[Senate Hearing 116-555]
[From the U.S. Government Publishing Office]
S. Hrg. 116-555
COVID-19: SAFELY GETTING BACK
TO WORK AND BACK TO SCHOOL
=======================================================================
HEARING
OF THE
COMMITTEE ON HEALTH, EDUCATION,
LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
ON
EXAMINING COVID-19, FOCUSING ON SAFELY GETTING BACK TO WORK AND BACK TO
SCHOOL
__________
MAY 12, 2020
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://www.govinfo.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
45-219 PDF WASHINGTON : 2022
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COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS
LAMAR ALEXANDER, Tennessee, Chairman
MICHAEL B. ENZI, Wyoming PATTY MURRAY, Washington
RICHARD BURR, North Carolina BERNARD SANDERS (I), Vermont
RAND Paul, Kentucky ROBERT P. CASEY, JR., Pennsylvania
SUSAN M. COLLINS, Maine TAMMY BALDWIN, Wisconsin
BILL CASSIDY, M.D., Louisiana CHRISTOPHER S. MURPHY, Connecticut
PAT ROBERTS, Kansas ELIZABETH WARREN, Massachusetts
LISA MURKOWSKI, Alaska TIM KAINE, Virginia
TIM SCOTT, South Carolina MARGARET WOOD HASSAN, New Hampshire
MITT ROMNEY, Utah TINA SMITH, Minnesota
MIKE BRAUN, Indiana DOUG JONES, Alabama
KELLY Loeffler, Georgia JACKY ROSEN, Nevada
David P. Cleary, Republican Staff Director
Lindsey Ward Seidman, Republican Deputy Staff Director
Evan Schatz, Minority Staff Director
John Righter, Minority Deputy Staff Director
C O N T E N T S
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STATEMENTS
TUESDAY, MAY 12, 2020
Page
Committee Members
Alexander, Hon. Lamar, Chairman, Committee on Health, Education,
Labor, and Pensions, Opening statement......................... 1
Murray, Hon. Patty, Ranking Member, a U.S. Senator from the State
of Washington, Opening statement............................... 5
Witnesses
Fauci, Anthony, M.D., Director, National Institute of Allergy and
Infectious Diseases, National Institutes of Health, Bethesda,
MD............................................................. 8
Prepared statement........................................... 9
Redfield, Robert, M.D., Director, United States Centers for
Disease Control and Prevention, Atlanta, GA.................... 12
Prepared statement........................................... 13
Giroir, Brett, M.D., Admiral, Assistant Secretary for Health,
United States Department of Health and Human Services,
Washington, DC................................................. 16
Prepared statement........................................... 18
Hahn, Stephen, M.D., Commissioner of Food and Drugs, United
States Food and Drug Administration, Silver Spring, MD......... 21
Prepared statement........................................... 23
ADDITIONAL MATERIAL
Statements, articles, publications, letters, etc.
Recommended Questions for the U.S. Senate Health, Education,
Labor, and Pensions Committee, Food & Beverage Issue
Alliance (FBIA)............................................ 74
COVID-19: SAFELY GETTING BACK
TO WORK AND BACK TO SCHOOL
----------
Tuesday, May 12, 2020
U.S. Senate,
Committee on Health, Education, Labor, and Pensions,
Washington, DC.
The Committee met, pursuant to notice, at 10:03 a.m., in
room 106, Dirksen Senate Office Building, Hon. Lamar Alexander,
Chairman of the Committee, presiding.
Present: Senators Alexander [presiding], Enzi, Burr, Paul,
Collins, Cassidy, Roberts, Murkowski, Scott, Romney, Braun,
Loeffler, Murray, Sanders, Casey, Baldwin, Murphy, Warren,
Kaine, Hassan, Smith, Jones, and Rosen.
OPENING STATEMENT OF SENATOR ALEXANDER
The Chairman. Well, good morning. The Committee on Health,
Education, Labor, and Pensions will please come to order.
First, some administrative matters. Based on the advice of
the attending physician and the Sergeant at Arms, after we
consulted the Department of Health and Human Services and the
Centers for Disease Control and Prevention, individuals in the
hearing room are at least 6 feet apart. As a result, there is
no room for the public to attend in person. Representatives of
the press are working as a pool to relay their observations to
colleagues.
The hearing may be watched online. An unedited recording
will be available on the Committee's website,
www.help.senate.gov
Witnesses are participating by videoconference in a one-
time exception. Some Senators, including the Chairman, are
participating by videoconference. Senators, we have been
advised, may remove their masks, talk into the microphone when
they are in the hearing room as they are 6 feet apart.
I am grateful to the Rules Committee, Sergeant at Arms, the
Press Gallery, the Architect of the Capitol, the Capitol
Police, Committee staff Chung Shek and Evan Griffis, all for
their hard work to keep us safe.
At our hearing last Thursday, I said that all roads back to
work and back to school run through testing, and that what our
Country has done so far on testing is impressive, but not
nearly enough. Over the weekend, Senator Schumer, the
Democratic leader, was nice enough to put out a Tweet quoting
half of what I said. He left out the other half, the impressive
part.
Let me say again what I meant by that. When I said
impressive, I meant that, according to the Johns Hopkins
University study, the United States has tested over nine
million Americans for COVID-19. That is twice as many as any
other country. We do not know what China has done. And, it is
more per capita than most countries, including South Korea,
which many Members of our Committee had cited as an example of
a country that had tested well. According to Dr. Deborah Birx,
the United States will double testing in the month of May,
which should get us up to about 10 million tests conducted.
Now, here is what I mean by impressive here in Tennessee,
where I am today. First, anyone who is sick, first responder,
or healthcare worker, can get tested. Our Governor, Bill Lee,
is also testing every prisoner, every resident and staff member
in a nursing home. He has offered weekend drive-through
testing. He has done specific outreach for testing to low-
income communities. A Tennessean can get a free test at the
local public health department. The Governor's slogan is, ``If
in doubt, get a test.''
Governor Lee sent his testing goals in May to the Federal
Government, as every state has done. The Federal Government is
helping him make sure that he has enough supplies in case he
has trouble getting them through the labs and the other
commercial sources. As a result, our state has tested about 4
percent of the population. The Governor hopes to increase that
by 7 percent in May. That is one of the best in the country.
This impressive level of testing is sufficient, we believe,
to begin Phase 1 of going back to work. But, as I said last
week, it is not nearly enough to provide confidence to 31,000
students and faculty members that we hope will show up at the
University of Tennessee campus in August when school starts.
Last week, I talked with U.T. Knoxville Chancellor, Donde
Plowman, about that. We said, what would persuade those 31,000
students, as well as the 50 million K through 12 students in
the country and the other 5,000 university students, what will
persuade them to go back to campus in August?
That is where the new Shark Tank comes in. Dr. Collins at
the National Institutes of Health calls it RADx. We had our
hearing about that on Thursday. It is a really remarkable
scientific exercise to take a few early stage concepts that are
swimming around in what we call that competitive Shark Tank to
see if Dr. Collins and his associates can find a few new
technologies to create millions of new tests that will scale up
rapidly and make it more likely that students will go back to
school in August.
For example, the FDA authorized last week its first
diagnostic test using saliva that a person provides at home
instead of a nose swab or blood. It authorized its first
antigen test--we are hearing a lot about those--like the ones
used for flu or strep throat, which involves the swabbing of a
nose, and you can get the result in just a few minutes.
Another proposal not yet approved is to put in your mouth a
sort of lollipop sponge, take a photo of that with your cell
phone, and send that to your doctor. If it lights up, you are
positive. Or, the university might send that saliva lollipop to
a nearby laboratory, which could be a gene sequencing
laboratory, which can deal with thousands of those samples
overnight. That same process could occur at a middle school. It
could occur at a factory.
Of course, anyone testing negative one day can test
positive the next. But, such widespread screening of entire
campuses, schools, or places of work will help identify those
who are sick, trace down those who are exposed. That, in turn,
should help persuade the rest of us to go back to school and
back to work.
In addition to more testing, I expect Dr. Fauci to talk to
us about additional treatments that will be available to reduce
the risk of death, and the administration's plan to do
something that our Country has never done before, which is to
start manufacturing a vaccine before it actually has been
proven to work in order to speed up the result in case it does
work.
Those vaccines, those treatments, are the ultimate
solution. But, until we have them, all roads back to work and
school go through testing. The more tests we conduct, the
better we can identify those who are sick and exposed, and we
can quarantine the sick and exposed instead of trying to
quarantine the whole country.
Now, in my opinion, this requires millions of new tests,
many from new technologies. Some of these will fail, but we
only need a few successes to get where we want to go. That is
why I said on Thursday that what our Country had done so far in
testing is impressive, but not nearly enough. First, squeeze
all the tests we can out of current technologies. Next, try to
find new technologies to help us contain the disease and
persuade us to go back to work.
Now, one other thing. This is a bipartisan hearing to
examine how well we are preparing to go safely back to work and
to school, and to determine what else we need to do in the U.S.
Senate. Such an exercise sometimes encourages finger pointing.
Before we spend too much time finger pointing, I would like to
suggest that almost all of us, the United States and almost
every country so far as I can tell, underestimated this virus;
underestimated how contagious it would be; underestimated how
it can travel silently in people without symptoms to infect
other people; how it can be especially deadly for certain
segments of our population--the elderly, those with pre-
existing conditions, minority populations.
Let me go back to the March 3d hearing that we had in our
Committee on coronavirus. Six weeks after the first case was
discovered in the United States, a day when only two deaths
were recorded in this country, I read at that hearing this
paragraph from the New York Times two days earlier on March the
1st.
They reported this. ``Much about the coronavirus remains
unclear,'' the Times reported, ``and it is far from certain''--
this is March 3rd--March 1--``that the outbreak will reach
severe proportions in the United States or affect many regions
at once. With its topnotch scientists, modern hospitals, and
sprawling public health infrastructure, most experts agree, the
United States is among the countries best prepared to prevent
or manage such an epidemic.'' That was the New York Times on
March 1.
A lot of effort has gone into trying to make our Country
well prepared. Over the last 20 years, four Presidents, several
Congresses, in response to 9-11, bird flu, Katrina, Ebola,
H1N1, MERS, passed nine major laws to try to help get this
country ready for what we are going through today. These laws
stood up the strategic national stockpile, created an Assistant
Secretary for Preparedness. It created incentives for the
developments of vaccines and medicines that we are using today,
strengthened the Centers for Disease Control, created BARDA.
Thanks to the leadership of Senator Blunt and Senator Murray
for five straight years, we have significantly increased
funding for the National Institutes of Health.
All of this was part of a shared goal--Democrats,
Republicans, four Presidents, several Congresses--to try to get
ready for what we are going through today, whether it was
known, like anthrax, or unknown, like COVID-19. But, despite
all that effort, even the experts underestimated COVID-19.
This hearing is about how we improve our response to this
virus, as well as the next one. During the Oversight hearing, I
also intend to focus on, as I just said, the next pandemic,
which we know is coming.
What can we learn from this one to be ready for the next
one? Can we--what can we learn from the fast-tracking of
vaccines and treatments that we are about to hear about that
will make it even faster the next time? How can we keep
hospitals and states from selling off protective equipment when
their budget gets tight? How can we make sure Congress does our
share of the funding responsibility? How do we provide enough
extra hospital beds without canceling elective surgery or
hurting other patients and bankrupting hospitals? Whose job
should it be to coordinate supply lines so that protective
equipment and supplies get where they are supposed to go when
they are supposed to go? What is the best way to manage the
stockpile?
My preacher once said, I am not worried about what you do
on Sunday; it is the rest of the week that concerns me. I am
afraid that during the rest of the week, between pandemics, we
relax our focus on preparedness. We become preoccupied with
other important things. Our collective memory is short. Just 3
months ago, this country was preoccupied with impeaching a
President. Now that seems like ancient Roman history.
Now, while this crisis has our full attention, I believe we
should put into law this year whatever improvements need to be
made to be well prepared for the next pandemic. If there is to
be finger pointing, I hope they are pointed in that direction.
We are fortunate today to have four distinguished witnesses
who are at the heart of the response to the coronavirus. We are
grateful for their service to our Country. I have asked them
each to summarize their remarks in 5 minutes. Then we will have
5-minute rounds of questions from each Senator. I have agreed
we will end our hearing about 12:30, after we have a full round
of questions. Every Senator will have a chance to have his or
her 5 minutes. Senator Murray will then have an opportunity to
ask the last question or to close the hearing, and I will then
close the hearing. There will be other hearings to follow this
hearing, like last Thursday's hearing, and Senators may submit
their questions in writing within the next 10 days.
Staying at home indefinitely is not the solution to this
pandemic. There is not enough money available to help all those
hurt by a closed economy. All roads back to work and back to
school lead through testing, tracking, isolation, treatment,
and vaccines. This requires widespread testing, millions more
tests, created mostly by new technologies, to identify those
who are sick and who have been exposed so they can be
quarantined. And, by containing the disease in this way, give
the rest of America enough confidence to go back to work and
school.
For the near term, to help make sure those 31,000 U.T.
students and faculty members show up in August, we need
widespread testing. Millions more tests, created mostly by new
technologies, to identify those who are sick and who have been
exposed so they can be quarantined. By containing the disease
in this way, give the rest of America enough confidence to go
back to work and back to school.
Senator Murray.
OPENING STATEMENT OF SENATOR MURRAY
Senator Murray. Well, thank you very much, Mr. Chairman. My
thoughts are with you and your team right now as you try to
navigate the same challenge so many in our Country are worried
about. We all wish your staff member a speedy recovery. And, as
everyone works to take appropriate safety precautions today, I
would like to thank not only our witnesses for joining us
today, but also our Committee staff for working to set up a
safe format for Members and witnesses and the public to
participate in this hearing remotely.
Families across the country are counting on us for the
truth about the COVID-19 pandemic, especially since it is clear
they will not get it from President Trump. Truth is essential
so people have the facts, so they can make decisions for
themselves and their families and their communities. Lives are
at stake. If the President is not telling the truth, we must,
and our witnesses must, and we are counting on you today.
Families need us to take this opportunity to dig into the
facts about where things did go wrong so we can finally get
them on track because the Trump administration's response to
this public health emergency so far has been a disaster all on
its own.
Delays, missteps have put us way behind where we need to be
on diagnostic tests and allowed inaccurate antibody tests to
flood the market. Corruption and political interference have
impeded efforts to secure desperately needed personal
protective equipment and promoted dangerous, unproven
treatments. And, we recently learned that after experts at the
Centers for Disease Control and Prevention spent weeks
developing a detailed guide to help our communities understand
how to safely reopen when the time comes, the Trump
administration tossed it in the trash bin for being too
prescriptive.
But, this is far from the first time this administration
has silenced experts who were doing their job and putting
public health first. The fact of the matter is, President Trump
has been more focused on fighting against the truth than
fighting this virus, and Americans have sadly paid the price.
Since this Committee last heard from these witnesses on
March 3d, we have seen over 900 deaths in my home State of
Washington, over 80,000 deaths nationally, and the numbers
continue to climb. Still, President Trump is trying to ignore
the facts and ignore the experts, who have been very clear we
are nowhere close to where we need to be to reopen safely. My
hope today is that we can cut through this and have a serious
discussion about what is needed to safely open, how close we
are as a country to meeting those needs, and how we actually
get there.
One thing that is abundantly clear, we need dramatically
more testing. It is unacceptable we still do not have a
national strategic plan to make sure testing is free, fast, and
everywhere. That is why I fought to make sure our last COVID-19
package included an initial $25 billion testing fund and a
requirement that the administration submit a plan by May 24th.
When I say a plan, I do not mean a PR plan. I mean a plan
with specific timelines and numeric goals for supply and
funding needs; one that actually addresses the issues we are
seeing on testing capacity and distribution and disparities and
building out our public health system; and makes clear to
states and tribes and employers and the American people what
they can expect and what the administration will do to keep
Americans safe.
But, testing alone will not be enough to reopen our
Country. We still need far more personal protective equipment
than has been available for our healthcare workers on the front
lines, and we will need far more for other workers as we
reopen.
