toll taken by the virus on people of color, in federal vaccination centers, over 60 percent of the shots have gone to people of color.
For example, Yakima County has been particularly hard hit throughout the COVID-19 pandemic with disproportionately high infection and hospitalization rates as compared to the rest of the state.
The President has set a goal of doubling the number of community vaccination centers run by FEMA and the U.S. military to ensure that we reach the hardest-hit communities in this historic effort.
We have much more work to do, but further progress was made this weekend.
With that, I’m going to turn this over to Dr. Walensky and then to Dr. Fauci for some important updates.
Dr. Walensky: Thank you, Andy. I’m delighted to be back with you all today. Let’s start with an overview on the state of the pandemic. The most recent seven-day average is about 53,800 cases per day, which is a slight increase from the previous seven-day period. And over the past two weeks, cases have continued to fluctuate somewhere between 50,000 and 60,000 daily cases.
The most recent seven-day average for new hospital admission is just over 4,500 per day. Like COVID-19 cases, hospital admissions have been relatively stable over the last two weeks, hovering around 4,500 to 5,000 admissions per day.
Deaths continue to decline – a lagging indicator – with the most recent seven-day average of deaths slightly over 1,000 per day. Slightly under – sorry – 1,000 per day.
The apparent leveling off of cases and hospital admissions after the consistent declines we saw in early January through the end of February I consider to be very concerning.
In addition, while deaths continue to drop, they remain at elevated levels. And in the past week, the rate of decline of deaths has slowed.
We also know that the trajectory of the pandemic varies across the United States, with some states and regions of the country, such as the Northeast and Upper Midwest, are beginning to again see a significant rise in cases.
Taken together, these statistics should serve as a warning sign for the American people. As I’ve stated before, the continued relaxation of prevention measures while cases are still high, and while concerning variants are spreading rapidly throughout the United States, is a serious threat to the progress we have made as a nation.
Increasingly, states are seeing a growing proportion of their COVID-19 cases attributed to variants. The newly identified variant, B1427/B1429, is estimated to account for 52 percent of cases in California, 41 percent in Nevada, and 25 percent in Arizona. And the B117 variant is estimated to be responsible for 9 percent of the cases in New Jersey and 8 percent in Florida.
Believe me, I get it – we all want to return to our everyday activities and spend time with our family, friends, and loved ones. But we must find the fortitude to hang in here for just a little bit longer. We are at a critical point in this pandemic, a fork in the road, where we as a country must decide which path we are going to take. We must act now. And I am worried that if we don’t take the right actions now, we will have another avoidable surge, just as we are seeing in Europe right now and just as we are so aggressively scaling up vaccination.
Nearly 25 percent of the American population have received at least one dose, and over 44 million people – about 13 percent of the population – is fully vaccinated. And we have more vaccine supply on the way.
Until then, we must do everything we can to stop the spread of COVID-19 and the proliferation of variants while we get more people vaccinated.
We now have 69 percent of adults over the age of 65 who have received at least one vaccine dose and 42 percent who are fully vaccinated. And we have seen that the vaccines are working. With increasing numbers of those over 65 presenting to our emergency departments because of COVID-19 is lower than those age 26 to 45 in the United States.
These vaccines work. We’re seeing it in the data. There are positive kinks in our curves. And we need to remain vigilant as we quickly get the rest of the American people fully vaccinated.
I’m calling on the American people to take action, whether vaccinated or not, to recommit to doing the right thing. Take the steps we know work to stop COVID-19: Wear a well-fitted mask, socially distant, avoid crowds and travel, and be ready to roll up your sleeve to get vaccinated when the vaccine is available to you.
Thank you, I’ll now turn things over to Dr. Fauci.
Dr. Fauci: Thank you very much, Dr. Walensky. We have some good news today in the field of vaccine, and that has to do with the results that were announced yesterday from the AstraZeneca trial.
As shown on this slide, there are three platforms that have six companies involved. For the discussion over the next couple of minutes, we’re going to be looking at the chimp adeno vector that is used by AstraZeneca, which yesterday revealed the results of their phase three trial.
