Fauci Testimony — Senate HELP Committee (CHRG-117shrg46765) (Part 1 of 2)

U.S. GOVERNMENT PUBLISHING OFFICE
WASHINGTON : 46–765 PDF 2022 S. H RG. 117–185
AN UPDATE FROM FEDERAL OFFICIALS
ON EFFORTS TO COMBAT COVID–19
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING AN UPDATE FROM FEDERAL OFFICIALS ON EFFORTS TO
COMBAT COVID-19
MAY 11, 2021
Printed for the use of the Committee on Health, Education, Labor, and Pensions
(
Available via the World Wide Web: http://www.govinfo.gov
(II) COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont
ROBERT P. CASEY, JR., Pennsylvania TAMMY BALDWIN, Wisconsin CHRISTOPHER S. MURPHY, Connecticut TIM KAINE, Virginia MAGGIE HASSAN, New Hampshire TINA SMITH, Minnesota JACKY ROSEN, Nevada BEN RAY LUJAN, New Mexico JOHN HICKENLOOPER, Colorado RICHARD BURR, North Carolina, Ranking
Member
RAND PAUL, M.D., Kentucky SUSAN M. COLLINS, Maine BILL CASSIDY, M.D., Louisiana LISA MURKOWSKI, Alaska MIKE BRAUN, Indiana ROGER MARSHALL, M.D., Kansas TIM SCOTT, South Carolina MITT ROMNEY, Utah TOMMY TUBERVILLE, Alabama JERRY MORAN, Kansas
E
VAN T. S CHATZ , Staff Director
DAVID P. C LEARY , Republican Staff Director
JOHN RIGHTER , Deputy Staff Director
(III) CONTENTS
STATEMENTS
TUESDAY, MAY 11, 2021
Page
COMMITTEE MEMBERS
Murray, Hon. Patty, Chair, Committee on Health, Education, Labor, and
Pensions, Opening statement .............................................................................. 1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State of
North Carolina, Opening statement ................................................................... 3
WITNESSES
Walensky, Rochelle, M.D., MPH, Director, United States Centers for Disease
Control and Prevention, Atlanta, GA ................................................................. 6
Prepared statement .......................................................................................... 7
Fauci, Anthony, M.D., Director, National Institute of Allergy and Infectious
Diseases, National Institutes of Health, Bethesda, MD ................................... 15
Prepared statement .......................................................................................... 17
Marks, Peter, M.D., Ph.D., Director, Center for Biologics Evaluation and
Research, United States Food and Drug Administration, Silver Spring,
MD ......................................................................................................................... 23
Prepared statement .......................................................................................... 25
Kessler, David, M.D., Chief Science Officer, COVID Response, United States
Department of Health and Human Services, Washington, DC ........................ 30
Prepared statement .......................................................................................... 31
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc. Collins, Hon. Susan:
A Misleading C.D.C. Number By David Leonhardt, The New York Times . 71
(1) AN UPDATE FROM FEDERAL OFFICIALS
ON EFFORTS TO COMBAT COVID–19
Tuesday, May 11, 2021
U.S. S ENATE ,
COMMITTEE ON HEALTH , EDUCATION , LABOR , AND PENSIONS ,
Washington, DC.
The Committee met, pursuant to notice, at 10:04 a.m., in room
106, Dirksen Senate Office Building, Hon. Patty Murray, Chair of
the Committee, presiding.
Present: Senators Murray [presiding], Casey, Baldwin, Murphy,
Kaine, Hassan, Smith, Rosen, Hickenlooper, Burr, Paul, Collins, Cassidy, Murkowski, Braun, Marshall, Tuberville, and Moran.
OPENING STATEMENT OF SENATOR MURRAY
The C
HAIR . Good morning. The Senate Health, Education, Labor,
and Pensions Committee will please come to order.
Today, we are hearing the latest update from Federal officials
about our efforts to fight the COVID–19 pandemic. Ranking Mem-ber Burr and I will each have an opening statement, and then I will introduce our witnesses, Doctors Walensky, Fauci, Marks, and Kessler.
I am glad to have you all back before our Committee today, and
I know we will continue to hear from you as we work to end this pandemic.
After the witnesses give their testimony today, each senator will
have 5 minutes for a round of questions.
Before we begin, I want to again walk through the COVID–19
safety protocols that are in place today. We will follow the advice of the Attending Physician and Sergeant at Arms in conducting this hearing. We are again grateful to all of our Clerks and every-one who has worked so hard to get this set up and help everyone stay safe and healthy.
Committee Members are seated at least 6 feet apart, and some
Senators are participating by videoconference. And while we are unable to have this hearing fully open to the public or media for in-person attendance, live video is available on our Committee website at help.senate.gov. And if you are in need of accommoda-tions, including closed captioning, you can reach out to the Com-mittee or the Office of Congressional Accessibility Services.
While we are not yet through this pandemic, it is clear we are
making significant progress. We administered well over 200 million COVID–19 vaccines in President Biden’s first 100 days. Over half the adult population has gotten at least one dose; one-third of the
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Country is fully vaccinated. Schools, businesses, and communities
are working to safely reopen. And, the Food and Drug Administra-tion has now authorized vaccines for adolescents. So, we have come a long way in the last few months.
But, even as we are encouraged by the progress so far, we are
all keenly aware more work lies ahead. This pandemic has touched every community in our Country and every corner of the world. To truly end it, vaccines have to be just as widespread.
While some progress is being made, for example in my home
State of Washington, they have released a dashboard with vaccina-tion data, the latest numbers from which show Washington State has vaccinated over five million people, and we are vaccinating around 50,000 more a day. The data also shows vaccinations are lagging in some areas, especially for Black, Latino, Tribal, and rural communities, and not just in my state, but across the Coun-try.
In some states, we are still lacking key data on demographic
characteristics, including race and ethnicity. We have to address systemic inequities and tear down barriers that are making it harder for some people to get vaccines. Everyone must have the op-portunity to get vaccinated regardless of race, zip code, disability, primary language, or internet access.
We are also seeing vaccination rates slow. It is a reminder that
making sure people can get vaccines is just half the battle. We need to make sure they do get them. To make that happen, we need to make sure people are getting reliable information about vaccines and hearing from voices they trust about why getting vac-cinated is so important, not just to protect themselves, but to pro-tect those around them and stop this disease from spreading or mutating into new deadly strains.
I am glad the Biden administration is continuing to release funds
from the American Rescue Plan to help address some of these chal-lenges, including last week when they announced almost a billion dollars to strengthen our response in rural communities, and one- quarter of a billion dollars to develop and support a community- based workforce to help underserved groups get information about vaccines, schedule appointments, arrange transportation, and more.
As we work to get our Nation vaccinated, we have to also ac-
knowledge this is a global fight and do our part to lead on the world stage. The deadly outbreak in India is a heartbreaking re-minder of what can happen when this virus spreads unchecked, when it mutates into more contagious, more deadly strains, and when it overwhelms healthcare systems. It is a reminder this pan-demic will not fully be over for our Country until it is over for the world, which is why I am glad the Biden administration is sending medical support to India, sharing some of our excess doses globally, and even considering other steps to remove barriers to vaccines for countries that need them, including a targeted waiver of COVID– 19 patent protections.
These moves will not just save lives in India. They will ulti-
mately save lives in Washington State, North Carolina, and across the Country. Because people get that when there is a fire down the street, it is in their best interest to put it out before it gets to their
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family’s home, not to mention that helping your neighbor is always
the right thing to do.
I am also hearing from lots of people in my home state who real-
ly feel we cannot simply end this crisis and never look back. We have to learn from it. We have to be better prepared for the next public health emergency so that we are never again in a situation like this, which is why Ranking Member Burr and I plan to develop bipartisan legislation to address and build on lessons learned from the COVID–19 response; ensure robust public health and medical capacity to provide services to those most at risk; improve and sup-ply the supply chain for critical medical supplies; tackle the health disparities that afflict so many of our communities; and strengthen the Nation’s public health infrastructure and medical preparedness and response programs at every level.
I look forward to having more hearings specific to that work soon
and hearing what our witnesses today have to say on that subject, as well.
As Federal officials on the front lines of this pandemic, you all
have an important perspective into the progress we are making today, as well as the lessons we must learn for tomorrow.
Now, I will turn it over to Ranking Member Senator Burr for his
opening remarks.
OPENING STATEMENT OF SENATOR BURR
Senator B
URR. Thank you, Madam Chair. I am glad we are hold-
ing another hearing to update us on the status of COVID–19 re-sponse. And, to our witnesses, thank you for the work you have done. More importantly, welcome back to the Committee.
It has been almost 18 months since the initial reports of severe
pneumonia in Wuhan, China surfaced. Since that time, we have tragically seen over a half million deaths in this Country from COVID–19. Government-backed shutdowns have jeopardized the livelihood of millions of Americans, and we have spent more tax-payer money than I could have ever imagined in response to this virus and the devastating effect it has had on our economy.
But, now, more than ever, there is reason for hope. We are see-
ing the promise of vaccines and treatments in real time. A month ago, the case count in the United States was over 70,000 new cases per day. Today, we are down to roughly 40,000 and headed south. The CDC is projecting continued declines in death and hospitaliza-tion rates.
Because of Operation Warp Speed, Dr. Marks, Dr. Fauci, Dr.
Hahn, and the FDA, we have fully vaccinated 115 million Ameri-
cans, which is roughly 44 percent of adults, and delivered almost 330 million doses to states. Operation Warp Speed and BARDA spent more than $18 billion to make vaccines available to Ameri-cans, manufacturing vaccines at risk, and the American people are benefiting from that today. Manufacturers were able to produce vaccines, enough vaccines, that the United States is now able to help provide vaccines to countries in need, like India.
Because of the collaborative efforts over the last year, we are
ready to turn the corner. The partnerships developing in manufac-turing the COVID–19 vaccines have been one of the biggest sci-entific success stories in generations. Industry answered the call at
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the start of the pandemic and partnered in an unprecedented way
to bring us these live-saving products.
Intellectual property is part of the reason we have these life-sav-
ing products today. If these protections are not in place for innovators of life-saving medicines, we will not have them for the next pandemic. It is that simple.
We held a hearing on the threat of China taking intellectual
property from U.S. research, and now the Biden administration has agreed just to hand it over. There is a way to support the manufac-turing of vaccines globally and help countries in need without act-ing in bad faith against innovators who stepped up when the world needed them the most.
It is the partnerships we are already seeing today that are sav-
ing lives, not silly ideas about socializing means of production. The action from the Biden administration to support waiving intellec-tual property rights will undermine the innovation we are relying on to bring this pandemic to an end and will leave us with a less- prepared future.
I am encouraged that some of our European allies cautioned
against this reckless action, and I hope the adults in the Biden ad-ministration will realize that what sounds good in a grad school ivory tower thesis paper does not make sense in the real world. You four are the adults in the room. I urge you to think about the real consequences if we just give away this science and this tech-nology.
The next part of our job is going to be the difficult part. I have
been looking to Israel to help predict the challenges that we may be in store for in the U.S. since they are ahead of us on vaccination rates today. Israel was able to vaccinate 40 percent of the adult population by the end of February. Their data shows that uptake stalled once they vaccinated about 60 percent of the adult popu-lation. While there are differences between our countries, we have to use the information we have to best predict our road ahead.
Every adult has the opportunity to be vaccinated, and supply is
starting to exceed demand. In other words, we have more shots than we have arms to put it in. We need to address vaccine hesi-tancy, and it needs to be done now.
I know this is the case in my state with recent reports from Wil-
mington, North Carolina that local officials are changing their ap-proach as vaccine demands slow. We must paint a picture for the American people showing the benefits of both a vaccination and a reopening of our Country. This is a simple message for those in leadership positions.
I got the vaccine. My wife got the vaccine. My sons got the vac-
cine. Their wives got the vaccine. I have encouraged all of my staff to take it as soon as it is available to them. And, I have gone through the last 24 hours with a real fear that I had a one-and- a-half year old grandson who might have had COVID. Fortunately, it all came back negative and he will hopefully leave the hospital
sometime today.
But, I would guess that everyone in this room is vaccinated,
which means if we follow the CDC guidelines, we can dispense with masks and social distancing. Tomorrow, I hope that we are going
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to have a vaccine that is approved for kids over 12, and ones
younger hopefully in the not-too-distant future.
We must reassure Americans that COVID vaccines are safe. Vac-
cines save lives. I might have been naive when we started this, be-lieving that staying out of the hospital and not dying might have been motivation enough to get people vaccinated. It clearly was not. And that is why we must reassure Americans that if you get a COVID vaccine, our lives can and will return to normal. But, we cannot assure, without painting that picture for them, what that looks like. Today’s response is preparing us for tomorrow’s threat.
As Senator Murray said, we have launched a joint effort to
strengthen our public health preparedness programs for the next threat, which we will inevitably face. That threat could be emerg-ing today, or it could be a new virus, another curveball from Moth-er Nature, or the result of deliberate, manmade attacks on our Country.
Our framework has always been flexible and it needs to stay that
way. There will always be lessons that we learn from each re-sponse, and our threat landscape is constantly evolving. Our expe-rience with this pandemic has made that even more clear.
Senator Murray and I look forward to working with each of you
and the Members of the Committee on this project to take stock of lessons learned and to actually put them into action.
To our witnesses today, thank you for all you have done up to
this point of the response, but know that the most challenging days may be the next several weeks and months ahead as we attempt to get to a vaccination level that changes the glidepath to one that is permanently in the decline.
With that, I thank the Chair. The C
HAIR . Thank you, Senator Burr, and I look forward to
working with you on that, and I wish your grandson well.
Senator B URR. Thank you.
The C HAIR . I will now introduce today’s witnesses.
Dr. Rochelle Walensky is the Director of the Centers for Disease
Control and Prevention and the Administrator of the Agency for Toxic Substances and Disease Registry.
Dr. Walensky, welcome back. Thank you for joining us today. Next, I would like to introduce Dr. Anthony Fauci, who is the Di-
rector of the National Institute of Allergy and Infectious Diseases and the Chief Medical Advisor on President Biden’s COVID–19 Re-sponse Team.
Dr. Fauci, good to have you back before the Committee, as well.
Thank you for joining us.
Dr. Peter Marks is the Director of the Center for Biologics Eval-
uation and Research for the Food and Drug Administration.
Dr. Marks, we are glad to have you here again, as well. Thank
you.
Finally, I would like to introduce Dr. David Kessler. Dr. Kessler
is the Chief Science Officer of the Biden administration’s COVID–
19 Response Team.
Dr. Kessler, glad to have you with us, as well. With that, we will begin our witness testimony. Dr. Walensky,
we will begin with you for your opening statement.
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STATEMENT OF ROCHELLE WALENSKY, M.D., MPH, DIRECTOR,
UNITED STATES CENTERS FOR DISEASE CONTROL AND PRE-
VENTION, ATLANTA, GA
Dr. W ALENSKY . Thank you, Chair Murray, Ranking Member
Burr, and Members of the Committee for the invitation to speak
with you today.
I last testified before this Committee less than 2 months ago.
Since that time, the dedicated professionals at CDC have been working diligently to provide additional resources to states, local-ities, territories, and tribes thanks to support from Congress. We are updating our guidance based on the latest scientific evidence, and we are working with our partners around the Country and around the globe to reduce the burden of COVID–19.
I am pleased to report that since January, we have seen a con-
sistent downward trend with daily averages of new infections drop-ping 76 percent, hospitalizations down 71 percent, and reported deaths decreasing by 75 percent.
This progress is also reflected in our data on the county-level
risk. Just a few months ago, 85 percent of all counties in the U.S. were experiencing high COVID–19 transmission rates and in-creased community risk. This morning, that is down to 33 percent of counties.
These trends give me hope. And, still, I continue to emphasize
that we must remain diligent and committed to our surveillance and prevention efforts because the emergence of variants could set us back.
With your help, CDC is using the $1.7 billion Congress provided
to expand nationwide genomic sequencing efforts. Since January, we have dramatically increased sequence output from 3,000 sam-
ples per week to approximately 35,000 samples per week.
We are also keeping our commitment to prioritize health equity.
Since March, we have announced a number of investments that center in health equity. These include $2.25 billion to address COVID–19-related health disparities and advance health equity among high-risk and underserved populations; $3 billion to strengthen vaccine confidence, with a focus on increasing uptake and equity in administration, particularly in communities hardest hit by the pandemic; $332 million in community health workers to support COVID–19 prevention and control; and $250 million to de-velop targeted strategies for vaccine education and outreach for up-take in specific communities.
In addition, CDC continues to update our guidance as we learn
more. This includes a recent update outlining levels of risk of ac-tivities for fully vaccinated and unvaccinated people. We will con-tinue to update this guidance to be clear that vaccines are a means of returning to activities we stopped as a result of the pandemic.
I am so proud to report the administration of more than 261 mil-
lion vaccine doses, including more than 133 million since I last tes-tified before you in March. Over 84 percent of Americans age 65 and older, and over 58 percent of all adult Americans have now re-ceived at least one vaccine dose.
With these cases trending down in the United States and more
people getting vaccinated, we are cautiously optimistic. However, globally, the pandemic is more severe than ever. India’s surge of
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cases is tragic and a reminder that the virus can rapidly outstrip
our efforts to contain it if we are not careful. We will not end this pandemic without working hand in hand with countries around the globe to fight COVID–19.
I want to take a moment to acknowledge that while we have
made great progress over the last few months, more than 579,000 people in the United States have died from COVID–19 during this pandemic. And just since I saw you in March, over 39,000 of our loved ones have died from COVID–19 in the United States. Every death is a stark reminder of why we must remain vigilant and fo-cused to end this pandemic as quickly as possible.
I want to close with a promise and an appeal to the American
people. My promise is that CDC will continue to follow the science as our guide. And, my appeal is to implore everyone to get a COVID–19 vaccine as soon as possible as the fastest way to end this pandemic.
But, even with this powerful tool, while we continue to have com-
munity transmission, we must also maintain public health meas-ures we know will prevent the spread of this virus—masks, hy-giene, hand hygiene, and physical distancing.
Finally, as we get through this pandemic, we must work together
over the months and years ahead to build on the investments, part-nerships, and innovations that we have created during this crisis. This includes achieving sustainable investments in public health infrastructure to be better prepared for whatever comes next. It is one way we can turn tragedy into lasting progress and improved health for all.
Thank you again for the opportunity and invitation to testify
today, and I look forward to answering your questions.