We desperately need this administration to step up and get
that equipment to states, who are doing everything in their
power to purchase supplies but simply cannot get nearly enough.
Because, the reality is, unlike states, the Federal Government
has the tools to actually fix the problem, if only the
administration would use them.
We also need that equipment to actually work, and for the
FDA to act promptly if it does not; not weeks later when people
may have already been exposed.
Just as importantly, we cannot expect people to go back to
work or to restaurants or to confidently send their kids to
school if there is not clear, detailed guidance about how to do
that safely.
Schools, from early childhood through college, need to know
how to keep their students, their staff, and their educators
safe. When should they wear masks? How do you run a school
cafeteria or a school bus? And, if they cannot reopen
classrooms, schools and families need to know we are working to
ensure every student gets an education.
Tools like online learning can only get us so far if we do
not address the digital divide that--so that every student can
access them. And, even then, there will be learning loss that
could deepen existing educational disparities among low-income
students, students with disabilities, English language
learners, and other vulnerable populations if we do not make
sure they get equal access to resources and support.
Of course, schools are not the only workplaces we have to
be thinking about. We need to make sure that industries across
the country know how to safely reopen and that people know
their workplace is safe. Secretary Scalia needs to stop
dragging his feet and do his job and have the Department of
Labor set forward a rule that makes clear worker safety is not
optional.
Mr. Chairman, I hope this Committee can hear about those
critical issues from Secretary Scalia and Secretary DeVos, as
well as other experts in the space in the days ahead.
This is especially important to protect workers and
residents at our nursing homes and other congregate care
facilities where we have seen some of the most deadly
outbreaks. And, as the rash of outbreaks at meatpacking plants
shows, this is not just an issue for the healthcare industry.
It is an issue for everyone.
Just as we need a plan before we can start to reopen, we
also need a plan well before we have a safe and effective
vaccine to guarantee that we can quickly produce and distribute
it on a global scale, and make it free and available for
everyone. So, I will be asking about our progress on those
issues today.
Today, safely reopening our Country may be a ways off, and
the administration's planning may be way behind, but there is
still a lot that Congress needs to do. There is not time to
spare. Some, including the White House, say we have already
provided enough economic relief. Well, my question to them is,
what good is a bridge that only gets you to the middle of the
river? We do not need to wait around to see if people need more
help. We know they do. We need to work quickly on another
aggressive relief package, and we need to make sure our
priorities in that bill are protecting our workers, our
students and our families, and addressing this public health
crisis, not bailing out corporations or protecting big business
from accountability.
People across the country are doing their part. They are
washing their hands and wearing masks and social distancing and
staying home. They need their Government to do its part, too.
They need leadership. They need a plan. They need honesty, and
they need it now, before we reopen, so they can rest assured
that we are doing things safely and competently with their
health and well-being as a top priority.
Thank you, Mr. Chairman.
The Chairman. This hearing, it is an important hearing, and
I know lots of people may be watching it for the first time. If
they are, I hope they notice that we have 23 Members of this
Committee, I believe, one more Republican than Democrat. We
have some very strong views, but we are able to work together
and to express those views and respect each other and our
witnesses, and I--and a big part of that goes to Senator Murray
and her staff. So, thank you for that.
Each witness will have up to 5 minutes to give his
testimony. Thank you for making an exception and agreeing to
testify by video because of these unusual circumstances. And,
thank you for what you are doing for our Country.
Our first witness is Dr. Anthony Fauci. He is director of
the National Institutes of Allergy and Infectious Diseases at
the National Institutes of Health. He has held that position
since 1984, which meant he has advised six Presidents and
worked on HIV-AIDS, influenza, malaria, Ebola, and other
infectious diseases. He was involved in treating Ebola patients
at NIH, and also worked on vaccine trials for Ebola.
Next, we will hear from Dr. Robert Redfield. He is director
of the U.S. Centers for Disease Control and Prevention, which
has its headquarters in Atlanta. More than 30 years, he has
been involved with clinical research related to chronic human
viral infections and infectious diseases, especially HIV. He
was the founding director of the Department of Retroviral
Research within the U.S. Military's HIV Research Program. He
spent 20 years with the U.S. Army Medical Corps.
Third, Admiral Brett Giroir. Admiral Giroir is Assistant
Secretary for Health at the U.S. Department of Health and Human
Services. That puts him in charge of development of public
health policy recommendations. He has taken on the
responsibility for coordinating testing and focused on the
increasing number of tests that we can do with existing
technology. His Federal service includes a variety of
activities with our Defense Department in advanced research,
threat reduction, and he was part of the Blue Ribbon Panel to
reform the U.S. Veterans Health System.
Finally, we will hear from Dr. Stephen Hahn. He is
Commissioner of the Food and Drug Administration. Before
joining FDA, he was the chief medical executive of the
University of Texas MD Anderson Cancer Center. He was chair of
the Department of Radiation Oncology at the University of
Pennsylvania. He was a senior investigator at the National
Institutes of Health. He was commander of the U.S. Public
Health Service Commissioned Corps from 89 to 95.
Now we will ask each of our witnesses to summarize their
remarks in 5 minutes. Following that, each Senator will have 5
minutes for questions and answers in order of seniority.
Dr. Fauci, let us begin with you. Welcome.
STATEMENT OF ANTHONY FAUCI, M.D., DIRECTOR, NATIONAL INSTITUTE
OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL INSTITUTES OF
HEALTH, BETHESDA, MD
Dr. Fauci. Thank you very much, Mr. Chairman, Ranking
Member Murray, and Members of the Committee. Thank you for
giving me the opportunity to discuss with you today the role
the National Institutes of Health has in research addressing
COVID-19.
The strategic plan that we have is fourfold: One, to
improve our fundamental knowledge of the virus and the disease
it causes; next, to develop new point-of-care diagnostics;
next, to characterize and test therapeutics; and finally, to
develop safe and effective vaccines.
First, with regard to diagnostics. As you probably heard
from Dr. Francis Collins last Thursday, the NIH has developed a
Rapid Acceleration of Diagnostics Program, called RADx, with an
award to that specific program up to a half a billion dollars
to support the development of COVID-19 diagnostics. It is a
national call for innovative technologies that will be
evaluated in a Shark Tank-like selection process to get to
either success or failure rapidly.
Moving on to therapeutics. I will talk a bit about the
Remdesivir success antiviral in a moment, but let me emphasize
that there are a number of broad-spectrum antivirals that are
in various stages of testing.
In addition, we will be looking at convalescent plasma,
which is plasma from individuals who have recovered from COVID-
19, to be used in passive transfer either in prevention or
treatment. In addition, hyperimmune globulin, which could be
used as a gammaglobulin shot. We will be looking at repurposed
drugs, as well as immune-based therapies and host modifiers.
And finally, monoclonal antibodies.
Let me take a moment to describe the Remdesivir placebo-
controlled, randomized trial, which was done internationally
with the power of more than a thousand individuals in sites
throughout the world. It was in hospitalized patients with lung
disease. The endpoint was primarily time to recovery. The
result was statistically significant, but really modest. And,
we must remember it was only a modest result showing that the
drug made a 31 percent faster time for recovery. We hope to
build on this modest success with combinations of drugs and
better drugs.
Moving on to vaccines. There are at least eight candidate
COVID-19 vaccines in clinical development. The NIH has been
collaborating with a number of pharmaceutical companies at
various stages of development. I will describe one very
briefly, which is not the only one, but one that we have been
involved in heavily developing with Moderna. It is a messenger
RNA platform.
You might recall in this Committee that in January of this
year, I said that it would take about one year to 18 months if
we were successful in developing a vaccine. The NIH trial moved
very quickly. On January 10th, the sequence was known. On
January 11th, the Vaccine Research Center met to develop a
plan. On the 14th of January, we officially started the vaccine
development. Sixty-two days later, we are now in Phase 1
clinical trial with the two doses already fully enrolled. There
will be animal safety. The Phase 1 will directly go into Phase
2/3 in late spring and early summer. And, if we are successful,
we hope to know that in the late fall and early winter.
There are some important issues, however, in COVID-19
vaccine development. We have many candidates and hope to have
multiple winners. In other words, it is multiple shots on goal.
This will be important because this will be good for global
availability if we have more than one successful candidate.
We also, as the Chairman mentioned, will be producing
vaccine at risk, which means we will be investing considerable
resources in developing doses even before we know any given
candidate or candidates work. I must warn that there is also
the possibility of negative consequences, where certain
vaccines can actually enhance the negative effect of the
infection. The big unknown is efficacy. Will it be present or
absent, and how durable will it be?
Finally, I want to mention the NIH has launched a public-
private partnership called Accelerating COVID-19 Therapeutic
Interventions and Vaccines. The purpose of that is to
prioritize and accelerate clinical evaluation of therapeutic
candidates with near-term potential.
Hopefully, our research efforts, together with the other
public health efforts, will get us quickly to an end to this
terrible ordeal that we are all going through.
Thank you very much. Happy to answer questions later.
Prepared Statement of Anthony Fauci
NIH is the HHS agency leading the research response to COVID-19 and
the novel coronavirus that causes it, SARS-CoV-2. Within NIH, NIAID is
responsible for conducting and supporting research on emerging and re-
emerging infectious diseases, including COVID-19.
NIAID responds rapidly to threats of infectious diseases as they
emerge, by accelerating fundamental basic research efforts, engaging a
domestic and international basic and clinical research infrastructure
that can be quickly mobilized, and leveraging collaborative and highly
productive partnerships with industry. NIAID also provides preclinical
research resources to scientists in academia and private industry
throughout the world to advance translational research on emerging and
re-emerging infectious diseases. These research resources help bridge
gaps in the product development pipeline, thereby lowering the
scientific, technical, and financial risks incurred by product
developers and incentivizing companies to partner with us in developing
safe and effective countermeasures including vaccines, therapeutics,
and diagnostics.
NIAID has a longstanding commitment to coronavirus research,
including extensive efforts to combat two other serious diseases caused
by coronaviruses: SARS and MERS. This research has improved our
fundamental understanding of coronaviruses and provides a strong
foundation for our accelerated efforts to address the challenge of
COVID-19 by developing vaccines, therapeutics, and diagnostics.
Developing Vaccines to Prevent SARS-CoV-2 Infection
A safe and effective vaccine for SARS-CoV-2 will be essential to
stopping the spread of infection, reducing rates of morbidity and
mortality, and preventing future outbreaks. NIAID is supporting
development of several SARS-CoV-2 vaccine candidates, including
vaccines based on platform technologies that have shown promise against
the coronaviruses that cause SARS and MERS.
The NIAID Vaccine Research Center has collaborated with the
biotechnology company Moderna, Inc., to develop a vaccine candidate
using a messenger RNA (mRNA) vaccine platform expressing the SARS-CoV-2
spike protein. On March 16, 2020, NIAID initiated a Phase 1 clinical
trial of this experimental vaccine at the Kaiser Permanente Washington
Health Research Institute, and later added clinical sites at Emory
University and the NIH Clinical Center. This trial was recently
expanded to enroll older adults to better define the safety of and
immune response to the vaccine across various age groups. The Coalition
for Epidemic Preparedness Innovations (CEPI) funded the manufacture of
the vaccine candidate for the Phase 1 trial, and BARDA plans to support
advanced development of the candidate.
Scientists at NIAID's Rocky Mountain Laboratories (RML) are
collaborating with University of Oxford researchers to develop a SARS-
CoV-2 chimpanzee adenovirus-vectored vaccine candidate, now in a Phase
1/2 clinical trial supported by the University of Oxford. RML
investigators also have partnered with University of Washington
scientists to investigate another mRNA vaccine candidate against SARS-
CoV-2. NIAID is working with additional academic and industry partners
to develop several other vaccine concepts.
The rigorous clinical testing required to establish safety and
efficacy means that it might take some time for a licensed SARS-CoV-2
vaccine to be available to the general public. The COVID-19 response
currently is focused on the proven public health practices of
containment and mitigation.
Identifying Therapeutics to Treat COVID-19
Effective therapeutics for COVID-19 are critically needed to treat
many patients globally who have been infected with SARS-CoV-2. On
February 21, 2020, NIAID launched a multicenter, randomized placebo-
controlled clinical trial to evaluate the safety and efficacy of
therapeutics for COVID-19, initially examining the antiviral drug
Remdesivir for treatment of COVID-19 in hospitalized adults. The
adaptive design of this trial will enable the evaluation over time of
additional promising therapies, such as the immunosuppressive drug
baricitinib, which was recently added to the study. An analysis of
preliminary data from 1,063 patients enrolled in the trial indicated
that those who received Remdesivir had a 31 percent faster time to
recovery, 11 days compared with 15 days for those who received placebo.
Additionally, the analysis found that Remdesivir may benefit survival,
though the mortality data did not reach statistical significance. A
mortality rate of 8 percent was observed for the group receiving
Remdesivir versus 11.6 percent for placebo. NIAID is developing and
testing other novel and repurposed therapies, including monoclonal
antibodies (mAbs). NIAID also is planning clinical trials to evaluate
hydroxychloroquine (HCQ) and azithromycin in patients with mild to
moderate COVID-19, and hyperimmune intravenous immunoglobulin (IVIG)
for treatment of COVID-19.
On April 6, 2020, the National Heart, Lung, and Blood Institute
(NHLBI) launched a clinical trial of HCQ in hospitalized COVID-19
patients through its Prevention and Early Treatment of Acute Lung
Injury (PETAL) clinical trials network. NHLBI also sponsored the
addition of a U.S. site for a Canadian Institutes for Health Research-
funded trial of colchicine--an anti-inflammatory drug commonly used to
treat gout--for treating COVID-19 in the outpatient setting.
Additionally, NHLBI is leveraging the NIH-funded Strategies to Innovate
Emergency Care Clinical Trials Network (SIREN) to study whether
convalescent plasma, or blood plasma from individuals who have
recovered from COVID-19, can help reduce the progression of COVID-19 in
patients with mild symptoms.
The National Center for Advancing Translational Sciences (NCATS) is
leveraging the NCATS Pharmaceutical Collection, a compilation of every
drug approved for human use by major regulatory agencies worldwide, and
other collections of small molecules and compounds to identify
potential SARS-CoV-2 therapeutics for further investigation. Institutes
and Centers across NIH also are working concurrently with partners in
academia and industry to pursue the development and testing of mAbs and
antiviral drugs for potential treatment of COVID-19. NIAID, the
National Cancer Institute (NCI), NHLBI, NCATS, the National Institute
of Arthritis and Musculoskeletal and Skin Diseases, and the National
Institute of Neurological Disorders and Stroke are all engaged in this
critical effort.
NIH, in collaboration with the Foundation for the NIH, recently
launched an innovative public-private partnership to speed the
development of COVID-19 therapeutics and vaccines. The Accelerating
COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private
partnership brings together stakeholders from across the U.S.
Government, industry, and the European Medicines Agency to develop an
international strategy for a coordinated research response to the
COVID-19 pandemic. Other Federal partners include BARDA, the Department
of Defense (DOD), the Department of Veterans Affairs, CDC, and FDA.
NIH also has convened the COVID-19 Treatment Guidelines Panel,
comprised of representatives of NIH and five other Federal agencies
along with representatives of eight professional organizations,
academic experts, and treating physicians including providers from high
incidence areas. On April 21, 2020, the panel issued the first release
of COVID-19 treatment guidelines for clinicians. The guidelines provide
recommendations regarding specific treatments currently available and
address considerations for special populations, including pregnant
women and children. The guidelines will be updated regularly as new
credible information emerges.
