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U.S. GOVERNMENT PUBLISHING OFFICE
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THE PATH FORWARD:
A FEDERAL PERSPECTIVE
ON THE COVID–19 RESPONSE
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
ON
EXAMINING A FEDERAL PERSPECTIVE ON THE COVID-19 RESPONSE,
FOCUSING ON THE PATH FORWARD, AFTER RECEIVING TESTIMONY FROM ROCHELLE P. WALENSKY, DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION, ANTHONY S. FAUCI, DIRECTOR, NA-TIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NA-TIONAL INSTITUTES OF HEALTH, JANET WOODCOCK, ACTING COM-MISSIONER OF FOOD AND DRUGS, FOOD AND DRUG ADMINISTRA-TION, AND DAWN O’CONNELL, ASSISTANT SECRETARY FOR PRE-PAREDNESS AND RESPONSE, ALL OF THE DEPARTMENT OF HEALTH AND HUMAN SERVICES.
JULY 20, 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, JULY 20, 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 ................................... 14
Prepared statement .......................................................................................... 15
Woodcock, Janet, M.D., Acting Commissioner, United States Food and Drug
Administration, Silver Spring, MD ..................................................................... 23
Prepared statement .......................................................................................... 24
O’Connell, Dawn, Assistant Secretary for Preparedness and Response, United
States Department of Health and Human Services, Washington, DC ............ 34
Prepared statement .......................................................................................... 36
QUESTIONS AND ANSWERS
Response by Rochelle Walensky, to questions of:
Senator Casey ................................................................................................... 70 Senator Baldwin ............................................................................................... 72 Senator Hassan ................................................................................................. 72 Senator Burr ..................................................................................................... 73 Senator Braun .................................................................................................. 75 Senator Tuberville ............................................................................................ 76
Response by Anthony Fauci, to questions of:
Senator Burr ..................................................................................................... 78 Senator Braun .................................................................................................. 81 Senator Tuberville ............................................................................................ 82
Response by Janet Woodcock, to questions of:
Senator Burr ..................................................................................................... 84 Senator Braun .................................................................................................. 86 Senator Scott ..................................................................................................... 87 Senator Tuberville ............................................................................................ 91
Response by Dawn O’Connell, to questions of:
Senator Baldwin ............................................................................................... 92 Senator Burr ..................................................................................................... 93 Senator Braun .................................................................................................. 96 Senator Tuberville ............................................................................................ 96
(1) THE PATH FORWARD:
A FEDERAL PERSPECTIVE
ON THE COVID–19 RESPONSE
Tuesday, July 20, 2021
U.S. S ENATE ,
COMMITTEE ON HEALTH , EDUCATION , LABOR , AND PENSIONS ,
Washington, DC.
The Committee met, pursuant to notice, at 10 a.m., in room 430,
Dirksen Senate Office Building, Hon. Patty Murray, Chair of the Committee, presiding.
Present: Senators Murray [presiding], Casey, Baldwin, Kaine,
Hassan, Smith, Rosen, Lujan, Hickenlooper, Burr, Paul, Cassidy, Braun, Marshall, Romney, Tuberville, and Moran.
OPENING STATEMENT OF SENATOR MURRAY
The C
HAIR . Good morning. Senate Health, Education, Labor, and
Pensions Committee will please come to order. Today we are hold-ing a hearing on our Federal response to the COVID–19 pandemic. Ranking Member Burr and I will each have an opening statement and I will introduce our witnesses. After they give their testimony, Senators will each have 5 minutes for a round of questions.
While we are yet unable to have the 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 anyone is in need
of accommodations, including closed captioning, please reach out to the Committee or the Office of Congressional Accessibility Services.
We are at a point of great promise and peril in the fight against
COVID–19. While I am encouraged by the fact that two-thirds of adults in our Country have received their first dose of vaccine, I am alarmed by how the rate of vaccination has been slowing, and how driven by the delta variant, rates of COVID–19 cases and deaths are once again on the rise. Five counties in my state cur-rently have high levels of transmission according to the Centers for Disease Control and Prevention. For example, in Walla Walla County, cases are up in July from June, and they were up in June from April and May.
Even though 99 percent of the COVID deaths nationwide last
month were among people who had not gotten vaccinated, we are still seeing fear and misinformation hold people back, huge dispari-ties in vaccination rates among communities of color and rural communities, skepticism about vaccines among some religious and conservative communities, and slow uptake among youth—young adults. Vaccines are safe, effective and free and easy to get. We
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need to make sure people know that. And we also need to make
sure they understand. Choosing not to get vaccinated doesn’t just put themselves at risk, it puts the people around them at risk and including people who are immunocompromised like those fighting cancer and kids who are not yet eligible for vaccines.
We also have to remember vaccinations are just one front of this
fight. Local health departments need the capacity to track emerg-ing outbreaks quickly through contract tracing sequence, virus samples to identify variants, help isolate ill people, and track vac-cination progress. And more experts need to evaluate the longevity of immunity, especially in the face of new variants and the poten-tial value of booster shots.
Researchers need to study the long term impacts of this disease
and how to treat long haul COVID–19 or PASC. And perhaps most importantly, we as a Nation need to fully learn the lessons of this pandemic and take action so we are never in this situation again. That is why Senator Burr and I have been working on bipartisan legislation and oversight to build the world class public health and preparedness infrastructure our people deserve. It is my hope that through this work, we will not only address challenges we faced during this pandemic but build on progress we saw in some states across the country.
In my home State of Washington, they worked to overcome chal-
lenges with sharing critical COVID data among health depart-ments, labs, and hospitals to improve how data was used to allo-cate critical medical supplies like respirators and develop a more complete dashboard for demographic data that broke out numbers, for example, for the Pacific Islander community. Michigan created a task force on racial disparities early on in the pandemic to ensure they were reaching communities of color for testing and contact tracing.
Alaska literally employed every mode of transportation to deliver
vaccines to hard-to-reach communities. One of the clearest lessons from this crisis is that you should have the same protection from a pandemic, chronic disease, or public health threat, regardless of where you live, who you are, or what your income is. And one of the best ways of providing that level of protection is through strong public health infrastructure.
The stronger our health departments are at every level, the more
effectively they can work to use sequencing technology and modern data systems to track the spread of diseases and monitor the suc-cess of vaccination efforts, stand up testing and contact tracing to stop disease outbreaks, develop science based guidelines to address local needs, build partnerships in hard to reach communities, and build trust as communicators and fight misinformation. There is a saying in health care, an ounce of prevention is worth a pound of cure. We need to have that same mindset when it comes to public health. That is why I have pushed for more funding for public health departments throughout our COVID response packages.
It is why earlier this year I reintroduced legislation to end the
cycle of crisis and complacency in public health funding by pro-viding $4.5 billion in dedicated annual funding and is why I am going to continue pushing for us to make these critical investments. We all want this pandemic to end. And it is clear, despite the in-
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credible progress we have made in the last few months, we still
have a lot more work to do. But even after we are through this cri-sis, our work won’t be done. We have to make sure we learn from this history and take action, so we never repeat it.
This crisis has cost too much, has taken too many lives for us
to do anything less. I look forward to hearing from all of our wit-nesses today. Thank you for being here. We want to hear about our response to this pandemic so far, the path forward, and how we better prepare for threats like this in the future. With that, I will turn it over to Ranking Member Burr for his opening remarks.
OPENING STATEMENT OF SENATOR BURR
Senator B
URR. Well, thank you, Madam Chair. I am pleased that
we are holding this hearing today. Our third panel with members of the Administration, this Congress on COVID–19. To our wit-nesses, welcome. Welcome back. Some of you are old hands at this now and others are relatively new. Dr. Fauci, Dr. Walensky, thank you for returning to the Committee for the third time this year to discuss this pressing matter. Ms., O’Connell, welcome. This is your first hearing before the Committee in your newly confirmed role as the ASPER.
I am glad that we are able to get you confirmed so quickly. You
have a lot of work in front of you and all of us, Republicans and Democrats, are ready to help you and the fine folks at ASPER get the job done. Dr. Woodcock, welcome back to the HELP Committee. The FDA has benefited from your leadership, and you are the right person at the helm as we continue to grapple with the pandemic.
I hope that we will see you again at another hearing to talk
about the great things that you are doing at the FDA, preferably a confirmation hearing. I look forward to hearing from each of you on your perspectives of the current response to COVID–19 and what we—where we should go from here. I have spent the better part of my career in Congress working to prepare our Country for the unthinkable and anticipating what we may need to respond to it. These early efforts had the support and leadership of many of my colleagues here now, including Senator Collins, our Chair, Sen-ator Murray, Senator Casey have all been important partners on preparedness with me, working to reauthorize PAHPRA and con-tinue to keep a focus on these items during peacetime. All of this effort was with the hope that we would never have to act on the authorities we provided. But it was also with an eye to what may be around the corner. Each law we wrote was designed to build on
the lessons that we learned from each event, Zika, West Nile, SARS and the anthrax attacks.
We tried to anticipate what we didn’t think of last time around
so that we could be better prepared for when the big one came. This Committee has been holding hearings on COVID–19 response since March 2020, at the very first hearing that raised concerns with our ability to keep pace with the virus, to track its where-abouts, and understand the impact it would have on the lives of the American people. We have the authorities needed, but we were and still are faced with many unknowns.
Each step of the way, we need to look around the corner and ask
ourselves, what do we need to do today to keep us up with the
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virus 30, 60, and 90 days from now? CDC estimated in mid-June
the delta virus, the variant accounted for more than 30 percent of all covered infections. As of mid-July, the cases caused by delta variant may be approaching 60 percent of all cases. The good news is the cases are down significantly since the peak. The bad news is the delta virus—variant is surging and vaccines have slowed be-cause of hesitancy of resistance. I can tell you that the next few weeks and months will require us to answer some very difficult questions, especially as we work toward the last few miles of ad-ministering the vaccine in this country. COVID won’t just go away.
We need all Americans who can get the vaccine to get the vac-
cine. If you won’t do it for yourself, do it for your friends, your fam-ilies, for your neighbors, and your local community. Do it for your grandchildren so they can go back to school. Do it for your grand-parents so they can finally go out and eat. Not only is a delta vari-ant a concern, but we need to look around the corner to the next mutation of the disease.
I would like to know if we are performing enough sequencing to
be able to quickly detect the presence of variants. And are we tracking the right metrics to understand the shift and drift of the virus so that we can see in real time what new variants may mean for our response? Last week, one vaccine company announced it was ready to file for FDA emergency use for booster shot. Do we need booster shots, when do we need them? What does this mean for a widely available vaccine? Israel started offering booster shots last week.
I am worried that American leadership is no longer what it once
was when it comes to public health and other countries are out-pacing us. We have the same data as Israel. Why aren’t we making the same decisions? Messages from public health experts won’t be followed if Americans don’t believe in the experts. The White House has the power to shape messaging, but it doesn’t and shouldn’t shape science in any administration. The last Administration lost the attention and trust of the American people with 2 hour press briefings. This Administration shouldn’t lose theirs for the sake of the teachers’ union. We need to know what we are being told by experts is the unvarnished truth. Don’t tell us what you don’t think we can handle. Don’t tell us what the Administration thinks we should hear. Level with us.
As we sit here today, we are just months away from flu season.
How do we get ready for the colder months ahead of us and the flu and cold season that it will bring along with it? Are the flu shots ready? Will we have enough? These questions should have been thought about weeks ago as they are already on our doorstep. The same is true for our legislative efforts and the long term changes we need to make now. While lessons learned from COVID response are top of our mind, the ASPER must play a more promi-nent role managing the threat landscape in peacetime and com-manding the public health and medical response during the emer-
gencies with better coordination among Federal agencies, better availability of data and public health surveillance, stronger part-nerships with innovators in the private sector, building on the good work of BARDA, and visibility into our supply chain for critical
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drug supplies, which are also—which also need to be more sustain-
able.
The CDC must be reformed to become a more focused, account-
able, and transparent partner in public health and public health preparedness and learn to adopt and leverage 21st century tech-nologies. The NIH should build on its ability to accelerate basic re-search, leaning on its long expertise in partnering with academia to better understand the pathogens that pose the greatest risk and what tools we may have in the research bench to combat them. And the FDA should build on the great success that we have had, staying the more nimble and creative agency it has become during the COVID–19 response.
This is especially important as the agency works to make final
its user fee agreements and transmit them to Congress for our ap-proval next year. Now is the time to anticipate what is next. I en-courage each of you, in this critical role that you play to engage with this Committee to provide the insight into the COVID re-sponse as you have over the last 18 months, but more importantly, to look ahead. We have a window to update our public health and medical preparedness policies, taking into account the lessons learned from COVID–19 and this Committee intends to act before the attention of Congress turns to other matters.
It is hard to believe, but memories will fade. I have had to fight
to keep funding for pandemic and threat awareness too many times to count. I hope to pass that baton onto one of my colleagues to pro-tect these important programs. But before I leave, I feel a great re-sponsibility to make things better in one final bill.
I am glad that the Chair is an active and able partner in that
effort. I appreciate her commitment to this bipartisan concern. And I think we have a real opportunity to make improvements. This ef-fort will be our focus going into the fall.
We welcome your feedback, your insight, and most importantly,
your expertise. There is nothing more important than the health and security of our Nation. With that, I thank the Chair and I yield.
The C
HAIR . Thank you, Senator. With that, I will introduce to-
day’s witnesses. We will begin with Dr. Rochelle Walensky. She 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.
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 in President Biden’s COVID–19 re-sponse team. Dr. Fauci, it is good to have you back before the Com-mittee. Thank you for joining us.
Our next witness is Dr. Janet Woodcock, the Acting Commis-
sioner of the Food and Drug Administration. Dr. Woodcock, thank you for being here. I look forward to your testimony. Finally, we have the Assistant Secretary for Preparedness and Response, John
O’Connell. It is good to see you, Assistant Secretary O’Connell.
Thank you for joining us. I am pleased to welcome you back to
the Committee following your confirmation to this new role. With that. Dr. Walensky, you may begin 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 . Good morning. Chair Murray, Ranking Member
Burr, Members of the Senate Health Committee. I am honored to join you today to provide an update on the COVID–19 pandemic and our four priorities of CDC’s ongoing response, tracking and preventing further spread of COVID, creating access to and con-fidence in vaccines, advancing health equity, and getting our chil-dren back to school. The current data reveal two divergent truths.
Since the epidemic peaked in January 2021, we have seen large
reductions in COVID–19 cases, hospitalizations, and deaths. And these trends are a testament to the success of our vaccination pro-gram and the tireless effort of professionals from across health, business, and Government sectors who have come together to re-spond.
On the other hand, our progress across the country is not uni-
form. Vaccine coverage varies by state and by county. Communities where people remain unvaccinated, are most vulnerable and most likely to experience increase in case counts. As of last week, nearly 50 percent of vaccine eligible population in this country is now fully vaccinated. 160 million people and still nearly two-thirds of coun-ties in the United States have vaccine coverage less than 40 per-cent.