[The prepared statement of Dr. Walensky follows:]
PREPARED STATEMENT OF ROCHELLE WALENSKY
Chairman Murray, Ranking Member Burr, and distinguished Members of the
Committee. It is an honor to appear before you again today to discuss the Centers
for Disease Control and Prevention’s (CDC) ongoing response to the COVID–19 pan-demic. I am grateful for this opportunity to address this Committee as well as for your partnership and leadership in responding to COVID–19.
It is my privilege to represent CDC. CDC is America’s health protection agency.
We work 24/7 to prevent illness, save lives, and protect America from threats to health, safety, and security. CDC is proud of its key role in preparedness and re-sponse to public health concerns here in the United States and abroad. Addressing infectious diseases and pandemics, like COVID–19, is central to our mission. CDC’s
expertise lies in our ability to study emerging pathogens like SARS-CoV–2, to un-derstand how they are transmitted, and to translate that knowledge into timely public health action. By deploying experts on the ground to support our state, Trib-al, local, and territorial partners, we translate science into guidance that protects individuals, communities, and populations. In our work with other Federal agencies we ensure the safe and appropriate use of medical countermeasures, including vac-cines, and collaborate with the academic sector to further our understanding of new diseases.
I’ve had the honor of being the Director of this agency for over 4 months, and it
is clear to me that all of this work is done by expert staff with great dedication to, and pride in, their work. They work tirelessly to respond to the COVID–19 pan-demic, and I am committed to making sure that their efforts to conduct and analyze the data allow science to drive our path forward.
CDC Efforts to Date
While COVID–19 cases have recently decreased, COVID–19 transmission remains
widespread across the Nation. We are hopeful. We have made significant progress
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in getting shots in arms. But, given that many people around the country are not
yet fully vaccinated and given the threat of variants, we must remain cautious.
It goes without saying, we have been tested over the past nearly year and a half.
It has been an extraordinarily difficult time for the United States. And I want to take a moment to recognize the more than 570,000 Americans—mothers, fathers, sisters, brothers, wives, husbands, grandparents, and children—who have died be-cause of the pandemic. Every loss is felt. By grieving families, by friends who are unable to say goodbye because of hospital mitigation strategies, by communities dev-astated by the disparate impact of this virus. We also acknowledge the millions of others who have suffered with this disease and recognize there are so many who will require long-term care and support.
As hard as this has been, we can still persevere. If we can just stay the course
a little longer by strengthening and maintaining evidence-based prevention meas-ures while vaccinations continue to ramp up, we can prevent a lot of disease and save a lot of lives.
Right now, we are in a race to stop transmission. Variants of this virus that have
slight genetic differences from the initial strain have emerged, and available data suggest some are more transmissible. CDC has expanded sequence surveillance across the United States to improve our understanding about the impact of these variants on vaccine effectiveness, severity of disease, transmission, and mortality.
We must continue to use every tool we have to fight this virus: wearing masks,
social distancing, handwashing, and administering vaccines.
The scale of this unprecedented public health emergency requires unprecedented
action—at CDC, more than 8,500 CDC personnel have been part of our COVID–19 response, both at CDC headquarters and in the field. More than 1,500 staff have taken part in over 3,000 deployments to nearly 300 locations across the United States and around the world.
CDC is working to ensure that public health decisions are based on the highest-
quality scientific information.
Since the start of the pandemic, over 250 COVID–19 studies have been published
in the Morbidity and Mortality Weekly Report (MMWR) on topics ranging from health disparities exacerbated during the pandemic, to prevention strategies, to emergence of new variants. CDC has also produced more than 6,000 documents to provide information and guidance for government agencies, businesses, and the pub-lic. CDC is actively studying the epidemiology of post-COVID conditions (often re-ferred to as long COVID), including the prevalence, duration, and severity of symp-toms following acute SARS-CoV–2 infection, as well as risk factors for developing post-COVID conditions. This work will help to establish a more complete under-standing of the natural history of SARS-CoV–2 infection and post-COVID condi-tions, which can inform healthcare strategies, clinical decision-making, and the pub-lic health response to this virus that will be required over the long term. A recent MMWR article found that among 3,000 adults with COVID–19 who didn’t require a hospital stay, two out of three returned for at least one outpatient visit within one to 6 months after COVID–19 diagnosis; many with recurring symptoms poten-tially related to COVID–19.
The new resources provided by President Biden’s American Rescue Plan will
further scale up the public health efforts needed to contain the virus ,
through six critical priorities:
•a strengthened national vaccination program,
•increased testing to protect at-risk populations,
•expansion of the public health workforce,
•protection for vulnerable populations,
•a commitment to U.S. leadership in the global response, and
•enhanced surveillance to identify emerging strains.
Now I want to take a moment to give you a more in-depth update on some key
areas for the COVID–19 response.
Variants
COVID–19 has brought to the forefront how interconnected we are as a global
community and the importance of our international scientific relationships.
In the fall of 2020, several SARS-CoV–2 variants emerged, some of which appear
to spread more easily than others. There is also concern with how well the variants
are neutralized by antibodies elicited through prior infection or vaccination. The
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emergence of variants is, of course, concerning, and it underscores the critical need
for genomic surveillance and increased vigilance in the implementation of public health prevention measures.
In anticipation of these ongoing threats, the Department of Health and Human
Services (HHS) established the SARS-CoV–2 Interagency Group to improve coordi-nation across the CDC, National Institutes of Health, Food and Drug Administra-tion (FDA), Biomedical Advanced Research and Development Authority, United States Department of Agriculture, and Department of Defense. This interagency group is focused on the rapid characterization of the emerging variants of concern and is actively monitoring the potential impact on critical SARS-CoV–2 counter-measures including vaccines, therapeutics, and diagnostics. This group is also en-gaging with international partners to improve global surveillance of variants and identify synergies in our collective assessment of the impact of variants globally.
We are monitoring dozens of variants and conducting ongoing and comprehensive
risk assessments through the SARS-CoV–2 Interagency Group and in consultation with our international colleagues. Of the emerging variants, five have captured our attention and have the highest risk to public health: B.1.1.7, B.1.351, B.1.427, B1.429, and P.1.
The B.1.1.7 variant, originally identified in the United Kingdom, was first identi-
fied in the United States on December 29, 2020. Data from CDC national surveil-lance project that B.1.1.7 viruses represented 72 percent of the viruses circulating for the two-week period ending April 24. The B.1.1.7 variant is the predominant strain of SARS-CoV–2 in the country now and has likely continued to increase as a proportion of all cases. Importantly, variant proportions are dynamic and are not the same in all parts of the country.
The B.1.351 variant, first identified in South Africa, and the P.1 variant, first
identified in Brazil, have also been identified in the United States. Data from CDC national surveillance project that B.1.351 viruses represented approximately 0.6 percent of the circulating viruses, and the P.1 variant represented approximately 5.6 percent for the two-week period ending April 24. The proportion of cases attributed to the B.1.427 and B.1.429 variants, which were first identified in California, have decreased in recent weeks. According to data for the two-week period ending April 24, the combined prevalence of B.1.427 and B.1.429 is 2.6 percent.
Available data suggest that antibodies elicited by vaccination with the currently
authorized vaccines are able to neutralize the B.1.1.7 variant but have reduced neu-tralization against the B.1.351 and P.1 variants. Based on preliminary data from a Johnson & Johnson vaccine clinical trial in South Africa where the prevalence of the B.1.351 variant was estimated to be 95 percent, the vaccine efficacy was 64 per-cent and had 81.7 percent efficacy in preventing severe disease, and promising effi-cacy data have been released from the Pfizer clinical trial in South Africa. Studies are currently underway to understand the impact on the real-world effectiveness of current vaccines against the B.1.351 variant and other variants of concern. Efforts are ongoing to better understand the impact of the variants on medical counter-measures.
Since January, CDC has dramatically built up our domestic genomic surveillance
platforms to monitor circulating variants, increasing the Nation’s sequencing output 75-fold, with over 36,000 specimens now sequenced weekly. With support from the funding the Administration announced in February as well as the resources pro-vided by the American Rescue Plan Act, we’re contracting with several large com-mercial diagnostic laboratories to get viral sequence data from around the country. These laboratories are providing data on over 22,000 virus samples per week. In ad-dition, public health laboratories around the country are sending CDC samples from 750 cases each week. These samples will allow us to both get the viral sequences and isolate the viruses so that we can do additional laboratory testing to better un-derstand virulence, transmissibility and the potential impacts on diagnostic tests, therapeutics, and vaccines. Moreover, U.S. state and local public health laboratories are also sequencing approximately 7,000 specimens per week and using the data to better understand the local epidemiology and to control outbreaks. In addition, U.S. academic institutions and industry are also sequencing another 7,000 viruses per week. These efforts are coordinated through CDC’s SPHERES collaboration, which is a national genomics consortium to coordinate large-scale SARS-CoV–2 sequencing across the country. In all, the United States is sequencing about 10 percent of the roughly 350,000 weekly cases. These partnerships with commercial labs, state and local health departments, and academic and research institutions will continue to grow. We are on our way to sequencing an even higher percentage of cases, a tre-mendous accomplishment. CDC is working with state and local public health de-
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partments to use these sequencing data as part of their COVID–19 response strat-
egy. CDC has also made significant strides to make our genomic surveillance data more accessible to the public through an interactive dashboard on our COVID Data Tracker website. This site is updated regularly with the prevalence of SARS-CoV– 2 variants at the national, regional, and state levels.
Each new variant can present different challenges. But each can be stopped by
the same methods: rigorous and increased compliance with public health prevention strategies such as vaccination, physical distancing, use of masks, hand hygiene, and isolation and quarantine.
Health Equity
COVID–19 has highlighted long-standing systemic health and social inequities.
Data repeatedly show the disproportionate impact of COVID–19 on racial and ethnic minority populations, as well as other population groups such as people living in rural or frontier areas, people experiencing homelessness, essential and frontline workers, people with disabilities, people with substance use disorders, people who are incarcerated, and non-U.S.-born persons. Inequities in social determinants of health, such as poverty, housing, and healthcare access, have influenced a wide range of health and quality-of-life outcomes for these groups experiencing dispropor-tionate impacts.
These factors and others are associated with more COVID–19 cases, hospitaliza-
tions, and deaths. Not surprisingly, they intersect with higher rates of some medical conditions in these same populations that increase one’s risk of severe illness from COVID–19.
Health equity must be a cornerstone of our public health work. CDC’s Chief
Health Equity Officer has been leading implementation of our Health Equity Strat-egy to accelerate progress in reducing COVID–19 disparities. The strategy outlines an approach to expand evidence-based approaches to reduce disparities in COVID– 19 hospitalizations and deaths; increasing testing, contact tracing, isolation options, and healthcare access in populations at increased risk for COVID–19; prioritizing equity in distribution and administration of COVID–19 vaccines; reducing stigma and bias; and expanding a diverse workforce, equipped to address the needs of a diverse population. We are engaging with community-based organizations and di-verse leaders to conduct outreach that is culturally and linguistically responsive to the needs of populations at increased risk of getting sick and dying from COVID– 19.
To operationalize the Health Equity Strategy, CDC is supporting activities and
interventions with organizations across multiple sectors, including community-and faith-based organizations that have been able to provide more insight about the challenges and needs of the populations they serve. They have also helped us craft and convey tailored prevention messages about COVID–19 to these important popu-lations across the country. With their guidance, CDC has developed toolkits and other resources to address the unique needs of, and to help, communities that have been disproportionately impacted by COVID–19.
We know we need the best possible data to more clearly understand these chal-
lenges and measure our progress as we implement solutions. While we have seen big improvements over the last year, we know that there are still critical gaps in these data. For example, race and ethnicity data continue to be missing from almost 40 percent of the COVID–19 cases reported to CDC. Progress has been slow because there are many data requisition forms and data interfaces in the data exchange
pathway that must be updated. Moreover, public health data systems are not set up in a way that captures the underlying drivers for which race and ethnicity are markers. Those drivers include social determinants of health such as occupation, housing, education, access to healthcare and other factors that are the underlying causes for the disparities we see by race and ethnicity. There are multiple barriers to collecting some of these data elements, including at the state and individual level—including reticence to report income or other socio-economic factors.
This pandemic response has illustrated the long-standing need for improvements
in the public health data network. Congress has been supportive of CDC and has responded to our partners’ concerns about antiquated public health data systems by providing resources to CDC for the data modernization initiative, the first com-prehensive strategy to modernize public health data, technology, and workforce ca-pabilities—together and at once. CDC is collaborating with our partners in the field to improve data collection and sharing.
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1https://www.cdc.gov/mmwr/volumes/70/wr/mm7005a3.htm?s-cid=mm7005a3-w .
2https://www.cdc.gov/mmwr/volumes/70/wr/mm7015e2.htm?s-cid=mm7015e2-w . In the last few months, data continue to document ongoing health disparities. In
February, CDC’s National Center for Health Statistics (NCHS) released data that
highlighted disparities in life expectancy between 2019 and 2020, demonstrating the impact of COVID–19 on Black and Hispanic/Latino communities. Additional CDC data
1released in February noted that racial and ethnic minority groups have expe-
rienced disparities in mental health and substance use disorder related to access to care, psychosocial stress, and social determinants of health, exacerbated by the pan-demic. Hispanic/Latino adults reported a higher prevalence of psychosocial stress re-lated to not having enough food or stable housing than did adults in other racial and ethnic groups. And more recently, in April, we published a report
2that found
racial and ethnic disparities in hospitalization rates during the early months of the pandemic, with rates being highest for Hispanic or Latino patients, although these disparities generally declined later in 2020 as the proportion of cases in White pa-tients increased.
While it is important to document these disparities, we do not need further docu-
mentation to take action, and we are making strides toward change using the data we have. These data compel us to do what we do best at CDC—to turn our research and science into policy and action to improve the health of all. CDC, in collaboration with other components of HHS, has made historic investments in the last month to address COVID–19 health disparities and promote health equity.
In March, CDC announced plans to invest $2.25 billion over 2 years to address
COVID–19 related health disparities and advance health equity among populations that are at 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 Pop-ulations at High-Risk and Underserved Communities, Including Racial and Ethnic Minority Populations and Rural Communities, will offer grants to public health de-partments to improve testing and contact tracing capabilities; develop innovative mitigation and prevention resources and services; improve data collection and re-porting; 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.
CDC is also investing $300 million over 3 years in jurisdictions for community
health worker services to support COVID–19 prevention and control, and an addi-tional $32 million for training, technical assistance, and evaluation related to this effort. This funding will be used to address disparities in access to COVID–19 re-lated services, such as testing, contact tracing, and vaccinations, and it will help ad-dress factors that increase risk of severe COVID–19 illness. This effort will benefit populations with increased prevalence of COVID–19 and disproportionately im-pacted by long-standing health disparities.
Through this funding CDC is committed to addressing these gaps, not only for the
COVID–19 response, but across public health. And as we do this work, we will si-multaneously take action on what we know—that these disparities exist, and they are unacceptable; addressing them is critical in ensuring success against COVID– 19 and future pandemics.
Vaccines
Vaccination is a critical tool in bringing this unprecedented pandemic to an end.
In the year since SARS-CoV–2 infections were first identified, the FDA has issued Emergency Use Authorizations for vaccines that meet the expectations for safety and effectiveness for emergency use that are being distributed and administered as we speak. We should all take a moment and acknowledge that this is a remarkable accomplishment and appreciate how vaccine efficacy helps prevent serious illness, hospitalization, and death from COVID–19. As of April 19, every person aged 16 and over in every state and territory is now eligible to get vaccinated, and 90 percent of Americans now have a vaccine site within 5 miles of their home. The country has
exceeded President Biden’s goal of administering 200 million shots in the first 100 days of his Administration.
A CDC study reviewing data from the first 3 months of vaccinations among health
care personnel, first responders, and other frontline and essential workers found that both Moderna and Pfizer vaccines were 90 percent effective in preventing COVID–19 infection, two or more weeks after full vaccination. In addition, another
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3https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm?s-cid=mm7018e1-w . recent CDC study3found these two vaccines were 94 percent effective against hos-
pitalization among fully vaccinated adults aged 65 years and older. These findings
demonstrate the high, real-world effectiveness of these vaccines.
COVID–19 vaccine safety is a top priority for the Federal Government, and we
take all reports of health problems following COVID–19 vaccination seriously. On April 23, following a thorough safety review, including two emergency meetings of the CDC’s Advisory Committee on Immunization Practices, the FDA and CDC deter-mined that the previously recommended pause regarding the use of the Janssen (Johnson & Johnson) COVID–19 Vaccine in the United States should be lifted and use of the vaccine should resume. The pause had been recommended after reports of six cases of a rare and severe type of blood clot in individuals following adminis-tration of the Janssen COVID–19 Vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of throm-bosis involving the cerebral venous sinuses (large blood vessels in the brain), and other sites in the body (including but not limited to the large blood vessels of the abdomen and the veins of the legs) along with thrombocytopenia, or low blood plate-let counts. The teams at FDA and CDC also conducted extensive outreach to pro-viders and clinicians to ensure they were made aware of the potential for these ad-verse events and could properly manage and recognize these events due to the unique treatment required for these blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome. The identification of this rare complication is an important validation of the sensitivity of vaccine safety monitoring systems to be able to pick up even very small numbers of vaccine safety concerns.
Building on long-standing relationships with state and local partners, CDC has
worked tirelessly to ensure that we are getting vaccines into arms as quickly, safely, and equitably as possible. As of May 6, about 325 million doses have been delivered, and more than 251 million doses of COVID–19 vaccine have been administered. Over 70 percent of all Americans age 65 years and older were fully vaccinated by this date, and about 57 percent of adult Americans had received at least one vac-cine. This is a whole-of-society effort, and it is inspiring to see people across govern-ment, business, and communities coming together to complete this important life-saving task.
I would like to touch on four core areas that drive CDC’s vaccine work: safety,
confidence, access, and equity. As shown during the recent Janssen (Johnson & Johnson) vaccine pause, our commitment to safety remains paramount to our work. Vaccines are rigorously studied during clinical trials and there is a vast network of safety systems that monitor vaccines once they are in use and safety protocols to monitor people when they receive the vaccine. It is important that we continually deliver the message that these vaccines are safe.
Strong confidence in vaccines within communities leads to more people getting
vaccinated, and to fewer COVID–19 illnesses, hospitalizations, and deaths. CDC is working in coordination with national, state, tribal, and local governmental and non-governmental partners to build trust in the vaccine, the vaccinator, and the vac-cination system. We will continue to work with these critical partners to address barriers to vaccinations, including in communities of color and disproportionally af-fected groups.