Just to refresh your memory, the vector is used in this platform is a chimp adenovirus with the SAR-CoV spike protein DNA was inserted. That non-replication-competent harmless adenovirus is injected into the muscle of an individual. The DNA then codes for RNA, which then essentially codes for the spike protein which the body makes the immune response against. That is the fundamental mechanism of this protein.
And so, the data: We’re talking about a phase three trial involving more than 32,000 participants who are 18 years of age or older, and it was at 88 sites – mostly in the United States, but also a small amount in Chile and Peru – with a 2-to-1 randomization of vaccine to placebo.
The demographic distribution is shown here. Around 79 percent White, 22 percent Hispanics, 8 percent Black/African American, and 4 percent Native Americans, including American Indians and Native Alaskans residing in the United States, and 4 percent Asian. Twenty percent was 65 years of age or older, and 60 percent had cormobidities associated with an increased risk for progression of severe COVID-19, such as diabetes, severe obesity, or cardiac disease. This is important to get that many people who have comorbidities.
So right at the efficacy data, good results: 78.9 percent vaccine efficacy of preventing symptomatic disease; importantly, with regard to severe or critical disease requiring hospitalization, there was zero in the vaccine arm and five in the placebo arm. The good news is also that there was comparable efficacy across ethnicity and age; namely, a very good efficacy – 79.9 percent – in participants who are 65 years of age or older.
The reactogenicity and overall safety profile were good. The vaccine was well-tolerated, and the Data and Safety Monitoring Board identified no specific safety concerns related to the vaccines. Importantly, and this is a quote from the DSMB, “No evidence of disproportionate risk of thrombosis or events characterized by thrombosis among the 21,583 participants who received at least one dose. An in-depth search of the database for venous thrombosis revealed no events in this study.”
The United States government has played a significant role in the conduct of this trial. It was funded by BARDA and by NIAID in a trial led by the company AstraZeneca; the NIAD supported by its clinical trial network, the CoVPN. The Data and Safety Monitoring Board was formed by NIAID, which monitored the trial to ensure safety and validity of the data. And NIAID intramural investigators co-authored key preclinical studies.
And finally, on the last slide: Importantly, this vaccine can be stored, transported, and handled at refrigerator temperature for at least six months. And also, importantly, conditional marketing authorization or emergency use is already in play in more than 70 countries across six continents, and it has been given emergency use listing by the WHO.
I’ll stop there. And back to you, Andy.
Acting Administrator Slavitt: Thank you, Dr. Fauci, Dr. Walensky.
Let’s go to questions, please.
MODERATOR: First question will go to Dan Vergano at BuzzFeed News.
Q: Thanks very much. I’m wondering if you could comment on what you see going forward, if we continue vaccinating the most high risk and elderly, with regard to the death rates versus the case rates. Are we going to see much lower death rate overall with continuing, you know, relatively high case numbers? And does that communicate your message about vaccination if the death rates decline? Assuming that’s a great thing, of course, but I wonder what kind of world we’re going to see going forward with more – as more people get the vaccine. Thanks.
Acting Administrator Slavitt: Why don’t we start with Dr. Walensky and then Dr. Fauci?
Dr. Walensky: Yeah. It’s an important question for us to consider. I think one thing we have to realize is that there’s still a death rate among people who are under the age of 65. And that death rate is certainly going to be consistent with the number of cases we have overall.
So while I consider it extraordinarily good news that our death rate is declining in those who have been vaccinated, there is still a death rate among those who are over, you know, 25 – over 20. And, you know, as those cases continue to increase in that demographic, we will see death rates in that demographic as well. So I think the messaging is very consistent. We still need to be vaccinating everyone who is eligible.
Acting Administrator Slavitt: Dr. Fauci, anything you’d add?
Dr. Fauci: No. Just to underscore with Dr. Walensky said: Every time we look at data, it looks at when you’re dealing with severe outcomes, hospitalizations, and deaths – the vaccines, all of them, have a good track record. So, as Dr. Walensky said, that just underscores the importance of getting everybody vaccinated as quickly as we possible can.
Acting Administrator Slavitt: Great. Thank you. Next question.
MODERATOR: Next we’ll go to Tom Howell at the Washington Times.