Enhancing Diagnosis and Understanding the Pathogenesis of COVID-19
NIH is supporting an HHS-wide effort to promote the development and
commercialization of diagnostic tests to detect current SARS-CoV-2
infection. On April 29, 2020, NIH announced the Rapid Acceleration of
Diagnostics (RADx) initiative, which will work to identify, support,
and make innovative strategies for COVID-19 testing widely accessible,
in collaboration with FDA, CDC, and BARDA. RADx will leverage the
Point-of-Care Technologies Research Network established by the National
Institute of Biomedical Imaging and Bioengineering (NIBIB) to allow for
potential roll out of new products by fall 2020. This initiative
expects to award up to $500 million to support development of point-of-
care and home diagnostic devices, as well as innovations that make
current laboratory tests faster, more efficient, and more widely
accessible. Innovators will be matched with technical, clinical,
regulatory, business, and manufacturing experts to increase the
odds of success. In addition, NIAID is using CARES Act funds to support
diverse SARS-CoV-2 diagnostic platforms including RT-PCR and enzyme-
linked immunosorbent assays, and facilitating development of sensitive,
specific, and rapid diagnostic tests by providing critical SARS-CoV-2
isolates and reagents to test developers. In addition, NCI is
coordinating with FDA and NIAID to assess the sensitivity and
specificity of marketed SARS-CoV-2 serological tests, which can detect
antibodies indicative of a prior exposure to SARS-CoV-2.
NIAID, NCI, NCATS, and NIBIB also are partnering on a new study to
investigate whether adults in the U.S. without a confirmed history of
infection with SARS-CoV-2 have antibodies to the virus, indicating
prior infection. In addition, NIH is supporting COVID-19 natural
history studies to understand the clinical course of infection,
including incidents of thrombosis, strokes and heart attacks, and other
sequelae of infection. Some of these studies will examine the quality
and durability of the immune response to SARS-CoV-2; this information
may be leveraged to develop SARS-CoV-2 therapeutics or vaccines.
Natural history studies also will inform our understanding of COVID-19
pathogenesis, including factors that may predict disease progression
and will help to identify individuals or groups at high risk.
NIH continues to expand efforts to elucidate the viral biology and
pathogenesis of SARS-CoV-2 and employ this knowledge to develop the
tools needed to diagnose, treat, and prevent disease caused by this
virus. NIH is focused on developing safe and effective COVID-19
vaccines and therapeutics, and sensitive, specific, and rapid point-of-
care diagnostic tests. These efforts will improve our response to the
current pandemic and bolster our preparedness for the next, inevitable
emerging disease outbreak.
______
The Chairman. Thank you, Dr. Fauci.
Dr. Redfield, welcome.
STATEMENT OF ROBERT REDFIELD, M.D., DIRECTOR, UNITED STATES
CENTERS FOR DISEASE CONTROL AND PREVENTION, ATLANTA, GA
Dr. Redfield. Good morning, Chairman Alexander and Ranking
Member Murray and Members of the Committee.
Our Nation is confronting the most serious public health
crisis in more than a century, yet we are not defenseless. We
have powerful tools to fight this enemy. We have tried and
true, effective public health interventions, such as early case
identification, isolation, and contact tracing, combined with
important mitigation strategy, including social distancing,
frequent hand washing, and face covering. These public health
tools have and will continue to slow the spread of COVID-19.
I appreciate the opportunity this morning to provide a
brief overview of some of CDC's ongoing work in response to
COVID-19. CDC has been working 24/7 to combat the pandemic.
CDC's Emergency Operations Center is supporting state,
tribal, local, and territorial public health partners in
building core capabilities, particularly workforce, laboratory,
and data and predictive analytics.
Epidemiologists are conducting surveillance for COVID-19,
as well as conducting health system surveillance.
Community mitigation teams are providing guidance on
infection control and contact tracing, and our laboratory
experts are performing serological testing to better define the
extent of asymptomatic populations.
As local leadership makes decisions to reopen, they will
require varying degrees of Federal support. Each location will
be different and will face unique circumstances. CDC has
conducted a state-by-state assessment of public health testing
capacity and contact tracing capacity, as well as surge plans.
CDC is providing technical assistance and funding to the
states provided through the Supplemental CARES Act and the
Paycheck Protection Program and Healthcare Enhancement Act. We
are working directly with the state public health leaders to
define their needs for testing and testing devices, supplies,
and manpower, surveillance, data collection and reporting,
contact tracing, infection control, and outbreak investigation.
I want to spend a moment to focus on several key elements.
First, testing. Rapid, extensive, and widely available, timely
testing is essential for reopening America. CDC's role in
testing continues to support diagnosis and contact tracing,
surveillance, and outbreak. We work with the public health
partners to define their particular testing strategy for their
jurisdiction. Admiral Giroir will address the testing
components of the response in greater detail.
Contact tracing. Increasing state, tribal, local, and
territorial contact tracing capacity is critical. It is a
critical part to stop the chains of transmission and prevent
the occurrence of sustained community transmission. CDC's role
is to provide technical training, assistance, and support for
the states as they hire and build a workforce necessary to be
fully prepared to effectively respond to the public health
challenges posed by the ongoing COVID pandemic. This will be an
expansive effort.
Surveillance. Our Nation's surveillance program is built on
a combination of systems, including existing syndromic
influenza and respiratory viral disease surveillance systems,
have been combined with commercial and research lab platforms
in our case reporting form system. CDC is adapting these and
optimizing it to have a surveillance system in response to
COVID-19.
Importantly, in light of the significant occurrence of
asymptomatic infection, the surveillance for asymptomatic
infection becomes an important public health tool for early
case identification. CDC is working with each public health
jurisdiction to develop a prospective surveillance program to
include active surveillance among those that are most
vulnerable, such as individuals in long-term care facilities,
inner-city clinics, and homeless shelters.
We need to rebuild our Nation's public health
infrastructure, data and data analytics, public health
laboratory resilience, and our Nation's public health
workforce. Now is the time to put it in place for the
generations to come, not only for the public health system that
our Nation needs, but for the public health system that our
Nation deserves.
Before I close, I want to recognize the tireless commitment
of the dedicated CDC staff, who have deployed to every corner
of this Nation to fight COVID-19. More than 4,000 employees
have deployed here and globally. Science and data continue,
with technical expertise and public service, to be the backbone
of CDC's contributions to the U.S. response.
I extend my serious gratitude to the healthcare workers on
the front lines, as well as their family, and the essential
emergency personnel, as well as the American people, to say
thank you for adhering to the stay-at-home guidelines and
protecting the most vulnerable.
It is important to emphasize that we are not out of the
woods yet. The battle continues, and we must, but we are more
prepared. We need to stay vigilant with social distancing. It
remains an imperative. We are a resilient Nation, and I am
confident that we will emerge from this pandemic stronger,
together.
Thank you.
Prepared Statement of Robert Redfield
CDC is America's health protection agency, and works 24/7 to save
lives and protect America from health, safety and security threats,
both foreign and in the United States. Addressing infectious diseases
like COVID-19 is fundamental to our mission and is our highest
priority. CDC is building upon decades of experience and leadership in
responding to prior infectious disease emergencies, including SARS,
MERS, Ebola, Zika, and pandemic influenza to meet new challenges
presented by COVID-19. These challenges are many, and they are
historic. Every single American is affected by this pandemic, and CDC
is leaning into this public health crisis with every applicable asset
we have. CDC is drawing on its emergency response capacity and its
relationships with State, tribal, local, and territorial (STLT),
global, and private sector partners; and is leveraging our workforce's
strengths in public health surveillance, and laboratory capacity, to
address this public health emergency. CDC is developing guidance for
healthcare professionals and the public to encourage safer practices,
improve health outcomes, and save lives. CDC is also working with
partners to develop guidance and decision tools to assist State and
local officials and other stakeholders in adjusting mitigation
strategies. Importantly, CDC is preparing the Nation's public health
system and the private sector for a vaccine when one is available.
Abroad, CDC is leveraging investments in global health security,
pandemic influenza preparedness and public health infrastructures and
capacities built through programs like the President's Emergency Plan
for AIDS Relief to support countries in mitigating and containing
COVID-19. The emergence and rapid spread of COVID-19 confirms that an
infectious disease threat anywhere is a threat to Americans everywhere,
including here at home.
When, in late December 2019, Chinese authorities announced a
cluster of pneumonia cases of unknown etiology centered in Wuhan,
China, CDC began monitoring the outbreak. At the beginning of January,
CDC began developing situation reports, which were shared with HHS, and
reaching out to the Chinese Center for Disease Control and Prevention
to offer CDC support. By January 7, 2020, CDC began expanding its
incident management (IM) and response structure to facilitate staffing
and communications. On January 21, 2020, CDC officially activated its
Emergency Operations Center for COVID-19. Using the IM structure, CDC
immediately set up task forces to address key needs and reached out
frequently to our State and local partners. On March 17, 2020, CDC
joined other HHS components and the Federal Emergency Management Agency
(FEMA) in coordinating activities through FEMA's National Response
Coordination Center. Addressing COVID-19 is taking an all-of-government
effort.
Congress has addressed the urgent need to respond to this pandemic
at home and abroad and has allocated substantial resources for CDC's
COVID-19 activities through the statutes mentioned above. This funding
supports a federally guided, State managed, and locally implemented
response to COVID-19 in the United States. With support provided by
Congress for global disease detection and emergency response through
COVID-19 appropriations, CDC is supporting prevention, preparedness,
and response efforts in partnership with public health agencies, health
ministry counterparts and multilateral and non-governmental agencies
worldwide. Here in the United States, CDC is working with STLT partners
to focus use of these resources to establish and enhance case
identification; conduct contact tracing; implement appropriate
containment and community mitigation measures; improve public health
surveillance; enhance testing capacity; control COVID-19 in high-risk
settings; protect vulnerable and high-risk populations; and work with
healthcare systems to manage and monitor capacity. As of May 1, 2020,
CDC has announced or obligated $1.627 billion in awards to
jurisdictions across America from the funds provided by Congress.
CDC is providing direct technical assistance and support to STLT
partners as they consider approaches to mitigate and contain COVID-19.
The White House, and Federal partners including CDC, have convened
calls with all 50 states, Puerto Rico and the District of Columbia to
identify State capacities and needs. The Federal Government has
committed to ensuring that states can meet testing objectives for the
month of May, as identified by each State. Through these calls and
other outreach efforts, CDC has worked with jurisdictions to identify
needs and develop plans to enhance testing capacity, State
surveillance, contact tracing, and surge staffing. These discussions
and plans for action will emphasize the need to serve vulnerable
populations and include focused efforts for long-term care facilities,
federally qualified health centers, and Tribal Nations, among others.
In addition, CDC has launched a multifaceted approach to enhance
and complement STLT efforts and expand support to communities during
the current public health emergency. The COVID Response Corps is a new,
nationwide community-focused initiative to identify surge staffing and
resources to STLT health departments on the frontlines of the fight
against COVID-19. Response Corps members will augment health department
teams and engage in core public health functions including contact
tracing, testing, infection prevention and control, call center
activities, COVID-19 education, and public health surveillance.
CDC relies on timely and accurate public health surveillance data
to guide public health action and inform the nationwide response to
COVID-19. This crisis has highlighted the need to continue efforts to
modernize the public health data systems that CDC and states rely on
for accurate data. Public health data surveillance and analytical
infrastructure modernization efforts started in fiscal year 2020 using
funds provided by Congress, which have been augmented by $500 million
provided for these efforts under the CARES Act. Timely and accurate
data are essential as CDC and the Nation work to understand the impact
of COVID-19 on all Americans, particularly for populations at greater
risk for severe illness, such as older Americans, those with chronic
medical conditions, and some racial and ethnic minorities. CDC is also
working to understand the impact of COVID-19 on healthcare workers,
first responders, and other essential workers. Accurate data are
critical as we continue to assess the burden placed on the American
healthcare system to inform reopening. CDC is capitalizing on multiple
existing surveillance systems run in collaboration with STLT partners,
including influenza and viral respiratory disease systems. In
collaboration with STLT partners, CDC is committed to making data
available to the public, while protecting individual privacy. CDC's
population-based COVID-NET system monitors COVID-19 associated
hospitalizations that have a confirmed positive test in greater than
250 acute care hospitals in 99 counties in 14 states. Data gathered are
used to estimate age-specific hospitalization rates on a weekly basis
and describe characteristics of persons hospitalized with COVID-19
illness. CDC is using these data to monitor hospitalizations by race,
ethnicity, underlying condition, age, and gender, and is now including
this information in CDC's weekly COVIDView summary. CDC is now
receiving more granular data on deaths by State and locality, allowing
us to identify and address where there may be racial and ethnic
disparities in morbidity and mortality. CDC also is augmenting the
existing National Healthcare Safety Network to monitor and analyze the
capacity of the healthcare system daily--including hospitals and
nursing homes--so that Federal, State, and local officials can adjust
their response and mitigation efforts as needed.
Regarding laboratory support, from the outset, CDC laboratories
have been applying sequencing technologies to SARS-CoV-2 and have made
the data available through domestic and global data bases. CDC is
leading the SARS-CoV-2 Sequencing for Public Health Emergency Response,
Epidemiology and Surveillance (SPHERES), a new national genomics
consortium to coordinate SARS-CoV-2 sequencing across the United States
to do large-scale, rapid genomic sequencing of the virus. These
advanced molecular detection and sequencing activities are being ramped
up at the State and local levels to give us a clearer picture of how
the virus outbreak is evolving and how cases are connected. CDC is
engaged with the National Institutes of Health (NIH), the FDA, and the
Biomedical Advanced Research and Development Authority (BARDA) to
evaluate serology tests, and CDC is supporting serological surveys to
help determine how laboratory testing can contribute to decisions about
enabling Americans to return to work.
CDC has developed a new serologic laboratory test to assist with
efforts to determine how much of the U.S. population has been infected
with SARS-CoV-2, the virus that causes COVID-19. The serology test
looks for the presence of antibodies, which are specific proteins made
in response to infections. It typically takes one to 3 weeks after
someone becomes sick with COVID-19 for their body to make antibodies;
some people may take longer to develop antibodies. The antibodies
detected by this test indicate that a person has had an immune response
to SARS-CoV-2, regardless of whether symptoms developed from infection
or the infection was asymptomatic. However, it is important to point
out that, at this point, we do not know whether the presence of
antibodies provides immunity to the virus. Currently, CDC's serologic
test is designed and validated exclusively for broad-based surveillance
and research that is giving us information needed to guide the response
to the pandemic and protect the public's health.
During the week of March 30, CDC and public health partners began
the first stage of studies of community transmission of SARS-CoV-2.
These initial studies use serum samples collected in the State of
Washington and New York City. In April, the second stage expanded to
include serologic testing in more areas with high numbers of people
with diagnosed infections. It also includes studies of households in
some states. By using seroprevalence surveys, CDC can learn about
people who have been infected, including those infections that might
have been missed due to lack of symptoms or testing not being performed
for other reasons. These surveys can also track how infections progress
through the population over time. This is done by taking ``snap shots''
of the percentage of people from the same area who have antibodies
against SARS-CoV-2 (also called the seroprevalence) at different time
points.
On April 27, 2020, CDC updated testing prioritization and focused
testing guidelines for those who may have or who are at risk for active
SARS-CoV-2 infection. Clinicians considering testing of persons with
possible COVID-19 should continue to work with their local and State
health departments to coordinate testing through public health
laboratories or use clinical laboratory viral tests for COVID-19 that
has been issued an Emergency Use Authorization (EUA) by FDA or are
being offered as outlined in FDA's policy regarding COVID-19 tests.
Increasing testing capacity will allow clinicians to consider the
medical necessity of COVID 0919 testing for a wider group of
symptomatic patients and persons without symptoms in certain
situations. CDC recommends that clinicians should use their judgment to
determine if a patient has signs and symptoms compatible with COVID-19
and whether the patient should be tested. Most patients with confirmed
COVID-19 have developed fever and/or symptoms of acute respiratory
illness (e.g., cough, difficulty breathing) but some people may present
with other symptoms as well. Other considerations that may guide
testing are epidemiologic factors such as the occurrence of local
community transmission of COVID-19 infections in a jurisdiction.
The American people, communities, public health professionals,
medical providers, businesses, and schools look to CDC for trusted
guidance on responding to COVID-19. CDC develops and disseminates
guidance for individuals and communities. These recommendations include
actions that every American should take, such as following good
personal hygiene practices, staying at home when sick, and practicing
social distancing to lower the risk of disease spread. CDC guidance is
available here https://www.cdc.gov/coronavirus/2019-ncov/prevent-
getting-sick-prevention.html.