Further supporting efforts to prioritize equity in our vaccine strategy, CDC an-
nounced an investment of $3.15 billion to support local efforts to increase vaccine access, uptake, and equity. In early April, these funds were awarded directly to states, territories, and some large cities, enabling them to support local health de-partments and community-based organizations in launching programs and initia-tives intended to increase vaccine access, acceptance, and uptake. The funding will focus on reaching communities hit hardest by the pandemic, including those with a high social vulnerability index, minority communities, and rural areas.
In order to enhance vaccine uptake among underserved communities of color and
to build trust and confidence in the authorized COVID–19 vaccines, CDC has devel-
oped a comprehensive program of approximately 20 national organizations that sup-port hundreds of local and community-based organizations to improve both COVID– 19 and influenza vaccination coverage among racial and ethnic groups who have his-torically had, and continue to experience, health disparities.
Improving access to underserved communities and populations who have histori-
cally experienced greater barriers to healthcare access is another critical component to prioritizing equity in vaccine distribution. Improving access also requires a multi- pronged approach. To that end, CDC is working closely with the Federal Emergency
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Management Agency (FEMA) and the Health Resources and Services Administra-
tion (HRSA) on two critically important programs with the goal of bringing vaccines to communities and improving access for populations disproportionately impacted by COVID–19. CDC partners with FEMA on the implementation of their Community Vaccination Centers. CDC also partners with HRSA to support COVID–19 vaccina-tions in select HRSA-funded health centers.
The Federal Retail Pharmacy Program is integral to the work CDC is doing to
maximize access to COVID–19 vaccines in all communities, including communities
of color and other underserved populations, such as rural communities. CDC is partnering with 21 national pharmacy organizations and independent pharmacy networks that represent over 40,000 locations nationwide—including 45 percent in highest-need neighborhoods—to ensure that the public has access to COVID–19 vac-cines in a familiar setting. Almost 90 percent of Americans live within five miles of a retail pharmacy. The retail pharmacy program was also instrumental in attain-ing the goal of prioritizing Pre-K through 12th grade educators, school staff, and childcare workers for COVID–19 vaccination in the month of March. As a result of this effort, our estimates show that approximately 80 percent of these essential frontline workers across the United States received at least one shot in March and more than 2 million teachers, school staff, and childcare workers were vaccinated through the Federal Retail Pharmacy Program in March. More than 52 million doses of vaccine in total have been administered through this program.
Last month, CDC also announced a new partnership with certain clinics to pro-
vide COVID–19 vaccinations to people receiving dialysis, as well as health care per-sonnel working in these clinics. Dialysis patients are disproportionately affected by COVID–19 and are at high risk for severe illness and death from COVID–19. It is estimated that 34 percent of people receiving dialysis are Black and 19 percent are Hispanic; and that 22 percent of staff in dialysis clinics are Black. People on dialysis who get COVID–19 have a 50 percent hospitalization rate and a 20 to 30 percent mortality rate. This effort is another important step in making sure that vaccines reach the most medically vulnerable communities and that prioritizing equity in vaccination continues to anchor our efforts to end the COVID–19 pandemic.
Looking to the future, we are optimistic that, in collaboration with our state, Trib-
al, local, and territorial partners, we have built a vaccine implementation infrastruc-ture that will expand vaccination coverage to allow our communities to resume some aspects of a normal life. Active investigations will continue to determine how much vaccines reduce asymptomatic infection and transmission, how long vaccine protec-tion lasts, and to what extent vaccines protect against emerging SARS-CoV–2 variants. CDC recently released updated guidelines for fully vaccinated people, pro-viding guiding principles on how to assess their own risk for COVID–19 and deter-mine what prevention measures, including masks, should be used. We look forward to revising this guidance as the science develops and as more of the population is protected through vaccination.
Schools
Since becoming the director of the CDC, I have stressed the importance of getting
children back to school for in-person learning. The safest way to open schools is to ensure that there is as little disease as possible in the community. The lower the amount of disease in the community, the less likely it is that cases will be intro-duced into the school environment. This means that all community members, stu-dents, families, teachers, and school staff should take actions to protect themselves and the community where they live, work, learn, play and worship.
CDC recommends that, among community institutions, schools should be the first
to open and the last to close. Because of the benefits of in-person learning and the key support services schools offer, it is critical for K–12 schools to open, and stay open, as safely and as soon as possible. This is especially true in low-resourced com-munities, which may include large representations of racial and ethnic minority groups and students with disabilities. CDC began working on guidance, resources, and tools for safe school reopening in March 2020 when the first schools closed. As CDC learned more about COVID–19, we continually updated our guidance, re-sources, and tools for schools, parents, teachers, and other staff.
In February of this year, CDC released new science-based resources and tools to
help schools safely reopen and stay open for in-person learning. Specifically, CDC conducted an in-depth review of the science and released the Science Brief: Trans-
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4https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/transmission-k-12-
schools.html.
5https://www.cdc.gov/coronavirus/2019-ncov/community/schools-childcare/operation-strat-
egy.html. mission of SARS-CoV–2 in K–12 Schools,4which informed CDC’s Operational Strat-
egy for K–12 Schools through Phased Prevention.5In developing the K–12 Oper-
ational Strategy, CDC gathered input from school superintendents, school officers
and nurses, national associations with a focus on education, organizations that rep-resent elected officials, and others. These resources complement CDC’s existing guidance and tools for K–12 schools, including a toolkit to assess risks and imple-ment prevention strategies to reduce the spread of SARS-CoV–2 in schools, a quick guide to assist teachers in modifying the layout of their classroom in a way that reduces the risk of virus spread, and updated materials about ventilation strategies in school and child-care settings. In March, CDC updated its school guidance reflect-ing the latest evidence to recommend that, with universal masking, students should maintain a distance of at least three feet in classroom settings. However, middle school students and high school students should be at least six feet apart in commu-nities where transmission is high, if cohorting (or podding) is not possible. CDC will continue to collaborate closely with our colleagues at the U.S. Department of Edu-cation to make sure that all schools have access to the latest guidance, as well as tools and best practices about how to apply this guidance.
Evidence indicates that many K–12 schools that have implemented prevention
strategies to reduce the spread of SARS-CoV–2 consistently and correctly have been able to safely open for in-person instruction and remain open. Regardless of the level of SARS-CoV–2 spread in the community, CDC recommends using a combina-tion of five key strategies to reduce the spread of SARS-CoV–2 in schools and help protect teachers, students, and staff. These strategies are universal and include the correct use of masks, physical distancing, handwashing and respiratory etiquette, cleaning and maintaining healthy facilities (including proper ventilation), and con-tact tracing, in combination with isolation and quarantine, in collaboration with the health department. We also point to the added layers of prevention to be gained from regular testing and vaccination.
Universal and correct use of masks and physical distancing are two prevention
strategies that are most essential to reducing SARS-CoV–2 transmission, but a lay-ered approach that uses all five of these strategies will provide the greatest level of protection.
In April, CDC provided $10 billion to states and jurisdictions to support COVID–
19 screening testing for K–12 teachers, staff, and students to assist schools in re-opening safely for in-person instruction. 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 funding, states can support the critical testing and testing supports schools need to imple-ment 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. A recent article in CDC’s MMWR found participation in a free, in- school COVID–19 testing program within Utah elementary schools was higher among students belonging to a racial or ethnic minority group and among students living in areas with higher rates of COVID–19. In-school testing could help reach underserved populations and reduce the spread of COVID–19 across the community.
SARS-CoV–2 is still a relatively new pathogen, and we are learning more about
it and how it impacts different people and communities all the time. CDC’s K–12 Operational Strategy presents recommendations based on the best-available evi-dence at the time of release. As science and data on SARS-CoV–2 and COVID–19
continue to evolve, we will update our guidance and recommendations to reflect new evidence. CDC stands committed to providing the best, most current data and sci-entific understanding available to protect the health, safety, and well-being of our communities, including our students, teachers, and school staff.
Looking to the Future
As I’ve said before, I’m cognizant that over the last 12 years, the United States
has faced four significant emerging infectious disease threats—the H1N1 influenza pandemic, Ebola, Zika, and COVID–19. While urgency demanded rapid and unique
15
responses to each of these threats, none resulted in the sustained improvements
needed in our Nation’s public health infrastructure.
This lack of preparation continues to present significant challenges in our ongoing
fight to tackle COVID–19. These experiences have proven that public health emer-gencies and, specifically, infectious disease threats are here to stay.
Looking to the future, I want to work within the Administration and with you to
address long-standing vulnerabilities in our core public health infrastructure, in-cluding data, workforce, laboratory, domestic preparedness, and global health secu-rity.
To avoid the substantial economic costs associated with both large-scale emer-
gencies and chronic public health concerns, we must be willing to make investments in our public health system. We also must offer up our technical expertise to sup-port efforts to advance global health security.
Conclusion
In closing, I want to emphasize that, while COVID–19 cases remain widespread,
there are reasons to be hopeful. I am looking forward to seeing more kids in school, more families able to connect with one another safely, and our Nation beginning to move forward and heal. We are committed to continuing to advance the science around COVID–19; moving more vaccines into more communities—especially those communities most at-risk for COVID–19 infection—and working to improve health equity.
Ending this pandemic requires more equitable access to affordable and timely
testing, treatment, and vaccination. Looking forward, we will continue to take a health equity approach, not only in future emergency responses, but in everything we do at CDC. And even when this crisis is over, we will still need a strong public health system. The COVID–19 pandemic has illuminated long-standing inequalities in health among racial and ethnic minority groups; demonstrated the need for resil-ient, fast, and accurate data systems; and showed the essential role a robust, skilled, and diverse public health workforce plays in protecting Americans.
The next few weeks and months will be critical, and we need everyone to continue
to wear masks properly, practice social distancing and handwashing, and get vac-cinated. I recognize that everyone is fatigued after a very long year. It is as critical as ever to continue these lifesaving efforts.
I look forward to working together to address both the immediate challenges
ahead in our fight against COVID–19, along with the weaknesses in our public health infrastructure that left our country vulnerable to this pandemic. CDC is grateful for your support.
We cannot strengthen the public health infrastructure our Nation needs to combat
public health emergencies—like pandemics and other infectious disease threats— overnight or in the middle of an emergency crisis. We must work together over the months and years ahead to reinforce the foundations, partnerships, modernizations, and innovations that we have initiated during this pandemic—ensuring robust pub-lic health systems continue to be grounded in science. It is one way we can turn tragedy into lasting progress and improved health outcomes for all. Thank you again for the invitation to testify today and I look forward to answering your ques-tions.
The C HAIR . Thank you.
Dr. Fauci.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NA-
TIONAL INSTITUTES OF HEALTH, BETHESDA, MD
Dr. F AUCI . Madam Chair, Ranking Member Burr, Members of
the Committee, thank you for giving me the opportunity to discuss
with you this morning the role of the National Institute of Allergy and Infectious Diseases and the NIH and research addressing the COVID–19 pandemic.
As I had mentioned to this Committee during the last hearing
that we attended, we have a strategic plan that has four major
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components—fundamental knowledge of the virus, diagnostics,
therapeutics, and the development of safe and effective vaccines. For the purpose of today’s discussion, I will focus on the issue of vaccines.
We often get asked how it could be possible that the virus was
discovered in January 2020 and we had doses of vaccine going into the arms of individuals, a vaccine that was highly efficacious and safe, 11 months later in December 2020. Well, the story behind that has been the decades of investment in basic and clinical, bio-medical research that has led to our ability to accomplish this ex-traordinary feat.
Just some examples. The basic preclinical and clinical research
in developing vaccine platform technology, particularly the highly successful MRNA platform.
In addition, scientists at the Vaccine Research Center at NIAID,
as well as grantees and contracts—contractors throughout the Country developed the optimal immunogen, which is the confirmationally correct spike protein, which is used by virtually all the vaccines that are being tested right now.
Finally, the utilization of a clinical trial network that we had set
up decades ago for influenza and for HIV.
When one thinks of efficacy, it really is what are the results of
a clinical trial. Often, when you get into the real world, the effec-tiveness of vaccines falls short of the original efficacy. That is not at all the case with the vaccines for COVID–19 because the real- world effectiveness is even more impressive than the results of the clinical trial.
One example, the University of Texas looked at 23,000 of their
employees and found that the incidence of infection was 0.05 per-cent, markedly lower than unvaccinated individuals.
The CDC has multiple MMWRs reporting on various aspects of
the real-world effectiveness. Importantly, a recent paper in The Lancet reported on the experience in Israel, which, as Senator Burr had mentioned, has done an extraordinary job of getting their citi-zens vaccinated. And, what we have seen is a remarkable diminu-tion in the number of infections that reached a critical turning point when they reached a certain percentage of the individuals who were vaccinated.
It was not only limited to Israel. Another recent paper in the
country of Qatar showed a similar type of result in which, not only was the MRNA vaccine highly effective in over 300,000 individuals tested in preventing the original wild-type virus, but it also had a very interesting capability of protecting against mild to moderate disease of a problematic variant from South Africa, the 351, and protected virtually 100 percent from severe disease, including hos-pitalization and death.
When the President makes the goal of 70 percent of adults re-
ceiving at least one vaccine by the 4th of July, we believe that is an attainable goal. The reason we feel it is important is that I be-
lieve that we are about at that critical turning point when we get a certain percentage—we do not know exactly what it is, but clear-ly the majority of individuals in the Country vaccinated, we will see a sharp turning point and a marked diminution in cases.
17
As I said the last time I testified before you, we are in a race
between the vaccine and the virus, if left to its own devices will
continue to surge. Based on experience thus far in this Country and globally, I feel confident that if we continue to vaccinate people at the rate that we are doing, that we will very soon have a situa-tion where we will have so few infections in this Country, we will begin to return to normality that all of us desire so much.
Thank you very much. [The prepared statement of Dr. Fauci follows:]
PREPARED STATEMENT OF ANTHONY FAUCI
Madam Chair, Ranking Member Burr, and Members of the Committee:
Thank you for the opportunity to discuss the role of the National Institute of Al-
lergy and Infectious Diseases (NIAID) in the research response to coronavirus dis-
ease 2019 (COVID–19) and its etiologic agent, severe acute respiratory syndrome coronavirus 2 (SARS-CoV–2). Within the Department of Health and Human Serv-ices (HHS) and the National Institutes of Health (NIH), NIAID is responsible for conducting and supporting basic and clinical research on emerging and re-emerging infectious diseases, including COVID–19. As the Director of NIAID and the Chief Medical Advisor to the President, I am pleased to discuss NIAID’s research address-ing this pandemic.
COVID–19 is a once-in-a-lifetime global infectious disease pandemic requiring an
unprecedented public-private research effort. NIAID plays a central and important role in the public health response to COVID–19. NIAID has capitalized on decades of investment in fundamental basic research, including groundbreaking structure- based vaccine design at the NIAID Vaccine Research Center (VRC); engaged domes-tic and international research infrastructure; and leveraged highly productive part-nerships with industry and longstanding relationships with community partners. NIAID utilized its existing domestic and international clinical trials infrastructure, originally established to conduct research on HIV and influenza, and worked with partners in the public and private sectors to establish the COVID–19 Prevention Network (CoVPN). The CoVPN has supported multiple COVID–19 vaccine can-
didates to progress in record time from concept to authorization for emergency use by the U.S. Food and Drug Administration (FDA). NIAID also has built on its long-standing relationships with community partners to successfully conduct these cru-cial clinical trials. NIAID initiated clinical trials with creative and adaptive designs, allowing the evaluation of multiple new and existing therapeutics for use against COVID–19. Several of these trials provided evidence of safety and efficacy of COVID–19 therapeutics and helped support authorization by the FDA.
These successes have helped slow the progression of the pandemic in the United
States. Currently, we are vaccinating approximately 2.5 million people per day, and we must continue to vaccinate as many people as we can as quickly as possible. FDA-authorized COVID–19 vaccines are safe and highly effective. The high levels of vaccine efficacy observed in the carefully controlled conditions of a clinical trial setting have been subsequently confirmed by their effectiveness in studies of vac-cines administered to broad segments of the public. Vaccination and adherence to public health measures are the fundamental tools that will help us head off another COVID–19 surge.
While we are cautiously optimistic about the future, we know that many chal-
lenges remain. One of the most concerning developments of the ongoing pandemic is the spread of genetic variants of SARS-CoV–2, some of which appear to be more transmissible than the original virus, more virulent, and/or less responsive to cer-tain therapeutic agents and vaccine formulations. So far, scientific evidence suggests that the COVID–19 vaccines distributed in the United States under FDA Emer-gency Use Authorizations (EUA) continue to be effective against these variants, but we must remain vigilant. NIAID is rapidly conducting research to better understand these emerging variants of SARS-CoV–2, how they interact with the immune sys-tem, and their implications for COVID–19 therapeutic and vaccine formulations.
We also know that our fellow Americans in underserved and minority commu-
nities have been disproportionally affected by this pandemic. NIAID is committed to continuing to work directly with these communities, as well as partnering with other agencies in the Federal Government, and with industry and academia, to en-sure that individuals in underserved and vulnerable communities are not left be-hind as we move forward toward defeating the COVID–19 pandemic. NIAID also
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recognizes that while many individuals with SARS-CoV–2 infection fully recover
after a relatively short time period, some individuals suffer longer-term effects after the initial phase of illness and after the virus is cleared from the body. NIAID is supporting collaborative efforts to study outcomes in patients across all ages, gen-ders, and co-morbid conditions, who have experienced a broad range of severity of original disease, to identify and characterize these post-acute sequelae of SARS- CoV–2 infection (PASC) and develop effective strategies to address them.
Developing Vaccines and Therapies to Prevent COVID–19
Sustained research investments by NIAID in the years prior to the emergence of
SARS-CoV–2 enabled the unprecedented pace of COVID–19 vaccine candidate devel-opment. Two activities predate successful COVID–19 vaccines: the development of versatile vaccine platforms and the adaptation of structural biology tools to design agents (immunogens) that powerfully stimulate the immune system. Long before the pandemic, NIAID VRC scientists and their collaborators made the critical scientific discovery of how to stabilize in a highly immunogenic form viral proteins that are important for infection, including the spike protein of the Middle East respiratory syndrome coronavirus (MERS-CoV), using a double mutation known as S2P. This key finding facilitated the design of vaccine candidates that generate robust immune responses against coronaviruses and other viruses of public health importance such as respiratory syncytial virus. As soon as the sequence of SARS-CoV–2 was made available in January 2020, VRC researchers rapidly generated a stabilized SARS- CoV–2 spike protein for use in COVID–19 vaccine development. This crucial break-through in structure-based vaccine design for coronaviruses has led to the develop-ment of safe and effective COVID–19 vaccine candidates across a range of vaccine platforms.