In areas where vaccine coverage is low, cases and hospitaliza-
tions are starting to climb again. Over the last week, we have aver-aged 239 deaths per day, an increase of nearly 48 percent over the prior week. Each death is tragic and even more heartbreaking when we know that the majority of these deaths could be prevented
with a simple, safe, available vaccine. Areas with limited vaccine coverage are allowing for the emergence and rapid spread of the highly transmissible delta variant. CDC has released estimates of variance across the country and predicted the delta variant now represents 83 percent of sequenced cases.
This is a dramatic increase, up from 50 percent for the week of
July 3rd. In some parts of the country, the percentage is even high-er, particularly in areas of low vaccination rates. To date, our data indicates that vaccines are available to neutralize but circulating variants in the United States and provide protection against severe disease, hospitalization, and death. The message from CDC re-mains clear, the best way to prevent the spread of COVID–19 variants is to prevent the spread of disease. And vaccination is the most powerful tool we have.
We must continue to expand vaccine coverage by building trust
and confidence in COVID–19 vaccines. And this is particularly im-portant in communities of color, rural communities, and other pop-ulation groups at risk. CDC is engaging trusted community leaders to reinforce messages about the safety, efficacy, and importance of vaccination. CDC remains committed to ensuring all of our work advances health equity. Thanks to supplemental resources, CDC has provided additional support to health departments to address health disparities and improve health equity among historically un-derserved populations at elevated risk. That includes racial and ethnic minority groups and people living in rural areas.
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We are training and integrating community health workers into
care teams, collaborating with partner organizations to improve vaccine access, and building vaccine confidence among medically underserved communities and disproportionately affected popu-lations. As the Director of the CDC, it is my priority to get our chil-dren back to school for safe in-person learning. Earlier this month, the CDC released updated guidance to reflect the latest science on COVID–19 and the widespread availability of safe and effective vaccines for those ages 12 and over.
We continue to recommend that schools implement layered pre-
vention strategies to protect those who are not fully vaccinated and encourage vaccination for those who are eligible. Masks continue to be a critical part of these layered prevention strategies. Working together, school administrators and public health workers can care-fully consider community transmission rates, local vaccine cov-erage, and occurrence of outbreaks when deciding what strategies are needed to help prevent the spread of COVID–19 and safeguard in-person education.
In summary, the overwhelming majority of deaths from COVID–
19 are now occurring in unvaccinated people. Vaccines are widely available across the country, and the suffering and loss is simply
entirely preventable, nearly.
For our entire Nation to heal and move forward, we must do all
our part to get our Country vaccinated. Thank you and I look for-ward to your questions.
[The prepared statement of Dr. Walensky follows:]
PREPARED STATEMENT OF ROCHELLE WALENSKY
Chair Murray, Ranking Member Burr, and distinguished Members of the Com-
mittee. 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. It is my privilege to represent CDC, 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 response to public health concerns here in the United States and abroad.
CDC Efforts to Date
Since we last met, COVID–19 cases have decreased from the spring to summer,
and we have made tremendous strides in getting people vaccinated, which has al-lowed many people to resume their daily activities safely. We are hopeful and have made incredible progress toward controlling this pandemic. However, many states and communities continue to have low vaccination rates, and the threat of variants is growing. We are now witnessing concerning increases in a number of jurisdictions and given the threat of variants, including the increased prevalence of the hyper- transmissible Delta variant, we must remain diligent as we continue to fight this virus.
On June 23rd we officially passed the heart wrenching milestone of over 600,000
deaths from COVID–19 in the United States. This tragic reminder is a powerful motivator for us all to continue to push to achieve higher vaccination rates and pre-vent the loss of as many more of our loved ones as possible.
As of July 15, about 89 percent of the U.S. population 65 years and older, 68 per-
cent of those 18 years and older, 65 percent of those 12 years and older, and nearly 56 percent of the total U.S. population received at least one dose of a COVID–19 vaccine. This is good news and demonstrative of continued progress. These gains are thanks to the tireless efforts of professionals from across the public health, medical, business, and multisectoral levels of government who have come together across the country to respond to this pandemic. However, looking state-by-state and county-by- county, it is clear that communities where people remain unvaccinated are commu-nities that remain vulnerable and, in many cases, are experiencing increased num-
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bers of cases. Preliminary data from a collection of states over the last several
months suggest the overwhelming majority of deaths from COVID–19 in the United States have occurred in unvaccinated people. Any suffering or death from COVID– 19 is tragic. With vaccines available across the country, the suffering and loss are nearly entirely avoidable.
Currently, nearly two-thirds of counties in the United States have vaccination cov-
erage less than 40 percent. We are seeing increasing rates of disease in different areas across the country, primarily in counties with low vaccination coverage. As the Delta variant continues to spread across the country, we expect to see increased transmission in these communities unless we can vaccinate more people. Our au-thorized vaccines provide protection against the variants circulating in this coun-try—including Delta. Vaccination is the key to protecting these vulnerable individ-uals, families, and communities and preventing severe disease, hospitalizations, and death from COVID–19. The scale of this unprecedented public health emergency re-quires unprecedented action—at CDC, 9,300 CDC personnel have been part of our COVID–19 response, both at CDC headquarters and in the field. About 1,700 staff have taken part in over 3,600 deployments to more than 300 locations across the United States and around the world.
As we well know and the world has learned from this pandemic, a public health
threat anywhere is a threat everywhere. To support the prevention of international spread, CDC is working around the world with global partners and many low-and middle-income countries to support the planning, implementation, and evaluation of COVID–19 vaccine programs. We will continue working to facilitate lesson sharing across countries to increase vaccine access to all, both here and abroad. CDC is working to ensure that public health decisions are based on the highest-quality sci-entific information. Since the start of the pandemic, over 300 COVID–19 studies have been published in the Morbidity and Mortality Weekly Report (MMWR) on top-
ics ranging from health disparities exacerbated during the pandemic, to prevention strategies, including the safety and effectiveness of COVID–19 vaccines, to emer-gence of new variants. CDC has also produced more than 6,000 documents to pro-vide information and guidance for government agencies, businesses, and the public. CDC is actively studying the epidemiology of post-COVID conditions (often referred to as long COVID), including the prevalence, duration, and severity of symptoms fol-lowing acute SARS-CoV–2 infection, as well as risk factors for developing post- COVID conditions. This work will help to establish a more complete understanding of the natural history of SARS-CoV–2 infection and post-COVID conditions, which can inform healthcare strategies, clinical decision-making, and the public health re-sponse to this virus that will be required over the long term. A recent MMWR arti-cle comparing patients who have had COVID–19 with cancer rehabilitation patients and the general adult population found that post-COVID patients had poorer phys-ical health, more pain, and greater difficulty with physical activities.
CDC has provided new guidance to assist healthcare professionals in evaluating
and caring for patients with post-COVID conditions. Recognizing and confirming the impact that post-COVID conditions can have on quality of life is important. The goal of managing post-COVID conditions is to help patients function in the best way pos-sible and improve quality of life.
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. The emergence of variants is, of course, con-cerning, and it underscores the critical need for genomic surveillance and increased vigilance in the implementation of public health prevention measures.
We are monitoring dozens of variants and conducting ongoing and comprehensive
risk assessments through the SARS-CoV–2 Interagency Group comprised of CDC, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Biomedical Advanced Research and Development Authority (BARDA), the United States Department of Agriculture, and the Department of Defense. We are also in consultation with many of our international colleagues. Of the emerging variants, four have captured our attention and have the highest risk to public health: B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), and B.1.617.2 (Delta).
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The Alpha variant, originally identified in the United Kingdom, was first identi-
fied in the United States in December 2020, and quickly became the predominant variant. However, based on CDC’s most recent data, the Delta variant is now pre-dicted to be the predominant lineage circulating in the United States. The Delta variant was originally detected in India and the earliest known case in the United States was in February 2021. According to CDC’s Nowcast model for the two-week period ending July 3, the national proportion of the Delta variant is projected to be 51.7 percent of cases, with the Alpha variant being the second-most predominant variant at 28.7 percent. The third most prevalent variant in the United States is the Gamma variant, with a projected national proportion of 8.9 percent for the two- week period ending July 3. The fourth variant of concern, Beta, is projected to be well below 1 percent.
Available data indicate that antibodies elicited shortly after vaccination with the
currently authorized vaccines are able to neutralize the circulating variants, al-though some have a reduced neutralization against the Beta and Gamma variants in laboratory studies. A recent study from the United Kingdom indicated that the Pfizer vaccine was 93 percent effective at preventing symptomatic infection with the Alpha variant and 88 percent effective at preventing symptomatic infection with the Delta variant, and a related study indicated that the Pfizer vaccine was greater than 95 percent effective at preventing hospitalization when infected with either the Alpha or Delta variants. Based on preliminary data from a Johnson & Johnson vac-cine clinical trial in South Africa where the prevalence of the Beta variant was esti-mated to be 95 percent, the vaccine was 64 percent effective in preventing infection and 81.7 percent effective in preventing severe disease. Additional data from among healthcare workers in South Africa vaccinated with the Johnson & Johnson vaccine demonstrate that 94 percent of breakthrough infections are mild, in a setting with a high prevalence of the Delta variant. Studies are currently underway to under-stand the impact on the real-world effectiveness of current vaccines against variants and to better understand the impact of the variants on medical countermeasures.
Since January 2021, CDC has dramatically built up our domestic genomic surveil-
lance platforms to monitor circulating variants. While the decline in SARS-CoV–2
cases compared to the high peak this past winter means that the number of speci-mens available for sequencing has declined, CDC continues to generate enough se-quences to detect emerging variants through the National SARS-CoV–2 Strain Sur-veillance (NS3) program and contracts with commercial diagnostic laboratories.
With the funding provided by the American Rescue Plan Act, we are further in-
vesting in public health infrastructure to strengthen genomic sequencing and bioinformatics capacity. We have issued 29 awards, totaling approximately $37 mil-lion, as part of the SARS-CoV–2 Sequencing for Public Health Emergency Response, Epidemiology, and Surveillance (SPHERES) Initiative. These awards are intended to fill knowledge gaps and promote innovation in the U.S. response to the COVID– 19 pandemic, and will help integrate next-generation genomic sequencing tech-nologies with bioinformatics and epidemiology expertise across the US public health system.
On July 1, to address low vaccination coverage and increasing cases due to spread
of the Delta variant in some communities, CDC, along with other Federal partners, intensified our efforts to help states prevent, detect, and respond to hotspots among the unvaccinated by launching COVID–19 Surge Response Teams. With this inter-agency initiative, CDC will participate in teams at-the-ready to deploy resources and personnel to communities at higher risk for—or already experiencing—out-breaks due to the spread of the Delta variant and under-vaccination. In collabora-tion with state, tribal, local, and territorial health department partners, interagency teams will define the needs on the ground and work to address these gaps. The most important step we can take to prevent these outbreaks is for everyone eligible to get vaccinated, and we continue to work with communities across the country on that goal.
Health Equity
Data continue to 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.
In June 2021, CDC began providing additional resources to health departments
to address COVID–19-related health disparities and advance health equity among populations that are underserved and facing conditions that place them at elevated
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risk, including racial and ethnic minority groups and people living in rural areas.
This funding represents an investment by CDC—$2.25 billion over 2 years—to sup-port communities affected by COVID–19-related health disparities. CDC’s new Na-tional Initiative to Address COVID–19 Health Disparities Among Populations at High-Risk and Underserved Communities, Including Racial and Ethnic Minority Populations and Rural Communities, is providing grants to local and state public health departments to work in partnerships with members of the affected commu-nities to improve testing and contact tracing capabilities; develop innovative mitiga-tion and prevention resources and services; improve data collection and reporting; build, leverage, and expand infrastructure support; and collaborate with partners to advance health equity and address social determinants of health as they relate to COVID–19.
Community Health Workers (CHW) have a demonstrated impact in the commu-
nities they serve yet persistent barriers have left them underutilized in addressing health disparities. In May 2020, CDC announced $332 million dollars in CARES Act funding for a grant program and evaluation to support Community Health Workers for COVID Response and Resilient Communities. The program will support the training and deployment of CHWs to bolster response efforts and strengthen com-munity resilience to fight COVID–19 by addressing existing health disparities. CHWs are well-positioned to reach communities, especially those disproportionately impacted by COVID–19. CHW interventions can improve uptake and access to health care services, improve communication between community members and health providers, reduce the need for emergency and specialty services, and improve adherence to health recommendations.
As of May 2021, CDC has released several publications examining vaccination
rates in certain population groups to monitor disparities and track progress toward health equity. The first study, Demographic and Social Factors Associated with
COVID–19 Vaccination Initiation Among Adults Aged ≤65 Years—United States,
December 14, 2020–April 10, 2021, found that after the first 3.5 months of the U.S. COVID–19 vaccination program, 79.1 percent of adults aged ≤65 years had received
≤1 dose, with higher vaccination initiation among men. Counties with lower vaccina-
tion initiation rates had higher percentages of older adults with social vulnerabilities. The second study, Disparities in COVID–19 Vaccination Coverage
Between Urban and Rural Counties—United States, December 14, 2020–April 10, 2021 , found that COVID–19 vaccination coverage was lower in rural counties (38.9
percent) than in urban counties (45.7 percent) and that disparities persisted among age groups and by sex. A third study, Patterns in COVID–19 Vaccination Coverage,
by Social Vulnerability and Urbanicity—United States, December 14, 2020–May 1, 2021 , found disparities in county-level vaccination coverage by social vulnerability
have increased as vaccine eligibility has expanded, especially in large fringe metro-politan (areas surrounding large cities, e.g., suburban) and nonmetropolitan coun-ties. By May 1, 2021, vaccination coverage among adults was lower among those liv-ing in counties with lower socioeconomic status and with higher percentages of households with children, single parents, and persons with disabilities.
Collectively, these findings highlight the need to continue monitoring demographic
and social factors affecting COVID–19 vaccine access; to prioritize efforts to ensure equitable access to COVID–19 vaccine; to tailor public health messaging for local populations and counties with high social vulnerability; and the need for public health practitioners to collaborate with health care providers, pharmacies, employ-ers, faith leaders, and other community partners to identify and address barriers to COVID–19 vaccination in rural areas.
While these data indicate additional work that lies ahead to achieve greater vac-
cination rates in certain population groups, we know there are communities that have been successful in their vaccination efforts. In June 2021, as part of the Na-tional Month of Action, CDC hosted a webinar as a call to action to increase the number of vaccinated people in Black or African American and Hispanic or Latino communities. The webinar highlighted organizations that have conducted successful mass vaccination activities for Black or African American and Hispanic or Latino people. These organizations shared their successes, challenges, and strategies used to increase vaccine education, awareness, and uptake with the nearly 500 partici-pants from public health, healthcare, clinical, and community organization leader-
ship. This effort is part of CDC’s ongoing work to share best practices around the country to help all communities achieve the highest rates of vaccination possible.