First responder and healthcare guidance documents cover a range of
topics--from addressing potential work-related exposures, implementing
infection prevention and control measures in health facilities, and
optimizing the supply of personal protective equipment to clinical
evaluation, testing, and clinical care. CDC is providing these
recommendations to support communities' efforts, while recognizing that
each sector and community is unique and will need to consider these in
the context of their community-level data and circumstances. CDC teams
on the ground and those aiding from Atlanta are and will continue
working with State and local officials to integrate these
recommendations into COVID-19 plans.
Mitigation and containment of COVID-19 are the key to public health
strategies and CDC is committed to using our expertise and partnering
with others on the frontlines. While surveillance, testing, contact
tracing, and community mitigation interventions are the best tools we
have right now, looking to the future, CDC continues to work to prepare
our Nation's public and private health systems to deliver effectively a
COVID-19 vaccine once it is available. This includes working with CDC's
64 immunization awardees to help ensure that the U.S. immunization
system can mount an effective vaccine delivery program, including
vaccine distribution and tracking. CDC remains committed to supporting
the COVID-19 response with all available resources.
______
The Chairman. Thank you, Dr. Redfield.
Admiral Giroir, welcome.
STATEMENT OF ADMIRAL BRETT GIROIR, M.D., ASSISTANT SECRETARY
FOR HEALTH, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN
SERVICES, WASHINGTON, DC
Admiral Giroir. I am here to provide you with an update on
the Nation's progress in testing for COVID-19.
On March 12th, Secretary Azar requested that I lead the
COVID-19 testing efforts within HHS, including oversight and
coordination of the FDA and CDC with regard to testing. Since
then, the Nation has performed more than nine million COVID-19
tests, a number far greater than any other country, and double
the per capita tests performed to date in South Korea. To reach
this point, we implemented a phased approach to meet testing
needs during mitigation, and now during Phase 1 reopening of
America.
Beginning March 20th, we pioneered 41 community-based,
drive-through testing sites in locations prioritized by the
CDC. These sites have been a profound success, testing over
167,000 high-risk individuals and demonstrating a prototype
that is being duplicated multifold in nearly every state.
Next, the administration leveraged trusted retailers,
including CVS, Rite Aid, Walgreens, Walmart, Kroger, and Health
Mart, who are now providing testing at 240 locations in 33
states, 69 percent of which are in communities with moderate to
high social vulnerability.
To meet the need for collection supplies, like swabs and
media tubes, we first secured the global supply chain through a
military air bridge. We worked directly with manufacturers to
increase domestic production. We collaborated with the private
sector and the FDA to validate multiple swab and media types
that vastly expanded supplies, while minimizing the need for
PPE.
Finally, we used Title III of the Defense Production Act to
further invest in domestic manufacturing to prepare us for
reopening.
To support the need for surveillance testing during
reopening, on April 27th, we issued a new testing framework
that also prioritized testing for persons without symptoms, who
are prioritized by health departments or clinicians for any
reason, including screening of asymptomatic individuals,
according to state and local plans.
Next, our Federal multidisciplinary team conducted multiple
calls with leadership from each state to set state-specific
testing objectives. Collectively, states and territories
established an overall goal to perform 12.9 million tests over
the next 4 weeks. The Federal Government is able to, and will,
support the achievement of this goal. Specifically, the Federal
Government is shipping to states 12.9 million swabs and over
9.7 million tubes of media in May alone.
Last month, we also detailed the location and capacity of
every lab machine in every state that could potentially run
COVID-19 assays, and our team has worked with test suppliers to
match reagents to these machines.
Looking forward, between now and the end of 2020, the
Federal Government will procure over 135 million swabs and 132
million tubes of media and distribute these to states, as
requested, to supplement the now robust commercial supply.
We anticipate marked increases in current tests, as well as
a dramatic expansion of new point-of-care tests, like the first
in class Quidel antigen test, authorized by the FDA just last
Friday. Quidel anticipates being able to distribute 300,000
tests per day within just a few weeks.
By September, taking every aspect of development,
authorization, manufacturing, and supply chain into
consideration, we project that our Nation will be capable of
performing at least 40 to 50 million tests per month if needed
at that time. And, if new technologies are authorized, like
whole genome sequencing approaches or any novel solutions
uncovered by NIH's new diagnostics initiative, that number will
be much higher.
Finally, I want to acknowledge and express my heartfelt
gratitude to the officers of the U.S. Public Health Service
Commission Corps, the uniformed service I am honored to lead.
Three thousand, four hundred and seventy-one men and women have
deployed in support of this pandemic; on the cruise ship in
Japan; to our military bases, repatriating Americans; to our
community-based testing sites and international airports; to
FEMA and our task forces; to nursing facilities, including King
County Washington; and to field hospitals in hard-hit
communities across our Nation. I thank each and every one of
these officers and their families. And, on their behalf, I
thank the Members of this Committee for supporting our training
needs and the establishment of a ready reserve to supplement
our ranks in future national emergencies.
Thank you for the opportunity to provide these remarks.
Prepared Statement of Brett Giroir
Diagnostics and Testing
Testing for the presence of SARS-CoV-2 is an essential component of
our Nation's response to the COVID-19 pandemic; its importance will be
further magnified as states enter Phase-1 of reopening. The indications
for viral testing depend heavily on the stage of the pandemic and the
extent of mitigation employed. In general, testing may be indicated for
diagnosis of those who are symptomatic, tracing of those in contact
with those who are infected, and surveillance testing of those who are
asymptomatic or mildly symptomatic to achieve infection control and/or
other public health objectives.
The focus of this testimony is on testing for the presence of the
virus, in contrast to testing for the presence of antibody to the
virus. The former determines whether the individual is actively
infected, and presumably infectious. The latter determines whether the
individual has been infected, has developed an immune response, and may
be protected from subsequent SARS-CoV-2 infections.
It is useful to understand the overall testing strategy in terms of
its chronology and sequential objectives, and to understand that this
virus was a new human pathogen for which no diagnostic tests had
previously been developed. In addition, the predominant type of test
relies on sophisticated RNA amplification technology that can only be
done in a laboratory certified to perform moderate or high complexity
testing. New point-of-care (POC) tests are an exception in that they
are low complexity; however, this class of test still represents a
minority of available testing capability and has limited utility
because of its low throughput. Finally, the pandemic caused an
unprecedented demand for all supplies and materials, such that overall
demand in a single month approximated total annual demand of some
components. This reality represented substantial challenges, but
Federal leadership has guided efforts to combat these challenges in
close collaboration with states, local jurisdictions, and the private
sector. Our overall strategy for testing includes:
Y Assuring that those who need testing, receive testing
Y Prioritizing testing to meet the stage of the pandemic
Y Increasing the number and diversity of tests
Y Enhancing states' ability to collect specimens through novel
``front ends'' like drive-through sites
Y Organizing and galvanizing the industry on an unprecedented
scale
Y Enhancing testing to underserved communities
Y Providing surge testing capacity during local outbreaks
Y Supporting critical infrastructure and national security
needs
Y Enhancing reimbursement for tests to stimulate the private
sector, and providing additional incentives for testing in
nursing homes and vulnerable communities
The overall testing strategy is outlined chronologically as we met
the needs of each evolving stage of the pandemic.
Stage 1: Launch: Engaging the Emerging Crisis
In the beginning stages of the COVID-19 pandemic, CDC was engaged
in building the foundation for diagnostic testing in the United States.
On January 10, 2020, Chinese researchers deposited the 2019-nCoV genome
sequence to GenBank and CDC began development of the CDC 2019-nCoV
Real-Time PCR Diagnostic Panel. On January 24th, CDC publicly posted
its assay for the CDC's newly developed diagnostic panel, allowing the
global community to develop their own assays using the CDC design. On
February 3d, CDC submitted an EUA request, and the FDA issued an EUA on
February 4th, enabling use of the CDC's COVID-19 diagnostic Panel.
Understanding the importance of increased testing, the FDA moved
swiftly to engage with more than 470 test developers that indicated
their intent to submit requests for EUAs. In mid-January, BARDA
convened a meeting of leading diagnostic companies from across America
to encourage development of COVID-19 tests. In the ensuing months,
multiple funding opportunities for the development of COVID-19
diagnostic tests were announced and NIH provided COVID-19 RNA to
diagnostic companies to expedite private-sector test development. With
a desire to ensure high quality diagnostic testing but also ensure
rapid development and dissemination of COVID-19 tests, the FDA has
provided EUA templates for laboratories and manufacturers in an effort
to streamline the entire process, and works with developers who wish to
use alternate approaches to the templates. FDA has issued a record
number of EUAs for COVID-19 tests. This has contributed greatly to the
dramatic increases in testing the Nation has seen in the past months.
The amount and expediency in which EUAs were issued for COVID-19 tests
far exceed past viral outbreaks. For example, in response to the 2016
Zika Virus outbreak, FDA issued 20 test EUAs; in response to the 2009
H1N1 outbreak, FDA issued 17 test EUAs. Currently, FDA has issued more
than 70 COVID-19 test EUAs. The timeliness and number of EUAs issued by
FDA for COVID-19 tests is unprecedented and has been critical to
improving the testing scale and capacity in our Country.
Throughout the COVID-19 outbreak, the Administration has encouraged
diagnostic test manufacturers, commercial laboratories, and
professional societies to expand capacity and scale for existing
nucleic acid testing platforms. Through the efforts of the
Administration, the United States has developed a multilayered,
multifaceted approach to testing that is capable of providing the right
test to the right person at the right time. This approach includes
contributions from State public health labs, high-throughput commercial
labs, academic and hospital labs, labs at CDC, the Indian Health
Service, the Department of Defense, and the Department of Veterans
Affairs. In addition, the ecosystem now includes POC testing that can
be done in rural areas at high risk without sophisticated supporting
infrastructure, or as a tool to investigate outbreaks in nursing homes
or other confined settings.
As of the beginning of May, our Nation is performing more than
200,000 tests per day, and this number will continue to increase.
Commercial laboratories are working more efficiently, processing tests
in rapid succession, which ensures patients receive their results, on
average, within 3 days. Hospital and academic laboratories typically
provide results within 2 days, and often much sooner. POC tests provide
results within 15 minutes.
Concurrent to the Federal Government's efforts to expand capacity
and scale of laboratories testing capabilities across the country, the
Administration also worked with State and local partners to establish
Community Based Testing Sites (CBTS). At the inception of this effort,
the 41 federally supported sites were developed and established by the
U.S. Public Health Service Commissioned Corps (Corps), in CDC-
prioritized locations across the country and 14 sites remain open with
Federal support. These sites are located in Colorado, Texas, Illinois,
New Jersey, and Pennsylvania. The Corps had unique expertise in COVID-
19 testing, since many officers had deployed to Japan and elsewhere to
assist in infection control, diagnosis, and eventual repatriation of
American citizens. The initial objectives of CBTS were to screen and
test healthcare facility workers and first responders, as prioritized
by local jurisdiction. The CBTS model has been a success, having tested
over 140,000 individuals, and with an overall COVID-19 test positive
rate of approximately 17 percent, meaning that the CBTS are testing the
right individuals at the right time. This effort has also supported and
co-evolved with technological advances such as the validation of nasal
self-swabbing, which minimizes the need for trained health
professionals and personal protective equipment. The CBTS initiative
was an early example to states and localities on how to conduct
community based COVID-19 testing, and this model has been replicated
throughout the country to screen and test hundreds of thousands more
Americans.
From the onset in January, and continuing to the present, the
President, Vice President, and senior Administration officials have
held numerous briefings with Governors and their State leadership. Many
of these briefings have focused on joint Federal-State efforts to
expand testing throughout the country. In addition to these calls with
the Nation's Governors, the White House and senior Administration
officials have organized numerous calls to enhance State, local,
territorial and tribal testing coordination efforts. The constant
communication between the Administration and State leadership has
helped provide guidance to states on how to best utilize testing
capacity in their own states. Another product that was produced by the
Administration to assist the states to leverage the full testing
capacity at their disposal was a data base of nationwide lab locations
and capacity, including the specific testing platforms at each
laboratory.
Stage 2: Scaling and Technological Innovation
The identification and expansion of public and private sector
testing infrastructure has been, and continues to be, a priority. One
example of expanding testing infrastructure through public-private
partnerships is the engagement of the Administration with well-known
retailers that have a regional or nationwide footprint. As of May 5 and
with the assistance of the Federal Government, United States retailers
have opened and are operating 102 testing sites in 31 states. In an
effort to expand testing further, the Federal Government is building
upon the public-private partnerships to increase the number of testing
sites offered at commercial locations across the country. The public-
private partnerships with these retailers are being expanded to support
many more testing sites that will be opened and operating in the coming
weeks. These commercial testing locations are also uniquely situated to
meet the testing needs of communities with moderate to high social
vulnerability, which was the focus of the original sites. Going
forward, retailers have indicated their intent to open hundreds more of
these sites depending on local needs.
Another effort of the Administration to further support and expand
the testing infrastructure in the United States has been strengthening
the testing supply chain. The Administration has massively increased
the availability of laboratory and testing supplies by engaging
directly with distributors and manufacturers to increase production
capacity through direct procurement, application of the Defense
Production Act, formation of various public-private partnerships, and
improved allocation criteria that ultimately help ensure that supplies
meet the state's needs and reach the locations where the supplies are
needed most. In addition, validation of additional supply types has led
to a dramatic broadening of available supplies and reagents.
As of April 30, the Federal Government had directly procured 6.7
million swabs, 3.3 million vials of transport media, 15 million
lancets, and 15 million alcohol pads. As of March 27th, the Federal
Government had also facilitated the nationwide delivery of 175.2
million masks, 14.7 million gowns, and 793.8 million gloves. Through
the mechanisms mentioned above, we are unlocking the full potential of
laboratories in the United States and this is allowing testing capacity
to expand consistently.
Stage 3: Support Opening Up America Again
Current efforts are focused on further scaling up testing
capabilities to guarantee that each State has the testing supplies and
capabilities they need to reopen according to their own individual
State plans. For example, the Federal Government is procuring over 21
million swabs and 13 million collection tubes with transport media (or
saline) in May. These supplies will be shipping out to states over the
course of the month. ThermoFisher, which has more than 3,000 lab
machines across the country, will be producing more than 10 million
extraction and PCR kits in May, enabling states to complete millions of
additional tests in May. In mid-March, the FDA issued an EUA for
Hologic's Panther COVID-19 test, which runs on more than 600 lab
machines across the United States. Hologic will be shipping several
million test kits to labs across the Nation starting in early May.
The Administration will continue to work hand in hand with
Governors to support testing plans and rapid response programs. The
Opening Up America Again guidelines, provided by the Administration,
describes roles and responsibilities as well as elements of the robust
testing plans and rapid response programs called for in the President's
Guidelines.
The Laboratory Testing Task Force is providing technical assistance
to all 50 states, tribes and territories through calls with every State
public health team to discuss their testing goals and the best
mechanisms to achieve them. The Federal Government is assisting states
to develop testing plans, supplying resources to help meet these
testing plans, and deploying teams to states that need additional
subject matter expertise.
Because of the Administration's success in rapidly scaling up of
the testing ecosystem, states will be fully equipped to conduct more
COVID-19 tests per capita each month than most countries have tested
cumulatively to this date.
The Federal Government will continue to support Americans by
providing expedited regulatory approvals for tests and equipment as
necessary and appropriate, updating guidance for administering
diagnostic testing, and catalyzing technological and scientific
innovation. The process of reopening the United States will be one that
is federally supported, state-led and locally executed.
We recognize that vulnerable populations in many underserved
communities are among the highest risk of suffering devastating health
and economic impacts of COVID-19. We issued a Notice of Funding
Opportunity on May 1. The 3-year initiative will include the
development and coordination of a strategic and structured network of
national, State, territorial, and local public and community based
organizations that will help mitigate the impact of COVID-19 on racial
and ethnic minority as well as rural and socially vulnerable
communities across the Nation. The initiative also includes a national
multi-media outreach and education effort. One of the primary goals of
these information dissemination efforts is to provide additional
education and community-level information on resources to help fight
the pandemic to those who need it most.