Q: Hey, thanks for doing the call. With the AstraZeneca news and also robust data from Novavax, it looks like both of those might get emergency approval by May. I’m just wondering how you’re thinking about that in terms of supplies – the challenge shifting now to what to do with any surplus; how to maintain interest in the shots here at home. How are you, kind of, working through, you know, whether we’re going to have more supply than we need and what the challenges are now? Thanks.
Acting Administrator Slavitt: Thank you, Tom. So, first of all, I’ll start and then see if Dr. Fauci, you want to add something.
So I think it’s too early for us to declare that we’re in a surplus position. We have been carefully planning. We have – obviously the highest priority is to, as Dr. Fauci just said, to vaccine the U.S. public as quickly as possible.
So – but obviously, the more we get confidence in our increased supply, the more flexibility that gives us for different events, whether its vaccinating adolescents, whether it is sharing that supply with other countries, as we announced at the end of last week – four more million doses were just shared with Mexico and Canada – or whether it’s other events.
So we are, obviously, monitoring the scenarios very closely and tracking these closely. Obviously, its is great news for both the U.S. and the world the more vaccines and the more supply that exist.
Dr. Fauci, anything you’d like to add?
Dr. Fauci: No, actually Andy, you said it very well. I just want to underscore one aspect of it, which was on one of the slides that I mentioned: that there are very many countries in Europe and throughout the world who have already authorized this. So the fact that a United States-run study has confirmed the efficacy and the safety of this vaccine I think is an important contribution to global health in general.
I’ll stop there.
Acting Administrator Slavitt: Yeah, and something that, Dr. Fauci, you may want to – both of us would say is: It’s important to just remind everyone that we cannot and will not get ahead of the FDA. The FDA has incredibly rigorous scientific process. And so while we would certainly call today’s news “encouraging” – it’s the kind of thing we like to see – we have a rigorous process that will come once an EUA is submitted, and that will give us all more information and reason to be comfortable.
MODERATOR: Let’s go to Jeremy Diamond at CNN.
Q: Hey, thanks for doing the briefing, as always. First of all, I’m wondering, you know, we’ve been between 54- and 58,000 new daily cases over the last two weeks. You guys are warning about the potential risks in that. What more are you doing to encourage states to maintain or re-impose coronavirus restrictions rather than relaxing them, as so many are?
And then, secondly, do you expect Johnson & Johnson to deliver 20 million doses by the end of the month, which is just a week away now? Thanks.
Acting Administrator Slavitt: So, Dr. Walensky – Dr. Walensky, would you like to take the first question about the kind of flattening of case rates and things that we can be doing as a country?
Dr. Walensky: Yeah, I’d be happy to. You know, we are looking at these data. We’re reaching out to individual states, trying to encourage them. We are having weekly governors’ calls. We’re doing outreach with states, territories to encourage them to look at their case data, to look at what’s happening with the variants, and to do as much outreach as we can to try and – to slow down the relaxation.
Acting Administrator Slavitt: Yeah. And obviously, you’ve heard the President say, and you’ve heard our – both Dr. Fauci and Dr. Walensky say that we believe it’s a mistake to get rid of mask mandates.
Obviously, governors have certain authority there, but so do corporations, so do employers, so do individuals. And we’re making concerted efforts to make sure that people know that whether or not there’s a mandate in place, people that – it’s in the people’s strong interest – strong interest – to continue to wear a mask until such time that people have had a chance to be vaccinated.
On the Johnson & Johnson question: We are obviously, working very closely with the company. We are going to see a nice increase in Johnson & Johnson this week. And we should have more information, you know, around the first week in April to report on how they’ve done. Obviously, they’ve got a lot of increases that they need to be committed to doing. So we’ll continue to keep everyone posted.
MODERATOR: We’ll go to Rachel Roubein at Politico.
Q: Hi, thanks for taking my question. I just wanted to follow up on the last one from Jeremy. Since April 1st is the end of the next week, do you think that J&J will have that 20 million shots? Can you give us an estimate of how many J&J shots are going out this week and how much states are seeing in their projections for next week?
Acting Administrator Slavitt: Yeah, I’m not going to give you precise numbers. Obviously, this is a ramped-up manufacturing process. We’re working with them very closely. I don’t think – yeah, I wouldn’t signal to you that they’re going t one far away from the numbers that they have projected at all, give or take a little bit. Obviously, we’re holding them accountable and working closely with them.