To assist decision-makers and researchers, CDC also launched a Health Equity
page on our COVID Data Tracker. The page catalogs current health equity-related data that align with populations and place-based focus groups identified in CDC’s COVID–19 Response Health Equity Strategy.
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1https://www.cdc.gov/mmwr/volumes/70/wr/mm7020e2.htm’s-cid=mm7020e2-w .
2https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e1.htm’s-cid=mm7018e1-w . Vaccines
Vaccination is a critical tool in bringing this unprecedented pandemic to an end.
As of May 10, every person aged 12 and over in every state and territory is eligible to get vaccinated. CDC has continued to improve accessibility by increasing distribu-tion of vaccines to medical offices. We have increased the number of medical prac-tices receiving vaccine by nearly 85 percent since early April and now have over 10,000 medical practices served by primary care doctors, administering vaccine alongside other routine medical care. The country exceeded President Biden’s goal of administering 200 million shots in the first 100 days of his Administration. A CDC study
1reviewing data from 2 months of early vaccinations among health care
personnel found that both Moderna and Pfizer vaccines were 94 percent effective in preventing symptomatic SARS-CoV–2 infection, seven or more days after the second dose. In addition, another CDC study
2found these two vaccines were 94 percent
effective against hospitalization among fully vaccinated adults aged 65 years and older. These findings demonstrate the high, real-world effectiveness of these vac-cines.
CDC will continue working with partners to monitor how well COVID–19 vaccines
work in real-word conditions through multiple studies looking at vaccine effective-ness in various populations, locations, and settings. Through these studies, CDC can obtain more representative, scientifically valid, and complete information about vac-cine effectiveness, including factors associated with vaccine breakthrough.
Vaccinations are highly effective against severe disease including hospitalizations
and death, thus protecting even the limited number of people who are vaccinated but still get COVID–19. A recent analysis led by CDC published in the New Eng-land Journal of Medicine found that mRNA COVID–19 vaccines show secondary benefits of vaccination for people who were fully or partially vaccinated and still got COVID–19. Secondary benefits included having shorter and milder illness and po-tentially being less likely to spread the virus to others compared to unvaccinated people with COVID–19.
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. Since April 2021, increased cases of inflammation of the heart muscle, called myocarditis, or outer lining, called pericarditis,—have been reported in the U.S. following mRNA COVID–19 vaccination (Pfizer or Moderna). This is a rare condition and reported cases have occurred predominantly in male adolescents and young adults. Following a thorough safety review and meeting of CDC’s Advisory Committee on Immuniza-tion Practices, which found the benefits of mRNA vaccination greatly outweighed the risks, CDC continues to recommend COVID–19 vaccination for everyone 12 years of age and older, given the risk of COVID–19 illness and related, possibly se-vere complications. FDA and CDC also conducted extensive outreach to providers and clinicians to ensure they were made aware of the potential for these adverse events.
CDC and FDA are monitoring reports of Guillain-Barre ´Syndrome (GBS) after re-
ceiving Johnson & Johnson’s Janssen (J&J/Janssen) COVID–19 Vaccine. GBS is a neurological disorder in which the body’s immune system damages nerve cells, caus-ing muscle weakness or in the most severe cases paralysis. Reports of GBS after receipt of the J&J/Janssen COVID–19 Vaccine in the Vaccine Adverse Event Report-ing System (VAERS) are rare, but do likely indicate a small possible risk of this side effect following this vaccine. Around 100 preliminary reports of GBS, mostly in males, many aged 50 years and older, have been detected in VAERS after 12.8 mil-lion doses of J&J/Janssen COVID–19 Vaccine administered. Available data do not show a similar pattern with mRNA vaccines (Pfizer-BioNTech and Moderna). On July 13, the FDA updated the label of the Johnson & Johnson vaccine to add a new warning suggesting an increased risk of Guillain-Barre ´Syndrome within 42 days
following vaccination. This issue will be discussed as part of an upcoming meeting of CDC’s Advisory Committee on Immunization Practices (ACIP) later in July. The
detection of rare complications, such as myocarditis, thrombosis-thrombocytopenia syndrome (a rare and severe type of blood clot), and GBS, is an important validation of the sensitivity of vaccine safety monitoring systems to be able to pick up even very small numbers of potential vaccine safety concerns.
Building on long-standing relationships with state and local partners, CDC has
worked tirelessly to ensure that we are getting vaccines to people as quickly, safely, and equitably as possible. As of July 16, 2021, about 389 million doses have been
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delivered, and more than 336 million doses of COVID–19 vaccine have been admin-
istered. About 79 percent of all Americans age 65 years and older were fully vac-cinated by this date, and about 68 percent of adult Americans had received at least one vaccine. This is a whole-of-society effort, and it is inspiring to see people across government, business, and communities coming together to complete this important lifesaving task.
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, local, and territorial govern-mental and non-governmental partners to build trust in the vaccine, the vaccinator, and the vaccination system. We will continue to work with these critical partners to address barriers to vaccinations, including in communities of color and disproportionally affected groups. It is important that we continually deliver the message that 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 safe-ty protocols to monitor people when they receive the vaccine. In order to address vaccine hesitancy, it is crucial to provide accurate scientific messaging across all sec-tors and multiple platforms, using creative communications approaches such as en-listing trusted community members to help address concerns over COVID–19 vac-cines. Listening to, and patiently addressing concerns, including on an individual basis, is a vital method that should be used to build confidence in vaccines.
Further supporting efforts to prioritize equity in our vaccine strategy, in early
April CDC awarded $3.15 billion directly to states, territories, and some large cities to support local efforts to increase vaccine access, uptake, and equity. The funding focused 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. Jurisdictions are also encouraged to consider factors such as the Social Vulnerability Index and current administration rates in local communities when reaching out to enroll providers. Guidance was disseminated to jurisdictions on increasing the proportion of vaccines allocated to providers who are located in socially vulnerable communities. In July, CDC added a new Vaccination Equity tab to display Social Vulnerability Index and vaccination coverage maps to the COVID Data Tracker. Improving access to under-served communities and populations that have historically experienced greater bar-riers to healthcare access is another critical component to prioritizing equity in vac-cine distribution. Improving access also requires a multi-pronged approach. For ex-ample, CDC partners with the Health Resources and Services Administration (HRSA) to provide COVID–19 vaccinations and technical assistance to interested HRSA-funded health centers, with the goal of bringing vaccines to communities and improving access for populations disproportionately impacted by COVID–19. As of June 29, roughly 7 million doses had been distributed to 2,200 HRSA-funded health centers across the Nation.
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 partnered with 21 national pharmacy organizations and independent pharmacy net-works that represent over 40,000 locations nationwide—to ensure that the public has access to COVID–19 vaccines in a familiar setting. Almost 90 percent of Ameri-cans live within five miles of a retail pharmacy. These pharmacies continue to reach out to communities, administering almost 3 million doses at nearly 10,000 mobile pop-up clinics, with 58 percent of people vaccinated by pharmacies in the last 2 weeks of June being in a minority group.
On May 13th, CDC released new guidance for fully vaccinated people, which said
that, anyone who is fully vaccinated can resume activities—indoor or outdoor—safe-ly without a mask or physical distancing, except where required by Federal, state, local, tribal, or territorial laws, rules and regulations, including local business and
workplace guidance. This decision was based on three major scientific developments: (1) Our vaccines working in the real world, with studies showing them to be >90 percent effective in the real-world settings in preventing mild and severe disease, hospitalization, and death, (2) Our vaccines proving to be effective against the SARS-CoV–2 variants currently circulating in the country, and (3) Research show-ing that if you are vaccinated, you are less likely to spread the virus. A growing
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body of evidence suggests that fully vaccinated people are less likely to have asymp-
tomatic infection and to be able to transmit SARS-CoV–2 to others. While we hope this was encouraging news for the country, we must remain vigilant in our efforts to continue increasing vaccination if we want to continue returning to normal. At this time, CDC sees no need to change our fully vaccinated guidance; however we will continue to monitor all indicators and data closely.
Schools
Since becoming the director of 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. With the wide-spread availability of safe and effective vaccines, we have seen reductions in COVID–19 cases, hospitalizations, and deaths. If vaccination rates continue to in-crease and community transmission rates decrease, the risk in schools is expected to decrease as well.
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, resources, and tools for schools, parents, teachers, and other staff. Earlier this month, CDC released updated guidance to help prevent the spread of COVID–19 and safeguard in-person learning. CDC’s Guidance for COVID–19 Prevention in K–12 Schools is now updated to reflect the
latest science on COVID–19, lessons learned from schools implementing COVID–19 prevention strategies, and the widespread availability of safe and effective COVID– 19 vaccines for those aged 12 years and older. Reports suggest that limited in—per-son instruction during the pandemic may have had a negative effect on learning for children and on the mental and emotional well-being of both parents and children. In addition, many K–12 schools globally implemented layered COVID–19 prevention strategies during the 2020–2021 academic year. These schools’ experiences contrib-uted to our knowledge of the nature of SARS-CoV–2 transmission in schools and in-formed updates to the K–12 guidance, which emphasizes the importance of offering in-person learning in K–12 schools.
CDC recommends schools implement layered prevention strategies to protect peo-
ple who are not fully vaccinated, including students, teachers, staff, and other mem-bers of their households. These strategies include vaccination for children and adults ages 12 and up, the correct use of masks, physical distancing, handwashing and respiratory etiquette, cleaning and maintaining healthy facilities (including proper ventilation), and contact tracing, in combination with screening testing, isola-tion, and quarantine for those exposed and not vaccinated. The guidance emphasizes the need for localities to monitor community transmission, vaccination coverage, screening testing, and occurrence of outbreaks to guide decisions on the level of lay-ered prevention strategies.
Mask use and physical distancing are two key prevention strategies for reducing
SARS-CoV–2 transmission, but a layered approach that uses several strategies will provide the greatest level of protection. Schools where not everyone is fully vac-cinated should implement physical distancing to the extent possible within their structures, in addition to masking and other prevention strategies. If it is not pos-sible to maintain adequate physical distancing, it is especially important that schools layer multiple other prevention strategies, such as masking and screening testing, to help ensure that no students need be excluded from in-person learning.
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 May, CDC also awarded $500 million to jurisdictions to expand the school-based public health workforce, including nurses and other health personnel. Combined, we believe these resources will provide sub-stantial help to schools around the Nation as they open in the fall.
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 Guid-ance for COVID–19 Prevention in K–12 Schools presents recommendations based on the best-available evidence 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 rec-ommendations to reflect new evidence. CDC stands committed to providing the best, most current data and scientific understanding available to protect the health, safe-ty, and well-being of our communities, including our students, teachers, and school staff.
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Conclusion
In closing, I want to emphasize that with increased vaccinations nationwide, we
can look 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. But we have to ensure that we are stamping out COVID–19 in all communities, not just some communities. We cannot risk only keeping parts of the U.S. moving forward safely while other parts of the country continue to see tragic numbers of cases and deaths from COVID–19. This will require sustained efforts from all stakeholders and across all levels of government and most importantly individuals making the decision to get vaccinated to protect themselves, their loved ones, and their commu-nities.
We also must address the long-standing vulnerabilities in our public health sys-
tem and the conditions that led to disproportionate burden of COVID–19 illness and death in some communities. The Fiscal Year 2022 President’s Budget Request in-cludes an increase of nearly $1.7 billion for CDC to invest across the public health system. This is an important first step in building back a better public health sys-tem that can deliver health security to all Americans.
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 . Thank you very much, Madam Chair, Ranking Mem-
ber Burr, Members of the Committee. Thank you for giving me the opportunity to discuss with you again the role of the National Insti-tute of Allergy and Infectious Diseases in the research response ad-dressing COVID–19. As I have mentioned to this Committee on prior hearings, the strategic plan for research for NIAID involves research on fundamental basic knowledge regarding the virus to development of diagnostics, therapeutics, and vaccines.
For the purposes of today’s discussion and my presentation, I
would like to focus on three vaccines that you know have been ap-proved through the emergency use authorization for use in the United States, and that is the two mRNA vaccines from Pfizer, Bio-genetic, and Moderna, and the J&J vaccine, which is a human adenovirus vector vaccine. As I mentioned to this Committee on prior hearings, the clinical trials that proved the extraordinary effi-caciousness of these vaccines to the tune of 93 and 94 percent are very, very clear right now.
What I would like to emphasize today is what has transpired
since the last hearing, and that is the accumulation of data on the real world effectiveness of these vaccines. In a situation we are con-fronted with a historic pandemic. And that is seen not only in the United States, but also in the UK in the form of England and Scot-land, in Israel, Qatar, and other places.
When one looks at the data, and one good example is the cohort
study from Israel in which the mRNA vaccine used in that popu-lation was highly effective in the real world beyond the clinical trial, including among asymptomatic, early symptomatic advanced disease, intensive care, and even deaths, and if one looked across the cohort, you saw that it was effective in essentially every age group from young individuals, middle aged, and even the elderly. That is the good news. The sobering news that you have already heard of is the fact that we are now challenged with a very difficult
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and problematic variant referred to as the delta variant. It has now
been detected in at least 90 plus countries throughout the world.
The reason it is so formidable is the fact that it has the capa-
bility of transmitting efficiently from human to human in an ex-traordinary manner, well beyond any of the other variants that we have experienced up to now, which has led to its becoming the dominant variant in this country. When I spoke to you last time, it was about 1 to 3 percent of the variance in the population. Right now it has gone to over 80 percent, and in some regions of the country, as high as 90 percent. That is the troubling news.
The fact is that, however, and the importance of vaccination is
that our vaccines that we are using in this country are very effec-tive against this variant, particularly, I point out, to the situation regarding advanced disease leading to hospitalizations and deaths where it is still well in the 90 percent of effectiveness. I would like to close with just one or two comments that we have been hearing about regarding the situation of booster or an additional third dose superimposed upon the double doses of the mRNA and the single dose of the J&J.
Right now, we are doing studies to determine whether or not we
will need boosters to increase the durability of protection. We don’t want people to believe that when you are talking about boosters, that means that the vaccines are not effective. They are highly ef-fective. We are talking about the durability of that. And we are doing studies now to determine that.
In addition, there are individuals who are immunosuppressed,
people who are on cancer, chemotherapy, a variety of other individ-uals, transplant individuals who may actually need a boost as part of their initial regimen in the sense of getting them up to the point where they are protected. So in closing, I want to underscore what Dr. Walensky just said a few moments ago, the extraordinary im-portance of getting as many people vaccinated as we possibly can.
We have the tools to end this epidemic. It is up to us to utilize
those tools to the maximum. Thank you very much, Madam Chair.
[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-
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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, more than 67 percent of U.S. adults have received at least one dose of a COVID–19 vaccine, and we must continue to vaccinate as many people as we can, as quickly as possible. FDA-authorized COVID–19 vaccines meet FDA’s
rigorous standards for safety and efficacy. The high levels of vaccine efficacy ob-served in the carefully controlled conditions of clinical trials have been subsequently confirmed by their effectiveness in studies of vaccines administered to broad seg-ments of the public in the United States and other countries. Vaccination and ad-herence to public health measures are the proven interventions that will be particu-larly important as we work to address the SARS-CoV–2 Delta (or B.1.617.2) variant and other variants with increased transmissibility or pathogenicity that may emerge.