United States Public Health Service Commissioned Corps
Since the early stages of the COVID-19 outbreak, the Corps has been
an indispensable asset leveraged to address the public health needs of
the Nation in response to this crisis. The Corps is one of the eight
uniformed services of the U.S. and the only uniformed service committed
to protecting, promoting, and advancing the health and safety of the
Nation. Corps officers serve throughout the Nation in communities that
are most in need by providing essential healthcare services to
underserved and vulnerable populations.
In January, the Corps deployed officers to provide expert outbreak
response in direct support of CDC. Deployment expanded rapidly from 38
officers on February 1, 2020 to more than 3,200 officers today with
many of them undertaking multiple or consecutive deployments. Corps
officers have been deployed across our Country and internationally to
assist with the outbreak response, to support the return of American
citizens, to assist in the management of hospitalized United States
citizens with COVID-19 abroad, and to support clinical trials related
to COVID-19. Corps officers provided critical assistance to community-
based testing sites throughout the Nation and their contributions to
this effort are immeasurable. In response to the escalating crisis, the
Corps established COVID-19 Clinical Strike Teams, which include
officers from the variety of disciplines needed on the frontlines. This
kind of ready-made unit allows the Corps to deploy a ``cavalry'' to
support healthcare systems under stress in states across the country.
COVID-19 Clinical Strike Teams have deployed to a long-term care
facility in Kirkland, Washington, to the Javits Center in New York
City; and to the TCF Center in Detroit. The Corps is also preparing to
send teams to the Navajo Nation to provide care amidst a surge of
COVID-19 cases.
The United States Public Health Service Commissioned Corps stands
ready and willing to respond to the public health needs of our Country
and to provide essential healthcare services.
______
The Chairman. Thank you, Admiral Giroir.
Now Dr. Stephen Hahn, our fourth and final witness.
STATEMENT OF STEPHEN HAHN, M.D., COMMISSIONER OF FOOD AND
DRUGS, UNITED STATES FOOD AND DRUG ADMINISTRATION, SILVER
SPRING, MD
Dr. Hahn. Chairman Alexander, Ranking Member Murray, and
Members of the Committee, thank you for inviting me to
participate in this hearing today.
I first want to start by thanking the American people for
their incredible efforts at mitigation and extend my
condolences to those who have lost loved ones.
From day one of this pandemic, the 18,000 FDA employees,
who are just incredible scientists, doctors, and nurses, have
taken an active role in the all-of-government response to this
pandemic.
FDA has worked to facilitate the development of medical
countermeasures to diagnose, treat, and prevent COVID-19. We
have worked closely with laboratories, manufacturers, academia,
product developers, our Federal partners, and companies--
companies that don't even make medical products but want to
pitch in, for example, by making hand sanitizer, personal
protective equipment, and ventilators.
Every decision we have made has been driven by data, with
the goal of protecting the health of the American people. In a
public health emergency, however, our responses balance the
urgent need to make medical products available with the
provision of a level of oversight that helps ensure the safety
and effectiveness of those medical products.
I would like to take a few minutes to tell you what FDA is
doing to help the country at this point, in which, Americans
safe to return to work and to school.
It starts with testing, as others have mentioned. FDA has
worked with more than 500 developers who have, or said they
will be submitting, Emergency Use Authorization requests for
COVID-19 tests. This includes some newer technologies that
not--that heretofore have not been used as part of diagnostic
tests in response to a pandemic.
We have issued 92 individual Emergency Use Authorizations
for test kit manufacturers and laboratories, and we have been
informed by more than 250 laboratories they have begun testing
under the regulatory flexibilities we outlined in March.
We are conducting rolling reviews of EUA submissions so
that we can quickly authorize tests which the data support. In
a public health emergency, the accuracy of diagnostic tests is
important, not only for the individual patient, but for the
patient at large, republic at large. FDA is helping to ensure
the availability of tests that are providing accurate answers.
We are also monitoring the market base for fraudulent tests
and are taking appropriate action to protect the public health,
and we are working to provide more clarity about which tests
have been reviewed and authorized by FDA and which have not.
Serologic tests will play a role in our recovery. Unlike
diagnostic tests, which detect the presence of the virus,
serologic tests measure the amount of antibodies or protein
present in the blood when the body is responding to an
infection like COVID-19. These tests can help identify
individuals who can overcome an infection and who have
developed an immune response. We will continue working with
labs, manufacturers, and across the Government to find a
balance between the assurance that an antibody test is
accurate, and timely access to such tests.
Of course, the way we will eventually beat this virus is
with a vaccine, and FDA is working closely with our Federal
partners, including the NIH, test--I mean, vaccine developers,
manufacturers, and experts across the globe. We intend to use
our regulatory flexibility to help ensure the most efficient
development of a safe and effective vaccine to prevent COVID-
19.
Until a preventative vaccine is approved, however, we need
medical products to bridge the gap. FDA has been working for
several months to facilitate the development and availability
of therapeutics as expeditiously as possible, and we have
created an emergency program for this acceleration called the
Coronavirus Treatment Acceleration Program, or CTAP. We have
reassigned staff to work with urgency to review requests from
companies, scientists, doctors, who are developing therapies,
and we are using every available authority and regulatory
flexibility that is appropriate to facilitate the development
of safe and effective products to treat COVID-19.
A variety of therapeutic areas are being evaluated, as
mentioned by Dr. Fauci and others, including antiviral drugs
and immunotherapies, as well as convalescent plasma,
hyperimmune globulin, and monoclonal antibodies.
As Dr. Fauci also mentioned, we recently announced the
positive results of the NIAID trial of Remdesivir and issued an
EUA for the treatment of hospitalized patients with COVID-19.
Two other promising treatments that I mentioned are the
antibody-rich products, convalescent plasma and hyperimmune
globulin, and I am certainly willing to go into more detail if
Members of this Committee have questions about this.
But, we are working very aggressively and closely with
stakeholders to facilitate the development of monoclonal
antibodies, which, if shown to be safe and effective, could act
as a bridge therapy to the development of a vaccine. We
recognize that developing vaccines and therapies need to go
hand in hand with ensuring that there will be sufficient
supplies for our companies--for our Country, so we are also
working with manufacturers to make sure that this supply chain
is robust.
Mr. Chairman, Ranking Member, and Members of the Committee,
please know that in FDA you have a dedicated team of some of
the Nation's finest scientists, healthcare providers, and
public health professionals. We are guided by science and data,
and we will not let up until we facilitate the development of
products that our Nation needs to get back to work. I look
forward to your questions.
Prepared statement of Stephen Hahn
From day one of this emerging public health emergency, FDA has
taken an active leadership role in the all-of-government response to
the COVID-19 pandemic, inspired by the resiliency of the American
people and our great innovators. Long before the first domestic case
was reported, FDA stood up an internal cross-agency group that
continues to ensure we are doing all we can to protect the American
public, helps ensure the safety and quality of FDA-regulated products
and provides the industries we regulate the tools and flexibility to do
the same. Work has focused on facilitating medical countermeasures to
diagnose, treat and prevent the disease, and surveilling the medical
product and food supply chains for potential shortages or disruptions
and helping to mitigate such impacts, as necessary to protect the
health of Americans. This work is a key component of the Federal
Government's efforts to address this pandemic and reopen the economy so
Americans can get back to work and school.
Diagnostic Testing
In an emergency, FDA oversees the validity of tests developed by
others through the Emergency Use Authorization (EUA) process. Every
action FDA has taken during this public health emergency to address the
COVID-19 pandemic has balanced the urgent need to make tests available
with providing a level of oversight that helps to ensure accurate tests
are being deployed.
COVID-19 has created a demand for new tests that is unprecedented
in both volume and urgency. As with other emergencies, FDA has been
extremely proactive and supportive of diagnostic test development by
all comers--laboratories, and large and small commercial manufacturers.
Even prior to any U.S. cases of COVID-19, FDA proactively reached out
to developers to encourage the development of tests and to see what the
Agency could do to facilitate development. In its COVID-19 Testing
Guidance, FDA has provided flexibility to encourage innovation and help
speed development of COVID-19 tests. FDA is engaging in rolling reviews
of EUA submissions and is quickly authorizing tests that the science
and data support. As outlined in the guidance, certain laboratories and
commercial manufacturers are developing their own diagnostic tests and,
once validated, are beginning to use them while they prepare an EUA
submission for FDA review. In addition, under our policies, states that
have the capacity and expertise to do so have been authorizing tests
for use within a laboratory in that state.
In a public health emergency, getting an accurate test is important
not only for the individual patient, but for the public at large. All
tests should be validated before use because it is critical that these
tests work. FDA's policies do not change that. False positive and false
negative results can contribute to the spread of COVID-19. As with
medical treatments, we want tests to be safe and, in the case of
diagnostics, accurate. FDA plays an important role helping to ensure we
are getting accurate answers. We are monitoring the market for
fraudulent and harmful tests. FDA has and will continue to take
appropriate action against firms that place the public health at risk
and follow-up with bad actors. There are several cases where developers
of tests have updated or changed claims at FDA's urging.
FDA is working on several fronts to provide more clarity about
which tests have been reviewed and authorized by FDA and which have
not. FDA has been posting on its website the tests for which it has
received a notification as outlined in its COVID-19 testing policies.
FDA has been working around the clock to 1) encourage and support
test development for the U.S. market, working with over 470 developers
since January; 2) issue EUAs for diagnostic tests, including those for
home self-collections; 3) research and mitigate shortages of test
components, including identifying and sharing scientifically acceptable
alternatives for components on FDA's website; 4) arrange with the
Department of Defense weekly airlifts of swabs to the United States; 5)
engage nontraditional device manufacturers to support use of new swabs
and other supplies that are needed in the United States; 6) offer
support to all developers through a 24-hour hotline and key resources,
including FAQs, that it updates regularly as it serves as a
clearinghouse for scientific information that helps everyone increase
testing capacity.
Serological Testing
Serological tests measure the amount of antibodies or proteins
present in the blood when the body is responding to a specific
infection, like the virus that causes COVID-19. Such a test detects the
body's immune response to an infection. These tests do not diagnose
COVID-19; however, we believe these tests can play a critical role in
the fight against COVID-19 by helping healthcare professionals to
identify individuals who may have overcome an infection in the past and
have developed an immune response. These tests may also aid in
identifying individuals with antibodies to the virus that causes COVID-
19 so they may donate convalescent plasma as a possible treatment,
which requires more data and research to determine if this is a safe
and effective treatment for COVID-19, but may help those who are
seriously ill from COVID-19.
In March, FDA issued a policy providing regulatory flexibility for
developers of certain serological tests that begin to market or use
their tests once they have performed the appropriate evaluation to
determine that their tests are accurate and reliable, without FDA
authorization, and as further outlined in the policy. The policy is
intended to allow for early patient access and flexibility for
developers, with appropriate transparency regarding the limitations of
these tests. On May 4th , FDA took important steps to build on this
policy by updating it to outline key expectations for antibody test
developers: 1) commercial manufacturers will submit EUA requests, with
their validation data, within 10 business days from the date they
notified FDA of their validation testing or from the publication date
of this policy, whichever is later, and 2) FDA has provided specific
performance threshold recommendations for all serology test developers.
The policy for laboratories certified under the Clinical Laboratory
Improvement Amendments (CLIA) to perform high-complexity testing,
regarding their developing and performing their own serology tests, has
not changed. They continue to perform their own validation and provide
notification to FDA, and should follow the other recommendations with
respect to labeling as described in the policy. In addition to these
updates, we are introducing a more streamlined process to support EUA
submissions and review. Two voluntary EUA templates for antibody tests
have been made available--one for commercial manufacturers and one for
CLIA certified high-complexity labs who decide to seek FDA
authorization. These templates will facilitate the preparation and
submission of an EUA request and can be used by an interested
developer. And as we do for diagnostic tests, we are happy to work with
developers of serology tests on other approaches if they do not want to
use one of the templates.
In addition, FDA issued an umbrella EUA for certain antibody tests
that undergo a validation evaluation at NCI, or another government
agency designated by FDA. Tests that FDA confirms meet the performance
and labeling criteria outlined in the EUA may be added under the
umbrella EUA, streamlining the submission and review of these important
tests.
We are continuing to provide updated information and educational
materials to states and health care partners. If particular commercial
manufacturers that are currently marketing serology tests under the
policy fail to submit an EUA within 10 business days of notification or
policy publication (whichever is later), we intend to share this
information publicly and take appropriate action as needed. We will
also keep up our work to stop illicit tests from entering the U.S., and
to keep fraudulent products off the market.
FDA will continue to take steps to balance assurances appropriately
that an antibody test is accurate and reliable with timely access to
such tests as the continually evolving circumstances and public health
needs warrant. To date, FDA has issued numerous EUAs for serological
tests, issued an ``umbrella'' EUA for certain serological tests, and is
working with hundreds of developers on pre-EUAs.
Importantly, we are working with developers and other partners to
evaluate the validity of serological tests, and are working to
authorize even more of these tests under EUAs. I continue to work
closely with my fellow Coronavirus Task Force members in examining the
role testing will play as we look to reopen our Country's schools,
businesses, and public services.
Vaccine Development and Treatment Interventions
At this time there is no FDA-approved vaccine to prevent being
infected with COVID-19. FDA is working closely with Federal partners,
vaccine developers, researchers, manufacturers, and experts across the
globe to help expedite the development and availability of vaccines and
drugs to prevent or treat COVID-19 infections. FDA intends to use
regulatory flexibility to help ensure the most efficient and timely
development of safe and effective vaccines to prevent COVID-19.
FDA is partnering with the NIH in their efforts to develop a
national strategy for a coordinated research response to the pandemic.
The Accelerating COVID-19 Therapeutic Interventions and Vaccines, or
ACTIV, partnership is developing a framework for prioritizing vaccine
and drug candidates, streamlining related clinical trials, coordinating
regulatory processes, and leveraging assets among all partners to
rapidly respond to COVID-19 and future pandemics.
Therapeutic Development
At this time there are no FDA-approved drug products to treat
COVID-19. 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 recently announced the
creation of an emergency review and development program for possible
therapies for COVID-19: the Coronavirus Treatment Acceleration Program,
or ``CTAP''. The Agency has been supporting the program by reassigning
staff and working day and night 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.
There are a variety of therapeutic areas being evaluated, including
antiviral drugs and immunotherapies, that may be helpful in reducing
lung inflammation and improving lung function in COVID-19 patients. All
this work is beginning to pay off, and we have recently announced the
positive results of the recent NIAID trial of Remdesivir in patients
with severe COVID-19. On May 1, FDA issued an EUA for Remdesivir for
the treatment of suspected or laboratory-confirmed COVID-19 in adults
and children hospitalized with severe disease.
Another promising approach for treatment is the use of antibody-
rich products such as convalescent plasma and hyperimmune globulin.
These blood products are manufactured from plasma donated by people who
have recovered from the virus and such products are being studied to
determine if they could shorten the length, or lessen the severity, of
the illness. It is important that we evaluate convalescent plasma in
the context of clinical trials as well as facilitate emergency access
for individual patients, as appropriate. As this work moves forward,
the key to ensuring the availability of convalescent plasma to those in
greatest need, as well as to support clinical development of
convalescent plasma and hyperimmune globulin, is getting fully
recovered COVID-19 patients to donate plasma if they meet FDA's donor
eligibility criteria. To that end, FDA is working with blood collectors
to facilitate the collection of convalescent plasma, and working with
developers of these therapies to move forward with clinical
evaluations.
Medical Product Supply
FDA has been monitoring and proactively adjusting to the worldwide
demand and supply chain disruptions for medical products caused by the
COVID-19 pandemic. We are working closely with manufacturers to help
ensure they continue to notify the Agency of any permanent
discontinuance or interruption of drug and biological product
manufacturing in a timely manner. In addition to our usual
communication with drug manufacturers, we are working closely with
healthcare and pharmacy systems, hospitals, providers, and others on
the frontlines of COVID-19 patient care to identify current or emerging
regional shortages of critical care drugs used to treat COVID-19.
We issued temporary policies under which outsourcing facilities
registered with FDA and pharmacists in state-licensed pharmacies or
Federal facilities can compound certain drugs used to treat patients
with COVID-19 under particular conditions explained in FDA guidance.