Five candidate COVID–19 vaccines have been assessed in large-scale Phase 3 clin-
ical trials in the United States thus far, and three have received EUAs from the FDA. Clinical trials to test COVID–19 vaccine candidates in pediatric populations are ongoing. On December 11, 2020, based on data from a Pfizer-supported Phase 3 clinical trial, an investigational vaccine developed by Pfizer and BioNTech became the first to receive an EUA from the FDA for the prevention of COVID–19 in indi-viduals 16 years of age and older. NIAID has helped to advance four additional COVID–19 vaccine candidates through support for research on the foundational biol-ogy underlying the vaccine concepts, as well as for clinical testing through the CoVPN. Two of these vaccine candidates, those from Moderna, Inc. and Johnson & Johnson/Janssen, have received EUAs.
Utilizing the CoVPN, NIAID is participating in the implementation of harmonized
protocols to test investigational vaccines and preventive interventions against SARS-CoV–2. These protocols were developed in collaboration with the Accelerating COVID–19 Therapeutic Interventions and Vaccines (ACTIV) public-private partner-ship, vaccine manufacturers, and the Biomedical Advanced Research and Develop-
ment Authority (BARDA). NIAID also supports the underlying critical infrastruc-ture for these clinical trials, such as a common Data and Safety Monitoring Board (DSMB), an independent group that periodically reviews data from the ongoing trials to ensure the safety of study volunteers and to determine whether efficacy has been achieved. The CoVPN has enrolled thousands of volunteers across the United States and internationally in clinical trials testing multiple investigational vaccines and monoclonal antibodies intended to protect people from COVID–19. The CoVPN also has developed an extensive community engagement framework to reach out to the underserved and minority communities disproportionally affected by COVID–19; to better understand their interest in, and concerns about, research participation; and to partner with them to ensure that their vital input is reflected in the conduct of these clinical studies.
To further address the critical challenges of participation in clinical trials as well
as vaccine acceptance and vaccine hesitancy, NIH established the Community En-gagement Alliance Against COVID–19 Disparities (CEAL) initiative, led by the Na-tional Heart, Lung, and Blood Institute (NHLBI) and the National Institute on Mi-nority Health and Health Disparities. CEAL brings together trusted community leaders to serve as champions who share information about the importance of par-ticipating in COVID–19 research and communicate data on the safety and efficacy of authorized COVID–19 vaccines.
mRNA–1273 (Moderna)
As part of a longstanding collaboration, the NIAID VRC worked with the bio-
technology company Moderna to develop a vaccine candidate designated mRNA–
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1273, which uses a messenger RNA (mRNA) vaccine platform to express the sta-
bilized SARS-CoV–2 spike protein. Early clinical trials demonstrated that mRNA– 1273 was generally well tolerated and induced robust immune responses in healthy adults. NIAID and BARDA then began working with Moderna on a Phase 3 clinical trial through the CoVPN that showed that mRNA–1273 was 94.1 percent efficacious in preventing symptomatic COVID–19. On December 18, 2020, after a thorough re-view of comprehensive data on mRNA–1273, the FDA issued an EUA for the mRNA–1273 vaccine for prevention of COVID–19 in individuals 18 years of age and older. In subsequent observational studies under ‘‘real-world’’ conditions in broader segments of the population, mRNA-based vaccines continue to display a high level of effectiveness. In an article published in Morbidity and Mortality Weekly Report (MMWR), Centers for Disease Control and Prevention (CDC) researchers and their collaborators showed that among health care personnel, first responders, and other essential workers, the mRNA–1273 and the Pfizer-BioNTech mRNA vaccine were 90 percent effective against SARS-CoV–2 infections 14 or more days after receiving a second dose. In another MMWR article, these vaccines reduced the risk of COVID–
19 hospitalization by 94 percent among people 65 years of age and older. Recently, NIAID scientists and their collaborators demonstrated that anti-SARS-CoV–2 anti-bodies persist for at least 6 months after the second dose of mRNA–1273.
Ad26.COV2.S (Johnson & Johnson/Janssen)
Decades of NIAID support for basic, preclinical, and clinical research on
adenovirus (Ad)-based HIV vaccines underpin the development by Johnson & John-son/Janssen of a coronavirus vaccine candidate based on the Ad26-vector, known as Ad26.COV2.S or JNJ–78436735. NIAID is supporting a Phase 3 clinical trial of Ad26.COV2.S through the CoVPN and has provided immunological testing of the candidate using NIAID-funded core laboratory infrastructure. As reported in the New England Journal of Medicine, the one-dose vaccine candidate was 66 percent effective overall at preventing moderate to severe/critical COVID–19 occurring at least 28 days after vaccination and 85 percent effective overall in preventing severe/ critical COVID–19 in the Phase 3 trial across several geographical regions, includ-ing areas where emerging viral variants predominate. In the United States, the effi-
cacy against moderate to severe/critical disease 28 days after vaccination with Ad26.COV2.S was 72 percent. On February 27, 2021, the FDA issued an EUA for Ad26.COV2.S for prevention of COVID–19 in individuals 18 years of age and older. On April 13, 2021, out of an abundance of caution, the FDA and CDC released a joint statement recommending a pause in the use of Ad26.COV2.S in order to review extremely rare case reports of blood clots after vaccine administration. Medical and scientific teams at the FDA and CDC found that available data suggest such blood clots are very rare events. Following their thorough safety review—and in accord-ance with recommendations from the CDC’s Advisory Committee on Immunization Practices—the FDA and CDC lifted the recommended pause on the use of Ad26.COV2.S on April 23, 2021.
Other COVID–19 Vaccine Candidates
NIAID, through the CoVPN, is supporting Phase 3 clinical trials of COVID–19
vaccine candidates from AstraZeneca (AZD1222) and Novavax (NVX-CoV2373). AstraZeneca’s AZD1222 COVID–19 vaccine candidate uses a chimpanzee adenovirus-vectored vaccine approach developed by researchers at the University of Oxford in collaboration with scientists at NIAID’s Rocky Mountain Laboratories. On March 25, 2021, AstraZeneca announced an updated interim analysis of AZD1222 reporting that the vaccine candidate was 76 percent effective at preventing sympto-matic COVID–19, including 85 percent effective in participants aged 65 years and over. Importantly, the efficacy of AZD1222 against severe COVID–19 disease was reported to be 100 percent.
Clinical Trials of COVID–19 Vaccine Candidates in Special Populations
To effectively end the COVID–19 pandemic, it will be important to vaccinate as
many people as possible, including those in special populations, such as pregnant and lactating women, children, and people with immune deficiencies. Tens of thou-sands of pregnant and lactating women already have received the COVID–19 vac-cines under FDA EUAs, and available data indicate that these vaccines are safe and effective in these populations. In addition, protective antibodies against SARS-CoV– 2 have been detected in babies born to pregnant women who received mRNA COVID–19 vaccines. NIAID-supported investigators plan to continue to monitor the safety and further study the immune responses to these vaccine candidates in preg-
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nant and lactating women. Efforts to evaluate COVID–19 vaccines in pediatric pop-
ulations are ongoing. On March 16, 2021, Moderna, in collaboration with NIAID and BARDA, announced the launch of KidCOVE, a Phase 2/3 study to evaluate the safe-ty and efficacy of mRNA–1273 in children ages 6 months to less than 12 years. This study is in addition to Moderna’s ongoing TeenCOVE study of mRNA–1273 in ado-lescents between the ages of 12 and 17. Other vaccine developers also have begun, or are planning to begin, trials to test their vaccine candidates in children, adoles-cents, and other special populations. On April 23, 2021, NIAID launched an observa-tional study at the NIH Clinical Center assessing how people with immune system deficiencies or dysregulations respond to COVID–19 vaccination. NIAID investiga-tors also will gather information about COVID–19 illness in these individuals. This study will inform decision-making about COVID–19 vaccination in people with im-mune deficiencies and dysregulation conditions.
Monoclonal Antibodies to Prevent COVID–19
NIAID scientists, collaborating with Regeneron Pharmaceuticals and Eli Lilly and
Company, also initiated two Phase 3 clinical trials to evaluate whether their inves-tigational monoclonal antibodies, REGEN-COV and bamlanivimab alone and in combination with etesevimab respectively, can prevent infection or symptomatic dis-ease in people at high risk of exposure due to their living or working conditions. Each company recently reported promising initial results. These studies have com-pleted enrollment and further analysis of the data from the trials is ongoing. Due to the sustained increase of SARS-CoV–2 viral variants that are resistant to bamlanivimab—when administered alone—the FDA revoked the EUA for bamlanivimab alone for the treatment of mild-to-moderate COVID–19 on April 16, 2021. In light of these concerns of variant resistance, the use of bamlanivimab alone is no longer being pursued for the prevention of COVID–19. The FDA now includes information on the susceptibility of SARS-CoV–2 variants in its fact sheets for health care providers for each of the monoclonal antibody therapies currently avail-able through an EUA (REGEN-COV and bamlanivimab in combination with etesevimab). In separate studies, NIAID-supported scientists and collaborators are evaluating the potential impact of emerging SARS-CoV–2 variants on the efficacy of monoclonal antibodies.
Identifying Therapeutics to Treat COVID–19
Safe and effective therapeutics are urgently needed to treat patients with COVID–
19. NIAID launched a multicenter, randomized placebo-controlled clinical trial, the Adaptive COVID–19 Treatment Trial (ACTT), to evaluate the safety and efficacy of multiple investigational therapeutics for COVID–19. ACTT–1 examined the antiviral drug remdesivir for treatment of severe COVID–19 in hospitalized adults. Based on positive data from ACTT–1, the FDA approved the use of remdesivir for treatment in adults and children 12 years of age and older and weighing at least 40 kg hospitalized due to COVID–19. ACTT–2 evaluated the anti-inflammatory drug baricitinib in combination with remdesivir, and based on favorable data from ACTT–2, the FDA issued an EUA for the use of baricitinib in combination with remdesivir for treatment of adults and children older than 2 years hospitalized with COVID–19 and requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. ACTT–3 is currently evaluating treatment of hospitalized COVID–19 patients with remdesivir plus interferon beta–1a, which is used to treat individuals with multiple sclerosis. ACTT–4, a study assessing baricitinib plus remdesivir versus the glucocorticoid dexamethasone plus remdesivir in adults hospitalized with COVID–19, has closed to enrollment because the study met pre-defined futility criteria.
NIAID, in collaboration with other NIH Institutes, also launched two clinical
trials as part of the ACTIV partnership, which utilizes master protocols allowing the addition of other investigational therapeutics as the trials continue. The two studies, ACTIV–2 and ACTIV–3, initially evaluated the use of the monoclonal antibody bamlanivimab to treat COVID–19 in outpatient and inpatient settings, respectively. ACTIV–2, which is focused on outpatients, has since been expanded to evaluate a combination monoclonal antibody therapy, BRII–196 and BRII–198, as well as four investigational therapeutics: SAB–185, a fully human polyclonal antibody produced in cattle; SNG001, an inhalable beta interferon; AZD7442, an investigational long- acting antibody combination; and camostat mesilate, an orally administered drug that may block SARS-CoV–2 from entering cells. ACTIV–3 currently is evaluating the AZD7442 monoclonal antibody combination in hospitalized patients. On April 22, 2021, NIAID and NHLBI launched the ACTIV–3 Critical Care study to test
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Zyesami and remdesivir (alone and in combination), for their safety and efficacy in
hospitalized COVID–19 patients who are experiencing acute respiratory distress syndrome, a life-threatening condition. Zyesami is a synthetic version of vasoactive intestinal peptide, which is made naturally in the human body and appears to have lung-protective antiviral and anti-inflammatory effects.
On April 13, 2021, NIAID announced the launch of the COVID–19 anti-CD14
Treatment Trial (CaTT) to evaluate the use of a monoclonal antibody known as IC14 in adults hospitalized with COVID–19. IC14 works by binding to and blocking a
human protein called CD14 that is associated with the development of severe in-flammatory reactions in some COVID–19 patients. In addition, NIAID completed a Phase 3 trial called, ‘‘Inpatient Treatment with Anti-Coronavirus Immunoglobulin,’’ or ITAC, to evaluate hyperimmune intravenous immunoglobulin (IVIG) for treat-ment of COVID–19 in hospitalized adults. The study demonstrated that IVIG plus remdesivir was not superior to remdesivir alone.
NIAID also launched the ACTIV–5/Big Effect Trial (BET), which is designed to
streamline the identification of experimental COVID–19 therapeutics that dem-onstrate the most promise. BET, an adaptive Phase 2 clinical trial, compares dif-ferent investigational therapies to a common control arm to identify treatments with relatively large effects as promising candidates for further study in large-scale trials. BET initially is evaluating two therapeutics: risankizumab, an immunomodulatory monoclonal antibody developed by Boehringer Ingelheim and AbbVie, which is FDA-approved for the treatment of severe plaque psoriasis; and lenzilumab, an investigational immunomodulatory monoclonal antibody developed by Humanigen.
The NIH also has established the COVID–19 Treatment Guidelines Panel to pro-
vide recommendations to health care providers regarding specific COVID–19 treat-ments based on the best available science. The Guidelines also address consider-ations for special populations, including pregnant women and children. Each Treat-ment Guidelines section is developed by a working group of Panel members with expertise in the area addressed in the specific section; these members conduct sys-tematic, comprehensive reviews of relevant information and scientific literature. The Panel comprises representatives of NIH and five other Federal agencies along with representatives of nine professional organizations, academic experts, and treating physicians including providers from high COVID–19 incidence areas, and commu-nity representatives. The Panel meets regularly to evaluate possible treatment op-tions for COVID–19 and update the Treatment Guidelines as new clinical evidence emerges.
Responding to Emerging Variants of SARS-CoV–2
NIAID is fully engaged in efforts to mitigate the potential impact of emerging
variants of SARS-CoV–2. NIH, including NIAID, participates in the HHS-estab-lished SARS-CoV–2 Interagency Group, along with CDC, FDA, BARDA, the Depart-ment of Defense (DOD), and the U.S. Department of Agriculture to address the po-tential impact of emerging variants on critical SARS-CoV–2 countermeasures. NIH, CDC, and DOD are assessing whether vaccine-induced immunity, or natural immu-nity from prior infection, can be effective in combating the variants. NIH, BARDA, and DOD also are determining the efficacy of certain authorized therapeutics against emerging variants in cell lines in vitro and in animal models.
NIAID is collaborating with vaccine manufacturers on key areas of research to in-
vestigate whether vaccines designed for the original strain of SARS-CoV–2 can maintain efficacy against emerging variants. NIAID also is conducting and sup-porting comprehensive studies to understand the ability of vaccine-induced anti-bodies to neutralize the variant viruses. NIAID researchers have analyzed the im-mune responses of individuals who recovered from COVID–19 prior to the emer-gence of variants and demonstrated that their T cells—a key component of the im-mune response to SARS-CoV–2—also were capable of recognizing the three most widespread SARS-CoV–2 variants, B.1.1.7, B.1.351, and P1. These findings, pub-lished in Open Forum Infectious Diseases, shed new light on the role of T cells in the development of immunity to SARS-CoV–2 and suggest that these cells also may help protect against emerging variants of concern. On March 25, 2021, NIAID launched a Phase 1 clinical trial in healthy adults to assess the safety and immunogenicity of second-generation COVID–19 vaccine candidates developed by Gritstone Oncology, Inc. Gritstone’s COVID–19 vaccine candidates utilize a strategy aimed at inducing both neutralizing antibodies and T cell responses to elicit a broad immune response. This approach could provide protection against emerging SARS-
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CoV–2 variants by targeting several viral antigens, all of which are highly con-
served among viral strains.
NIAID also plans to test new vaccine formulations that may protect against cer-
tain variants that show early indications of reduced sensitivity to existing counter-measures. On March 31, 2021, NIAID launched a Phase 1 clinical trial of an inves-tigational Moderna vaccine based on its FDA-authorized COVID–19 vaccine, de-signed specifically to target the B.1.351 SARS-CoV–2 variant first detected in South Africa. NIAID and Moderna are evaluating this vaccine candidate as a pre-cautionary measure as we gain more data to confirm that current vaccines provide an adequate degree of protection against currently circulating SARS-CoV–2 variants.
NIAID, the National Human Genome Research Institute, and the National Li-
brary of Medicine are participating in the SARS-CoV–2 Sequencing for Public
Health Emergency Response, Epidemiology, and Surveillance (SPHERES) initiative. SPHERES is a national genomics consortium led by CDC that helps to coordinate SARS-CoV–2 sequencing across the United States. NIAID is working with partners to identify, monitor, and calculate the frequency of current variations in the SARS- CoV–2 genome to help predict emerging variants. NIAID also facilitates the use of cutting-edge modeling and structural biology tools to understand how variants might affect interactions between the virus and the immune system or COVID–19 therapeutics. NIAID scientists are helping to inform our understanding of trans-missibility of the variants by studying their stability in the environment of infected individuals and their ability to grow in human lung cells. These efforts add to a growing body of knowledge about SARS-CoV–2 variants and our ability to combat them.
Understanding the Immunology and Pathogenesis of COVID–19
NIH is supporting studies to understand the incidence of SARS-CoV–2 infection
in specific populations, including children, as well as certain aspects of the clinical course of infection, including thromboses, strokes, heart attacks, and other sequelae of infection. NIAID is working with partners to delineate biological and immune pathways responsible for the varied manifestations of COVID–19. NIAID also will examine the quality and durability of the immune response to SARS-CoV–2; this in-formation may be leveraged to develop novel SARS-CoV–2 therapeutics or vaccines and inform public health measures.
NIAID, along with FDA, is supporting a National Cancer Institute (NCI) effort
to determine the sensitivity and specificity of certain SARS-CoV–2 serological tests, which can detect antibodies indicative of a prior exposure to SARS-CoV–2. NCI and NIAID also are working to establish a collaborative network to increase national ca-pacity for high-quality serological testing with rapid return-of-results to subjects. These efforts include the use of serological testing to support clinical trials of con-valescent serum and the establishment of registries for seroprotection studies. NIAID, NCI, the National Center for Advancing Translational Sciences, and the Na-tional Institute of Biomedical Imaging and Bioengineering are partnering on a study, called the Serological Sciences Network or SeroNet, to investigate whether adults in the United States without a confirmed history of SARS-CoV–2 infection have antibodies to the virus, thus indicating prior infection. The study is evaluating the durability of the immune response and aspects of the immune response that contribute to protection against COVID–19.