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 variants of SARS-CoV–2 such as the Delta (B.1.617.2) variant. So far, scientific evidence suggests that the COVID–19 vaccines distributed in the United States under FDA Emergency Use Authorizations (EUA) continue to be ef-fective against severe disease caused by these variants, but we must remain vigi-lant. NIAID is rapidly conducting research to better understand these emerging variants, how they interact with the immune system, 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 and partnering with other agencies in the Federal Government, and with industry and academia to ensure that nobody in vulnerable communities is left behind as we move forward toward defeating the COVID–19 pandemic. NIAID also recognizes that while many individ-uals 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. NIAID is supporting collaborative efforts to study COVID–19 outcomes in patients across all ages, genders, and co-morbid conditions. These studies include people who expe-rienced a broad range of COVID–19 disease severity so we can identify and charac-terize post-acute sequelae of SARS-CoV–2 infection (PASC) and develop effective strategies to address them.
Developing Vaccines and Monoclonal Antibodies 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 development. Two activities in particular predate successful COVID–19 vaccines: the development of versatile vaccine platforms and the adaptation of structural biology tools to design specific proteins (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 pro-teins that are important for infection. These included the spike protein of Middle East respiratory syndrome coronavirus (MERS-CoV), which was stabilized using a double mutation known as S2P. This key finding facilitated the design of vaccine candidates that generate robust immune responses not only against coronaviruses but also 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 breakthrough in structure-based vaccine design for coronaviruses led to the development of safe and effective COVID–19 vaccine candidates across a range of vaccine platforms.
Six candidate COVID–19 vaccines have been or are in the process of being as-
sessed in large-scale Phase 3 clinical trials in the United States thus far, and three have received EUAs from the FDA. Clinical trials to test COVID–19 vaccine can-didates 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
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prevention of COVID–19. This vaccine is now authorized for emergency use in indi-
viduals 12 years of age and older. NIAID has helped to advance five 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 tens of 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 par-ticipation; 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– 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 high levels of effectiveness. For example, in an article published in Morbidity and Mortality
Weekly Report (MMWR) , Centers for Disease Control and Prevention (CDC) re-
searchers and their collaborators showed that among health care personnel, first re-sponders, 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. Other MMWR articles reported that these vac-cines were 94 percent effective at preventing symptomatic COVID–19 among health care personnel and reduced the risk of COVID–19 hospitalization by 94 percent among people 65 years of age and older. Recently, NIAID scientists and their col-laborators demonstrated that anti-SARS-CoV–2 antibodies persist for at least 6 months after the second dose of mRNA–1273. On June 26, 2021, FDA updated the EUAs for the Moderna and Pfizer COVID–19 vaccines to include information on the potential risks of myocarditis and pericarditis, particularly following the second dose. According to CDC, reports of myocarditis and pericarditis following vaccination with mRNA COVID–19 vaccines are rare. Most patients who received care have re-sponded well to treatment and rest, and patients usually can return to their normal daily activities after their symptoms improve. Given the significant potential health risk of COVID–19, the CDC continues to recommend that individuals ages 12 and older be vaccinated with the relevant FDA-authorized COVID–19 vaccine.
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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 in combination with low blood platelets after vaccine administration. Medical and scientific teams at the FDA and CDC found that available data suggest that the chance of this serious adverse event oc-curring is very low. Following their thorough safety review—and in accordance 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. On July 12, 2021, FDA announced revisions to the vaccine recipient and caregivers and vaccination providers fact sheets for the Johnson & Johnson/ Janssen COVID–19 vaccine regarding a suggested increased risk of Guillain-Barre ´
syndrome during the 42 days following vaccination. The chance of this occurring fol-lowing vaccination appears to be very low.
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. Novavax’s NVX-CoV2373 COVID–19 vaccine candidate uses a protein nanoparticle vaccine approach. On June 14, 2021, Novavax an-nounced that NVX-CoV2373 demonstrated 90.4 percent efficacy in preventing symp-tomatic COVID–19 and 100 percent protection against moderate and severe disease. In addition, the company reported that NVX-CoV2373 showed 91 percent efficacy in preventing symptomatic COVID–19 in people 65 years or older, as well as those with certain comorbidities or those who were identified as being likely to experience regular exposure to SARS-CoV–2. FDA has not yet authorized either of these vac-cine candidates.
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. More than
130,000 pregnant and lactating women already have received the COVID–19 vac-cines under FDA EUAs, and early data are promising. These data do not dem-onstrate any safety concerns for women who are pregnant or their babies. In addi-tion, protective antibodies against SARS-CoV–2 have been detected in babies born to pregnant women who received mRNA COVID–19 vaccines. On June 23, 2021, NIAID launched an observational study, MOMI-VAX, to evaluate the immune re-sponses generated by COVID–19 vaccines administered to individuals during preg-nancy or up to 2 months postpartum. The study also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.
Efforts to evaluate COVID–19 vaccines in pediatric and other special populations
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-
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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. On May 10, 2021, the FDA expanded the EUA for Pfizer’s COVID–19 vaccine to include adolescents ages 12 to 15 years of age, and Pfizer also is evaluating their vaccine candidate in younger individuals. Other vaccine developers also have begun, or are planning to begin, trials to test their vaccine candidates in children, adolescents, and other special populations. On April 23, 2021, NIAID launched an observational study at the NIH Clinical Center assessing how people with immune system deficiencies or dysregulations respond to COVID–19 vaccination. NIAID investigators also will gather information about COVID–19 illness in these individuals. This study will inform decision-making about COVID–19 vaccination in people with immune deficiencies and dysregulation conditions.
Monoclonal Antibodies to Prevent COVID–19
NIAID, collaborating with Regeneron Pharmaceuticals and Eli Lilly and Com-
pany, also initiated two Phase 3 clinical trials to evaluate whether their investiga-tional monoclonal antibodies, REGEN-COV and bamlanivimab respectively, can pre-vent infection or symptomatic disease in people at high risk of exposure due to their living or working conditions. Regeneron reported in a preprint publication that REGEN-COV prevented symptomatic and asymptomatic infection in household con-tacts of individuals who had recently tested positive for SARS-CoV–2. Bamlanivimab also was reported to prevent symptomatic and asymptomatic infec-tion in residents and staff of skilled nursing and assisted living facilities, and these findings were published in the Journal of the American Medical Association . FDA
has not yet authorized the use of either of these drugs for prevention of COVID– 19. Clinical trials to test the safety and efficacy of monoclonal antibody therapies for the treatment of COVID–19 are being tested through the ACTIV partnership, and these are discussed below.
Identifying Therapeutics to Treat COVID–19
Safe and effective therapeutics are urgently needed to treat patients with COVID–
19. NIAID has worked quickly from the earliest days of the pandemic to evaluate promising therapeutics for COVID–19 in rigorous, randomized, controlled clinical trials.
The Adaptive COVID–19 Treatment Trial
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 currently is 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.
The ACTIV Public-Private Partnership
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 two combination monoclonal antibody therapies—BRII–196 plus BRII–198 and BMS– 986414 plus BMS–986413—as well as four additional investigational therapeutics: SAB–185, a fully human polyclonal antibody produced in cattle; SNG001, an
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inhalable beta interferon; and AZD7442, an investigational long-acting monoclonal
antibody combination. Camostat mesilate, an orally administered drug that may block SARS-CoV–2 from entering cells, was evaluated but ultimately not included in ACTIV–2 efficacy studies, as it failed to induce early changes in viral shedding or improvement in symptoms. ACTIV–3 currently is evaluating the AZD7442 monoclonal antibody combination, as well as the small molecule ensovibep, in hos-pitalized patients. Ensovibep binds to several sites on the SARS-CoV–2 spike pro-tein, which may inhibit the virus’s ability to infect human cells. On April 22, 2021, NIAID and NHLBI launched a new trial, known as ACTIV–3 Critical Care, to test 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.
Three monoclonal antibody therapies currently have FDA EUAs for the treatment
of COVID–19 in outpatients. Due to concerns of variant resistance to monoclonal antibody therapies, the FDA now includes information on the susceptibility of SARS-CoV–2 variants in its fact sheets for health care providers for each of these therapies. NIAID-supported scientists and collaborators are evaluating the potential impact of emerging SARS-CoV–2 variants on the efficacy of monoclonal antibodies.
Additional NIAID-Supported Therapeutics Activities
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 (hIVIG) for treat-ment of COVID–19 in hospitalized adults. The study demonstrated that hIVIG 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.
NIH recently launched the Antiviral Program for Pandemics, a collaboration be-
tween NIH and BARDA that aims to develop safe and effective antivirals to treat and prevent SARS-CoV–2 infection. The program also will build sustainable plat-forms for targeted drug discovery and development of antivirals directly targeting viruses with pandemic potential. As part of this effort, NIAID will establish Antiviral Drug Discovery Centers for Pathogens of Pandemic Concern. These multi-disciplinary research centers will create platforms that will initially target coronaviruses, and then could be expanded to other viruses with pandemic poten-
tial—helping to better prepare the Nation for future viral threats.
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.
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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 at the time, Alpha (also known as B.1.1.7), Beta (B.1.351), and Gamma (P1). These findings, published in Open Forum Infectious Dis-
eases , 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 vac-cine 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 pro-tection against emerging SARS-CoV–2 variants by targeting several viral antigens, all of which are highly conserved 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 Beta (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. In addition, NIAID is leading a study in fully vaccinated individuals to de-termine the safety and efficacy of boosting with a COVID–19 vaccine different than the one used for the initial vaccination. The results of this trial are intended to in-form public health policy decisions on the potential use of mixed vaccine schedules
should booster doses be needed.
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.
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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.
Early in the pandemic, the intramural research programs of NIAID, NCI, the Na-
tional Center for Advancing Translational Sciences, and the National Institute of Biomedical Imaging and Bioengineering partnered to rapidly deploy the SARS-CoV– 2 Pandemic Serosurvey. The study investigated whether adults in the United States
without a confirmed history of SARS-CoV–2 infection have antibodies to the virus, thus indicating prior infection. Findings from the first time point of this longitudinal study suggest that the prevalence of COVID–19 in the United States during the spring and summer of 2020 may have far exceeded the number of cases medically diagnosed. Extrapolating from analyses of blood samples from people who did not have a previously diagnosed SARS-CoV–2 infection, along with socioeconomic, health, and demographic data, the researchers estimate that there may have been an additional 16.8 million undiagnosed SARS-CoV–2 infections through mid-July 2020. Continued analysis of the one-year follow-up data from the study will be very important in better understanding mortality rates, prevalence of immunity, and the impact SARS-CoV–2 has had on various communities in the United States.
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 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 the Researching COVID to Enhance Recovery (RECOVER) Initiative, a trans-NIH effort to address PASC, including targeted funding for research in this critical area. The NIH RECOVER 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
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even predict, the clinical severity of COVID–19. Since May 1st, 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 these efforts will improve our response to the cur-rent pandemic and bolster our preparedness for the next, inevitable viral disease outbreak.
The C HAIR . Thank you.
Dr. Woodcock.
STATEMENT OF JANET WOODCOCK, M.D., ACTING COMMIS-
SIONER, UNITED STATES FOOD AND DRUG ADMINISTRA-TION, SILVER SPRING, MD
Dr. W OODCOCK . Good morning, Chair Murray, Ranking Member
Burr and Members of the Committee. Thanks for the opportunity to be here today. I am going to provide a brief update of what the agency has been doing in our COVID–19 response. But first, I want to start by recognizing the thousands of FDA employees who have really been working nonstop for the past year and a half. I really
commend their efforts and thank them for their service to the coun-try. It has been extraordinary.
From the earliest days of this public health emergency, there was
a need for reliable diagnostics, as we all know. We began gauging developers in early January 2020. And as of last week, FDA has authorized nearly 400 tests and sample collection devices that pro-vide a wide range of options for testing beyond diagnostics. We have evaluated emergency use requests for ventilators and novel devices such as continuous renal replacement therapy products. We continue to review additional submissions for COVID medical de-vices and rigorously monitor safety signals and reports, including their performance against variance for the products on the market.
This is in addition to addressing numerous device shortages that
occurred during the pandemic and working with our Government partners to prevent counterfeit and substandard PPE and other products from entering the United States because, of course, people take opportunities to try to get substandard products into the coun-try. FDA has also supported development and availability of COVID therapeutics as expeditiously as possible. On March 31st, we announced the creation of an emergency review and develop-ment program, the Coronavirus Treatment Acceleration Program. We reassigned staff from other areas to review the hundreds and hundreds of requests from companies, scientists, and doctors who are working to develop treatments as of June 30th.
We have reviewed more than 460 trials for potential COVID
therapies. These include antivirals, neutralizing antibodies, cell
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and gene therapies, and combinations of these products. The diver-
sity of therapeutic approaches that are being investigated is really critical to increasing our knowledge of this disease in its different stages. And these efforts have led to one approved drug therapy to treat COVID–19 and 10 therapeutics currently authorized for emergency use.
In addition, FDA issued EUA, as you know, for three COVID–
19 vaccines. These vaccines were authorized without cutting cor-ners or sacrificing our rigorous standards. Intensive interactions between FDA and manufacturers minimize the time between dif-ferent ordinary phases of the clinical development process and al-
lowed for seamless movement through development, manufac-turing, and our rigorous scientific review.
Throughout the vaccine authorization process, we took steps to
facilitate transparency and trust by posting trial data, putting out guidances on what our standards would be, key decisional memo-randa, and we held public advisory committee meetings. These vac-cines have met the standards and quality to support an EUA and are helping, as you have heard, in our fight against the pandemic. Our work did not end with the authorization of these vaccines, though we have to share as much information as we can with the public to help with trust and transparency. We are also deeply in-volved with CDC on the safety surveillance for the vaccines as they go into millions of healthy people to understand what adverse events might be related. And we continue to find that the known and potential benefits of these vaccines far outweigh the known risks, even as additional rare risks have been discovered.
All this is in addition to the critical work we do to protect the
Nation’s food supply, which also came into some jeopardy during this, and to interdict substandard medical products at our ports of entry, courier facilities, and international mail facilities. Since March 2020, with coordination with Customs and Border Protection colleagues, we have intercepted and destroyed almost 60,000 illegal and unapproved medical products that were attempting to get into the country.
FDA has also played a major role in investigating the numerous
shortages of medical products that have occurred during the pan-demic. Partnering with our sister agencies represented here and far beyond, we have responded quickly and decisively while main-taining our commitment to protecting the health of the American people. We look forward to working with the Committee to address further issues. Thank you.
[The prepared statement of Dr. Woodcock follows:]
PREPARED STATEMENT OF JANET WOODCOCK
Introduction
Chair Murray, Ranking Member Burr, distinguished Members of the Committee,
I am Dr. Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Adminis-tration (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 Fed-eral Government, to help ensure the development, authorization, licensure, and availability of critical, safe, and effective medical products to address the COVID– 19 public health emergency.