FDA understands the significant impact shortages can have on patient
care and is doing everything within its authority to help prevent and
alleviate this impact. In addition, when we identify a shortage, we
react swiftly to mitigate the impact to U.S. patients and health care
professionals, and quickly share that information with the public.
We are working to increase the supply of personal protective
equipment (PPE) and other critical devices that patients and those on
the front lines of the U.S. response rely upon. FDA has issued three
EUAs to help make more respirators available to health care personnel
and help ease burdens on the health care system. These allow for the
emergency use of NIOSH-approved respirators in health care settings for
healthcare personnel and the importation of non-NIOSH approved
respirators that meet certain specified criteria, as set forth in the
various EUAs. FDA has also issued several guidances to provide
flexibility for those manufacturing PPE for the COVID-19 response, and
we have published conservation strategies for gloves, gowns, and masks.
To support these efforts further, FDA has issued several EUAs for
devices used to decontaminate respirators for reuse by health care
workers in hospital settings.
FDA has also issued guidances for several other critical devices
including ventilators, clinical electronic thermometers, and imaging
systems, as well as remote digital pathology and remote monitoring
devices intended to help facilitate remote care that puts patients and
health care providers at less risk for exposure to COVID-19.
Taken together, FDA's policies and engagement have helped to
accelerate patient access to critical devices. FDA appreciates Congress
including provisions in the CARES Act for additional device shortages
authority during or in advance of a declared public health emergency,
and looks forward to continuing to work with Members of Congress to
expand further these authorities, consistent with the fiscal year 2021
Budget so that we can address shortages in other situations as well.
Food Supply
FDA is working with our Federal, State, and local partners as well
as industry to help ensure a safe and adequate food supply for both
people and animals. I want to reassure you there is no evidence of food
or food packaging being associated with transmission of COVID-19.
Although food product production and manufacturing in the United States
remains strong, resilient, and is for the most part dispersed
throughout the United States, some components are under stress.
There has been a significant shift in where consumers are buying
food, because of the pandemic. We have taken steps to provide temporary
guidance to provide flexibility in packaging and labeling requirements
to help industry divert products manufactured for food service and
institutional use to retail grocery stores.
FDA recognizes that the food supply chain is dependent on the
safety of the Nation's food and agricultural workforce. Along with our
Federal partners, we have provided best practices for food workers,
industry, and consumers on how to stay safe, keep food safe, and ensure
the continuity of operations in the food and agriculture critical
infrastructure sector during the pandemic.
FDA continues to monitor closely the overall safety of the Nation's
food supply. Importantly, we continue to work with CDC, the U.S.
Department of Agriculture, and our State and local partners to protect
consumers from foods contaminated with pathogens such as listeria,
salmonella and E. coli. FDA's Coordinated Outbreak Response and
Evaluation team has remained at work during the pandemic, is fully
staffed, and on-the-job looking for signs of foodborne illness
outbreaks.
Fraudulent Products
FDA is exercising its regulatory authority to protect consumers
from firms selling unproven products with false or misleading claims,
including by issuing warning letters and pursing enforcement actions
such as injunctions, against firms and individuals that violate the
law. For example, we are actively monitoring for firms selling
fraudulent and unproven products with claims to prevent, treat,
mitigate, diagnose, or cure COVID-19.
In addition, FDA investigators remain on the front lines at ports
of entry, quickly examining and reviewing import entries, and refusing
admission where appropriate. We are in close communication with our
partners at U.S. Customs and Border Protection to proactively identify
and mitigate any potential backlogs. FDA participates in FEMA Supply
Chain Task Force meetings, providing regulatory support and subject
matter expertise to respond to questions concerning medical products
identified by FEMA, to facilitate the lawful entry and use of imported
medical products coordinated through FEMA, and to inform medical
product supply chain discussions.
Conclusion
Thank you for the opportunity to be here to provide an update on
the activities of HHS in responding to COVID-19 and to answer any
questions.
______
The Chairman. Thank you, Dr. Hahn. And, thanks to all four
of you for your expertise, for your dedication to our Country,
and your hard work.
We will now begin a round of 5-minute questions from each
Senator on the Committee, alternating between Republicans and
Democrats. Each Senator has--if you are on videoconference, you
have a little time clock at the bottom, and I would ask you to
try to stay within 5 minutes for your questions and answers.
I will start. I have a question for Dr. Fauci and then
Admiral Giroir.
Doctor, let us look down the road 3 months. There will be
about 5,000 campuses across the country trying to welcome 20
million college students, 100,000 public schools welcoming 50
million students. What would you say to the chancellor of the
University of Tennessee Knoxville or the president--or the
principal of a public school about how to persuade parents and
students to return to school in August? Let us start with
treatments and vaccines first, Dr. Fauci. And if you could save
about half of my 5 minutes for Admiral Giroir for testing, I
would appreciate it.
Dr. Fauci. Thank you very much, Mr. Chairman. Well, I would
be very realistic with the chancellor and tell him that what we
are thinking in terms----
The Chairman. It is a her in this case, sir.
Dr. Fauci. Oh, Okay. I would tell her--I am sorry, sir--
that in this case, that the idea of having treatments
available, or a vaccine, to facilitate the reentry of students
into the fall term would be something that would be a bit of a
bridge too far.
As I mentioned, the drug that has shown some degree of
efficacy was modest, and it was in hospitalized patients; not
yet, or maybe ever, to be used either yet as prophylaxis or
treatment. So, if the issue is that the young individuals who
would be going back to school would like to have some comfort
in that there is a treatment, probably the thing that would be
closest to utilization then would likely be passive transfer of
convalescent serum.
But, we are really not talking about necessarily treating a
student who gets ill, but how the student will feel safe in
going back to school. If this were a situation where we had a
vaccine, that would really be the end of that issue in a
positive way. But, as I mentioned in my opening remarks, even
at the top speed we are going, we don't see a vaccine playing
in the ability of individuals to get back to school this term.
What they really want is to know if they are safe, and that is
the question that has to do with what we discussed earlier
about testing.
I am about halfway through the remarks. I would like to
just pass the baton to Admiral Giroir, who would address the
question of the availability of testing and what role that
might play in returning to school. Thank you, sir.
The Chairman. Well, thank you, Doctor. Thank you, Dr.
Fauci.
Admiral Giroir, you said that while we are doing about 10
million tests this month that we might be as high as 40 or 50
million by September, in a month, which is a significant
increase. So, if I am chancellor of the University of
Tennessee, could I develop a strategy where I would say to all
of my students, we have, for example, an antigen test, which is
quick and easy? We want everybody on campus to come by and take
it once before you begin school? That will at least let
everybody know that on that day, we have isolated anybody who
is positive, and then we can continue to monitor. Is that
strategy possible in August and September?
Admiral Giroir. Thank you, Mr. Chairman, and I may reserve
20 seconds for Dr. Redfield, as well.
The strategy that is going to be employed really depends
heavily on what is the community spread at that time. If there
is almost no community spread, your strategy will be different.
If there is high community spread, it will also be different.
But yes, technically, we will have the ability and your
chancellor will have the ability. We expect there to be 25 to
30 million point-of-care tests per month available. It is
certainly possible to test all of the students.
Or, it is much more likely that there would be a
surveillance strategy done where you may test some of the
students at different times to give an assurance that there is
no circulation. That would be done in conjunction with the CDC
and the local health department.
There is also strategies that are still needing to be
validated, but of pooling samples. We know in some experimental
labs, as many as 10 or 20 samples can be pooled, so essentially
one test could test 20 students.
Finally, there are some experimental approaches that look
interesting, if not promising, that, for example, waste water
from an entire dorm or an entire segment of a campus could be
tested to determine whether there is coronavirus in that
sewage, the waste water. So, there are other strategies being
developed.
I would like to at least give 20 seconds to Dr. Redfield,
who really will be working on the strategy of how to employ the
tests given different community spread.
The Chairman. Dr. Redfield.
Dr. Redfield. Yes, just some quick comments, sir. I mean,
first, I think it is really important to evaluate critically
the role of changes in social distancing on college campuses
and schools in the situation, not to forget the importance of
what we have learned.
Clearly, also developing a progressive program for wellness
education, making sure people understand when they are
symptomatic, they need to seek evaluation.
I think that you are going to have to look at the role of
testing. I think there is going to be an important role of
testing in these circumstances, and I think it will be
individualized based on where these different schools are,
where they--how much infection is in an area.
The Chairman. I am going to wrap it up there so I can set a
good example for the other Senators with their 5 minutes.
Senator Murray.
Senator Murray. Thank you very much, Mr. Chairman, and
thank you to all of our witnesses.
Dr. Fauci, you have warned of needless suffering and death
if we push to reopen too soon, but the President has actually
been sending the opposite message. I want to ask you today,
what is the most important message you have for communities and
states that are reopening, even as our public health experts
make it clear it is too soon? Tell us what the consequences
are.
Dr. Fauci. Thank you very much for that question, Senator
Murray. As I have said many times publicly, what we have worked
out is a guideline framework of how we safely open America
again. And, there are several checkpoints in that, with a
gateway first of showing, depending on the dynamics of an
outbreak in a particular region, state, city, or area, that
would really determine the speed and the pace with which one
does reenter or reopen.
My word has been, and I have been very consistent in this,
that I get concerned if you have a situation with the dynamics
of an outbreak in an area of such that you are not seeing that
gradual, over 14-day decrease that would allow you to go to
Phase 1. And then, if you pass the checkpoints of Phase 1, go
to Phase 2 and Phase 3.
What I have expressed then, and again, is my concern that
if some areas, cities, states, or what have you, jump over
those various checkpoints and prematurely open up without
having the capability of being able to respond effectively and
efficiently, my concern is that we will start to see little
spikes that might turn into outbreaks. So, therefore, I have
been being very clear in my message to try to the best extent
possible to go by the guidelines, which have been very well
thought out and very well delineated.
Senator Murray. If a community or a state or a region does
not go by those guidelines and reopens, the consequences could
be pretty dire, correct?
Dr. Fauci. The consequences could be really serious,
particularly--and this is something that I think we also should
pay attention to, that states, even if they are doing it at an
appropriate pace, which many of them are and will, namely a
pace that is commensurate with the dynamics of the outbreak,
that they have in place already the capability that, when there
will be cases, there is no doubt, even under the best of
circumstances, when you pull back on mitigation, you will see
some cases appear. It is the ability and the capability of
responding to those cases with good identification, isolation,
and contact tracing will determine whether you can continue to
go forward as you try to reopen America.
It is not only doing it at the appropriate time with the
appropriate constraints, but having in place the capability of
responding when the inevitable return of infections occur.
Senator Murray. Well, thank you for that. And, it is very
clear, in order to do that, we need knowledge, which is about
testing. And, for months, this administration's approach to
testing has really been plagued by unrealized goals and
disregard for systemic problems within that supply chain. And,
last week, an average of just 250,000 tests per day were
performed in the United States. That is a small fraction of
what we need. And yesterday, President Trump had the gall to
declare the U.S. had ``prevailed'' on testing in a press
conference that was filled with misinformation and distortions.
Dr. Giroir, public health experts do not think the U.S. has
prevailed. I am glad you finally committed that states,
including my home State of Washington, will receive enough
tests to meet their goals for May and June, but this
administration has had a record of giving us broken promises
that more tests and supplies are coming and they don't. And we
know, by the way, that testing is going to--needs will persist
long past June, long past.
I wanted to ask you today, will the administration's
forthcoming strategic plan that is now required under the COVID
package that was just passed and signed into law, will that
strategic plan on testing include specific numeric targets for
testing capacity, supply chain capacity, and projection of
shortages?
Admiral Giroir. Thank you for that question and statement,
Senator Murray. Yes, we are--as I have stated, we continue to
have a work in progress as we build the testing capacity. We
have established the targets with the states of over 12 million
tests over the next 4 weeks. We think those targets are going
to be good in May and June. But, as Dr. Fauci said, we really
have to be evidence based. We expect those targets to go up as
we progressively open, as communities go through Phase 1 and
then into Phase 2. And, certainly those numbers will need to go
up significantly again in the fall when we potentially have
influenza circulating with COVID.
Yes, there will be targets. The targets will need to change
based on the evidence that we see, but we are highly committed
to securing the supply chain. We have worked daily with every
manufacturer, and I am just pleased we are in May and June able
to get ahead of the states so that we can supply them what they
need so they have those assurances.
Senator Murray. Well, so my----
Admiral Giroir. There is not going to be any doubts about
that.
Senator Murray. My question to you is, when you put out
that specific plan that you are required to do, we will see
numbers that you are going to tell us that you will reach,
targeted for testing and supply chain capacity and projections,
and so forth? Instead of just saying we hope to have a million
this week, next week, so you will give us the specific targets,
correct?
Admiral Giroir. We know specifically--I will say yes,
ma'am, we know the specific--we know the specific amounts of
tests we have. Over the summer, we are I think----
Senator Murray. Not have; how many we need.
Admiral Giroir. Yes, ma'am. We develop the needs statements
by working with the states individually, with epidemiologists,
with the CDC, so that overall, in May, we will be testing about
3.9 percent of the overall U.S. population.
Senator Murray. Okay. But what I am telling you----
The Chairman. Well over time, Senator Murray.
Senator Murray [continuing]. Not how many we have, but how
many we will need. Not just for May, but in the coming months
so that we can be prepared to have them.
Admiral Giroir. Yes, ma'am. And, not to be repetitive, but
we need to be evidence and data driven because what we may see
in May or June will drive differences in the amount of test
goals we have. So, we really just need to be very humble about
this. We need to look at the data. We know that the testing
needs will go up over May and June as we progressively open,
and we will do our best to predict that. But, you have to
understand, we have to see what the data and the evidence show
at that time.
Senator Murray. Okay. I appreciate that. Mr. Chairman,
again, what our strategic plan requires is what is the goal;
not how many we have, but how many we need, and that is what we
will be looking for. Thank you.
The Chairman. Thank you, Senator Murray.
Senator Enzi.
Senator Enzi. Thank you, Mr. Chairman, and I particularly
appreciated your opening statement where you had a very
succinct list of preparations we need to learn from this
pandemic for the next one. Not only should we be working on
this and preparing, but we need to look at the future, too. And
I think we have learned a lot. We are fighting a virus at the
same time that scientists are learning about it.
We need to be nimble. We also need to be sure that we are
prepared for a second wave of outbreaks that could coincide
with the start of the flu season, potentially stressing our
healthcare system even more than it already has been.
Admiral Giroir, I thank you for your comments. I think they
have been comforting, about what has been done and what can be
done. I agree with Senator Murray that we need to have some
specific goals. As an accountant, that is always one of the
things that I am looking for.
For questions, Dr. Hahn, our understanding of the clinical
picture of COVID-19 continues to evolve. What first looked like
a respiratory illness now seems much more comprehensive,
potentially affecting the heart, the brain, the kidneys, and
other organs. How does this evolving picture impact the ability
to evaluate the appropriate clinical or surrogate endpoints for
review of vaccines and treatment?
Dr. Hahn. Thank you, Senator, for that question. The
evolving clinical picture, and obviously the way this is
manifesting around the country clinically, does in fact inform
the endpoints that we will work with developers of therapies on
so that we can get the absolute, most efficient, but also the
most accurate information and appropriate endpoints to make the
necessary authorizations and approvals.
We have set up this program called the Coronavirus
Treatment Acceleration Program where our top scientists and
clinicians have been at the table consulting with our
colleagues at NIH and CDC to actually address those questions--
what are the appropriate endpoints?
I will give you an example. We do know that in some
circumstances, patients who have had severe COVID disease have
developed thrombotic or clotting-type episodes, and so we
prioritize review of agents that we think might be beneficial.
And, obviously, the clinical endpoints for those trials will be
different than an agent that is an antiviral, like Remdesivir,
where, as Dr. Fauci mentioned, we are looking at time to
recovery.
We want to adapt it to the clinical circumstance, as well
as to the type of therapy that is put before us.
Senator Enzi. Thank you. Another question to Dr. Hahn. We
have made a lot of progress in vaccine development already.
BARDA has identified that domestic manufacturing of needles and
syringes, there is a significant gap in pandemic preparedness.
What has HHS done in advance of a potential national
vaccination campaign to ensure that we have sufficient capacity
to administer a vaccine?