NIAID scientists are participating in leadership of the COVID Human Genetic Ef-
fort, an international consortium of hospitals and genetic sequencing hubs that aim to discover genetic factors conferring resistance to SARS-CoV–2 infection or predis-posing to severe COVID–19 disease. The consortium has identified a subgroup of pa-tients with severe COVID–19 that have ineffective immune responses to SARS-CoV– 2, some of whom have identifiable mutations in key immune pathways. NIAID also supports efforts to understand the rare, but extremely serious, multisystem inflam-matory syndrome in children (MIS-C) that has been associated with SARS-CoV–2 infection in children and adolescents. NIAID hosted a virtual workshop on MIS-C with scientists and clinicians from academia, NIH, FDA, and industry, and a report of the workshop recommendations was published on November 2, 2020. NIAID also supports the Pediatric Research Immune Network on SARS-CoV–2 and MIS-C (PRISM) to evaluate acute and long-term clinical and immunological effects of MIS- C and SARS-CoV–2 infection in children. In addition, NIAID is collaborating with Children’s National Medical Center to follow 1,000 children with a history of SARS- CoV–2 infection, including those with MIS-C, to determine long-term effects of the illness. NIAID is participating in a trans-NIH effort to coordinate MIS-C research
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led by NHLBI and the Eunice Kennedy Shriver National Institute of Child Health
and Human Development. This centralized effort, the Collaboration to Assess Risk
and Identify Long-term Outcomes for Children with COVID (CARING for Children with COVID), will permit data to be shared across studies to determine the spec-trum of illness and predict long-term consequences of infection.
Monitoring the Long-term Effects of COVID–19
Many people who have had COVID–19 experience continued symptoms or other
sequelae as they transition from the acute to post-acute phases of the disease, and we continue to learn more about the duration and manifestations of COVID–19 as we hear from these patients. In December 2020, NIAID hosted a Workshop on Post- Acute Sequelae of COVID–19 with clinicians, immunologists, virologists, and mem-bers of the patient community to present existing data, identify key knowledge gaps, and explore different perspectives on this heterogeneous condition. A report from this workshop highlighting the key scientific questions and knowledge gaps regard-ing PASC was recently published in the Annals of Internal Medicine. NIH has an-nounced a trans-NIH effort to address PASC, including targeted funding for re-search in this critical area. The NIH PASC Initiative will complement ongoing NIAID studies to better understand the various post-acute manifestations of COVID–19 in various populations.
NIAID intramural scientists initiated the Longitudinal Study of COVID–19
Sequelae and Immunity to better understand PASC and determine whether people
who have recovered from acute SARS-CoV–2 infection develop an immune response to SARS-CoV–2 that provides protection against reinfection. NIAID-supported inves-tigators also have established the Immunophenotyping Assessment in a COVID–19 Cohort (IMPACC) to determine how immunological markers correspond to, or may even predict, the clinical severity of COVID–19. Since May 1, 2020, IMPACC re-searchers have collected detailed clinical data along with blood and respiratory sam-ples from more than 1,200 hospitalized COVID–19 patients of diverse race and eth-nicity at approximately 20 hospitals nationwide. The cohort will be followed during hospitalization and up to 1 year after discharge to assess their functional and immunologic recovery.
Conclusion
NIAID continues to expand efforts to elucidate the biology, pathogenesis, and clin-
ical manifestations of SARS-CoV–2 infection, including emerging variants, and to employ this knowledge to develop safe and effective interventions to diagnose, treat, and prevent SARS-CoV–2 infection and COVID–19. NIAID is focused on developing safe and effective SARS-CoV–2 vaccines and therapeutics and sensitive, specific, rapid point-of-care molecular diagnostic and serological tests. NIAID also is con-ducting early stage research on candidate vaccines that could protect against mul-tiple strains of coronaviruses. All of these efforts will improve our response to the current pandemic and bolster our preparedness for the next, inevitable viral disease outbreak.
The C HAIR . Thank you.
Dr. Marks.
STATEMENT OF PETER MARKS, M.D., PH.D., DIRECTOR, CEN-
TER FOR BIOLOGICS EVALUATION AND RESEARCH, UNITED
STATES FOOD AND DRUG ADMINISTRATION, SILVER SPRING, MD
Dr. M ARKS . Chair Murray, Ranking Member Burr, distinguished
Members of the Committee, thank you for the opportunity to testify
before you again to describe FDA’s continued COVID–19 response efforts, and particularly our efforts on vaccines.
First, yesterday evening, the FDA announced the expansion of
the emergency use authorization for the Pfizer-BioNTech COVID– 19 vaccine to include adolescents down to age 12 years. We know that this is a big step for our Country as vaccinating a younger
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population can bring us closer to a sense of normalcy and to ending
this pandemic.
To look at the safety of the vaccine, the FDA evaluated a clinical
trial of more than 2,000 adolescents age 12 through 15. Half of the participants received the Pfizer-BioNTech vaccine, and half re-ceived a saline placebo. The side effects experienced by those age 12 through 15 were similar to those experienced by individuals age 16 and older.
To look at effectiveness, the FDA evaluated data about how par-
ticipants’ immune systems responded to the vaccine, comparing 190 individuals, age 12 through 15, to 170, age 16 through 25.
The FDA also evaluated data on cases of COVID–19 among ado-
lescents age 12 through 15, 7 days after the second dose of vaccine was given. And no cases of COVID–19 occurred among 1,005 ado-lescents who received the vaccine, compared to 16 cases in 978 pla-cebo recipients, thus indicating the vaccine was completely effective in preventing COVID–19 in the trial that was symptomatic.
Parents and guardians can rest assured that the Agency under-
took a rigorous and thorough review of all available scientific data, as we have with all of our COVID–19 vaccine authorizations, and the CDC’s Advisory Committee on Immunization Practices will next review the data tomorrow.
Also, as we announced yesterday, we intend to convene a virtual
meeting of the Vaccines and Related Biological Advisory Committee on June 10, 2021, during which we will provide a status update on our approach to emergency use authorization in individuals age 12 through 17 years of age. And, we will also discuss the data needed to support an emergency use authorization and a biologics license application in children less than age 12.
Second, as COVID–19 vaccination expands into adolescents, we
continue to work diligently with CDC and other partners on safety surveillance of the authorized vaccines. We are grateful to Con-gress for the American Rescue Plan funds, which are supporting expanded vaccine safety surveillance, among other critical prior-ities. We have seen that our safety surveillance systems are doing what they are supposed to do in detecting important adverse events.
Recently, our surveillance systems detected a safety signal for
rare blood clots and low blood platelets, known as thrombosis thrombocytopenia syndrome, with the Janssen or Johnson & John-son COVID–19 vaccine. Following a brief pause taken to evaluate the situation and educate providers, based on the rare but in-creased risk of this adverse event, mainly in women age 18 through 50 years of age, FDA modified the fact sheet for healthcare pro-viders to include a warning pertaining to the risk of thrombosis with thrombocytopenia, and the fact sheets for recipients and care-givers was also updated.
We will continue to diligently monitor the safety of all of these
vaccines.
Third, the CDC and FDA are working closely together to track
the emergence and the spread of COVID–19 variants. Currently available evidence suggests that the three available FDA-author-ized vaccines adequately address COVID–19 variants circulating in the United States. However, we are working with manufacturers
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and government partners to plan the composition of the vaccine so
that we can administer booster vaccinations if necessary of an ap-propriate composition.
Fourth, the FDA recently completed an inspection of Emergent
BioSolutions, the proposed manufacturing facility for the Janssen COVID–19 vaccine. At the close of the inspection of Emergent Bio-Solutions, FDA investigators cited several observations concerning whether the facility’s practices met our regulatory requirements and standards. We are now working with Emergent BioSolutions to address the conditions identified. It has been made public that no product has been released from this facility for use in the United States, and we will not agree to the release of any product from this facility until we are truly confident that it meets our ex-pectations for quality.
Additionally, moving forward, the Agency is refining how to opti-
mally evaluate the manufacturing quality during this and any fu-ture public health emergency. We are committed to maintaining the trust of the public in the vaccines and hope that every eligible individual will consider getting vaccinated to help end this pan-demic.
Thank you. [The prepared statement of Dr. Marks follows:]
PREPARED STATEMENT OF PETER MARKS
Introduction
Chair Murray, Ranking Member Burr, distinguished Members of the Committee,
I am Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research
(CBER) at the U.S. Food and Drug Administration (FDA or the Agency). Thank you for the opportunity to testify before you today to describe FDA’s coronavirus disease 2019 (COVID–19) response efforts. All of our efforts are in close coordination and collaboration with our partners, both within the Department of Health and Human Services (HHS) and across the Federal Government, to help ensure the develop-
ment, authorization, licensure, and availability of critical, safe, and effective medical products to address the COVID–19 public health emergency.
While my testimony will focus on FDA’s work regarding COVID–19 vaccines, I
want to note at the outset that this is in the context of the breadth of work FDA is doing across the Agency to address this pandemic, including our efforts on diagnostics and therapeutics.
With the urgency called for during this pandemic, FDA, through our transparent
scientific review process, has issued Emergency Use Authorization (EUA) for three COVID–19 vaccines. In doing so, we have relied upon the Agency’s rigorous stand-ards for safety, effectiveness, and manufacturing quality. Vaccine development is a highly de-risked process that generally proceeds sequentially through the various stages of clinical development, and manufacturing scale-up only takes place when the data support the safety and effectiveness of a vaccine and is on track for regu-latory approval. These vaccines were developed without cutting corners or sacri-ficing our standards. Intensive interactions between FDA and manufacturers mini-mized the time between different studies in the clinical development process; al-lowed seamless movement throughout the different phases of clinical trials; and si-multaneously proceeded with manufacturing scale-up before it was clear whether the safety and effectiveness data for a vaccine would support emergency use author-ization.
For the three vaccines authorized to date, our EUA process not only included a
thorough evaluation of the data by the Agency’s career staff, but also included input from independent scientific and public health experts through our public advisory committee process. Throughout this process, FDA took additional steps to facilitate transparency, such as posting sponsor and FDA briefing documents and key decisional memoranda.
The three authorizations make available COVID–19 vaccines in the United States
that have shown clear and compelling effectiveness in large, well-designed phase 3
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1https://www.fda.gov/media/139638/download.
2https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-
19/covid-19-frequently-asked-questions. trials and that meet rigorous standards for safety and effectiveness to support emer-
gency use authorization. Vaccines are helping us in the fight against this pandemic, which has claimed almost 600,000 lives here in the United States alone. All the
COVID–19 vaccines that FDA has authorized for emergency use have far surpassed being at least 50 percent more effective than placebo in preventing COVID–19, which was recommended in our June 2020 guidance document, Development and Li-
censure of Vaccines to Prevent COVID–19.
1A vaccine with at least 50 percent effi-
cacy would have a significant impact on disease, both at the individual and societal level.
As part of our continued efforts to be transparent and educate the public, we have
a wealth of information on our website about the authorized COVID–19 vaccines. The information includes fact sheets for healthcare providers (vaccination providers) and vaccine recipients with important information such as dosing instructions; infor-mation about the benefits and risks of each authorized vaccine; and topical Ques-tions and Answers developed by FDA for each authorized vaccine.
2
It is also important to highlight that, as part of each EUA, we are requiring the
manufacturers and vaccination providers to report serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID–19 that result in hospitalization or death to the Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program jointly run by FDA and the Centers for Disease Control and Prevention (CDC).
At this time, data are not available to make a determination about how long these
authorized vaccines will provide protection, nor are we certain that the vaccines pre-vent transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV– 2) from person to person. Additionally, although we do not yet know the full range of SARS-CoV–2 variants that each of the authorized vaccines will protect against, there is evidence that the current vaccines protect against disease caused by variants circulating in the United States.
Finally, manufacturers whose COVID–19 vaccines have been authorized for emer-
gency use are expected to continue their clinical trials in order to obtain additional safety and effectiveness information and pursue licensure (approval) through the submission of a Biologics License Application (BLA).
FDA’s Role Working With COVID–19 Vaccine Manufacturers
FDA plays a critical role in the development and authorization or licensure of vac-
cines, spanning the entire product lifecycle. The Agency provides scientific and regu-latory advice to industry, researchers, and other stakeholders across the vaccine de-velopment spectrum. Interactions with product developers begin long before any for-mal regulatory submission is made and continue throughout development under FDA’s investigational new drug application process. FDA is committed to working with all manufacturers developing products to prevent or treat COVID–19 and has had numerous interactions with COVID–19 vaccine manufacturers developing these vaccines and seeking emergency use authorization.
FDA makes use of all available regulatory tools and expedited programs, as ap-
propriate, to help advance products critical for public health, including vaccines, from early product development to when a product application is submitted to FDA for our evaluation of safety and effectiveness to support authorization or approval.
Following approval of a BLA or issuance of an EUA request, the Agency uses real-
world data to monitor the safety and effectiveness of vaccines through both passive and active post-market surveillance. Passive surveillance involves the submission of adverse event reports by patients, providers, and manufacturers to FDA through the Vaccine Adverse Event Reporting System (or VAERS). The Agency also performs ac-tive post-market surveillance of safety and effectiveness of vaccines through various data bases, including an FDA partnership with the Center for Medicare & Medicaid Services (CMS) to use Medicare data and use of the FDA’s of BEST (Biologics Eval-uation and Safety) system.
FDA works with manufacturers of approved or authorized products to help ensure
continued supply and availability of critical medical products. The Agency does this by promptly reviewing proposed technical or manufacturing changes and monitoring the continued quality of these products.
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3https://www.fda.gov/media/142749/download. FDA is committed to providing timely scientific and regulatory advice to support
rapid COVID–19 response efforts. To assist manufacturers with the development of
COVID–19 vaccines, provide scientific and regulatory advice, and outline FDA’s ex-pectations, the Agency issued specific COVID–19 vaccine guidances. In June 2020, FDA issued guidance titled Development and Licensure of Vaccines to Prevent COVID–19. In October 2020, FDA issued guidance titled Emergency Use Authoriza-tion for Vaccines to Prevent COVID–19 and updated it in February 2021 .
3
During the COVID–19 public health emergency, FDA is utilizing all available
tools and sources of information to support regulatory decisions on applications or EUA requests that include manufacturing sites where FDA’s ability to inspect facili-ties is impacted due to COVID–19. During this interim period, we are using addi-tional tools, where available, to determine the need for an onsite inspection and to support the application assessment, such as reviewing a firm’s previous compliance history, and requesting records in advance of or in lieu of onsite inspections or vol-untarily from facilities and sites. Following notice by a sponsor of intent to submit an EUA request, FDA will continue to work with the sponsor regarding resolution of any necessary manufacturing site issues resulting from a site visit or other infor-mation submitted. FDA will assess current good manufacturing practices (CGMP) or CGMP compliance for each manufacturing site using all available tools and infor-mation.
The EUA Process for COVID–19 Vaccines
A determination by the previous HHS Secretary issued on February 4, 2020, de-
clared that there is a public health emergency that has significant potential to affect national security or the health and security of U.S. citizens living abroad. Declara-tions were issued stating that circumstances exist justifying the authorization of emergency use of unapproved products. These declarations permit FDA to issue EUAs to allow unapproved medical products or unapproved uses of approved med-ical products to be used in an emergency to diagnose, treat, or prevent COVID–19 when there are no adequate, approved, and available alternatives.
The issuance of an EUA is different than an FDA approval (licensure) of a vac-
cine, in that a vaccine available under an EUA is not approved. In determining whether to issue an EUA for a vaccine, FDA evaluates the available evidence to de-termine whether the product may be effective, and assesses any known or potential risks and any known or potential benefits. If there is evidence that convinces us that the vaccine may be effective and the benefit-risk assessment is favorable, it may be made available during the public health emergency. Once a manufacturer submits an EUA request for a COVID–19 vaccine to FDA, the Agency evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to FDA.
The EUA requires fact sheets that provide important information, including dos-
ing instructions and information about the benefits and risks of the COVID–19 vac-cines, be made available to vaccination providers and vaccine recipients.
Each of the manufacturers of FDA-authorized COVID–19 vaccines submitted a
pharmacovigilance plan to FDA describing their commitment to monitor the safety of their vaccines. The pharmacovigilance plans include plans to complete longer- term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plans also include other activities aimed at monitoring the safety profile of the COVID–19 vaccines and ensuring that any safety concerns are identi-fied and evaluated in a timely manner. FDA also expects manufacturers whose COVID–19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licen-sure).
FDA, CDC, Centers for Medicare & Medicaid Services (CMS), Veteran’s Health
Administration and Department of Defense are conducting post-authorization safety and effectiveness monitoring in their surveillance systems including VAERS, CMS
Medicare data, FDA BEST, the CDC Vaccine Safety Datalink and others.
Specific updates about each of the authorized vaccines are provided below.
Pfizer COVID–19 Vaccine
As Pfizer announced, FDA received the company’s request to amend its emergency
use authorization (EUA) to expand the authorized age range for its COVID–19 vac-
28
4https://www.fda.gov/media/144637/download.
5https://www.fda.gov/media/147762/download. cine to include individuals 12 through 15 years of age. Currently, the vaccine is au-
thorized for emergency use to prevent COVID–19 in individuals ages 16 and older. While the Agency cannot predict how long its evaluation of the data and information will take, we will review the request as expeditiously as possible using a thorough and science-based approach. Based on an initial evaluation of the information sub-mitted, at this time the Agency does not plan to hold a meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) pertaining to this re-quest to amend the EUA for the Pfizer-BioNTech COVID–19 Vaccine. The original EUA request was discussed at a VRBPAC meeting in December 2020. The VRBPAC voted in favor of the determination that based on the totality of scientific evidence available, the benefits of the Pfizer-BioNTech COVID–19 Vaccine outweigh its risks for use in individuals 16 years of age and older. After considering all the evidence, including the VRBPAC’s advice, FDA issued an EUA for the Pfizer vaccine. As with all FDA-authorized COVID–19 vaccines, we are committed to transparency with this EUA review process.
Moderna COVID–19 Vaccine
On April 1, 2021, FDA announced two revisions regarding the number of doses
per vial available for the Moderna COVID–19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are available, in that the maximum number of extractable doses is 11, with a range of 10–11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial con-tains a maximum of 15 doses, with a range of 13–15 doses that can potentially be extracted. The type of syringes and needles used to extract each dose affect the number of doses that can be extracted from the vials.