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I want to note at the outset that this is just a snapshot of some of our recent
work and is in the context of efforts across the Agency to address this pandemic. There are thousands of FDA employees who have been working non-stop for the past year-and-a-half. I want to commend and recognize their efforts and thank them for their service.
From the beginning of this public health emergency, FDA has taken an active
leadership role in the all-of-government response to the COVID–19 pandemic, in-spired by the resiliency of the American people and our great innovators. FDA stood up an internal cross-agency group that continues to ensure we are doing everything possible to protect the American public, help ensure the safety, efficacy, and quality of FDA-regulated medical products, and provide the industries we regulate with the
guidance and tools to do the same. We continue to focus on facilitating the develop-ment and availability of medical countermeasures to diagnose, treat, and prevent COVID–19, surveilling the medical product and food supply chains for potential shortages or disruptions, and helping to mitigate such impacts, as necessary to pro-tect the public health.
Biologics and Vaccines
FDA’s Center for Biologics Evaluation and Research (CBER) uses every tool avail-
able to help patients access promising biological products while facilitating research to evaluate their safety and efficacy as well as manufacturing efforts.
CBER is working on multiple fronts to address the COVID–19 pandemic, includ-
ing:
•Expediting clinical trials for vaccines and certain therapeutic biological
products that hold promise to prevent or treat COVID–19 by providing timely interactions, scientific advice, and recommendations for specific sponsors, and generally through guidance documents;
•Supporting product development and facilitating the scaling up of manu-
facturing capacity for high priority products to treat COVID–19;
•Expediting the review of Emergency Use Authorization (EUA) requests
and Biologics License Applications (BLAs) for critical medical products to address COVID–19;
•Helping to ensure an adequate and safe blood supply; and
•Providing information to healthcare providers and researchers to help
them submit expanded access IND requests to permit the use of inves-tigational products for patients with COVID–19.
Through our transparent scientific review process, FDA has issued EUAs for three
COVID–19 vaccines. In doing so, we have relied upon the Agency’s rigorous stand-ards for safety, effectiveness, and manufacturing quality. Development of a vaccine generally proceeds sequentially through the various stages of clinical development; ordinarily this process minimizes scientific and financial risk for the manufacturer. Manufacturing scale-up only takes place when the data support the safety and effec-tiveness of a vaccine and it is on track for regulatory approval. These three COVID– 19 vaccines were developed without cutting corners or sacrificing our standards. In-tensive interactions between FDA and manufacturers minimized the time between different studies in the clinical development process; allowed seamless movement throughout the different phases of clinical trials; and simultaneously facilitated manufacturers proceeding with manufacturing scale-up before it was clear whether the safety and effectiveness data for a vaccine would support EUA.
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 meetings. Throughout this process, FDA took additional steps to facili-tate 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 efficacy in large, well-designed phase 3 trials. These vaccines have met rigorous standards for safety and effectiveness to support EUA and are helping us in the fight against this pandemic. All the COVID–19 vac-cines that FDA has authorized for emergency use are at least 50 percent effective compared to placebo in preventing COVID–19, which is the expectation we conveyed in our June 2020 guidance document, Development and Licensure of Vaccines to Pre-
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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 . vent COVID–19 .1A vaccine with at least 50 percent efficacy, we noted, 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 and caregivers, with important information such as dosing instructions; information about the benefits and risks of each authorized vaccine; and topical Questions and Answers developed by FDA for each authorized vaccine.
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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).
These surveillance efforts have led the Agency to take steps to proactively address
emerging safety signals. In April, out of an abundance of caution, FDA and CDC recommended a pause in the use of the Janssen COVID–19 vaccine while we inves-tigated reports of thrombosis with thrombocytopenia syndrome. Later that month, after careful evaluation of the data, FDA announced revisions to the vaccine recipi-ent fact sheet to include information about the risk of thrombosis with thrombocytopenia, and the vaccination provider fact sheet to include a warning about the risk of thrombosis with thrombocytopenia syndrome. We concluded that the available data suggest that the chance of this serious adverse event occurring is very low. 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. As with all of the COVID–19 vaccines, we continue to closely monitor the safety of the Janssen COVID–19 Vaccine.
On June 25, FDA announced revisions to the vaccine recipient and caregivers and
vaccination provider fact sheets for the Moderna and Pfizer-BioNTech COVID–19 vaccines regarding the suggested increased risks of myocarditis and pericarditis fol-lowing vaccination. The chance of these adverse events occurring following adminis-tration of either the Moderna or Pfizer-BioNTech COVID–19 vaccine appears to be very low, but the level of potential risk due to vaccination is still under investiga-tion. FDA and CDC are monitoring the reports, collecting more information, and will follow-up to assess longer-term outcomes over several months.
On July 12, FDA announced revisions to the vaccine recipient and caregivers and
vaccination providers fact sheets for the Janssen COVID–19 vaccine regarding a suggested increased risk of Guillain-Barre ´syndrome during the 42 days following
vaccination. The chance of this occurring following vaccination appears to be very low.
At this time, data are not yet available to make a determination about how long
these authorized vaccines will provide protection, nor are we certain that the vac-cines prevent 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).
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. We are highly engaged in ensuring that all COVID–19 vaccines meet the high quality that Americans expect and deserve and are also actively engaged in ensuring the safety of these vaccines following deploy-ment. FDA is also working with international partners as part of multinational ef-forts to end this global pandemic. We have provided guidance and technical assist-ance, and continue to share information as we evaluate and release vaccine doses for use in other countries. The Agency is very proud of these efforts, and we believe that the vaccines will help bring this pandemic to an end.
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Therapeutics
Since the beginning of the COVID–19 pandemic, FDA has been working tirelessly
to facilitate the development and availability of therapeutics for use by patients, physicians, and health systems as expeditiously and safely as possible. FDA has also accelerated the development and publication of guidance and other information for industry and researchers on developing COVID–19-related treatments. Further, on March 31, 2020, FDA announced the creation of an emergency review and develop-ment program for possible therapies for COVID–19, the Coronavirus Treatment Ac-celeration Program, or ‘‘CTAP.’’ The primary goal of CTAP is to help accelerate the development of therapeutics for patients and consumers. The Agency has supported the program by reassigning staff and working continuously to review requests from companies, scientists, and doctors who are working to develop therapies. Under CTAP, FDA is using every available authority and regulatory flexibility to facilitate the development of safe and effective products to treat patients with COVID–19. As of June 30, 2021, there are more than 630 drug development programs in planning stages and the Agency has reviewed more than 460 trials of potential therapies for COVID–19. These include antivirals, immunodulators, neutralizing antibodies, cell and gene therapies, and combinations of these products. The diversity of therapeutic approaches being investigated is important because it rapidly expands our under-standing of the effect of different categories of potential treatments.
FDA has approved one drug to treat COVID–19 and eleven therapeutics are cur-
rently authorized for emergency use. Our goal is to be as transparent as possible about the scientific basis for recommending that a drug or biological product be au-thorized for emergency use under section 564 of the Federal Food, Drug and Cos-metic Act (21 U.S.C. 360bbb–3) or for recommending that an EUA be revised or re-voked.
FDA also continues to work closely with manufacturers to mitigate and prevent
shortages as the COVID–19 pandemic evolves. For example, the Agency has issued three EUAs to authorize the emergency use of certain therapeutic products intended to treat serious or life-threatening diseases or conditions (e.g., Acute Kidney Injury, Acute Respiratory Distress Syndrome) caused by COVID–19 after determining that the FDA-approved alternatives to these products were not available in sufficient quantities to fully meet the emergency need. This has helped to alleviate shortages of some therapies that are essential for the care of critically ill COVID–19 patients. FDA is also working with manufacturers to increase supplies to meet current de-mand by expediting review of applications. In addition, the Agency has prioritized the review of generic drug applications for potential treatments and supportive therapies for patients with COVID–19, such as antibiotics, sedatives used in venti-lated patients, anticoagulants, and pulmonary medications. In June 2021, FDA reached a milestone of approving 1,000 original and supplemental generic drug ap-plications since the start of the pandemic to help in the treatment of patients with
COVID–19. This supports FDA’s everyday mission of improving access to safe, effec-tive, high-quality treatment options, especially during the COVID–19 pandemic.
Medical Devices
The need for medical devices to respond to the COVID–19 pandemic has far ex-
ceeded what we experienced in any prior Public Health Emergency (PHE). The first EUAs issued for the COVID–19 PHE were for medical devices, and the volume of EUA requests quickly surpassed (by two orders of magnitude) that of any prior PHE or other situation. Further, the emergency use requests included submissions for de-vices that CDRH had never received EUA requests for during prior PHEs. This in-cluded ventilators and novel devices such as continuous renal replacement therapy devices. Since the start of the pandemic, FDA has issued EUAs or granted full mar-keting authorization to almost 1,500 medical devices for COVID–19-related uses. In addition, FDA rigorously monitored safety signals and medical device reports using the information to publish 21 letters to healthcare providers and seven safety com-munications, and FDA completed other pivotal work activities such as addressing supply chain shortages and counterfeit products related to COVID–19.
Diagnostic tests are the first line of defense in an outbreak, and FDA plays an
important role to ensure they work through EUA review. The EUA pathway expe-dites access to accurate diagnostic tests during emergencies, when information gaps and false results may adversely affect individual patient care and public health deci-sion-making. EUAs enable molecular diagnostic tests to be developed, validated, au-thorized, and deployed within weeks rather than several months to over a year, as is typical for test development and traditional premarket submissions. The Agency has employed its EUA authorities to facilitate availability of tests in each PHE or
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threat situation since 2009, when the Secretary of HHS declared that circumstances
exist justifying the authorization of emergency use of in vitro diagnostics. In PHEs, FDA is generally open to receiving and reviewing EUA request for tests from any developer, including commercial kit manufacturers and laboratories.
FDA sought to facilitate COVID–19 test evaluation and authorization through the
development and availability of templates. The templates provide recommendations for test validation and a fill-in-the-blank form to streamline the paperwork and make it easier for developers to provide information in support of a request for emergency use authorization. Since providing the first template in January 2020, FDA has been in daily contact with test developers to answer questions and help them through the EUA process. This has proved to be a helpful tool for many. FDA has now made nine templates available for a variety of test types. As of July 13, 2021, these nine templates have received 510,725 hits from those visiting FDA’s website. FDA also supported test developers through establishment of a dedicated mailbox, 24–7 toll-free hotline that ran until July 2020, the posting of over 100 fre-quently asked questions on our website, and by hosting weekly virtual town halls for test developers. The Agency has worked with over 1,000 test developers since January 2020.
Since early 2020, FDA has adopted agile, interactive, and innovative approaches
to EUA review for all types of devices. For example, FDA developed the umbrella EUA approach to efficiently authorize multiple devices of the same type meeting the same criteria. The Agency has also issued 28 guidance documents (including 17 revi-sions) outlining policies to help expand the availability of medical devices needed in response to COVID–19. For example, developers of certain tests offered their tests, upon validation and notification to FDA prior, to issuance of an EUA during Agency review of the EUA request. Further, FDA made several improvements to our EUA review processes to make the most efficient use of our resources, including es-tablishing a front-end triage process to identify devices that would have the greatest impact on the public health. These improvements incorporate the latest information on device availability and shortages, prioritizing novel or critical devices not yet available on the market or those that would address significant device shortages.
As of July 13, 2021, FDA has authorized 397 tests and sample collection devices
for SARS-CoV–2. As noted in the graphic below, these include 282 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 30 antigen tests. Among these are 11 diagnostic tests that can be run at home (three molecular and eight antigen tests), seven of which do not require a prescrip-tion. We have also authorized 18 tests for serial screening programs (11 antigen and seven molecular). The volume and variety of available tests is a testament to FDA’s support of innovative test design and our commitment to public health.
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FDA has authorized a wide variety of other medical devices for use in combating
the pandemic, including a wide range of personal protective equipment (PPE), ven-tilators, and other therapeutic devices. As of July 13, 2021, FDA has authorized 270 PPE devices including 39 surgical masks, and has authorized 205 filtering facepiece respirators (FFRs), 13 systems for PPE decontamination or bioburden reduction at
29
3https://www.fda.gov/news-events/press-announcements/fda-brief-fda-revokes-emergency-use-
authorizations-certain-respirators-and-decontamination-systems . the time there was a need for these types of devices due to PPE shortages,3and
13 EUAs for face shields and other barriers intended to protect the user from bodily fluids, liquid splashes, or potentially infectious materials (see related graphic below). In addition to granting EUAs, FDA has also cleared, through its premarket notification pathway, over 250 PPE 510(k)s.
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FDA recognizes that medical devices, particularly tests, will continue to play an
important role in the next phase of the pandemic response. The Agency is con-tinuing to monitor its policies, the marketplace, and national needs, and will con-tinue to adapt as the circumstances of the evolving pandemic warrant.
Human and Animal Food
Food security is national security. Thus, throughout the pandemic, FDA has
worked with Federal, state, and local partners, as well as industry, to help ensure a safe and adequate food supply for both people and animals.
While SARS-CoV–2 is not transmitted by food, some components of the food sys-
tem experienced challenges and supply chain imbalances, particularly at the outset of the pandemic. Overall, food production and manufacturing in the U.S. has re-
mained resilient. We continue to monitor the food supply chain systems closely to efficiently and promptly identify mitigation strategies when necessary. Early on, the pandemic caused a significant shift in where consumers were buying food. We took steps to provide temporary guidance to provide flexibility in packaging and labeling requirements to help industry redirect products manufactured for food service and institutional use to retail grocery stores, or if needed to the animal food industry so the food does not go to waste.
FDA also recognizes that food supply chain continuity and worker safety are two
sides of the same coin. Thus, a robust food supply is dependent on the safety and health of the Nation’s food and agricultural workforce. Along with our federal, state and local partners, we have provided best practices for food and agricultural work-ers, industry, and consumers on how to stay safe, and help ensure the continuity of operations in the food and agriculture critical infrastructure sector during the
30
pandemic and now as restaurants and other retail establishments resume regular
operations.
In response to the pandemic, FDA’s Office of Food Policy and Response, Center
for Food Safety and Applied Nutrition, Office of Regulatory Affairs, and Center for Veterinary Medicine developed 21 Forward , a food supply chain data management
tool, to help identify where risks for interruptions in the continuity of the food sup-ply due to COVID–19 transmission among workers may be greatest. As part of 21
Forward , FDA also conducted targeted outreach to the food industry to offer addi-
tional resources and technical assistance in addressing challenges.
In collaboration with HHS, CDC, and US Department of Agriculture (USDA),
data from 21 Forward have been made available to assist states with their vaccine
distribution efforts for workers in the food and agriculture sectors, including migra-tory and seasonal agricultural workers.