But with – at this point in time, I don’t want to commit to what’s going to happen over the course of the coming week. I would leave that to the company.
MODERATOR: Next we’ll go to Nancy Cordes at CBS.
Q: Thank you. How do you plan to deal with hesitancy surrounding the AstraZeneca vaccine in particular? Or do you anticipate that by the time it’s in circulation, there will be so much supply of the other vaccines that it really won’t matter?
And then, given Dr. Walensky’s comments about the uptick in cases and the fork in the road that the country is facing, what’s your guidance for people who have been vaccinated when it comes to going on vacation? Because the TSA just reported that Sunday was its busiest air travel day of the year so far.
Acting Administrator Slavitt: Okay, so let me start with Dr. Fauci with the first question, just to begin with the facts. Because I think the best – the best method for talking about people’s perception is to start with the actual ground-truth facts. It’s the reason why we do these briefings in the first place.
So, Dr. Fauci, do you want to reiterate the points your – you – your point of view?
Dr. Fauci: Yeah. The vaccine hesitancy surrounding AZ, related to reports from the European group that there was a greater incidence of thromboembolic events associated with the vaccine: During this trial here, there was no indication all. Now, remember, you’re dealing with 30,000 people in a trial.
The important thing to point out is that when you give vaccine to millions and millions of people, you got to make sure that when you look at the occurrence of what could appear to be an adverse event, that you essentially compare that into what the background of that type of event would be anyway in society. And the European Medicines Agency – the EMA – indicated in their examination that they did not see an increased risk of these types of events. Of note, in the trial I just reported on, they also did not see this, even though it was only in 30-plus thousand.
But as Andy has mentioned just a moment ago, the FDA is going to very, very carefully go over all of these data. There will be an application for an EUA, and I can tell you, you can rest assured that the FDA will put a great deal of scrutiny in every aspect of these data.
Acting Administrator Slavitt: Yes. And I just very much appreciate that – those comments. And it’s one of the reasons why it’s so important people ask, “Why does the FDA take time to do their work?” People also ask, “Why do you make such a point of emphasizing the FDA’s independence?” and “Why do you make such an important point about emphasizing the transparency?” It’s because the science is going to be what the science is. The result are going to be what the results are going to be. And the American public will need to hear that directly, and it’s important that they have great confidence in what comes out of our independent scientific agencies.
So we’re going to hold on any judgement, other than what Dr. Fauci has indicated from these studies, until we hear from the FDA. And they will go through a very rigorous process, and after that, we will help interpret the results to the public.
So there was a second question, which I think is for Dr. Walensky, which is, I believe, commenting on travel and the uptick in travel. And I think there as a – part of that question was, you know, “What about the vaccinated people that are traveling?” I don’t think – what I saw, down in Miami – it didn’t look like a whole bunch of vaccinated people, but I could be wrong. But maybe you want to address that one.
Dr. Walensky: Yeah, you know, as we’ve articulated before, CDC is working on updated guidance for what you can do if your vaccinated, and that will include travel.
But I want to, sort of, go back to what Andy said, and that is: Much of the travel, we know, is related to people who are going on spring break. For the most part, people who go on spring break are not the demographic that we’ve been focusing in on travel. We’re worried not just for what happens when you are on the airplane itself, but what happens when people travel. That is, they go out; they mix – they mix with people who are not vaccinated.
We currently are at a situation – if we look at our European friends – we just don’t want to be at this rapid uptick of cases again, and that is very possible that that could happen. We’ve seen that. We’re behind the eight ball when that starts to happen. And that results in uptick of cases, hospitalizations, and then death.
So we’re so close to vaccinating so many more people. So I would just encourage people and remind people: Now is not the time to travel.
Acting Administrator Slavitt: I think that’s a great way to end this briefing. Thank you very much for listening in and your questions. And we will be back again on Wednesday.
March 22: National Institutes of Health (NIH) posted a News Release titled: “Investigational AstraZeneca vaccine prevents COVID-19” From the News Release:
Results from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine. The United Kington-based global biopharmaceutical company AstraZeneca developed the vaccine and led the trial as regulatory sponsor.