Both of these revisions positively impact the supply of Moderna COVID–19 Vac-
cine, which will help provide more vaccine doses to communities and permit more people to be vaccinated. Ultimately, more vaccinations administered in a timely manner in the United States and around the world should help bring an end to the pandemic more rapidly.
Depending on the type of syringes and needles used to extract each dose, there
may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses.
To support these changes to the EUA, FDA evaluated data showing the number
of doses that could be extracted from the vials and on the fill volumes for both vials that were submitted by ModernaTX, Inc. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Prescribing Information
4have
been revised to reflect the new information and are intended to help frontline work-ers administering COVID–19 vaccines understand the number of doses that can po-tentially be extracted per vial.
Janssen (Johnson & Johnson) COVID–19 Vaccine
As part of our regulatory processes for reviewing all manufacturing facilities, FDA
recently completed an inspection of Emergent BioSolutions, a proposed manufac-turing facility for the Janssen COVID–19 Vaccine. As Johnson & Johnson an-nounced last month, FDA has not authorized this facility to manufacture or dis-tribute any of the Janssen COVID–19 Vaccine or components and, to date, no
COVID–19 vaccine manufactured at this plant has been distributed for use in the U.S.
FDA’s inspections are thorough, and these assessments review the quality of man-
ufacturing procedures, including records, staff training, facility operations, drug pro-duction and testing, and the systems in place to ensure product quality. At the close of the inspection of Emergent BioSolutions, FDA investigators cited a number of ob-servations concerning whether the facility’s practices met our regulatory require-ments and standards. These observations are outlined in an inspection closeout re-port, also known as an ‘‘FDA Form 483.’’
5
Typically, firms respond to the observations cited on an FDA Form 483, and the
Agency then works with a company to help identify a path forward to remedy the issues.
Indeed, it is often in the public’s best interest that FDA work with firms to quick-
ly resolve inspectional observations to ensure that the public has access to medical
29
6https://www.fda.gov/media/146304/download. products that meet the Agency’s high standards for quality, safety, and effective-
ness.
In the case of Emergent BioSolutions, we are working with the company to ad-
dress the conditions identified. At the Agency’s request, Emergent BioSolutions has
agreed to pause new production while it works with FDA to resolve potential quality issues. For the vaccines already manufactured, the products will undergo additional testing and will be thoroughly evaluated to ensure their quality before any potential distribution. We will not allow the release of any product until we are confident that it meets our expectations for quality.
We have notified various health authorities regarding the findings we observed
at the Emergent facility and are providing additional information as requested. FDA will continue to work closely with its international partners, as it has throughout the pandemic. Additionally, moving forward, the Agency is considering how best to further evaluate manufacturing quality during this and any future public health emergency.
These manufacturing actions are unrelated to an ongoing evaluation by FDA and
CDC of clinical reports of blood clots along with low levels of platelets that have occurred in some people after receiving the Janssen COVID–19 Vaccine, described further below.
We are committed to ensuring that the COVID–19 vaccines given to the people
of this Nation have met the Agency’s high standards for quality, safety, and effec-tiveness. We know that every time a person, including members of our own families, receives a COVID–19 vaccine, they are putting their trust in us. We are committed to maintaining that trust.
COVID–19 Vaccine Safety Surveillance
On April 13, 2021, FDA and CDC issued a joint statement, announcing that, out
of more than 6.8 million doses administered as of that date, six reports of a rare and severe type of blood clot combined with low blood platelet levels occurring in people after receiving the Janssen COVID–19 Vaccine had been reported to VAERS. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms oc-curred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this circumstance, administration of heparin may be dangerous, and alternative treatments need to be given.
Out of an abundance of caution, FDA and CDC recommended a pause in the use
of the Janssen COVID–19 Vaccine while we investigated reports of these serious ad-verse events. This was important, in part, to help ensure that health care providers were made aware of the potential occurrence of these adverse events and could plan for proper recognition and clinical management due to the unique treatment re-quired for thrombosis with thrombocytopenia syndrome.
FDA and CDC have reviewed all of the available data, and CDC’s Advisory Com-
mittee on Immunization Practices (ACIP) held emergency meetings to discuss the data on April 14 and April 23, 2021. Those data, plus the deliberations and rec-ommendations of the ACIP, informed our assessment that the known and potential benefits of Janssen COVID–19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We concluded that, at this time, the available data suggest that the chance of this serious adverse event occurring is very low. Thus, on April 23, 2021, FDA and CDC determined that the recommended pause regarding the use of the Janssen COVID–19 Vaccine in the U.S. should be lifted and use of the vaccine should resume. However, investigation into the level of poten-tial excess risk due to COVID–19 vaccination is ongoing.
The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Pro-
viders) has been updated to include a Warning pertaining to the risk of thrombosis with thrombocytopenia.
6The Fact Sheet for Recipients and Caregivers has also
been updated to include information about these serious adverse events.
FDA and CDC will continue to closely monitor the safety of these vaccines. We
will continue to closely monitor the safety of the Janssen COVID–19 Vaccine.
30
The pause in the use of this vaccine was an example of our extensive safety moni-
toring system working as it is designed to work—identifying even this small number
of cases.
As of May 4, 2021, a total of 23 cases of thrombosis with thrombocytopenia fol-
lowing post-authorization use of Janssen COVID–19 Vaccine were confirmed, involv-ing cerebral venous sinuses and other sites in the body. These cases have been asso-ciated with three deaths. FDA anticipates these numbers will change over time as additional cases are reported and investigated.
FDA continues to inform the public of these cases and has noted that a causal
relationship with Janssen COVID–19 Vaccine is plausible for thrombosis with thrombocytopenia syndrome. The teams at FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the poten-tial for these adverse events. The outreach also provided information so that they could properly clinically manage and recognize these events due to the unique treat-ment required for these blood clots and low platelets, also known as thrombosis- thrombocytopenia syndrome (TTS). Specific risk factors for thrombosis with thrombocytopenia after vaccination continue to be investigated.
As noted earlier, CBER is monitoring the safety of all authorized COVID–19 vac-
cines through both passive and active safety surveillance systems. CBER is doing so in collaboration with CDC, CMS, the Department of Veterans Affairs, and other academic and large non-government healthcare data systems. In addition, CBER participates actively in ongoing international pharmacovigilance efforts, including those organized by the International Coalition of Medicines Regulatory Authorities and the World Health Organization. These efforts are in addition to the pharmacovigilance efforts being undertaken by the individual COVID–19 vaccine manufacturers for authorized vaccines. A coordinated and overlapping approach using state-of-the-art technologies has been implemented.
Conclusion
The process FDA uses to evaluate the safety and effectiveness of medical products
is respected worldwide and commonly referred to as the ‘‘gold standard.’’ Because of a well-established history, the Agency’s review processes are globally recognized as the most rigorous.
Having three vaccines authorized to date that meet FDA’s expectations for safety
and effectiveness only 1 year after the declaration of the COVID–19 pandemic is a tremendous achievement and a testament to the dedication of developers and FDA’s career scientists and physicians, many of whom have been working tirelessly to con-duct comprehensive and rigorous evaluations of the data submitted for vaccines to prevent COVID–19. We are highly engaged in ensuring that all COVID–19 vaccines meet the high quality that Americans expect and deserve and are also actively en-gaged in ensuring the safety of these vaccines following deployment. The Agency is very proud of these efforts, and we hope that the vaccines will help bring this pan-demic to an end.
The C HAIR . Thank you.
Dr. Kessler.
STATEMENT OF DAVID KESSLER, M.D., CHIEF SCIENCE OFFI-
CER, COVID RESPONSE, UNITED STATES DEPARTMENT OF
HEALTH AND HUMAN SERVICES, WASHINGTON, DC
Dr. K ESSLER . Chair Murray, Ranking Member Burr, distin-
guished Members of the Committee, thank you for the invitation to
provide an update on our COVID–19 response.
Allow me to succinctly set out what we are focused on today.
First, we have delivered to date 330 million doses of vaccine in the United States and have administered over 260 million of them. The most important thing we all need to do is to get a vaccine to every-one who wants to be vaccinated in the United States.
The current vaccine supply exceeds demand. Nothing is more im-
portant than achieving the President’s goal of having 70 percent of
31
adults with at least one shot before—by July 4. The long-term fate
of many of our communities depends on getting people vaccinated.
There are many reasons why many people have not yet been vac-
cinated. We need to recognize at the core for many is simply a fear of the unknown. All the data support the basic proposition that these vaccines are safe and effective. Getting vaccinated will pre-vent hospitalization and death.
Second, the FDA took a significant step yesterday in the fight
against COVID–19 by expanding the Pfizer EUA to adolescents ages 12 to 15. Pending the recommendation of the ACIP tomorrow, we plan to offer the Pfizer vaccine to all young people ages 12 to
15.
Right now, the Pfizer vaccine is available at many local phar-
macies and larger health clinics. We are working to make smaller trays available so that the Pfizer vaccine can be administered by more pediatricians, family doctors, and rural healthcare providers.
By late fall, we expect to have data on the safety and effective-
ness of vaccines for children under 12.
Third, we are planning—and I underscore the word planning—
to have booster doses available if necessary for the American peo-ple. Increased age, the natural waning of antibodies over time, and new variants all increase the probability that booster doses may be needed.
Fourth, it is absolutely essential that we begin sharing doses
made in the United States with the rest of the world. Supplying other nations with vaccines is not just the right thing to do for life-saving, humanitarian purposes; it is also in the best interest of the United States to mitigate the risk of viral evolution.
Fifth, we need to hasten our search for an antiviral. I am con-
cerned that even after we finish vaccinating most of the people who want to be vaccinated by this summer, there will still be a signifi-cant number of cases and an unacceptable number of deaths. Peo-ple who are immunosuppressed, who do not mount an immune re-sponse for a number of reasons, or choose not to be vaccinated will continue to be vulnerable, and we need options for them. The anti-body treatments are one approach, but a simple oral antiviral can add to our armamentarium to bring this epidemic under control.
Last, we need to build a program for vaccine preparedness for fu-
ture pandemics. This will need to be done in partnership with the private sector and build on all the lessons we have learned to date.
Thank you for the opportunity to testify today, and I look for-
ward to your questions.
[The prepared statement of Dr. Kessler follows:]
PREPARED STATEMENT OF DAVID KESSLER
Introduction
Chair Murray, Ranking Member Burr, and distinguished Members of the Com-
mittee. I am Dr. David Kessler, and I am honored to be serving as the Chief Sci-entific Officer for the COVID–19 Response. Thank you for the opportunity to testify before you today, provide this update, and discuss our planned actions and priorities going forward.
Today, the United States is in a special position, with three vaccines that have
met our standards for safety and effectiveness and are authorized for the prevention of COVID–19. I am privileged to work with colleagues on the COVID–19 Response who coordinate efforts with state and local partners to deliver and administer those
32
doses. I am pleased to report that more than 83 percent of people over the age of
65 have received at least one dose and over 70 percent of them are fully vaccinated. As of April 19, 2021, every person aged 16 and over in every state and territory is now eligible to get vaccinated. The country has exceeded President Biden’s goal of administering 200 million shots in the first 100 days of his Administration.
We are carefully monitoring the supply chain, raw materials and our manufac-
turing capacity for vaccines. I am pleased to report that our supply remains strong as we work toward achieving President Biden’s goal of having 70 percent of adult Americans with at least one shot and 160 million Americans fully vaccinated by July 4.
We have provided Federal support and Federal personnel for over 1,800 commu-
nity vaccination centers and mobile sites across the country. We have also launched the Federal Retail Pharmacy Program, a collaboration between Federal Govern-ment, states, and territories, and to 21 national pharmacy networks to expand ac-cess to vaccines for the American public, with over 40 percent of locations in highest need neighborhoods. We increased the number of pharmacies providing vaccines to nearly 40,000. Today 90 percent of all Americans have a vaccination site within 5 miles of where they live. In addition, we have launched a program to directly send vaccine to community health centers, currently reaching over 750 centers who have ordered nearly 6 million COVID–19 vaccine doses for over 2,000 sites. HHS just launched a Rural Health Clinic program and announced expanded COVID–19 Test-
ing and Mitigation funding for small rural facilities and critical access hospitals— to mitigate the spread of the virus in ways tailored to local rural communities.
I want to stress how important it is that our fellow citizens get vaccinated and
that we help ease the minds of those who are considering getting vaccinated. We need to confront the reality of vaccine hesitancy. I have focused my career on study-ing drug safety. We can help people overcome their concerns about vaccines by being transparent with them about the safety of these products. When it comes to the mRNA vaccines, real world data show that they are more than 90 percent effective in preventing infection two or more weeks after the second dose, and that these vac-cines have to date an excellent safety profile.
I also want to emphasize that we are committed to helping other countries fight
COVID–19, most recently India. We delivered 20,000 treatment courses of the antiviral drug remdesivir to India to help treat hospitalized patients. We have redi-rected the United States’ own order of AstraZeneca vaccine manufacturing supplies to India. This will allow India to make over 20 million doses of COVID–19 vaccine. We are also delivering critical supplies to help provide oxygen to patients and addi-tional personal protective equipment for healthcare workers. Supplying other na-tions with vaccines and personal protective equipment (PPE) is not just the right thing to do for life-saving humanitarian purposes, it is also in the best interests of the United States to mitigate the risk of viral evolution. The best way to stop new variants from emerging is to prevent outbreaks that allow mutations to occur.
Today, I want to provide updates on three topics that we know are vitally impor-
tant to the overall effort to bring COVID–19 under control in America.
First, we are developing plans to provide booster doses to Americans, if deter-
mined to be necessary later this year. We know that neutralizing antibodies persist for some time after the second dose of an mRNA vaccine, with a relatively slow de-cline over time. We are supporting research to determine who would benefit from booster doses and when these should be administered. We expect to have more in-formation this summer about the potential benefits that a booster dose could pro-vide, as well as the process and timing for regulatory review of these vaccines. We are also supporting research to evaluate the use of different combinations of booster doses, so that a person’s booster dose might be from a different manufacturer than that person’s initial vaccine regimen. As part of our plans, we will carefully evaluate whether we might need doses that are modified to address variants. As these efforts progress, we will work with manufacturers to make those doses available, as need-ed, to continue to protect Americans from COVID–19.
Second, if the Food and Drug Administration (FDA) authorizes vaccines for ado-
lescents between the ages of 12 and 15, we will make sure those adolescents have access. After a careful review of the data by FDA and the Centers for Disease Con-trol and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP), we plan to have about 20,000 pharmacy sites across the country ready to vaccinate adolescents. We will also work to get vaccines into the offices of pediatri-cians and family physicians so that parents and their children can talk to their doc-tor about vaccines and have an option of receiving their dose from a trusted pro-vider.
33
Finally, I want to talk about our work on therapeutics. Taking a whole of govern-
ment approach, we have worked to accelerate the clinical development and manufac-
turing scale-up of therapeutic candidates most likely to have a broad public health impact to complement the vaccine effort, with successful therapies at sufficient quantities. There are two monoclonal antibody (mAb) treatments with emergency Use authorization (EUAs) currently available, Regeneron’s cocktail (casirivimab and imdevimab) and Eli Lilly’s combination treatment (bamlanivimab + etesevimab). We have procured almost 3 million monoclonal antibody doses that are being provided to the US healthcare system at no cost, with approximately 980,000 total doses shipped to 5956 (suggest—almost 6000) provider sites. As of April, mAbs were being
administered to approximately 1 out of 5 eligible high-risk patients. We continue to support efforts to increase awareness of treatments and expand infusionsites and services to help ensure fair and equitable administration of mAbs.
Our efforts are also focused on the research and development of antiviral drugs,
particularly small molecule oral antivirals to treat individuals who are not vac-cinated or who might become infected after vaccination. These drugs could also help patients in the event of rapidly emerging variant strains. Monoclonal antibodies and other drugs in development target those at high risk of severe disease, but a safe and effective oral drug that demonstrates an endpoint of symptom resolution would be an important treatment option for Americans. We are committed to supporting research and development of antivirals for COVID–19.
I look forward to working with Members of this Committee as we address the
issues I have highlighted. Thank you for the opportunity to testify today on our re-cent COVID–19 Response actions.
The C HAIR . Thank you to all of our witnesses for being here
today and your testimony.
We will now begin a round of 5-minute questions of our wit-
nesses, and I ask our colleagues to keep track of your clock and
stay within those 5 minutes. We do have votes starting at 11:30 today.
Dr. Fauci, I am going to start with you. The surge of COVID–
19 that is devastating India is a painful reminder, really, that we cannot end the pandemic here until we end it everywhere. And I am glad the Biden administration is leading that global fight by re-joining the World Health Organization and funding global vaccine efforts and committing to donate 60 million AstraZeneca vaccines to other countries by July 4th. India’s outbreak really underscores the need for a robust public health infrastructure in the U.S. to re-spond appropriately to this pandemic and future outbreaks, as well.
I wanted to ask you today, Dr. Fauci, what can we learn from
India’s outbreak that we should apply to our response here in the U.S.?
Dr. F
AUCI . Well, I think one of the important things is do not
ever underestimate the situation. You know, the reason that India is in such dire straits now is that they had an original surge and made the incorrect assumption that they were finished with it. And what happened, they opened up prematurely and wind up having a surge right now that we are all very well aware of is extremely devastating. That is the first thing.
The second thing is preparedness with regard to public health
preparedness, which we, as a lesson learned for future pandemics, have to realize that we need to continue to buildup our local public health infrastructure. Which, over the last decades, we have let ac-tually, in many respects, go into disarray, likely because of our suc-cesses in controlling so many diseases.
34
The other lesson that is learned, Madam Chair, is that this is a
global pandemic that requires a global response. And, we need to
pay attention to the responsibility that we have, not only for our own Country, but to join with other countries to make sure that we have the access to interventions, particularly vaccines, throughout the world because if it continues to have dynamics of virus any-where in the world, we have a threat here in the United States, particularly with variants. And, there is one variant in India that is also a new variant, number 617B617.
Those are just a few of the lessons that I believe we can take
from what is going on in India. Thank you.
The C
HAIR . Thank you.
Dr. Marks, I am really encouraged by how the FDA has worked
both quickly and carefully to get multiple COVID vaccines author-ized. But, having said that, I am very concerned about the reports involving Emergent BioSolutions. You mentioned it in your re-marks. It is a contractor that received $628 million to manufacture COVID vaccines, and I wanted to ask you to explain FDA’s recent findings. Because after receiving reports of cross-contamination with another vaccine, FDA inspected the Emergent facility, as you said, and asked the contractor to pause manufacturing, and the cross-contaminated vaccine was not distributed for any use.