FDA’s Coordinated Outbreak Response and Evaluation team has been working
throughout the pandemic, is fully staffed, and on the job looking for signs of foodborne illness outbreaks and initiating responses as needed. FDA’s Center for Veterinary Medicine is also monitoring the animal food supply and initiating needed responses, working closely with other veterinary diagnostic laboratories in its Vet-erinary Laboratory Investigation and Response Network (VET-LIRN). In terms of inspectional work, FDA investigators continue to conduct mission-critical inspections domestically and abroad, including inspections and investigations in response to foodborne outbreaks during the pandemic. FDA transitioned to standard operations for domestic surveillance inspections in July 2021. Additionally, our import inves-tigators and laboratory analysts continue to work on-site by:
•Staffing our ports of entry, helping to ensure the efficient distribution
and safety of the Nation’s imported food supply; and
•Conducting examinations, sample collections, and laboratory analyses of
imported and domestic food to ensure the safety of our Nation’s food sup-ply.
FDA continues to screen every line of every shipment of imported food entering
the United States utilizing our Predictive Risk-Based Evaluation for Dynamic Im-port Compliance Targeting (PREDICT) tool. We adjusted the algorithm in PREDICT to place increased scrutiny on shipments from facilities where foreign inspections have been postponed. FDA has made greater use of our Foreign Supplier Verification Program (FSVP) regulation to oversee compliance with FDA Food Safe-ty Modernization Act (FSMA) requirements. The shift to remote FSVP inspections, along with other tools utilized by the foods program, has been critical to ensuring the safety of human and animal food from foreign suppliers during the COVID–19 pandemic. Since March 26, 2020, FDA has conducted 1,888 FSVP inspections. Since March 2020, FDA has refused approximately 8,469 lines of imported food products. FDA will continue to target and refuse human and animal foods that are unsafe, misbranded, or may cause a serious health concern for the public.
FDA continues to closely monitor the overall safety of the Nation’s food supply,
in collaboration with CDC, USDA, U.S. Customs and Border Protection (CBP) and our state and local partners, to protect consumers from foods contaminated with pathogens.
One year ago, FDA announced the New Era of Smarter Food Safety Blueprint
outlining the Agency’s plans over the next decade to create a more digital, traceable, and safer food system. We have learned from our response as an Agency to the pan-demic that there is an accelerated need for certain goals in this blueprint, especially those involving supply chain continuity and resilience, modernized inspectional ap-proaches, and strengthening food safety infrastructures with regulatory partners.
Inspections, Compliance, and Protecting the Medical Supply Chain
Similar to their work protecting the food supply, import investigators have been
onsite protecting the medical supply chain at our ports of entry, courier facilities, and the international mail facilities (IMFs) throughout the pandemic. Through con-tinued vigilance, FDA has prevented unsafe and unauthorized pharmaceuticals and other medical products from entering the country. Since March 2020, with the co-operation of and in coordination with CBP, FDA has received and destroyed almost 60,000 products, totaling over 11,093,868 capsules, pieces, and tablets of illegal or unapproved drugs.
Since March 2020, FDA has refused approximately 94,725 lines of imported viola-
tive medical products. We have maintained the same level of pre-pandemic screen-
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4https://www.fda.gov/regulatory-information/search-fda-guidance-documents/remote-inter-
active-evaluations-drug-manufacturing-and-bioresearch-monitoring-facilities-during-covid . ing for imported products. However, FDA has focused examinations on COVID–19
relief supplies to ensure compliant products are expedited while maintaining our commitment to refusing imported medical products that are unsafe, misbranded, un-approved, counterfeit, or may cause serious illness or injury to the public. In fact, our import and domestic officers have evaluated donations of shipments destined for the Federal Emergency Management Agency (FEMA) and met the first vaccines (Pfizer Belgium) on their arrival into the United States in December 2020 to ensure proper transport, storage, and reconciliation of products. Our officers also assisted with expediting the importation of other compliant vaccine-related shipments.
Despite pausing domestic and foreign surveillance inspections in March 2020 to
safeguard the health and well-being of our staff, as well as employees at facilities we inspect, our investigators continued to conduct mission-critical inspections both domestically and abroad to ensure FDA-regulated industries were meeting applica-ble FDA requirements. In July 2020, FDA resumed prioritized domestic inspections. To arm our investigators with the most reliable and accurate information, FDA de-veloped a rating system to assist in determining when and where it was safest to conduct prioritized domestic inspections.
On May 5, 2021, FDA issued a report titled, ‘‘Resiliency Roadmap for FDA
Inspectional Oversight,’’ outlining the Agency’s inspectional activities during the COVID–19 pandemic and its detailed plan to move toward a more consistent state of operations, including FDA’s priorities related to this work going forward.
The report outlines inspections that the Agency was unable to complete during
the past year due to travel restrictions or inability to ensure the safety of our work-force or the workforces within the industries the Agency regulates. The report also outlines the number of mission-critical inspections FDA completed during that time, such as inspections of facilities for which there was a drug shortage, inspections needed for the approval of novel drugs or drugs related to the potential treatment of COVID–19, support of pre-market and pre-license applications, and response to foodborne disease outbreaks or other food safety risks such as food contaminated with pathogens.
Of note:
•From March 2020 through March 2021, FDA conducted a total of 821
mission-critical inspections, including 29 in foreign countries.
•Additionally, the Agency conducted a total of 777 prioritized domestic in-
spections since resumption of that work in July 2020.
•Of the more than 13,500 applications for medical product approval or au-
thorization received since March 2020, only approximately 68 applica-tions have been delayed due to the inability to conduct inspections—and a majority of these applications are not deemed mission-critical.
Additionally, the Resiliency Roadmap Report outlines FDA’s continued, successful
use of alternative tools and approaches where inspections were or are not currently feasible, including remote interactive evaluations (e.g., remote livestreaming video of operations, teleconferences, or screen sharing), making record requests to regu-lated establishments, and leveraging information from trusted regulatory partners. For example, FDA made over 1,300 record requests to human and animal drug and biological product manufacturers, to support on-time regulatory decision actions. In
addition, since March 2020, FDA has added products from 18 firms to import alerts as subject to detention without physical examination, based on records requests in advance or in lieu of inspection that FDA submitted pursuant to section 704(a)(4) of the FD&C Act.
Notably, FDA’s bioresearch monitoring program staff have conducted more than
130 remote interactive evaluations that were directly used for application deci-sions.
4The new tool was incentivized for and supported by industry and continues
to provide the Agency with valuable information to assist with risk-based targeting for inspections. FDA recognizes that remote approaches do not replace inspections, and that there are situations where only an inspection is appropriate based on risk and history of compliance with FDA regulations.
The Resiliency Roadmap Report further outlines the ongoing steps the Agency is
taking to resume standard operational levels of inspection activities, including how it intends to prioritize domestic and foreign inspections that were not performed during the pandemic. The plan highlights a variety of possible scenarios given the continued uncertainty of the trajectory of the ongoing COVID–19 pandemic. On July
32
1, FDA activated the base-case scenario (COVID response continues on current
trend) to transition to standard operations for domestic inspections and other oper-ational work, as detailed in the report. Inspections considered critical to FDA’s mis-sion will remain the primary focus. When planning routine surveillance inspections, the Agency will prioritize higher-risk establishments. This means that postponed in-spections will be prioritized based on risk and conducted over a longer period of time, ultimately increasing the amount of time between inspections of certain lower- risk facilities in order to focus on products that present the greatest risk to public health.
The Agency will also soon begin a multi-year modernization effort to further
transform our data enterprise platforms and cross-program interoperability infra-
structure to better support innovation related to its regulatory oversight role. This includes adopting technology to support regulatory assessments to improve our re-mote receipt, review, and analysis of industry data and records, and improve remote interactions with industry entities to be easier, more efficient, more consistent, and more secure. This modernization effort will include a review of inspectional ap-proaches using next-generation assessment technologies and improvements. FDA is also establishing an Agency-wide Inspectional Affairs Council that will provide for coordination of inspection approaches and assessment processes. The Agency in-tends to share more information on these efforts as this work progresses. FDA will continue to leverage and maximize every available tool and resource to meet its inspectional responsibilities, while achieving optimal public health outcomes.
Compliance and Enforcement
FDA exercises its regulatory authority by, among other things, issuing warning
letters and pursuing civil and criminal actions against firms and individuals who do not comply with regulatory requirements, including those selling unapproved products with false or misleading claims that the products prevent, treat, mitigate, diagnose, or cure COVID–19. In March 2020, FDA launched Operation Quack Hack, which leverages Agency expertise and advanced analytics to protect consumers from fraudulent medical products, including unproven cures, illegitimate test kits, and substandard or counterfeit respirators. FDA has sent thousands of abuse complaints to domain name registrars and internet marketplaces. The Agency also has sent more than 241 warning letters to sellers of unproven COVID–19 products. Working with the Department of Justice (DOJ), FDA has sought and obtained preliminary injunctions that require defendants to halt the sale of fraudulent products claiming to treat or prevent COVID–19, including one product, ‘‘Miracle Mineral Solution,’’ that, when used as directed, is equivalent to industrial bleach.
In addition, FDA’s Office of Criminal Investigations (OCI), working with other
Federal and local law enforcement agencies, investigated a hospital pharmacist who tampered with COVID–19 vaccine doses at a Wisconsin hospital where he worked. On two successive overnight shifts at the hospital in late December 2020, the phar-macist purposefully removed a box of COVID–19 vaccine vials manufactured by Moderna—which must be stored at specific temperatures for specific time periods to remain viable—from the hospital’s refrigeration unit intending to render the vac-cines inert and no longer effective. The pharmacist acknowledged that after leaving the vaccines out for several hours each night, he returned them to the refrigerator to be used in the hospital’s vaccine clinic the following day. Before the full extent of his conduct was discovered, 57 people received doses of the vaccine from these vials. In January 2021, the pharmacist pled guilty to two counts of attempting to tamper with consumer products with reckless disregard for the risk that another person will be placed in danger of death or bodily injury. He has been sentenced to 3 years imprisonment, followed by 3 years of supervised release, and he must pay approximately $83,800 in restitution to the hospital.
In addition, FDA investigators remain on the front lines at ports of entry, quickly
examining, reviewing, and sampling import entries, and refusing admission where appropriate. We protect the supply chain in two equally critical ways, by helping to ensure that (1) safe products are coming in; and (2) illegal, dangerous, and fraud-ulent products do not get into the country. These efforts include partnering with CBP in establishing satellite laboratories at selected IMFs with scientists using state-of-the-art screening tools to rapidly identify unapproved, counterfeit and illicit products.
In March 2020, OCI, with the help of domestic law enforcement partners and for-
eign counterparts in the United Kingdom, led the investigation of fraudulent COVID–19 ‘‘treatment kits’’ that were falsely declared as ‘‘water treatment.’’ Import examination of these shipments found misbranded ‘‘kits’’ intended to treat SARS-
33
5https://www.fda.gov/media/149616/download . CoV–2. As a result of this investigation, a British national was charged and arrested
for shipping mislabeled and unapproved products. Subsequently, in April 2020, FDA intercepted a bulk shipment of hydroxychloroquine coming from China going to a physician in California. The physician was thereafter charged with mail fraud and making a false statement stemming from the allegations that he smuggled hydroxychloroquine from China to make his own pills and concealed the shipment from CBP by mis-declaring it as yam extract. In May 2020, FDA worked with CBP to intercept several shipments of counterfeit facemasks, with the result that they were refused and destroyed before getting into U.S. commerce.
More recently, FDA has taken steps to address hand sanitizer products that pose
safety concerns, such as products that do not meet the required ethanol or isopropanol levels, or that contain or may contain toxic ingredients like methanol or 1-propanol. Regarding the latter, substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Ingesting 1-propanol can cause central nervous system depression, which can result in death. FDA has tested sev-eral hundred products using field-based and laboratory-based tools, found more than a hundred violative products, issued warnings to consumers not to use contaminated hand sanitizers, and has taken steps to help ensure that these dangerous or sub-potent products do not enter domestic commerce. FDA has coordinated with CBP to identify such products, and we have listed products made by more than 40 manu-facturers on import alert. FDA also placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products from entering the United States that appear to be in violation until the Agency is able to review the products. That action marked the first time the FDA has issued a countrywide im-port alert for any category of drug product.
Medical Product Supply Chain
FDA monitors and responds to worldwide demand and supply chain disruptions
for medical products caused by the COVID–19 pandemic. We work closely with man-ufacturers to help ensure they continue to notify the Agency of any permanent dis-continuance or interruption of drug (human and animal), biological product, and de-vice manufacturing in a timely manner and, as noted in FDA’s fiscal year 2022 budget, we are working to better position the Agency and our health care system to assure a strong domestic supply chain in future emergencies.
5
In addition to our usual communication with drug manufacturers, we work closely
with healthcare and pharmacy systems, hospitals, providers, and others on the frontlines of COVID–19 patient care to identify current or emerging regional short-ages of critical care drugs used to treat COVID–19.
FDA understands the significant impact shortages can have on patient care and
is doing everything within our authorities to help prevent and alleviate disruptions. When we identify a shortage, we react swiftly to mitigate the impact to U.S. pa-tients and health care professionals, and quickly share that information with the public. For example, we issued temporary policies for outsourcing facilities reg-istered with FDA and pharmacists in state-licensed pharmacies or Federal facilities, regarding the compounding of certain drugs used to treat hospitalized patients with COVID–19 when approved drugs are not available. The Agency has also published
guidance to help applicants and manufacturers provide FDA with timely and in-formative notifications about changes in the production of certain drugs (including animal drugs) and human biological products, and urging the submission of these notifications, which may assist in our efforts to prevent or mitigate shortages of such products.
The Agency quickly identified the need to help ensure widespread access to hand
sanitizers as demand spiked, while also continuing our mission to ensure these products are not contaminated by removing adulterated products from the market. FDA has published and continues to update three guidance documents designed to help facilitate the production of alcohol-based hand sanitizer in non-traditional set-tings such as pharmacies or distilleries. The Agency has launched several enforce-ment initiatives and import alerts to help stop adulterated and subpotent hand sani-tizer products from getting into U.S. distribution channels.
Our experience with COVID–19 demonstrates that a strong domestic supply chain
depends on a resilient supply chain for medical devices as well. Indeed, multiple en-tities across the public and private sector have important parts to play in strength-ening the domestic medical device supply chain. FDA can play a critical role in iden-
34
tifying and preventing shortages for devices, because the Agency not only reviews
and authorizes these products, but also has unique, collaborative relationships that allow direct engagement with device manufacturers, patients, distributors, healthcare organizations and other stakeholders. Even before the pandemic hit the United States, there were already problems in the supply chain due to demand for devices in other nations where COVID–19 was already prevalent. As a result, FDA began shortage mitigation activities for medical devices in January 2020 before the PHE was declared in the U.S., and months before a pandemic was declared world-wide. The Agency took several actions to rapidly respond to supply chain needs, in-cluding reassigning 130 staff to perform shortages work across CDRH and con-tacting over 1,000 manufacturing facilities in 12 countries in just a few weeks’ time to get as much information as possible about critical devices.