Dr. Hahn. Senator Enzi, thank you for that question. This
is a really important point because, as you mentioned, it is
not just about the vaccine, or hopefully vaccines, that are
developed. It is all about--it is also about the supplies that
are needed, as well as an operational plan for administering
the vaccine.
This is an all-of-government approach. There is a program
that has been set up called Operation Warp Speed that includes
Dr. Collins, Dr. Fauci, his colleagues at NIH, the Department
of Defense, as well as other members of HHS and FDA. Dr. Peter
Marks from our Center for Biological Evaluation and Research
has been helping coordinate that and is working very closely
with Dr. Fauci and his team.
We have created what is called a Gantt chart to look
forward, what are the necessary supply chain issues, syringes,
needles, et cetera, depending on the various vaccines that are
being developed, how many times they have to administer it, and
the route of administration. So, we have been leaning in on
this supply chain to ensure that when a vaccine is ready to go,
we will have the necessary supplies to actually administer it
and operationalize the vaccination.
Senator Enzi. Thank you. I have a couple more questions.
But again, the clock is not visible there, so I suspect I have
used up my time. I will submit those in writing.
The Chairman. Thank you, Senator Enzi.
Senator Sanders.
Senator Sanders. Thank you very much, Mr. Chairman, and let
me thank all of the panelists for the hard work they are doing
and for being with us today.
It is sad to say that we have a President of the United
States, the leader of our Country, who, from day one,
downplayed the dangers facing this country from the pandemic;
who told us that the crisis would be over in a few months; that
we did not have to worry; who fired those members of the
government who wanted to act aggressively; and, among other
things, at a time when we need international cooperation, cut
funding for the World Health Organization.
Let me also say that I think we understand that facts are
terribly important. Not everybody--that we don't fully
understand all of the ramifications of the COVID-19 epidemic.
But, let me ask Dr. Fauci a few questions, if I might.
First off, the official statistic, Dr. Fauci, is that
80,000 Americans have died from the pandemic. There are some
epidemiologists who suggest the number may be 50 percent higher
than that. What do you think?
Dr. Fauci. I am not sure, Senator Sanders, if it is going
to be 50 percent higher. But, most of us feel that the number
of deaths are likely higher than that number because, given the
situation, particularly in New York City when they were really
strapped with a very serious challenge to their healthcare
system, that there may have been people who died at home who
did have COVID, who were not counted as COVID, because they
never really got to the hospital.
A direct answer to your question, I think you are correct
that the number is likely higher. I don't know exactly what----
Senator Sanders. Right.
Dr. Fauci [continuing]. Percent higher, but almost
certainly, it is higher.
Senator Sanders. Dr. Fauci, let me ask you this. In the
terrible pandemic of 1918, the virus exploded in the fall. It
came back with a vengeance. Are we fearful that if we don't get
our act together, as bad as the situation is now, it could
become worse in the fall or winter?
Dr. Fauci. Senator, thank you for that question. It is a
frequently asked question, and I think that a possibility does
exist. However--and the reason I say that is that when you talk
about will this virus just disappear--and as I have said
publicly many times, that is just not going to happen because
it is such a highly transmissible virus. And, even if we get
better control over the summer months, it is likely that there
will be virus somewhere in this--on this planet that will
eventually get back to us.
My approach toward the possibility of a rebound and a
second wave in the fall is that, A, it is entirely conceivable
and possible that it would happen. But, B, I would hope that
between now and then, given the capability of doing the testing
that you have heard from Admiral Giroir, and the ability of us
to stock up on personal protective equipment, and the workforce
that the CDC under Dr. Redfield will be putting forth to be
able to identify, isolate, and contact trace, I hope that if we
do have the threat of a second wave, we will be able to deal
with it very effectively to prevent it from becoming an
outbreak not only worse than now, but much, much less.
Senator Sanders. Okay. Let me ask--we have heard a lot of
this question about vaccines. Obviously, everybody in Congress
and in this country wants a vaccine. We want it as quickly as
possible, as effective as possible. Let me ask the honorable
FDA commissioner.
Sir, if, God willing, a vaccine is developed and if we are
able to produce it as quickly as we all hope we can, I would
imagine that vaccine would be distributed to all people free of
charge; or make sure at least that everybody in America who
needs that vaccine will get it, regardless of their income. Is
that a fair assumption?
Dr. Hahn. Senator, I certainly hope so. FDA is very
committed to making sure that all populations in the United
States, including those most vulnerable, are included in the
clinical trials, and very much----
Senator Sanders. That is not what I am asking. What I am
asking is, if and when the vaccine comes, it won't do somebody
any good if they don't get it. And, if they have to pay a sum
of money for it in order to profit the drug companies, that
will not be helpful. Are you guaranteeing the American people
today that vaccine will be available to all people regardless
of their income?
Dr. Hahn. Sir, the payment of vaccines is a not a
responsibility of FDA, but I am glad to take this back to the
task force. I share your concern that this needs to be made
available to every American.
Senator Sanders. Does anybody else want to comment on that?
Mr. Giroir, do you think we should make that vaccine, when
hopefully it is created, available to all, regardless of
income? Or, do you think that poor people and working people
should be last in line for the vaccine?
Admiral Giroir. I am sorry, Senator. Were you asking me----
Senator Sanders. Yes, I was, sir. Yes, I was.
Admiral Giroir. No. I--my office is one of the offices
committed to serving the underserved, and we need to be
absolutely certain that if a vaccine or an effective
therapeutic or preventative is available, that it reaches all
segments of society, regardless of their ability to pay, or any
other social determinants of health that there may be.
Senator Sanders. Good. So, what you are telling the
American people today, that regardless of income, every
American will be able to gain access to that vaccine when it
comes?
Admiral Giroir. They should gain access to it. I don't
control----
Senator Sanders. Well, you represent--you represent an
administration that makes that decision.
Admiral Giroir. I will certainly advocate that everyone is
able to receive the vaccine, regardless of income or any other
circumstance.
Senator Sanders. Let me just----
The Chairman. Senator Sanders.
Senator Sanders. I am sorry. Alright. Thank you, Mr.
Chairman.
The Chairman. Those are important questions. I don't want
to cut Senators off, but--and it is hard to see the time clock.
But if we could stay as close as possible to 5 minutes, then
all Senators can get their questions in. Thank you Senator
Sanders.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman, and thank our
witnesses today for what you have done for the people in this
country and their safety, and people around the globe.
Let me ask you, Dr. Fauci, because you have been in the
task force and at a majority of the press conferences. Has
anybody in this administration ever asked you or any member to
take the foot off the gas in trying to find a cure or any type
of countermeasure?
Dr. Fauci. No, Senator, not at all. As a matter of fact, we
at NIH, as you know, have been right from the very beginning,
put our foot right on that accelerator in every aspect,
including the development of vaccines and therapeutics. And as
I described in my opening statement, we actually started that
in January, literally days after the virus was known and its
sequence was published. So, no, I have never been told by
anyone to hold back on the development of any countermeasure or
any basic, including the research project that we have been
involved in.
Senator Burr. Thank you, Dr. Fauci.
This question is for Dr. Redfield. Dr. Redfield, we have
authorized in this Committee and appropriated out of Congress
multiple times over the last few decades money for
biosurveillance, and you talked about it. In the past 4 years,
from Fiscal Year 2016 to Fiscal Year 2020, it has been $23
million a year, and with the CARES Act, it is over $1 billion
in biosurveillance. We have seen the private sector go out and
use data available to track the progress and spread of
coronavirus around the world. Why has CDC not contracted with
private sector technology companies to try to use their tools
for biosurveillance?
Dr. Redfield. Senator, thank you for the question. This is
a critical issue, as you know, and also comes into one of the
core capabilities I talked about, data analytics and data
modernization, which we are appreciative of the additional
funding Congress has given.
I can tell you that this is under critical review now, and
we do have contracts with some of the private sector groups now
to try to make the type of availability of data that we have
seen with Florida available in all of our jurisdictions across
the country and in the process of making that happen.
Senator Burr. Dr. Redfield, in April of last year--June of
last year, we reauthorized the Pandemic and All-Hazards
legislation, which authorized at that time 30 new billets, 30
new employees, at CDC, specifically in surveillance. Now, I
asked Dr. Schuchat in March how many of those 30 had been
filled. She said zero. As of mid-April, zero of those 30
billets had been filled. How many of those 30 employees that
this Committee authorized CDC to bring on for biosurveillance
have been filled today?
Dr. Redfield. Sir, again, thank you for the question. I
know our staffs have been in discussion since Dr. Schuchat's
testimony, and I know we are in the process of continuing to
try to figure out how to move that forward, sir. I can get back
to you on it as I discuss what progress has been made since we
had that discussion post her hearing with you when you brought
that to light.
Senator Burr. Well, I brought it to light the 1st of March,
and now we are in mid-May. So, I am hopeful that we won't just
talk about surveillance; we will actually execute it and will
focus the unbelievable amounts of money that we have provided
for you, that they will show some benefit to the American
people.
Dr. Fauci, let me come back to you. This is one of the
fastest development timelines we have ever seen for vaccines,
and the American people, and hopefully people around the world,
will be the beneficiary of what you find and the eventual
licensure of that product. What are the biggest unknowns with
this particular virus that can affect the development process?
And, Dr. Hahn, if you have anything to add after that to this,
please do.
Dr. Fauci.
Dr. Fauci. Thank you very much, Senator Burr. Well, there
are a couple of things that I think are inherent in all vaccine
development.
First of all, there is no guarantee that the vaccine is
actually going to be effective. As you well know, because we
have discussed this many times in the past, that you can have
everything you think that is in place and you don't induce the
kind of immune response that turns out to be protective and
durably protective. So, one--the big unknown is, it will be
effective. Given the way the body responds to viruses of this
type, I am cautiously optimistic that we will, with one of the
candidates, get an efficacy signal.
The other thing that is an unknown that is of concern, but
we will be able to get around that by doing the tests properly,
is that, do you get an enhancement effect? Namely, there have
been a number of vaccines, two in particular, Dengue and
respiratory syncytial virus, when the vaccine induces a
suboptimal response, and when a person gets exposed, they
actually have an enhanced pathogenesis of the disease, which is
always worrisome. So, we want to make sure that does not
happen.
Those are the two major unknowns. Putting all those things
together, Senator Burr, I still feel cautiously optimistic that
we will have a candidate that will give some degree of
efficacy, hopefully a percentage enough that will induce the
kind of herd immunity that would give a protection to the
population at whole.
Senator Burr. Dr. Hahn, anything to add to that?
Dr. Hahn. Yes, sir. Thank you for the question. The
obstacles from a regulatory point of view I think are being met
by the approaches being taken out of HHS and led by Peter
Marks. That is, a common, preclinical development pathway so
that we can appropriately assess one vaccine against the other,
and then a master protocol that allows for a common control
group and an assessment of very common endpoints. That will let
us be as efficient as possible for the development of vaccine.
We will evaluate approximately 10 candidates pre-clinically
and then in the Phase 1 and Phase 2 studies, and then take four
to five into Phase 3 studies in this HHS effort.
I think those are the obstacles that can be broken down to
speed the development, but also allow us to ensure safety and
effectiveness.
Senator Burr. Mr. Chairman, yesterday, the State of North
Carolina started to publicize the recovered numbers, those
individuals who had coronavirus but have recovered. It is my
hope that nationally, we will start reporting the recovered
numbers. I think that is important for the American people to
hear. I yield back.
The Chairman. Thank you, Senator Burr.
Senator Casey.
Senator Casey. Mr. Chairman, thank you for the hearing, as
well as Ranking Member Murray.
Mr. Chairman, I wanted to start today with a question
regarding nursing homes. In particular, across the state like
ours, we have had, as you might know, a high number of cases in
Pennsylvania. At last count, over 57,000 cases. The number of
deaths have gone above 3,700 and, of course, a lot of those
deaths are in nursing homes. We are told that nationally, more
than one-third, as high as 35 percent, of all deaths, have been
in nursing homes, either the death of a resident of a nursing
home or a worker. So, I want to start today with a question for
Dr. Redfield.
Doctor, when we consider this challenge in our long-term
care facilities, when we look at the number of deaths in
nursing homes, I think a lot of families want basic
transparency. That is one of the reasons why Senator Wyden and
I sent you a letter dated April the 2d. It was directed to you,
as well as the administrator of the Centers for Medicare and
Medicaid Services, Seema Verma.
In that letter, we asked for basic information about what
the administration was doing to track the outbreaks in nursing
homes, to provide information, basic information, to families
and residents, the families of residents in nursing homes,
certainly to the workers, as well as to the community and
public health professionals.
Now, it took you over--about a month to respond to that.
But, in your response, you didn't give us any information about
the timeline. These families need this information. And, now we
are told by the CMS administrator, after pressing her as
Senator Wyden and I did, that this information may not be
available until the end of May.
I need to hear from you today, why has there been a delay,
a 3-month delay, in basic information that families and people
within a community need about the outbreaks in nursing homes,
the number of cases, what is happening in nursing homes? Tell
us when we are going to see that information.
Dr. Redfield. Well, thank you very much, Senator, and you
have highlighted one of the great tragedies that we have all
experienced together. Clearly, the long-term care facilities
have been particularly hard hit by this pandemic.
Several things. I know that, again, the CMS, who has
oversight, several things have been done, and I can get back to
you in terms of where they are at in terms of activation. But,
clearly, all nursing homes now are required to report cases in
either their individuals that are patients there or staff to
the CDC.
Second, I know that Dr. Verma and I have put a policy in
place at all nursing homes that required that they notify the
members of that nursing home of the existence of COVID in that
nursing home, including family members. In--verify in terms of
when that is, if that is operational as of today or last week,
but I will get back to you with that.
One of the most important--we have decided, as we talk
about key in reopening, as Tony mentioned, we need--symptomatic
cases. We need to be able to do the contact tracing.
But, the other thing that we really need to do is to do
surveillance because this virus does appear to have a high
propensity for asymptomatic infection, which means the
traditional ways of identifying cases is going to be blunted.
And, so, we are developing a national surveillance system, and
first and most important in that is to do comprehensive
surveillance in all the nursing homes in the United States. CDC
will be doing that in partnership with the state and local and
territorial health departments. I think HRSA is going to have
the responsibility to do it within the inner city clinics that
are selected, and the Indian Health Service for the Indian
Health Service clinics.
But, this is critical, that we get in front of this and do
comprehensive surveillance of everybody in these nursing homes.
We have also done, aggressive outreach in all of them in
enhancing infection control procedures, et cetera. CDC has been
out to help these nursing homes with that and to the guidance,
along with the--but, I will get back to you in terms of the
time. I am pretty confident they are already--it is already
operational, but I need to double check just to make sure
because I know Seema has announced it. They are all reporting
to the CDC now any infection in workers or patients, and that
they are required now to notify other members in the nursing
home, as well as family members, when COVID is one of those
places.
Senator Casey. Mr. Chairman, I just have one question for
Dr. Fauci.
Doctor, I wanted to ask you, in your testimony earlier in
response to a question by Senator Murray, you outlined a basic
concern you have with regard to states reopening. Can you
restate that for us?
Dr. Fauci. Yes. Thank you, Senator Casey. Yes. My concern
is that if states or cities or regions, in their attempt,
understandable, to get back to some form of normality,
disregard to a greater or lesser degree the checkpoints that we
put in our guidelines about when it is safe to proceed in
pulling back on mitigation. Because I feel if that occurs,
there is a real risk that you will trigger an outbreak that you
might not be able to control, which, in fact, paradoxically,
will set you back, not only leading to some suffering and death
that could be avoided, but could even set you back on the road
to trying to get economic recovery because it would almost turn
the clock back rather than going forward. That is my major
concern, Senator.
Senator Casey. Thank you, Doctor. Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Casey.
Senator Paul.
Senator Paul. Dr. Fauci, scientists have shown that rhesus
monkeys that are infected with COVID-19 cannot be re-infected.
Several studies have also shown that plasma from recently
infected coronavirus patients neutralizes the virus in lab
experiments. In addition, infusion of convalescent plasma is
based on the idea that recovering coronavirus patients are
developing immunity and that it can be beneficial as donating.