But, Dr. Marks, what steps is FDA taking to make sure the qual-
ity, safety, and effectiveness of all COVID–19 vaccines?
Dr. M
ARKS . Chair Murray, thank you for that question. So, we
are currently, for the Emergent facility, we are actively working with all of the parties involved to ensure that the facility’s defi-ciencies are all remediated so that before they actually are able to release vaccine, it meets all of our quality standards that Ameri-cans deserve from vaccines.
Also, as we move on to other facilities that may be producing
vaccines, we will take the approach of using all of our inspectional tools to ensure that the quality of those is the highest nature. And, as with all of our biologics license applications, we, for the—gen-erally, will be performing onsite inspections of those facilities to en-sure the quality of those products.
The C
HAIR . Thank you. And I am really deeply concerned about
what happened, and my expectation is in the future, nothing like that happens again.
Dr. Walensky, in my last minute here, let me just ask you. The
CDC says that while fewer children have been sick with COVID– 19 compared to adults, children can be infected, get sick, and spread the virus. With the authorization of Pfizer yesterday for children 12 to 15, what would you say to parents who are consid-ering getting their kids vaccinated now?
Dr. W
ALENSKY . I would encourage all parents to get their chil-
dren vaccinated. I know many parents are enthusiastic and have been texting me, cannot wait to get their children vaccinated. I rec-ognize that there—some parents want to sort of see how it goes
first. But, I am encouraging all parents to get their children vac-cinated. Some parents will not want to be first.
But, I am also encouraging children to ask for the vaccine. I have
a 16-year old myself, and I can tell you he wanted to get the vac-
35
cine. He wants his life back. These kids want to go back to school.
They want to go back to the things they love.
The C HAIR . Thank you.
Senator Burr. Senator B
URR. Thank you, Chair.
Dr. Kessler, we have shipped 2.7 million doses of AstraZeneca,
I think, to Mexico. That is the only country we have shipped to. We have additional doses of AstraZeneca in inventory in this Country. We talked about July 4th exporting more. Why have we not taken the AstraZeneca, which is not approved for vaccination in the United States, why have we not mobilized that to other countries of the world today?
Dr. K
ESSLER . Senator, it is a very important question. We have
shipped a total of four million doses to date, including to Mexico, and I believe 1.5 to Canada. We are ready to ship up to 60 million doses of AstraZeneca. But, as the Chair pointed out, and as my col-league, Dr. Marks, responded, there are issues with Emergent that are under review by the Food and Drug Administration. If and when those issues are resolved and we can say that these are qual-ity doses, we will do just as you say.
Senator B
URR. Correct me if I am wrong. I did not think the
Emergent Baltimore facility had anything to do with AstraZeneca production. Am I wrong, Dr. Marks?
Dr. M
ARKS . Senator Burr, no. The AstraZeneca vaccine was being
produced in that facility, and the FDA feels it is imperative that before vaccine can be shipped to any other partner, it has to meet the quality standards that it would meet for any American, as well.
Senator B
URR. How long do you anticipate that testing the
AstraZeneca vaccine that is currently manufactured would take to verify?
Dr. M
ARKS . We are working on that as quickly as we can. We un-
derstand the imperative here. There is a working group across our Office of Regulatory Affairs and our center and others at FDA that are working together to try to clear that—those doses as quickly as we can. I cannot give you an exact time, but we understand the im-perative to be able to have them available so that Dr. Kessler can arrange for them to be shipped to those in need.
Senator B
URR. Okay. Dr. Kessler, one of the reasons we are as
successful today is that partnerships have been leveraging vaccina-tions around the world, and over 275 partnerships have been cre-ated to scale up vaccine production and manufacturing.
I guess I am asking you this. If we waive intellectual property
in the United States, do we not stand the risk of affecting innova-tion in the future when, if we did it to scale up manufacturing ca-pacity, the private sector has done that through partnerships al-ready and that is the reason that we have been so successful? Should we not let the private sector continue to do something that—I think Dr. Fauci and I have said in the past, we never an-ticipated this. This is novel that they would have the relationship to do it. Why mess with a good thing?
Dr. K
ESSLER . I applaud the actions of the pharmaceutical indus-
try. Senator, this is a once-in-a-century pandemic. I think we all recognize that extraordinary circumstances call for extraordinary measures. We know—and I agree with you, Senator—that a waiver
36
alone will not result in the scale and speed we need to make
enough vaccines to end the pandemic. That is why we will continue to ramp up our efforts working with the private sector and all pos-sible partners to expand vaccine manufacturing and distribution around that, around the world. I mean, our job is to do, as you say, to increase that supply. That is what we are focused on. We want to make vaccines available to the world.
Senator B
URR. David, here is the reality. When Pfizer went to
open up its Kansas plant to produce vaccine, it took them, I be-lieve, 7 months to retool and to get everything done. This belief that you can export intellectual property and you are going to have a standup around the world instantaneously of vaccine production is a joke. Dr. Marks has already expressed concern over the back-logs for inspections and how long would it take for us to inspect foreign sites, if in fact there was a vaccine pool that found its way in and out of the United States.
Let me just get this before my time runs out. Can anybody give
me the number? There has been 33 million Americans infected with COVID that have actually tested positive. How many of that 33 million have then been vaccinated? Does anybody know what that number is?
[Brief silence.] Senator B
URR. Here is why I make the point, and here is why
I think it is relevant. If we are looking at a certain number that we do not know exactly what it is, Dr. Fauci, that we want to get to, and we have vaccinated 115 million, it is important for us to know, of the counted vaccine number, how many of those already had protection because they were COVID-positive.
If we are trying to reach a number—when the President says 70
percent vaccination, if we get to 65 vaccinated and 5 percent got COVID and they had protection, is that not like being at 70?
I think one of the problems that—the goal post continues to be
too far. And we now have the harder part of how do we take the 40 percent that are not real comfortable with getting vaccinated and at least have a shot at vaccinating 50 percent of that 40 per-cent. And, it may be that our number is higher today on the pro-tected. I know it is. I do not think 33 million have all been vac-cinated that were positive, but I think it is absolutely crucial that we figure out what that number is. I am not sure whose responsi-bility it is that we figure out what that number is and put that into our formula of how many Americans have protections.
I thank the chair. The C
HAIR . Thank you, Senator Burr.
Senator Casey. Senator C
ASEY . Chair Murray, thank you very much. And I want
to thank our guests, Dr. Fauci, Dr. Kessler, Dr. Marks, and Dr. Walensky. I think I will have at least one question for Dr. Walensky and one for Dr. Marks.
I am going to start with you, Dr. Walensky. I want to thank you
for your leadership and the leadership of the CDC and your efforts to ensure that children and adolescents are up to date on vaccina-tions, particularly as students return to in-person learning.
You and others have noted, there are over 11 million doses
through the Vaccines for Children Program that have been missed.
37
These missed doses could seriously and negatively impact efforts to
protect children, their families, and communities from vaccine-pre-ventable diseases and conditions. Of course, we are talking here about diseases other than COVID–19.
At the same time, with 12 to 15 year olds now able to get vac-
cinated against COVID–19, there is an even greater need to ensure parents are aware of all the vaccines, all the vaccines that children should receive in order to remain healthy. The Rescue Plan con-tains funding to build vaccine confidence, and specifically includes provisions to ensure funding is allocated toward increasing vaccina-tion rates throughout the U.S.
Here is the question, Doctor. In addition to the public awareness
efforts that you and CDC have already undertaken, will the CDC be releasing the funding to both states and communities to ensure that children and adolescents are caught up on both routine and recommended vaccinations, particularly as children return to in- person learning?
Dr. W
ALENSKY . Thank you, Senator, for that. You raise an issue
that is near and dear to my heart and I am very worried about. More than 20 percent of our measles vaccines were not used this year. We have the same issue with meningococcal vaccines, and es-pecially among our adolescents.
Unfortunately, we actually do not have data on whether we can
co-administer the COVID–19 vaccine and other routine immuniza-tions and whether we get the same protection from the COVID–19 vaccines and the routine administration of other immunizations. That is one issue that the experts at ACIP are going to address to-morrow as to whether that can safely be done and that we could potentially get adequate protection.
You are right. We need to, as we are putting forward these ef-
forts in vaccine confidence for the COVID–19 vaccine, we need to take this outreach and make sure that we are breaching these com-munities and not only conveying the importance of getting the COVID–19 vaccine, but, if we are not able to co-administer them, to make sure we get back to these children and be able to admin-ister the routine vaccines that they have lost before the school year.
Senator C
ASEY . In terms of the funding, though, that will be re-
leased? Do you have any sense of the timing of that?
Dr. W ALENSKY . I do not, but we can get back to you.
Senator C ASEY . Okay. Thank you.
Dr. Marks, I wanted to start with you regarding Pfizer. We have
heard a lot this year about emergency use authorization, and we know that Pfizer has recently filed their application for full licen-sure of their COVID–19 vaccine. I think we get a lot of questions at home on a range of these issues, and, in particular, what does it mean? What does it mean? What does full licensure mean? One of the concerns that we have heard a lot about as the vaccines are provided, this emergency use authorization, but what is the next
step for a vaccine? Can you explain what it means to get full licen-sure? That is question No. 1.
Second, what additional information would a company need to
submit beyond what was required just for so-called EUA?
38
Dr. M ARKS . Senator, thanks very much for that question. The full
licensure is something that a manufacturer submits with a full
data package, which I will go into in a moment.
But, I just want to go back to pick up on something that Dr.
Fauci said. These COVID–19 vaccines, they were expedited not by cutting corners, but by going through a development plan in which kind of empty space, space that would have been normally just not stuff happening, was taken away. So, manufacturing was done while the clinical trials were done.
The large clinical trial programs were of the size of normally li-
censed vaccines in the United States. The one place where we are a little bit short was the duration of safety follow-up. But, we are very confident from the amount of safety follow-up, at least a meet-ing of 2 months safety follow-up on this safety data set for the emergency use authorization, that the large majority of adverse events became apparent. So, we are very confident in recom-mending these vaccines for everyone—our families, all Americans.
The difference that will happen with the biologics license applica-
tion is that the manufacturers will be able to submit additional safety data, perhaps 6 months of safety data rather than just the median 2 months safety data. And, additionally, there are some technical things that will be there that many people may not care a lot about, but we do. That is, manufacturing conformance lots, the formal facilities inspections will occur, and additional ancillary studies will be put in that package.
I think the main message to the American public is that for all
intents and purposes, the vaccine that is being used is very close to what we would normally have in a biologics license application. There are some little things around the margins that will go into the biologics license application when we have a formal approval.
Senator C
ASEY . Thank you.
Thank you, Chair Murray. The C
HAIR . Senator Paul.
Senator P AUL. Dr. Fauci, we do not know whether the pandemic
started in a lab in Wuhan or evolved naturally, but we should want to know. Three million people have died from this pandemic, and that should cause us to explore all possibilities.
Instead, government authorities, self-interested in continuing
gain-of-function research, say there is nothing to see here. Gain-of- function research, as is juicing up naturally occurring animal vi-ruses to infect humans.
To arrive at the truth, the U.S. Government should admit that
the Wuhan Virology Institute was experimenting to enhance the coronavirus’ ability to infect humans. Juicing up super viruses is not new. Scientists in the U.S. have long known how to mutate ani-mal viruses to infect humans.
For years, Dr. Ralph Baric, a virologist in the U.S., has been col-
laborating with Dr. Shi Zhengli of the Wuhan Virology Institute, sharing his discoveries about how to create super viruses. This gain-of-function research has been funded by the NIH. The collabo-ration between the U.S. and the Wuhan Virology Institute con-tinues. Doctor Baric and Shi worked together to insert bat virus spike protein into the backbone of the deadly SARS virus and then used this manmade super virus to infect human airway cells.
39
Think about that for a moment. The SARS virus had a 15 per-
cent mortality. We are fighting a pandemic that has about a 1 per-
cent mortality. Can you imagine if a SARS virus that has been juiced up and had viral proteins added to it, to the spike protein, if that were released accidentally?
Dr. Fauci, do you still support funding of the—NIH funding of
the lab in Wuhan?
Dr. F
AUCI . Senator Paul, with all due respect, you are entirely
and completely incorrect that the NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virol-ogy.
Senator P
AUL. Do they fund Dr. Baric?
Dr. F AUCI . We do not fund gain——
Senator P AUL. Do you fund Dr. Baric’s gain-of-function research?
Dr. F AUCI . Dr. Baric is not doing gain-of-function research. And,
if it is, it is according to the guidelines, and it is being conducted in North Carolina, not——
Senator P
AUL. You do not think——
Dr. F AUCI [continuing]. In China.
Senator P AUL [continuing]. Inserting a bad virus spike protein
that he got from the Wuhan Institute into the SARS virus is gain- of-function?
Dr. F
AUCI . That is not——
Senator P AUL. You would be in the minority because at least 200
scientists have signed a statement from the Cambridge Working Group——
Dr. F
AUCI . Yes.
Senator P AUL [continuing]. Saying that it is gain-of-function.
Dr. F AUCI . Well, it is not. And, if you look at the grant and you
look at the progress reports, it is not gain-of-function, despite the fact that people Tweet that and——
Senator P
AUL. Do you still——
Dr. F AUCI [continuing]. Write about it.
Senator P AUL [continuing]. Support sending money to the Wuhan
Virology Institute?
Dr. F AUCI . We do not send money now to the Wuhan——
Senator P AUL. Do you support——
Dr. F AUCI [continuing]. Virology Institute.
Senator P AUL [continuing]. Sending money? We did, under your
tutelage. We were sending it through EcoHealth. It was a sub- agency and a sub-grant. Do you support that the money from NIH that was going to the Wuhan Institute?
Dr. F
AUCI . Let me explain to you why that was done. The SARS-
CoV–1 originated in bats in China. It would have been irrespon-sible of us if we did not investigate the bat viruses and the serology to see who might have been——
Senator P
AUL. Or perhaps it——
Dr. F AUCI [continuing]. Infected in China.
Senator P AUL [continuing]. Would be irresponsible to send it to
the Chinese government that we may not be able to trust with this knowledge and with these incredibly dangerous viruses.
Government scientists, like yourself, who favor gain-of-function
research——
Dr. F
AUCI . I do not favor——
40
Senator P AUL [continuing]. Maintain——
Dr. F AUCI [continuing]. Gain-of-function research in China.
Senator P AUL [continuing]. That the disease arose naturally.
Dr. F AUCI . You are saying things that are not correct.
Senator P AUL. Government defenders of gain-of-function, such as
yourself, say that COVID–19 mutations were random and not de-
signed by man. But, interestingly, the technique that Dr. Baric de-veloped forces mutations by serial passage through cell culture that the mutations appear to be natural. In fact, Dr. Baric named the technique the no-see-um technique because the mutations appear naturally.
Nicholas Baker of the New York Magazine said nobody would
know if the virus had been fabricated in a laboratory or grown in nature. Government authorities in the U.S., including yourself, un-equivocally deny that COVID–19 could have escaped a lab. But, even Dr. Shi in Wuhan was not so sure.
According to Nicholas Baker, Dr. Shi wondered, could this new
virus have come from her own laboratory? She checked her records frantically and found no matches.
That really took a load off my mind, she said. I had not slept for
days.
The director of the gain-of-function research in Wuhan could not
sleep because she was terrified that it might be in her lab.
Dr. Baric, an advocate of gain-of-function research, admits the
main problem that the Institute of Virology has is the outbreak oc-curred in close proximity. What are the odds, Baric responded.
Could you rule out a laboratory escape? The answer in this case
is probably not.
Will you, in front of this group, categorically say that the
COVID–19 could not have occurred through serial passage in a lab-oratory?
Dr. F
AUCI . I do not have any accounting of what the Chinese
may have done, and I am fully in favor of any further investigation of what went on in China.
However, I will repeat again, the NIH and NIAID categorically
has not funded gain-of-function research to be conducted in the Wuhan Institute of Virology.
Senator P
AUL. You do support it in the U.S. We have 11 labs
doing it, and you have allowed it here. We have a committee to do it, but the committee is granted every exemption. You are fooling with Mother Nature here. You are allowing super viruses to be cre-ated with a 15 percent mortality. It is very dangerous and it was a huge mistake to share this with China, and it is a huge mistake to allow this to continue in the United States. And, we should be very careful to investigate where this virus came from.
Dr. F
AUCI . I fully agree that you should investigate where the
virus came from. But, again, we have not funded gain-of-function research on this virus in the Wuhan Institute of Virology. No mat-ter——
Senator P
AUL. You are parsing words.
Dr. F AUCI [continuing]. How many times you say it, it did not
happen.
Senator P AUL. There was research done with Dr. Shi and Dr.
Baric. They have collaborated on gain-of-function research where
41
they enhanced the SARS virus to infect human airway cells, and
they did it by merging a new spike protein on it. That is gain-of- function. That was joint research between the Wuhan Institute and Dr. Baric. You cannot deny it.
The C
HAIR . Senator Paul, your time is expired.
Dr. Fauci, I will let you respond to that. We need to move on. Dr. F
AUCI . Excuse me?
The C HAIR . I will allow you to respond to that, and then we will
move on.
Dr. F AUCI . Yes. I mean, I just wanted to say, we—I do not know
how many times I can say it, Madam Chair. We did not fund gain- of-function research to be conducted in the Wuhan Institute of Vi-rology.
The C
HAIR . Thank you.
Senator Smith. Senator S
MITH . Thank you, Chair Murray. And thank you so
much to our panelists for being here today.
I want to just, following up on that exchange, just ask Dr. Fauci
a question.
Dr. Fauci, what is the impact of conspiracy theories pedaled by
Senator Rand Paul and others on Americans’ willingness to take this vaccine? A vaccine that, by all accounts, is remarkable for its safety and efficacy.
Dr. F
AUCI . Well, conspiracy theories certainly are not helpful in
what we are trying to do. I guess I can say that with some degree of confidence.
Senator S
MITH . Well, I would agree. And I think, in this moment
we are at a critical moment for our response to this pandemic. And, in only 14 months since we—this pandemic started, we are here today to acknowledge that we have 261 million doses of vaccine in people’s arms. We have over 58 percent of Americans with at least one dose. I mean, this is an incredible and—an incredible accom-plishment.