In addition, FDA has conducted horizon scanning to assess demand for devices
needed to respond to the pandemic, including PPE, ventilators, diagnostic supplies, infusion pumps, and non-contact infrared thermometers; and established a rapid re-sponse team, working with field personnel to address fraudulent imports. The Agen-cy has likewise worked to prevent and mitigate shortages of testing supplies. For example, FDA collaborated with U.S. Cotton, one of the world’s largest manufactur-ers of cotton swabs, to develop and produce a polyester-based swab for testing. FDA also collaborated with laboratories and clinical investigators validating potential al-ternative sources of control materials, transport media, and swabs. As individual de-velopers validated these alternative components, FDA requested their permission to share their findings publicly so that others could benefit, and we posted these alter-natives on our website. In this way, FDA has been serving as a clearinghouse for scientific information that the entire community can leverage to mitigate shortages and increase testing capacity. FDA continues to post this information on a rolling basis on an FAQ website so that labs have access to the latest information regard-ing alternative controls, transport media, extraction, instruments, and swabs.
Congress has acknowledged the importance of this work to our health care sys-
tem, and we want to continue working with this Committee and others to ensure FDA has the resources and authorities needed to ensure U.S. patients and health care providers have the products they need each day, and especially during public health emergencies.
Conclusion
FDA continues to advance its mission to protect and promote public health by en-
suring the safety of human and animal food, and the safety and effectiveness of medical products. We take our public health mandate very seriously and will con-tinue to work each day to end this pandemic. We continue to communicate with the American public and make regulatory decisions based on data and sound science. I look forward to continuing to work with the Committee on these efforts and thank you again for the opportunity to testify today.
The C HAIR . Thank you.
Assistant Secretary O’Connell.
STATEMENT OF DAWN O’CONNELL, ASSISTANT SECRETARY
FOR PREPAREDNESS AND RESPONSE, UNITED STATES DE-PARTMENT OF HEALTH AND HUMAN SERVICES, WASH-INGTON, DC
Ms. O’C ONNELL . Chair Murray, Ranking Member Burr, and dis-
tinguished Members of the Committee, I am honored to testify be-fore you today regarding efforts within the Office of the Assistant Secretary for Preparedness and Response to support the ongoing response to COVID–19. First, let me thank you for your support of my confirmation. It was just 6 weeks ago that I was before you as a nominee, and it has been just over 3 weeks since I was confirmed as the ASPER.
I am honored that you have entrusted me with this important
role, and I pledge to do everything I can to maintain your trust and confidence in my abilities to lead this Office with vision, precision,
35
and transparency. While I continue to assess ASPER’s work, one
thing is abundantly clear. The ASPER team is working tirelessly to end this pandemic, and I am pleased to share some examples of the work that they are leading. As you know, the Strategic Na-tional Stockpile, or SNS, worked to backstop states’ medical supply needs when the pandemic strained global supply chains.
The SNS has deployed more than 200 million items including
personal protective equipment or PPE, ventilators, Federal medical stations, and pharmaceuticals. ASPER has invested approximately $10 billion from COVID–19 supplementals to replenish the SNS to levels at or above pre-COVID–19 amounts. A new mission ASPER has taken on over the course of the pandemic is securing the med-ical supply chain. This work is complex and challenging and has forced our organization to stretch in new ways. A secure and resil-ient medical supply chain is not only necessary for our current COVID–19 response but will be critical for any nationwide re-sponse that follows.
ASPER is investing in industrial base expansion efforts to reduce
supply chain vulnerabilities and generate a domestic warm base for manufacturing that can be leveraged in a crisis. So far, ASPER has supported efforts for domestic manufacturing of PPE, active phar-maceutical ingredients, COVID–19 tests and supplies such as re-agents and resins.
In support of this work, ASPER is also leveraging the authorities
delegated to the secretary under the Defense Production Act to en-sure that private sector partners making life saving products have the materials they need to deliver their product. So far, ASPER has priority rated 55 contracts to directly and indirectly support the COVID–19 response effort.
ASPER will continue to leverage all of the tools we have at our
disposal to ensure the supply chain is secure and that we are never again in this situation we found ourselves in last year. The na-tional disaster medical system has completed nearly 5,400 mission assignments. The teams have brought surge capacity to ICU and emergency rooms, established medical overflow centers, provided mortuary support in places like New York City, established sites to deliver therapeutics, and operated Federal vaccination sites. They are currently standing by to participate in surge teams being stood up by the Administration to respond to recent hotspots.
The ASPER’s Biomedical Advanced Research and Development
Authority, or BARDA, has supported over 65 medical counter-measure projects for the COVID–19 response. Most notably, BARDA led the vaccine development work for what was then known as Operation Warp Speed and is now known as the Coun-termeasures Acceleration Group and advanced the development of the three vaccines currently authorized by the FDA.
This was done, as you know, at historic speed with less than a
year between the identification of the virus in the authorization of the first vaccine. ASPER is also working with HHS leadership and the Department of Defense to transition the Countermeasures Ac-celeration Group to a long term sustainable management structure within HHS. Dr. Robert Johnson, a senior leader at BARDA, re-cently assumed the responsibilities as the Chief Operating Officer of the mission.
36
I look forward to using this transition planning period as an op-
portunity to evaluate gaps and bring in the additional logistical ca-pacity needed at ASPER and HHS to sustain the enduring mission for as long as it is required. As we move forward, I would like to build on this foundation to accelerate and recalibrate the work where needed and continue to do all we can to bring an end to the pandemic as quickly as possible.
Thank you again for inviting me to testify and allowing me to
share these examples of the work ASPER is leading on behalf of the Administration wide COVID–19 response effort. I look forward to answering your questions.
[The prepared statement of Ms. O’Connell follows:]
PREPARED STATEMENT OF DAWN O ’CONNELL
Chair Murray, Ranking Member Burr, and distinguished Members of the Com-
mittee, it is an honor to testify before you today on efforts within the U.S. Depart-ment of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) to support the ongoing response to COVID–19. I am grateful for this opportunity to address this Committee and appreciate your continued support for the ongoing response efforts.
When I first appeared before the Committee in early June as the ASPR nominee,
I shared my top three priorities for the office, which are reflected in the Fiscal Year 2022 Budget request:
First, I wanted to ensure that ASPR has the resources and support nec-
essary to continue its critical COVID response work, and help the Nation emerge quickly from the current pandemic. This critical work is in addition to our normal preparedness and response efforts for natural disasters, chemical, biological, radiological, and nuclear incidents, and pandemic influ-enza PI events.
Second, I wanted to restore and strengthen capacities that have become
strained during the COVID–19 pandemic. Specifically, I wanted to ensure the Strategic National Stockpile (SNS) is appropriately resourced, replen-ished, and ready to respond to future challenges, and that the medical sup-ply chain is resilient and can support our country’s needs.
Finally, I wanted the organization to increase readiness for future public
health emergencies by working with our colleagues both inside the Depart-ment and across the interagency to prepare for whatever manmade or natu-rally occurring threats may come next.
A month into the job, these remain my top priorities. Every passing day I am
awed by the hard work and dedication of the ASPR team. It is clear to me that they are working as hard now to end the pandemic as they did when the outbreak first began. Today, I am pleased to share with you an update on the tireless work they have been doing to respond to COVID–19.
Update on ASPR’s COVID–19 Response Effort
Countermeasures Acceleration Group
The response to the COVID–19 pandemic has required an unprecedented whole
of government approach. As you are familiar, HHS and the Department of Defense (DoD) forged a partnership formerly called Operation Warp Speed (OWS) that is now known as the Countermeasures Acceleration Group (CAG). This partnership brought together the two Departments to develop, manufacture, and deliver safe and effective vaccines and therapeutics to the American people. ASPR has played a significant leadership and coordination role on behalf of HHS in the effort. This endeavor has delivered nearly 390 million vaccine doses and over a million thera-peutic doses to protect the American people from COVID–19.
In addition, the President has committed to sharing 580 million doses of vaccine
with the world. This includes half-a-billion Pfizer doses the United States will pur-chase and donate to 100 countries in need—the largest-ever donation of COVID–19 vaccines by a single country, and a commitment to share 80 million doses of our
37
own surplus U.S. supply. The CAG has delivered nearly 40 million vaccines to 25
countries, with millions more en route.
Now, work is underway to transition DoD’s role in the CAG to HHS for long term
sustainability and management. Dr. Robert Johnson, the Director of the Influenza and Emerging Infectious Diseases Division of ASPR’s Biomedical Advanced Re-search and Development Authority (BARDA), assumed the responsibilities as the Chief Operating Officer of the CAG earlier this month. Under Dr. Johnson’s leader-ship, ASPR’s role in the response is more apparent than ever.
Biomedical Advanced Research and Development Authority
ASPR’s BARDA has supported over 65 medical countermeasure projects for the
COVID–19 response. All of these contract awards are listed on medicalcountermeasures.gov in detail and include 14 therapeutics, 48 diagnostics,
and seven vaccine candidates. Notably, BARDA, as part of the then-Operation Warp Speed, accelerated the availability of three vaccines—Moderna, Pfizer, and Johnson & Johnson. This was done at historic speed, with the novel virus identified and the first vaccine authorized in under a year.
Looking forward, BARDA will leverage the supplemental appropriations provided
by Congress to continue its work as part of the CAG to support the development of additional vaccines and therapeutics to end the COVID–19 pandemic. There are still populations—like children under the age of 12—that cannot yet receive the vac-cine as we complete careful clinical testing. It is critical that the work continue to
develop vaccines and to establish successful treatments for those who do become in-fected. I look forward to working with this Committee on specific plans toward this effort.
Strategic National Stockpile and Medical Supply Chain
The pandemic has severely strained our public health and medical supply chains.
As this Committee is well aware, the medical supply chain ecosystem is complex, with different private sector players and market dynamics across categories of med-ical equipment and supplies. Many vital products are primarily made overseas, and practices like ‘‘just in time’’ inventory management resulted in difficulty surging manufacturing when demand surged last spring. This created significant and dev-astating challenges for states and healthcare systems that needed these key sup-plies.
Over the course of the COVID–19 response, the SNS has worked to backstop
States’ medical supply needs at an accelerated pace. As of June 15, 2021, the SNS deployed more than 200 million items to aid the national response including Per-sonal Protective Equipment (PPE), ventilators, Federal Medical Stations, and phar-maceuticals. Now, ASPR is working to replenish the SNS to levels at or above pre- COVID–19 amounts, so it is prepared for any subsequent wave of additional cases.
As of July 9, 2021, the SNS has utilized approximately $10 billion from COVID–
19 supplemental appropriations provided by Congress to inventory approximately: 517 million N95 respirators (35 times pre-pandemic levels); 272.5 million surgical and procedure face masks (eight times pre-pandemic levels); 11.9 million face shields (two times pre-pandemic levels); 22 million gowns and coveralls (five times pre-pandemic levels); 524.7 million gloves (17 times pre-pandemic levels); and 167,000 ventilators (10 times pre-pandemic levels).
While replenishing the SNS is essential, it is also critical to address the root-
causes of why supply chains were so strained in the first place. ASPR is taking on this work as well since ensuring a safe and consistent supply chain for medical ma-terials, ingredients, and supplies is critical for any national response to public health emergencies.
To start, ASPR is leveraging the authorities delegated to the Secretary under the
Defense Production Act (DPA) to ensure that private sector partners making life- saving products are able to acquire raw materials, retool their machinery, scale their production facilities, train their workforces, and ultimately deliver their prod-uct. Throughout the COVID–19 response, ASPR has used the DPA authority to issue 46 priority ratings for U.S. Government (USG) contracts for health resources, eight priority ratings for USG contracts for industrial expansion, 3 priority ratings for non-USG contracts to support the production of resins for both diagnostics and infusion pumps, and the manufacture of closed suction catheters for treatment of patients with COVID–19. Going forward, ASPR will continue to build capacity and partnerships with private industry toward the shared goal of ending the COVID– 19 pandemic.
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In addition, ASPR is working to steward Congress’s investment in expanding the
domestic industrial base. These industrial base expansion (IBx) efforts seek to re-duce supply chain vulnerabilities and generate a domestic ‘‘warm-base’’ for manufac-turing that can be leveraged in a crisis. So far, ASPR has supported domestic manu-facturing of PPE; active pharmaceutical ingredient manufacturing capacity; and COVID–19 testing, including swabs, tests and kits, and supplies such as reagents and resins. Each of these domestic manufacturing initatives meet current, as well as future COVID–19 needs, and seek to create or sustain high-value domestic jobs.
Healthcare System Preparedness
Finally, I want to share more about ASPR’s work to prepare our healthcare sys-
tem to surge to meet the demands of those being treated for COVID–19, without compromising day-to-day health care needs.
Through ASPR’s Hospital Preparedness Program (HPP), the only Federal program
that supports preparedness efforts within the healthcare system, ASPR has invested $350 million from supplemental appropriations in the National Special Pathogen System (NSPS). These investments span the 62 HPP funding recipients, their asso-ciated 55 Special Pathogen Treatment Center sub-recipients, 10 Regional Ebola and Special Pathogen Treatment Centers (RESPTC) recipients, the National Ebola Training and Education Center (NETEC) (a consortium of three academic medical centers), and 53 hospital associations, and helped leverage and amplify technical guidance from the Centers for Disease Control and Prevention (CDC). These compo-nents work together to provide a coordinated, national approach to preparing health care systems to surge for public health and medical emergencies.
During the COVID–19 pandemic, the NSPS coordinated national expertise, re-
gional capabilities, and state and local healthcare capacities across the public and private sectors to support an effective pandemic response. Looking ahead, I look for-ward to examining ways to strengthen investments like these in preparedness to en-sure the healthcare system is ready to surge for future public health and medical incidents.
Further, if a public health or healthcare system becomes overwhelmed with pa-
tients, states can request National Disaster Medical System (NDMS) personnel to provide additional support. During the COVID–19 response, NDMS has completed nearly 5,400 mission assignments so far, and counting. For these deployments, NDMS personnel supported hospital augmentation including emergency room sup-port; hospital decompression; setting up medical overflow centers for patients and mortuary support; establishing monoclonal antibody therapy sites; ICU augmenta-tion; and, operating Federal vaccine sites. With the aid of NDMS personnel and re-sources, communities were able to continue to provide care to those in need of med-ical assistance and treatment. NDMS will continue to support such requests.
Conclusion
Thank you again for inviting me to testify before you on efforts within ASPR to
support the COVID–19 response. I look forward to answering your questions and working with my team at ASPR and our colleagues across HHS to end the COVID– 19 pandemic.
The C HAIR . Thank you very much to all of our panelists today.
We will now begin a round of 5 minute questions of our witnesses. I ask all of my colleagues, please keep track of your clock. Stay within those 5 minutes. We do have votes starting at 11:30 a.m. and we have many Members in attendance today. My first question is for the whole panel.
We are at a pivotal point in this pandemic, and after weeks of
declining rates of cases and deaths, we are now seeing a resurgence of COVID–19 in part due, as you mentioned, to the circulation of variants. Vaccination rates are plateauing and COVID fatigue is setting in around the country. So I want to ask each of you, what is the one thing everyone can do to help keep us from returning to the early days of this pandemic?