The National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health, and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, provided funding support for the trial through the federal COVID-19 response.
The placebo-controlled trial began in August 2020. The analysis is based on results from 32,449 adult volunteer participants enrolled across 88 sites in the United States, Chile and Peru. One participant received a placebo for every two participants who received AZD1222, resulting in approximately 20,000 people receiving the investigational vaccine. The vaccine was administered as two doses of 5 x 1010 viral particles four weeks apart.
AZD1222 demonstrated statistically significant vaccine efficacy of 78.9% in preventing symptomatic COVID-19 and 100% efficacy in preventing severe or critical disease and hospitalization. In participants 65 years and older, who comprised 20% of the trial population, vaccine efficacy against symptomatic COVID-19 was 79.9%.
The DSMB conducted a review of thrombotic events (blood clots) and cerebral venous sinus thrombosis (CVST) among participants and found no increased risk of these conditions in vaccinated participants.
Approximately 79% of participants were white, 22% were Hispanic, 8% were Black or African American, 4% were Native American, including Indian/Alaska Native participants residing in the U.S., and 4% were Asian. Vaccine efficacy was consistent across ethnicity. Approximately 60% of participants of any age had underlying health conditions associated with an increased risk of developing severe COVID-19, such as diabetes, severe obesity or cardiac disease.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees. Today’s results build on data from multiple clinical trials of AZD1222 conducted worldwide. The World Health Organization has recommended use of the vaccine for the prevention of COVID-19 in adults and it is currently available for use in more than 70 countries. The European Commission has granted a conditional marketing authorization for the vaccine in the European Union.
The current trial defined symptomatic COVID-19 as having SARS-CoV-2 infection and at least one respiratory symptom (pneumonia, shortness of breath or low oxygen requiring supplemental oxygen) or at least two of the following symptoms: fever, new or worsening cough, and loss of smell and/or taste. Severe or critical COVID-19 was defined as having SARS-CoV-2 infection and any of the following: clinical signs of severe systemic illness, respiratory failure (defined as needing a high-flow oxygen, noninvasive ventilation, mechanical ventilation or extracorporeal membrane oxygenation, known as ECMO), evidence of shock, significant acute renal, hepatic or neurologic dysfunction, or admission to an intensive care unit or death.
AD1222 was developed by Oxford University’s Jenner Institute and Oxford Vaccine Group and then licensed to AstraZeneca for further development. It is a viral vector-based vaccine that uses a safe, non-replicating chimpanzee adenovirus to deliver the genetic code of a protein found on the surface of SARS-CoV-2 (called the spike protein) to human cells so that the cells can make the protein. Adenoviruses can cause the common cold in humans, but the virus has been modified so that it cannot replicate and cause disease. The technology is based on a vaccine that Oxford previously was developing for Middle East respiratory syndrome coronavirus (MERS-CoV). AZD1222 can be stored, transported and handled at 36 at 46 degrees Fahrenheit (normal refrigeration temperatures) for at least six months.
A DSMB formed by NIH monitored the vaccine to ensure participant safety and the validity and integrity of the data. The same DSMB is overseeing other ongoing Phase 3 vaccine clinical trials as part of the federal COVID-19 response effort. Representatives from AstraZeneca, NIAID, and BARDA receive recommendations from the DSMB.
Sites that are part of the COVID-19 Prevention Network (CoVPN) enrolled volunteers in the clinic trial. The CoVPN is composed of existing NIAID-supported clinical research networks with infectious disease expertise and was designed for efficient and thorough evaluation of vaccine candidates and monoclonal antibodies for the prevention of COVID-19. CoVPN investigators Ann R. Falsey, M.D., professor of medicine, University of Rochester School of Medicine in New York and Magdalena E. Sobieszcyk M.D., associate professor of medicine at Columbia University Medical Center in New York, are coordinating investigators for the trial.
Participants will continue to be followed as part of the trial for approximately two years following their second injection. More details about the trial are available at PreventCovid.org and at clinicaltrials.gov under identifier NCT0516746.
March 22: U.S. Food and Drug Administration (FDA) posed a News Release titled: “FDA Warns Companies Illegally Selling Over-the Counter CBD Products for Pain Relief”. From the News Release:
The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.