We also know that we have more work to do, and it seems to me
that we ought to be focused on that work. We have to make sure that our comprehensive strategy that you have been working on, Dr. Fauci, for a long time, and I am so grateful for the support that you are getting from the Biden-Harris administration. A com-prehensive strategy that is around vaccinations, around surveil-lance testing, around treatment, social distancing and masks, and also centering our work around health equity. I mean, this is what we need to be really focused on, seems to me.
I would like to ask Dr. Walensky a question about how we go
about this question on this issue of getting people—getting vaccines into people’s arms now.
Vaccines—an acceptance of vaccines seem to be really a spec-
trum, from people that are gung-ho and ready to go to people who have a serious resistance to taking vaccines. And, we are seeing some learning, it seems to me, about what works.
I have a great example of that in Duluth, Minnesota where pub-
lic health nurses set up a pop-up vaccine clinic at the Duluth Transportation Center. And, Minnesotans, who were taking their bus home or going to pick up their children at childcare can go to that vaccine pop-up clinic, fill out their paperwork, and get their
42
shot, all in one dose. So, it is breaking down some of the logistical
challenges that a lot of Americans and Minnesotans still have, and they are finding just great success.
There was a story on Minnesota Public Radio just in the last cou-
ple of days about a woman named Karen Moore, who was waiting to get a vaccine and hoping that she would be able to get it at a convenient location, and was able to do it all in one spot. And that made all the difference in the world to her in terms of overcoming her so-called vaccine hesitancy, which was not hesitancy. It was just the logistics challenges.
Dr. Walensky, can you tell us a little bit about what the CDC
is doing, working with states and localities, to deploy methods like we are seeing in Duluth, Minnesota to help people get easy access to vaccines?
Dr. W
ALENSKY . Thank you so much, Senator. We have spent $3
billion getting money to states and localities to advance these ef-forts in trying to get vaccines into people and to enrich vaccine con-fidence.
I would invite all of you to take out your cell phones and to text
GETVAX, 438829. You put in your zip code. You get a list of all the places where vaccines are available to you. You can do that by an 800 number, or you can go to vaccines.gov and type your zip
code and find out which vaccines are available nearby to you.
We are trying to make it—we are working to make it easy. We
do have to do some of the pivoting, as you discussed, and ensure that——
Places now have pop-up sites. They have mobile vaccination
units; that we are reaching out to rural communities; that we are putting vaccines in federally qualified healthcare centers; that we have a We Can Do This campaign now, a campaign with 5,000 community core members from everyone from NASCAR and NFL to Infectious Disease Society of America, to faith-based organiza-tions, sending our messages, being the trusted messengers. And we are starting to see the effects of this work.
Just this morning, CDC released new racial and equity data on
how we are doing in reaching racial and ethnic minorities with vac-cines. The bar graph now shows not just our overall progress, but what we have done in the last 2 weeks. And, in the last 2 weeks, we have been really successful in reaching racial and ethnic mi-norities in ways we had not up until this time.
We have to do more. We recognize we have to do more. We have
vaccine confidence consults that you can—locals and states can call the CDC and say, we are having a hard time reaching people in this community, what are the things that we can do.
This is just a brief list of the many, many activities that we are
engaged with every single day to get vaccines into people for—and to recognize that all hesitancy is not the same flavor. Some people, it is convenience. Some people want to understand the science more. Some people just need the time off.
Senator S
MITH . Thank you so much.
Thank you, Madam Chair. I want to just say I appreciate the
work of the CDC and others to support the innovative and strategic efforts of states like mine to overcome some of those barriers. Thank you.
43
Dr. W ALENSKY . Thank you so much, Senator.
The C HAIR . Senator Collins.
Senator C OLLINS . Thank you.
Dr. Walensky, I used to have the utmost respect for the guidance
from the CDC. I always considered the CDC to be the gold stand-
ard. I do not anymore, and I want to give you three examples where I think the conflicting, confusing guidance from your agency has undermined public confidence and contradicts the scientific guidance of many experts.
The first has to do with school openings, an issue that we have
talked about before. The New York Post reported that a powerful teachers’ union, the AFT, successfully secured changes, verbatim, in draft guidance on school reopenings. This came about because of an outside group that did a FOIA request that revealed extensive interactions between the AFT and the CDC.
This has been described by Dr. Monica Gandhi, a professor who
has written extensively about the coronavirus, as very, very trou-bling. She is referring to the emails back and forth between the CDC and the AFT. And, she says, this is not how science-based guidance should work or be put together.
My second example is from a New York Times story that ap-
peared today. It talks about CDC guidelines on mask wearing, and it—where the CDC announced that less than 10 percent of COVID– 19 transmission was occurring outdoors. The article points out that this is, quote, almost certainly misleading, and goes on to say, there is not a single documented COVID infection anywhere in the world from casual outdoor interactions, such as walking paths, someone on a street, or eating at a nearby table.
The third example has to do with new guidance the CDC has
issued for summer camps, and here are the reactions of two ex-perts. One, a pediatric immunologist at Columbia referred to the recommendations as, quote, senseless. The editor-in-chief of the Journal of the American Medical Association Pediatrics called the guidance, quote, unfairly draconian.
Here we have unnecessary barriers to reopening schools, exag-
gerating the risks of outdoor transmission, and unworkable restric-tions on summer camps. Why does this matter? It matters because it undermines public confidence in your recommendations, in the recommendations that do make sense, in the recommendations that Americans should be following.
I would like you to respond to why the CDC is not following the
standard procedures, why it is having offline, secret negotiations with one stakeholder that was revealed only through reporting in a FOIA request, why it is exaggerating outdoor transmission. We know that masks make a big difference indoors. They do not out-doors.
Dr. W
ALENSKY . Thank you for that question. Maybe if I could
take each of your examples one by one.
First, the school guidance. As a matter of practice, the CDC en-
gages with stakeholders, with consumers who take our guidance, who use our guidance, before it is finalized so we can understand whether it addresses their needs. For our school guidance, we did that with 50 different stakeholders. Over 50, actually. I personally engaged with both parents and teachers and many different stake-
44
holders to address what could be done to improve the draft guid-
ance we had.
One of those stakeholders recognized that in our guidance we
had addressed what you do if you have immunocompromised chil-dren at risk of severe disease, but we had neglected in our draft to address what happens if you have immunocompromised teach-ers—teachers who are getting chemotherapy, who have immunocompromising diseases.
The request was that we add some language for what happens
if you have immunocompromised teachers and how they should be-
have in school. That is what we did. We used CDC-based science to make that addition, but the request was to address what hap-pens if you have immunocompromised teachers. And that was an oversight in our initial draft, and we included a science-based re-sponse—or science-based language in our guidance.
With regard to the New York Times piece this morning, there is
a meta-analysis from Journal of Infectious Diseases that was pub-lished in November, I believe, where the topline result of all stud-ies that were included in the systematic review said less than 10 percent of cases were transmitted outdoors. It is that meta-analysis that combined science from all sorts of—all different science from many different places. I think over 19 studies were included. The topline result was less than 10 percent, published in the Journal of Infectious Diseases, one of our top infectious disease journals. That is where that came from. It was a published study that syn-thesized studies from many places.
With regard to camp, I have a 16-year old. Every day—every
year, he comes home from camp and he writes the number of days until he returns to camp the next year. This year, it got to zero and I told him he was not going. I want our kids back in camp. We now have 38,000 new infections on average per day. Last May 11, it was 24,000, and we sent a lot of kids home and camps were closed. The camp guidance is intended to get our kids to camp and allow them to stay there.
Thank you. Senator C
OLLINS . Madam Chair, I would just ask unanimous
consent that the full New York Times story, dated today, be placed in the record because it answers—I realize I am out of time. It an-swers Dr. Walensky’s response.
The C
HAIR . So ordered.
[The information referred to can be found on page 70]
The C HAIR . Senator Kaine.
Senator K AINE . Thank you, Madam Chair, and thank you to the
witnesses for your important testimony.
Some of you have been before this Committee so often. I can re-
member the first time you were before us on January 24, 2020.
And so much has happened since then and there is so much to talk about, but my colleagues have done a good job already in address-ing many of my interests.
At the last hearing that we had together, which I believe was in
March, Dr. Fauci, I talked to you a little bit about long COVID. When the day comes where the President declares that the na-tional emergency is over, there is still going to be at least two chal-
45
lenges: Long COVID, and then the mental health challenges that
have resulted from a year of such loss.
I want to ask Dr. Fauci and Dr. Walensky to dig into a little bit
how you are using the funds that have been provided to deal with the long COVID issue for folks who are suffering symptoms after they have recovered from COVID.
Dr. F
AUCI . Thank you very much for that question, Senator. This
is really an important problem. The NIH has been given $1.15 bil-lion to study this, and we are doing this in collaboration with CDC and other organizations.
Long COVID is a real issue. Anywhere from 10 to, in one study,
as high as 30 percent of individuals who recover from the acute manifestations of COVID–19, who have virologically no virus in them at all and they should be on the road to an uneventful recov-ery. But, unfortunately, what we have been able to find out now— and we are going to be putting together a number of cohort studies to determine the extent, the duration, any possible underlying pathogenesis, and any intervention.
But, the symptoms are somewhat common. There is a com-
monality among them. It is extreme, sometimes debilitating fa-tigue; muscle aches; temperature dysregulation, you feel hot or cold; dysautonomia, which is related to that; unexplained rapid heartbeat, or tachycardia; neurological symptoms and what people refer to as brain fog, or the inability to focus or concentrate over an extended period of time.
These are real symptoms, and they can last for a long time. We
have people that we have followed now up to 9 months or longer where this occurs. It is a very important problem. We take it very seriously.
We have a task force at the NIH. Multiple NIH institutes—not
only my own—Heart, Lung, and Blood, Neurology, and Mental Health, all of which are going to be looking at this over the next year or so because it is something that we really do feel we need to find out what is the underlying cause and what we can do about it.
Senator K
AINE . Thank you for that, Dr. Fauci. That is going to
provide a lot of comfort to people who are grappling with these symptoms.
Dr. Walensky, I want to shift to the second concern that I have.
Again, we are not at a point yet where the emergency is over. And, yet, even when we are at that point, the mental health impact of this very, very challenging time on the American public and people all around the world is very significant.
I have worked closely with colleagues, including Senator Cassidy,
really to pinpoint mental health impact on frontline healthcare workers, whose experience of dealing with death and illness at such a massive scale, having to manage end-of-life conversations with people who would normally be having those conversations with their own family members. This is a real significant concern.
My colleagues supported inclusion of provisions of the Dr. Lorna
Breen Act in the recent work that we have done, and I understand that CDC and NIOSH are starting to focus on a public information campaign to frontline healthcare providers to reduce stigma to seeking mental health assistance should they need it.
46
Could you talk a little bit about those efforts, and more broadly,
the question of keeping our healers healthy?
Dr. W ALENSKY . Thank you very much for that question, Senator,
and for the resources. I think it would be hard to overestimate the
trauma that our healthcare providers, our frontline workers, have seen over this last year. Having been there before I was here, I can tell you, pulling up to driveways in your hospital that have morgues in the parking lot is really a striking thing to find.
I am grateful for the resources. We are collaborating—NIOSH is
collaborating with our Injury Prevention Center within the CDC to create mechanisms and support tools to do outreach for our healthcare workers.
I would also mention that we saw mental health challenges
ahead of COVID–19, so these are not just mental health challenges because of COVID–19. Even among our youth, between 2009 and 2019, before COVID ever started, we saw 40 percent increase in mental health challenges. So, we need this not just for our healthcare workers, but through—for the society at large.
Senator K
AINE . Thank you very much.
Thanks, Chair Murray. The C
HAIR . Thank you.
Senator Cassidy. Senator C
ASSIDY . Doctors, thank you all for being here. I ap-
proach you now kind of as a physician who has done research in vaccines as much as a—more so than I am approaching you as a Senator.
I was struck—and, by the way, I am incredibly frustrated, and
the American people are frustrated because they hear you are fol-lowing science, but then they just have a sense that the lag time between the implementation of that and recommendations is far too long. It is not just the American people. I will put it this way. Not just the people in my state.
Here is a Stat Article, CDC’s Slow Cautious Messaging Seems
Out of Step with the Moment.
Want to Go Back to the Office? Don’t Wait on the CDC. That is
from the Wall Street Journal.
The Liberals Who Can’t Quit Lockdown from The Atlantic. First, I was struck when Senator Burr suggested that previous
immunization actually confers immunity. Do any of you agree with that? Dr. Fauci?
Dr. F
AUCI . Does previous immunization confer——
Senator C ASSIDY . Does previous infection confer immunity?
Dr. F AUCI . It does. We do not know what the durability of it is,
but——
Senator C ASSIDY . Okay.
Dr. F AUCI [continuing]. It certainly does confer immunity.
Senator C ASSIDY . Now, so, but we still recommend that they be
vaccinated?
Dr. F AUCI . Yes, we do.
Senator C ASSIDY . That seems out of step.
Dr. F AUCI . No, actually—actually, Senator, a study has shown
very clearly that if you vaccinate someone who has previously got-ten infected and recovered, the level of neutralizing antibodies and T cells are extraordinarily high not only against the wild type——
47
Senator C ASSIDY . Let me——
Dr. F AUCI [continuing]. Virus, but also against——
Senator C ASSIDY . Let me interrupt.
Dr. F AUCI [continuing]. The variants.
Senator C ASSIDY . I am aware of that research. I pulled some of
the research that refers to that.
Dr. F AUCI . Right.
Senator C ASSIDY . My concern is that would happen if you had
another infection. All the immunization does is mimic a pre-exist-
ing infection. That is very well established with other viruses. No one has not established it for this virus. And, indeed, some of this research shows that within 4 days, which is the window period, if you will, for an infection to become an illness, those antibodies rise quite precipitously.
But, we still recommend that they get two doses, even though
the same literature shows that there is an increase in side effects when someone gets a second dose and they have been previous im-munized. So—now, not life threatening, but, nonetheless, an in-crease in side effects. But, nowhere do I see a recommendation that, well, do not get the second dose because the literature shows that after one dose, you have topped out your immunologic re-sponse and you are at an increased risk with the second dose.
Would anybody like to speak to that? Dr. M
ARKS . There are studies ongoing to look at the first versus
second dose. I agree with you, it is a very reasonable proposition for study. But, the purpose of immunizing somebody who has been infected previously is to develop higher antibody titers. Those high antibody titers are what is so critical in preventing a——
Senator C
ASSIDY . If I may, again, the studies of other viruses
show—hopefully we have research showing here, but it appears to that a second—that a re-immunization merely mimics what would happen if somebody were exposed to the virus. All it does is kind of mimic that which would occur.
Dr. M
ARKS . Senator, this is a different virus. Each virus——
Senator C ASSIDY . It is a different virus.
Dr. M ARKS [continuing]. Has its unique——
Senator C ASSIDY . Dr. Marks, is there research going to explore
that which I am referring to? Because the research so far shows that within 4 days, you get a significant increase in antibody titer.
Dr. M
ARKS . There is research that has been done to show that
after the vaccination, the nature of the immune response gives a sufficiently high titer antibodies that the post-——
Senator C
ASSIDY . That is with every virus.
Dr. M ARKS [continuing]. Vaccination immune response——
Senator C ASSIDY . That is with every virus. That is not unique to
this.
Dr. M ARKS . It is likely superior to natural infection in this case
in preventing against some of these variants, and I think that is
what Dr. Fauci was getting to.
Senator C ASSIDY . I also point out that the vaccines themselves,
and presumably the previous infection, is also effective against the variants.
48
By the way, can people go back to work if they have been vac-
cinated and not wear a mask, assuming they are not
immunocompromised?
Dr. W ALENSKY . We have about a third of people in this Country
who are vaccinated. We have about a third of counties in this Country that still have over 100 cases per 100,000. We are working to review our guidance and to update our guidance. We have put out three different guidances.
Senator C
ASSIDY . I am sorry. Let me just ask again. If I am vac-
cinated and I have antibody and I am exposed to somebody else, what is my risk of coming down with symptomatic infection?
Dr. W
ALENSKY . Five percent.
Senator C ASSIDY . Five percent if I am—no, that is overall. Not
if I have been vaccinated and if I have antibody. That is if I am vaccinated overall, correct. If I have antibody——
Dr. W
ALENSKY . We do not have—I do not think we have data on
what you are looking at. We did not check antibodies on everybody who was vaccinated.
Senator C
ASSIDY . But, we could.
Dr. W ALENSKY . We absolutely could, but——
Senator C ASSIDY . Absolutely could.
Dr. W ALENSKY [continuing]. To date, we only have information
about——
Senator C ASSIDY . We do know that if we are in a—if we know
that critical mass or if we know that herd immunity is somewhere north of 60 or 70 percent, if we go into a workplace where, within that workplace, there is 100 percent immunization, such as here, we have achieved herd immunity. Yes, there is somebody in here that may not be responding to the vaccine, but because everybody else has, they are protected. That is nowhere reflected. And right now, we have Federal agencies, which we have had employees not working for a year, because the union says that they have to have special workplace precautions for them to return to work. There is consequence to this kind of delay, as the Stat article shows, of the kind of updating of these recommendations.
The American people are incredibly frustrated. And, as Senator
Collins said, they are beginning to disregard what you say that is true

Summary:
Official printed transcript of a Senate HELP Committee COVID-19 response hearing featuring Anthony Fauci's testimony.

Excerpt: U.S. GOVERNMENT PUBLISHING OFFICE WASHINGTON : 46–765 PDF 2022 S. H RG. 117–185  AN UPDATE FROM FEDERAL OFFICIALS  ON EFFORTS TO COMBAT COVID–19  HEARING  OF THE   COMMITTEE ON HEALTH, EDUCATION,  LABOR, AND PENSIONS  UNITED STATES SENATE  ONE HUNDRED SEVENTEENTH CONGRESS  FIRST SESSION  ON  EXAMINING AN UPDATE FROM FEDERAL OFFICIALS ON EFFORTS TO  COMBAT COVID-19  MAY 11, 2021  Printed for the use of the Committee on Health, Education, Labor, and Pensions  (  Available via the World Wide Web: http://www.govinfo.gov  (II) COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS  PATTY MURRAY, Washington, Chair  BERNIE SANDERS (I), Vermont  ROBERT P. CASEY, JR., Pennsylvania TAMMY BALDWIN, Wisconsin CHRISTOPHER S. MURPHY, Connecticut TIM KAINE, Virginia MAGGIE HASSAN, New Hampshire TINA SMITH,…