Dr. Walensky.
39
Dr. W ALENSKY . Get vaccinated and get your neighbors vac-
cinated.
Dr. F AUCI .
[Technical problems.] The C
HAIR . Dr. Woodcock.
Dr. W OODCOCK . Couldn’t say it better.
The C HAIR . Ms. O’Connell.
Ms. O’C ONNELL . Get vaccinated.
The C HAIR . Thank you to all of you and I hope everyone heard
that. Dr. Fauci, the quick development of effective COVID vaccines has been a real success story during this pandemic. People are get-ting vaccinated. It is really key to everyone’s ability to return to normal lives. With the spread of variants, as we all talked about, driving and increases in cases and deaths now, I am encouraged to see public health experts and vaccine developers are now consid-ering the possible need for boosters. You mentioned this a bit in your opening remarks, but I want to ask you, how do you assess the duration of vaccine efficacy and the impact of variants on that efficacy?
Dr. F
AUCI . Thank you very much, Madam Chair. There are two
ways that are actively being used now to assess the answer to your question. One is there are correlates of immunity which have been established. In other words, you have a level of measurable labora-tory, for example, neutralizing antibody, which is the easiest to measure. There are also areas of immunity that are more difficult to measure, like T-cell responses. But the one that seems to be very well correlated is the antibody level.
We know from studies, from the clinical trials, as well as from
animal studies that there is a baseline level below which you go, you are much more vulnerable to getting a breakthrough infection. So the first is laboratory data. The second is watching and fol-lowing cohorts of people to see if you have an increase in break-through infections. We know, according to the clinical trial, take for an example, the mRNA, they are 93 to 94 percent effective in pre-venting clinically recognizable disease.
If you see a fall below that into the 80’s or even unfortunately
hope it never happens into the 70’s, then you reached the point where the durability needs a boost. Those studies are ongoing right now.
The C
HAIR . We don’t have any data about whether or not we are
seeing that?
Dr. F AUCI . No, we don’t. There are some preliminary data that
we have heard about from Pfizer, which studies that they did in Israel and in their own studies, which seem to indicate that there is waning immunity. We have a lot of cohorts that we are fol-lowing. The CDC is following at least 20 cohorts that will be able to amplify on that data and give us much more of a basis of mak-ing a decision.
The C
HAIR . How will the Administration determine if booster
shots are needed?
Dr. F AUCI . Just by those very studies. Just by the following the
cohort studies and we are waiting. We will be maybe—perhaps Dr. Walensky would like to comment because she has in her domain of the CDC a number of cohort studies that will inform us. In the
40
meantime, we at NIH are doing studies now to determine when
you give a booster, how high up do you get it and what kind of a cushion do you get for antibody responses?
The C
HAIR . Okay.
Dr. Walensky. Dr. W
ALENSKY . Yes. Thank you, Senator. We have numerous co-
hort studies. They represent tens of thousands of people, and they are represented across the United States. These include data from 14,000 nursing home facilities, long term care facilities. We have a heroes cohort that is essential workers of over 5,000 people that are actually getting weekly PCR testing. We have health care worker cohorts.
We have cohorts across the country where we are following these
data and really looking at it every several weeks to understand what the vaccine efficacy is. And it is among that, and the labora-tory data will be the decisions that we use. Fortunately, we are an-ticipating that this will wane and not plummet. So as we see that waning, that will be our time for action.
The C
HAIR . Okay, thank you very much. We really appreciate it.
We will stay in touch on that. I will reserve the balance of my time because there are many Members here.
Senator Burr. Senator B
URR. Thank you, Madam Chair. I have got to say, the
last exchange was, oh, my god, we haven’t learned anything. Let me just make this point. I remember early on in this when the question of testing came up, the CDC said we do testing. And CDC demanded to do the test and we lost weeks. And I am not here to evaluate data. Tony, that is your job and Rochelle and others. But to say we are going to make this decision based upon the research we have got going on at CDC, based upon the information that we have put out and only our research counts, and to basically ignore the Israeli data or the Pfizer data—and I am not suggesting that we are totally doing that.
I guess my question would be, is Israel giving us transparency
into their data? If you still lived in a world when we didn’t accept foreign data for applications, which FDA has had the authority to do since 1996 when I changed the law, but it took COVID to actu-ally make that happen. So I realized that we want accuracy. But do we really have to wait for CDC to complete the data? Do you think you are going to come to a different conclusion than Israel did? Share with me.
Dr. W
ALENSKY . Thank you for that question, Senator. Absolutely
not. We have to have collaboration across the globe because this is a global problem. So we have already had two conversations with Israel. We have data sharing from our collaboration—from our co-horts as well as from theirs. We have also been in discussions with the UK to see what data they have because, of course, they are sev-eral weeks ahead of us in the delta variants. So we intend to lever-age all of the data we have around the world to share liberally with other countries and the hopes that they will share with us so that we can make the proper decisions here in this country and around the world.
Senator B
URR. Is there a reason to believe that the Israeli data
is flawed?
41
Dr. W ALENSKY . I am sorry?
Senator B URR. Is there reason to believe the Israeli data is
flawed?
Dr. W ALENSKY . Flawed, we are in discussions, epidemiologic dis-
cussions. There are numerous cohorts in Israel, those in the Min-istry of Health, those in their health care systems. And we have seen some of their data. They are actually continuing to analyze the data. And so where we are in those active epidemiologic con-versations.
Senator B
URR. My point is they have made a decision to do boost-
er’s based upon their data. And we are saying we are still going to work out through our research to determine. And that is where you begin to lose the trust of the American people in our health care experts. In April, the Biden administration announced a $1 billion commitment for sequencing at CDC. To date, only 844 cases from North Carolina have been sequenced, according to CDC website. We had over a million cases. It seems there is a major problem again at CDC. Let me just ask you, in CDC’s recent up-dated mask guidance for schools, says community should use local outbreak data to make decisions.
Yet I would challenge you that if only 844 cases have been
sequenced, those local people don’t have the data they need to make that determination as to what the policies are going to be at a local level. Would you agree?
Dr. W
ALENSKY . That discussion is based on cases, not based on
variance. So we are actually getting data from around the country based on variance as well, based from the local health departments within North Carolina and with all of the states, as well as aca-demic centers, and commercial labs. And the recommendations for schools was based on test positivity and positive cases, not nec-essarily based on variance.
Senator B
URR. But shouldn’t transparency by the local health de-
partment about the variant in their community be important to their decision as to what they do in the schools?
Dr. W
ALENSKY . Absolutely. And we have data by region for
variants that are posted on our website. They have been updated this morning with 83 percent. So not only are we looking at test positivity actually down to the county level, but variants that come in as well from each of the individual states, from the academic partners, from the labs.
Senator B
URR. Dawn, I know you have only been there 3 weeks.
What are your plans to address the pressure that the flu is going to cause on the system?
Ms. O’C
ONNELL . Ranking Member, thank you for that question.
That has been something that we have been—the ASPER team has been considering and planning for over the last several months. There is now an interagency process set up by the White House Supply Chain Coordinator that ASPER has been actively partici-pating in, working with manufacturers of both flu vaccines and
COVID vaccines to make sure that the supplies are there so we have access to both vaccines as we head into the fall.
But it is something that we will continue to monitor and recali-
brate if needed so we are sure that we can do both at the same
42
time. At this point, our planning assumption suggests that we can,
but I will continue to monitor that.
Senator B URR. Thank you. Thank you, Chair.
The C HAIR . Senator Kaine.
Senator K AINE . Thank you, Chair Murray and Ranking Member.
Thank you to the witnesses. I want to say a word about disinformation and then have some questions. Former President Trump was on television this weekend and he said one of the rea-sons people won’t get vaccinated is because, ‘‘they don’t trust the election results.’’ And when I heard that, I sort of chuckled at that. I thought that was odd to be connecting a big lie about the election to refusal to get vaccinated. But it caused me to do something that I hadn’t done, which is look at the vaccination rates in all 51 states, including the District of Columbia.
The CDC data from yesterday morning shows the following. The
21 jurisdictions with the highest vaccination rates all vote for Joe Biden. 25 of the 30 jurisdictions with the lowest vaccination rates voted for Donald Trump. There is a difference between causation and correlation. But possibly what the President said on television on Sunday, there may be something to it that repeated disinformation about the election is now connecting in people’s minds with this information about willingness to take the vaccine.
It didn’t have to be this way because one of the great things
about President Trump and the Trump administration working with partners and funded by Congress was setting a world record in terms of developing really super effective vaccines in record time. President Trump had COVID in October. He decided to get vaccinated in January. He didn’t tout the vaccination. It came out months later. But he could still tout it, he could still say this is a Trump accomplishment and encourage people in these states who are lagging behind the national average to get vaccinated.
That won’t solve all of the problem because there are many rea-
sons people don’t get vaccinated. But I am now convinced, I just came back from Latin America. In Latin America, they are so thrilled at the U.S. donation of vaccines, and they view our vac-cines as state-of-the-art compared to the China and Russia vac-cines. And they appreciate that we are donating them rather than charging them, which China and Russia are doing. So around the world, people are beating a door down to try to get to U.S. vaccines if they can. And here we have near universal availability.
Again, I thought it was sort of comical, the President’s comments
this past weekend. But as I look at the CDC data, maybe it is not so comical, but it is incredibly serious. Dr. Walensky, I wanted to ask you this question. I think you stated in your opening testimony that the overwhelming majority of deaths now are people who are not vaccinated. Now, when you say overwhelming majority, are you talking about 60 percent, 80 percent, 95 percent, 99 percent? What is the statistic?
Ms. O’C
ONNELL . In a five-month study from January to May and
numerous states, five or six states, it was 99.5 percent.
Senator K AINE . Now, obviously, before the vaccine started, it was
100 percent. 100 percent of people who died before we were vacci-nating were unvaccinated by definition. And since the vaccine has begun to be deployed, 99.5 percent of people who died are people
43
who are unvaccinated. Those are very, very powerful statistics. As
the Administration has begun to say this is now a pandemic of the unvaccinated. Dr. Walensky, I am very concerned with a CDC press release, I guess, from last week about overdose deaths in the last calendar year. A 29 percent increase in overdose deaths.
It appears to be connected to the isolation. Substance use dis-
orders is often a disorder of isolation. It appears to be connected to the intense isolation of the last year. Can you tell us what CDC and other partners are doing to look at this and work together with us to try to combat the resurgence of a scourge which we had seen some positive movement on in the last few years?
Dr. W
ALENSKY . Yes, thank you, Senator. You know, there have
been two things in the last decades that have decreased life expect-ancy in this country. One is COVID–19 and the second is overdose. And so we are now seeing a collision of those two things happening at the same time. And in fact, as you noted, the report dem-onstrated a 29 percent increase in overdose deaths a year over year.
We are actively working to not only study this issue and not only
study the overdose deaths, but the overdose hospitalizations, to look at surveillance, to look at the infectious diseases associated with injection drug use, to promote certain services programs, naloxone programs, as well as to provide services and toolkits around the country for not just substance use disorders, but for mental health, Hear Her Now campaigns—Hear Her Now cam-paigns for maternal mortality, toolkits for suicide prevention for youth. Parental toolkits.
We are actively not only doing the surveillance and the studying
of this, but also the—in the communities for the toolkits on the pre-vention side.
Senator K
AINE . Right, thank you. I yield back, Chair Murray.
The C HAIR . Thank you.
Senator Paul. Senator P
AUL. Dr. Fauci, as you are aware, it is a crime to lie
to Congress. Section 1001 of the U.S. Criminal Code creates a fel-ony and a five-year penalty for lying to Congress. On your last trip to our Committee on May 11, you stated that the NIH has not ever and does not now fund gain of function research in the U.S. Insti-tute of Virology. And yet gain of function research was done en-tirely in the Wuhan Institute by Dr. Xi and was funded by the NIH.
I would like to ask unanimous consent to insert into the record
the human virology paper entitled, Discovery of A Rich Gene Pool of Bats SARS Related Coronaviruses. Please deliver a copy of the Journal article to Dr. Fauci. In this paper, Dr. Xi credits the NIH and lists the actual number of the grant that she was given by the NIH. In this paper she took two bat coronavirus genes, spiked genes, and combined them with a SARS related backbone to create new viruses that are not found in nature.
These lab created viruses were then shown to replicate in hu-
mans. These experiments combine genetic information from dif-ferent coronaviruses that infect animals but not humans to create novel artificial viruses able to infect human cells. Viruses that in
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nature only infect animals were manipulated in the Wuhan Lab to
gain the function of infecting humans.
This research fits the definition of the research that the NIH
said was subject to the pause in 2014 to 2017, a pause in funding on gain of function. But the NIH failed to recognize this defines in a way, and it never came under any scrutiny. Dr. Richard Ebright, a molecular biologist from Rutgers, described this research in Wuhan as, ‘‘the Wuhan lab used NIH funding to construct novel chimeric SARS related coronaviruses able to infect human cells and laboratory animals.
This is high risk research that creates new potential pandemic
pathogens—potential pandemic pathogens that exist only in the lab, not in nature. This research matches,’’ these are Dr. Ebright’s words, ‘‘this research matches, indeed epitomizes the definition of gain of function research done entirely in Wuhan,’’ for which there was supposed to be a Federal pause.
Dr. Fauci, knowing that it is a crime to lie to Congress, do you
wish to retract your statement of May 11th where you claimed that the NIH never funded gain of function research in Wuhan?
Dr. F
AUCI . Senator Paul, I have never lied—.
Senator B URR. Microphone.
The C HAIR . The Microphone.
Dr. F AUCI . Senator Paul, I have never lied before the Congress,
and I do not retract that statement. This paper that you were re-ferring to was judged by qualified staff up and down the chain as not being gain of function.
Senator P
AUL. What does—.
Dr. F AUCI . Let me finish——
Senator P AUL. You take an animal virus, and you increase its
transmissibility to humans. You are saying that is not gain of func-tion?
Dr. F
AUCI . That is correct. And Senator Paul, you do not know
what you are talking about, quite frankly. And I want to say that officially. You do not know what you are talking about. Okay, you get one person—can I answer your question?
Senator P
AUL. From the NIH definition of gain of function—this
is your definition that you guys wrote. It says that scientific re-search that increases the transmissibility among mammals is a gain of function. They took animal viruses that only occur in ani-mals, and they increased their transmissibility to humans. How you can say that is not gain of function.
Dr. F
AUCI . It is not.
Senator P AUL. It is a dance, and you are dancing around this be-
cause you are trying to obscure responsibility for 4 million people dying around the world from a pandemic.
The C
HAIR . Let’s let—Dr. Fauci.
Dr. F AUCI . I have to—well, now you are getting into something.
If the point that you were making is that the grant that was fund-ed as a sub-award from Eco Health to Wuhan created SARS-CoV– 2, that is where you are getting. Let me finish.
Senator P
AUL. We don’t