“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products, may have dangerous health impacts and side effects. We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety. Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products – prioritizing those that pose a risk to public health.”
The FDA issued warning letters to:
Honest Globe Inc.
Biolyte Laboratories LLC
The products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There has been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers claim, what an appropriate does might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.
The FDA has previously sent warning letters to other companies illegally selling unapproved CBD products that claimed to prevent, diagnose, mitigate, treat or cure various diseases, in violation of the FD&C Act.
Under the FD&C Act, any product intended to diagnose, cure, mitigate, treat or prevent a disease, and any product (other than a food) that is intended to affect the structure or function of the body of humans, is a drug. OTC drugs must be approved by the FDA or meet the requirements for marketing without an approved new drug application under federal law, including drug products containing CBD, regardless of whether CBD is represented on the labeling as an active ingredient or an inactive ingredient.
The FDA has not approved any CBD-containing drug products other than one prescription drug for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome, and Dravet syndrome in human patients.
The FDA has requested written responses from these companies within 15 working days stating how they will address these violations or providing their reasoning and supporting information, as to why they believe these products are not in violation of the law. Failure to adequately address the violations promptly may result in legal action, including product seizure and/or injunction.
March 22: National Institutes of Health posted a News Release titled: “Graduates of comprehensive preschool program less likely to be obese in adulthood, NIH-funded study finds”. From the News Release:
Such programs could lead to improvements in body mass index later in life.
Children in high-poverty neighborhoods who participated in a comprehensive preschool program that provided parents with health and educational services and job training had a lower body mass index (BMI) in their late 30s than a similar group who participated in the in the usual early childhood programs, according to a study funded by the National Institutes of Health. The study authors concluded that comprehensive, school-based early childhood programs could lead to improvements in body mass index later in life. The study was conducted by Arthur J. Reynolds, Ph.D., of the University of Minnesota and colleagues. It appears in JAMA Pediatrics.
Funding was provided by NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Of the study participants, nearly 700 had attended the Child-Parent Center preschool program, which enrolled children in high-poverty, majority Black neighborhoods in Chicago. Offering small classes and intensive instruction in school readiness skills, the program also provides parents with job and parenting skills training, educational classes, and social services. The children were provided with healthy meals and learned how to make healthy food choices. Compared to a similar group of more than 350 people who had not attended the program, participants showed a 3.2% reduction in BMI at 37 years of age. Women participants had a 7.5% reduction in BMN. Women also were 27% less likely to be best compared with women who had not attended the program. The researchers found no significant differences in obesity rates among men who took part in the study, as the men in both groups had a low obesity rate.
Previous studies of the program’s graduates have found that, as adults, they have higher rates of educational attainment and household income than adults of the same background who did not partake in the program.
James A. Griffin, Ph.D., chief of the NICHD Child Development and Behavior Branch, is available for comment…
March 22: U.S. Department of Health and Human Services (HHS) posted News titled: “Statement by HHS Secretary Xavier Becerra on the Anniversary of the Affordable Care Act” From the News:
“President Biden promised to bring down health care costs and that is exactly what we at the Department of Health and Human Services will do, beginning with implementation of the American Rescue Plan.”
Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra released the following statement on the eve of the 11th anniversary of the Affordable Care Act:
“In the eleven years since it became law, the Affordable Care Act has saved lives, brought down health care costs, and expanded Medicaid to our most vulnerable neighbors. The lifesaving law has been a game changer, protecting roughly 133 million people with pre-existing conditions and extending quality, affordable health care to millions more.
“While health care is more in reach today, we have more work to do. The COVID-19 pandemic has thrust families into crisis. Over the last year, too many people have had to mourn lost love ones or struggle to pay their bills. President Biden promised to bring down health care costs and that is exactly what we at the Department of Health and Human Services will do, beginning with the implementation of the American Rescue Plan.
“Beginning on April 1, millions of Americans will be eligible for even more affordable options on HealthCare.gov. Because of the American Rescue Plan, four out of five enrollees will be able to qualify for coverage for as little as $10 per month.
“As HHS Secretary, I’m committed to building on this monumental progress to bring every American the peace of mind that comes with knowing you can take care of your family without going into debt.”
March 23: The White House posted about “Bill Signing: S.579”. From the post:
On Tuesday, March 23, 2021, the President signed into law:
S 579, which modifies the effective date of the elimination of the five month waiting period to receive Old Age, Survivors, and Disability Insurance benefits for individuals diagnosed with amyotrophic lateral sclerosis (ALS).
March 23: National Institutes of Health (NIH) posted a News Release titled: “NIAID Statement on AstraZeneca Vaccine”. From the News Release:
Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial. The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. We urge the company to work with DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees…
March 23: The White House posted “Press Gaggle by Press Secretary Jen Psaki Aboard Air Force One en route Columbus, Ohio”. From the Press Gaggle:
Ms. Psaki: Okay. Welcome to our trip to Ohio. Today, on the anniversary of the Affordable Care Act being signed into law by President Obama, we’re traveling to Columbus as part of the “Help Is Here” tour to highlight how the American Rescue Plan will lower healthcare costs for many families – a big deal, as my boss might put it.
In Ohio, the President – he added another word, but for the children. (Laughter.) In Ohio, the President will talk about how the Affordable Care Act has changed the lives of millions of Americans, enabling millions of families to have the peace of minds that comes with access to quality, affordable healthcare. He’s always thought that this was – the Affordable Care Act was something that would be built upon. And the American Rescue Plan is an opportunity to do exactly that.
In Ohio alone, the ACA has cut the state’s uninsured rate by half, dropping from 12 percent. This also provided protections for millions of Ohioans with pre-existing conditions.
And the American Rescue Plan makes coverage under the ACA even more affordable for Ohio families. Over 90,000 currently uninsured Ohioans can get a better deal on health insurance because of the Rescue Plan, and premiums for people who have coverage under the ACA will fall by an average of $50 per person per month.
He will also remind Americans to sign up for insurance at HealthCare.gov during the special enrollment period, and he’ll have an update on that, as well, today.
I also just wanted to note that our Health and Human Services Secretary, Xavier Becerra, is also traveling to Carson City, Nevada, to visit a health center today.
Update from the governors call – the weekly governors call that Jeff Zeints did this morning: Today, in our weekly governor’s call, he announced that we will have 27 million doses allocated across all channels this week. Of those 27 million doses, 4 million will be Johnson & Johnson. Two-thirds of the 27 million doses will be going to states and jurisdictions, and the rest will go to other channels, primarily the pharmacy program, which has been very successful and we’ve been increasing supply to.
This means that in 62 days since taking office, we’ve more than tripled vaccine output from 8.6 million doses to 27 million doses.
And then, the last update is: The President spoke with the governor – Governor Polis of California – sorry, of Colorado, this morning to, of course, offer his condolences and support as the state and Boulder deals with the tragedy of last evening.
With that, who wants to kick it off?…
…Q: Jen, NATO is making an effort for a virus-free summit for world leaders in June. What does the President think about that possibility of him traveling and being there in the environment?
Ms. Psaki: Well, we certainly are aware of the timing of the upcoming NATO Summit. And certainly the President, I know, would love to go overseas and travel overseas and have discussions about global issues and how to work together on a range of issues, including the pandemic, economic recovery, et cetera. But we’re going to rly on the advice of our health and medical experts, and I don’t have anything to preview on the likelihood of the trip at this point in time…
March 23: U.S. Food and Drug Administration (FDA) posted a News Release titled: “Coronavirus (COVID-19) Update: March 23, 2021”. From the News Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic.
In a March 22 Consumer Update, the FDA provided an update on simple steps to help slow the spread of coronavirus disease to protect ourselves, our families and our communities. Read more: Help Stop the Spread of Coronavirus and Protect Your Family
The FDA and the NIH CURE ID app has received the 2021 Golan Christie Taglia Patient Impact Philanthropy Award from Cures Within Reach. CURE ID is an internet-based repository that lets the clinical community share novel uses of existing drugs for difficult-to-treat infectious diseases. The FDA and the NIH have made critical updates to CURE ID to be a more effective tool during COVID-19.
As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to PYRLess Group, LLC dba Dr. Fitt for selling unapproved products with COVID-19 claims. The FDA r