Studies show that the recovering COVID-19 patients from the
asymptomatic to the very sick are showing significant antibody
response.
Studies show that SARS and MERS, also coronaviruses, induce
immunity for at least 2 to 3 years, and yet the media continues
to report that we have no evidence that patients who survive
coronavirus have immunity. I think actually the truth is the
opposite. We have no evidence that survivors of coronavirus
don't have immunity, and a great deal of evidence to suggest
that they do.
The question of immunity is linked to health policy and
that workers who have gained immunity can be a strong part of
our economic recovery. The silver lining to so many infections
in the meat processing industry is that a large portion of
these workers now have immunity. Those workers should be
reassured that they likely won't get it again instead of being
alarmed by media reports that there is no evidence of immunity.
You have stated publicly that you would bet it all that
survivors of coronavirus have some form of immunity. Can you
help set the record straight that the scientific record as it
is being accumulated is supportive that infection with
coronavirus likely leads to some form of immunity?
Dr. Fauci.
Dr. Fauci. Thank you for the question, Senator Paul. Yes,
you are correct that I have said that, given what we know about
the recovery from viruses, such as coronaviruses in general, or
even any infectious disease with very few exceptions, that when
you have antibody present, it very likely indicates a degree of
protection.
I think it is in the semantics of how this is expressed.
When you say, has it been formally proven by long-term, natural
history studies, which is the only way that you can prove, one,
is it protective--which I said and would repeat is likely that
it is--but also, what is the degree or titer of antibody that
gives you that critical level of protection, and what is the
durability?
As I have often said, and I again repeat, you can make a
reasonable assumption that it would be protective, but natural
history studies over a period of months to years would then
tell you definitively if that is the case.
Senator Paul. I think that is important because--in all
likelihood is a good way of putting it. The vast majority of
these people have immunity, instead of saying there is no
evidence. You know, the WHO kind of fed into this by saying no
evidence of immunity. And, in reality, there is every evidence
stacking up. In fact, a lot of the different studies have shown
that it is very unlikely that you get it again in the short
term.
With regard to going back to school, one thing that was
left out of that discussion is mortality. I mean, shouldn't we
at least be discussing what the mortality of children is? This
is for Dr. Fauci, as well.
You know, the mortality between zero and 18 in the New York
data approaches zero. It is not going to be absolutely zero,
but it almost approaches zero.
Between 18 and 45, the mortality in New York was 10 out of
100,000.
Really, we do need to be thinking about that. We need to
observe with an open mind what went on in Sweden where the kids
kept going to school. The mortality per capita in Sweden is
actually less than France, less than Italy, less than Spain,
less than Belgium, less than the Netherlands, about the same as
Switzerland.
But, basically, I don't think there is anybody arguing that
what happened in Sweden is an unacceptable result. I think
people are intrigued by it, and we should be. I don't think any
of us are certain when we do all of these modelings. There have
been more people wrong with modeling than right. We are opening
up a lot of economies around the U.S., and I hope that people
who are predicting doom and gloom and saying, oh, we can't do
this, there is going to be a surge, will admit that they were
wrong if there is not a surge because I think that is what is
going to happen.
In rural states--we never really reached any sort of
pandemic levels in Kentucky and other states. We have less
deaths in Kentucky than we have in an average flu season. That
is not to say this is not deadly. But really, outside of New
England, we have had a relatively benign course for this virus
nationwide.
I think the one-size-fits-all that we are going have a
national strategy and nobody is going to go to school is kind
of ridiculous. We really ought to be doing it school district
by school district, and the power needs to be disbursed because
people make wrong predictions. And really, the history of this
when we look back will be of wrong prediction after wrong
prediction after wrong prediction, starting with Ferguson in
England.
I think we ought to have a little bit of humility in our
belief that we know what is best for the economy. And, as much
as I respect you, Dr. Fauci, I don't think you are the end-all.
I don't think you are the one person that gets to make a
decision. We can listen to your advice, but there are people on
the other side saying there is not going to be surge and that
we can safely open the economy.
The facts will bear this out, that if we keep kids out of
school for another year, what is going to happen is the poor
and underprivileged kids who don't have a parent that is able
to teach them at home are not going to learn for a full year.
I think we ought to look at the Swedish model, and we ought
to look at letting our kids get back to school. I think it is a
huge mistake if we don't open the schools in the fall. Thank
you.
Dr. Fauci. Mr. Chairman, could I respond to that even
though there are only 32 seconds left?
The Chairman. Yes. And you might make it clear whether or
not you suggested that we shouldn't go back to school in the
fall.
Dr. Fauci. Well, first of all, Senator Paul, thank you for
your comments. I have never made myself out to be the end-all
and only voice in this. I am a scientist, a physician, and
public health official. I give advice according to the best
scientific evidence. There are a number of other people who
come into that and give advice that are more related to the
things that you spoke about, about the need to get the country
back open again and economically. I don't give advice about
economic things. I don't give advice about anything other than
public health. So, I wanted to respond to that.
The second thing is that you used the word 'we should be
humble' about what we don't know. I think that falls under the
fact that we don't know everything about this virus and we
really better be very careful, particularly when it comes to
children. Because the more and more we learn, we are seeing
things about what this virus can do that we didn't see from the
studies in China or in Europe. For example, right now, children
presenting with COVID-16--with COVID-19 who actually have a
very strange inflammatory syndrome, very similar to Kawasaki
Syndrome. I think we better be careful if we are not cavalier
in thinking that children are completely immune of the
deleterious effects.
Again, you are right in the numbers that children, in
general, do much, much better than adults and the elderly and
particularly those with underlying conditions. But, I am very
careful, and hopefully humble, in knowing that I don't know
everything about this disease, and that is why I am very
reserved in making broad predictions. Thank you.
The Chairman. Thank you, Senator Paul.
Senator Baldwin.
Senator Baldwin. Thank you, Mr. Chairman and Ranking Member
Murray and our witnesses.
I want to try to cover a lot of territory in my 5 minutes,
so I would certainly be appreciative of concise answers.
But, I want to start with Dr. Redfield. Dr. Redfield, do
you think that the current testing protocols at the White House
presents a model for other essential workplaces?
Dr. Redfield. I am sorry, Senator. You broke up at the
beginning of your question. If you could just say it again. I
am sorry.
Senator Baldwin. Yes. Dr. Redfield, do you think that the
testing protocols currently in place in the White House present
a model for other essential workplaces?
Dr. Redfield. Well, I think--thank you for the question. I
think one of the important things you bring up is the essential
worker guidance that CDC put out. And I think it was originally
modeled, obviously, on healthcare workers where there were
significant healthcare shortages and individuals that were
exposed----
Senator Baldwin [continuing]. Workplaces. I am asking you
if you think that the White House protocols for testing are a
model for other essential workplaces.
Dr. Redfield. I would just say that I think each workplace
has to define their own approach as to how to operationalize
our----
Senator Baldwin. You already had some considerable comment
on the fact that OSHA has not stood up an enforceable,
mandatory emergency temporary standard for workers in all sorts
of work settings. But that aside, would you say that the PPE
rules and protocols in effect right now in the White House are
a model for other essential workplaces?
Dr. Redfield. We would--my own view would go back to the
guidelines that CDC has put out about essential workplaces for
people. If they are an essential workforce, that they go in
public, they maintain 6 feet distancing and they wear face
coverings.
Senator Baldwin. Okay. Admiral Giroir, you have testified
about how far you have come with regard to testing assessments.
I want to ask you if you believe that we already have a
national testing strategy today that spans from the nationwide
testing needs assessment to the nationwide testing supply
assessment, and a strategy to fill that gap to procure
domestically what we need in terms of bridging that gap with
testing platforms, swabs, specimen collection media and
reagents, and the PPE needed to conduct those tests.
Admiral Giroir. Thank you for that. We do have a strategy
that spans us at least to the fall and beyond. As I mentioned,
we are working individually with every state, and I think
Senator Paul is correct that Kentucky, Wyoming or New Jersey,
Rhode Island are different. There are vastly different testing
needs. The East Coast will have multiples of testing versus
other states, and we are working those individually.
Senator Baldwin. So----
Admiral Giroir. Yes.
Senator Baldwin. I know you testified earlier that not only
are you working with the states, but you are working with every
lab in every state----
Admiral Giroir. Correct.
Senator Baldwin [continuing]. Trying to increase capacity.
What about working with those who would be the--those who would
need testing to, say, reopen their school, their university,
their business? Each of them have identified what they think
are their testing needs based on, guidance, not mandatory,
enforceable rules. But, are you in contact at that level? Does
your dashboard have visibility at that lowest level, or are you
mostly in contact with the states and with the labs?
Admiral Giroir. Over the last few months, we have done a
lot of the individual work at nursing homes, at meat packing
plants, and other--I mean, really down to the very granular
level.
Senator Baldwin. Okay.
Admiral Giroir. Where we are right now, however, is we are
really working with the state leadership, with the public
health lab, the state epidemiologist, the SHOs, the state
health officials, because they really need to understand what
their sum is going to be in their state.
Senator Baldwin. Okay. Thank you.
Admiral Giroir. Then the funding, we are asking very
specifically, in the CDC funding, for specific plans for
schools, nursing homes, underserved, et cetera.
Senator Baldwin. Thank you. I have two more points that I
am going to make. I don't have time for questions.
One is about the transparency of that needs assessment. Can
the public see it? Can the states see it? Can the HELP
Committee Members see it? Is it publicly available?
Second, the delivery of this supply is a critical issue,
and it seems to me that the logistics for getting this out,
whether it is PPE, testing, or medical equipment, is still
extremely fragmented, leading to price gouging and many other
inefficiencies. We need to stand up the full power of the
Defense Production Act.
Admiral Giroir. Would you like me to comment on that,
ma'am? I am sorry.
Senator Baldwin. I am happy to have you comment with the
indulgence of the Chairman. We have gone over time and----
The Chairman. Why don't you try to give a succinct answer
to the Senator, please, Admiral Giroir.
Admiral Giroir. Yes, ma'am, and yes, sir. Particularly for
things like swabs and media, there is still a very, I would
say, non-mature industry within the country, and that is why we
have made the decision to procure that all centrally through
December and then distribute that to the states. Because there
are just too many small companies, too many--too many variables
to control without a really heavy Federal hand. That is just an
example of where we really moved into that and used the DPA for
swabs to help support American industry.
In more mature aspects of the industry, like some of the
large test producers, we feel that by helping direct them to
make sure that the states get what they need in the right
distribution, that we are not procuring them directly by us.
But again, we are going to be very evidence and data driven as
we move on.
Thank you, sir.
The Chairman. Thank you very much, Senator Baldwin.
Senator Collins.
Senator Collins. Thank you, Mr. Chairman.
Let me begin by first thanking each of our witnesses today
for their expertise, their dedication, and their hard work.
Dr. Redfield, I want to start with you. I am hearing from
dentists all over the State of Maine that the fact that they
cannot practice in our state, despite following very strict
infection control protocols, is causing growing health
problems.
Dentists tell me that teeth with cavities that could have
been filled are now going to need root canals. Teeth that could
have been treated with root canals are now going to require
extractions. People with oral cancers cannot get the treatment,
the cleanings, that they need before beginning their treatment.
Dental health is clearly so important, and Maine State
officials, as well as our dentists, are seeking assistance in
reaching the right decisions. Forty-seven other states either
have reopened dental practices or have a day set for them to
reopen.
My question to you is this. If dentists are following the
American Dental Association guidelines, if they are instituting
strict protective measures for their patients, their staffs,
their hygienists, themselves, and if they are closely examining
and seeing a decline in the number of COVID-19 infections in
their county, are these reasonable factors for states to
consider in reopening the practice of dentistry?
Dr. Redfield. Yes, Senator. Thank you for the question. You
know, we have been interacting and talking with dentists and
working with the state and local public health officials to
update our guidelines on reopening a variety of medical
services, as you know. And I think you raise a very important
point, and I would not disagree with what you said about
looking at the American Dental Association, as well as the
reality of the outbreak in the area. But, we are in the process
of updating those guidelines, and they will include direct
guidelines for dental practices.
Senator Collins. Thank you very much, Doctor.
Dr. Giroir and Dr. Hahn, recently there has been a
significant demand for Remdesivir, I may be mispronouncing it,
which transitioned to receiving an Emergency Use Authorization.
Last week, Maine's two largest hospital systems contacted
me with questions about how this therapeutic will be allocated
going forward. HHS finally released a statement on Saturday
about allocations going to states; interestingly, not directly
to hospitals. But, once again, the decision making behind these
allocations is very unclear.
HHS and the Assistant Secretary for Preparedness and
Response say that each state is expected to receive an
allocation, but no timetable has been provided. Beyond those
who are being treated with this drug at Maine Medical Center
through a clinical trial, I am concerned that hospitalized
patients in Maine will have little or no ability to be treated
with this promising therapeutic for the foreseeable future.
As this and more therapeutics, and ultimately a vaccine,
come onto the marketplace, how can these allocation and
distribution issues be resolved so that patient care is not
delayed and so that it does not depend on which state you live
in whether or not you are going to get access to these
treatments and ultimately a vaccine?
Dr. Hahn. Senator Collins, this--oh, go ahead, Admiral
Giroir.
Admiral Giroir. Go ahead. Go ahead, Commissioner.
Dr. Hahn. Senator Collins, I think we completely agree with
you that this has to be an evidence based approach getting the
medical therapeutics, vaccines, Remdesivir, whichever it
happens to be, to the people in need. I think we can all agree
upon the fact that we learned a lot of lessons from the
Remdesivir situation. And, of course, as you mentioned, that is
being led by HHS and ASPR.
What you see in the most recent announcement is that what
the task force did was provide guidance to HHS regarding where
the most significant outbreak of hospitalizations, outbreak
occurred and where those hospitalized patients were. This
represented about one-quarter of the supply of drug that we
have, and more will be allocated according to methodology that
gets the drug to where those hospitalized patients are.
I think valuable lessons can be learned and will be learned
with respect to other therapies, and to vaccines in particular,
and we must incorporate those into our operational plans moving
forward.
Senator Collins. Thank you, Doctor.
Admiral, do you have anything to add? I am over time.
Sorry. Thank you. If you have anything to add, if you would do
so for the record.
Admiral Giroir. No, ma'am. No, ma'am. I agree with the
commissioner. It is absolutely critical that it is evidence
based, based on the people who could benefit from it, and also
fair and just throughout our Country.
Senator Collins. Thank you.
The Chairman. Thank you, Senator Collins.
Senator Murphy.
Senator Murphy. Thank you very much, Mr. Chairman. Thank
you to you and Senator Murray for convening this. Thank you to
all the witnesses for your service.
This is obviously an exceptional hearing today in that
three of our witnesses are in quarantine. So, I just want to
start by asking a pretty simple yes or no question that I think
I know the answer to.
Dr. Fauci, Dr. Hahn, and Dr. Redfield, I am correct that
all of you are drawing a salary, as you should, during your
period of quarantine. Is that correct?
Dr. Fauci. Senator, let me start off. I think we better be
careful about the issue of quarantine. We are essential workers
as part of the essential infrastructure, and we are, when
needed, which is often, do our duties in our respective places
at the White House. I was at the White House yesterday, and I
will likely even--perhaps even be there today, and in my office
at the NIH. So, it is not really strictly speaking a quarantine
as we know it, but it is performing our duties as critical
workers. And I would be happy to have my colleagues also
respond to that.
Dr. Hahn. Senator Murphy, this is Steve Hahn. I agree with
Dr. Fauci. And yes, I am drawing a salary, and I have continued
to work during my quarantine. And, as an essential worker, will
participate in meetings face to face when that attendance is
considered critical.
Senator Murphy. My point here--listen, you all should draw
a salary while you are taking precautionary steps because of
the contacts you have made. My point is that quarantine is
relatively easy for people like you and me. We can still work
and get paid. We can telework.
But, there are millions of other Americans who work jobs
that cannot be performed from home, or are paid by the hour.
And, it is just remarkable to me that this administration has
not yet developed a mechanism for states to implement and pay
for a quarantine system that will work for all Americans. Your
plan to reopen America requires states develop that plan, and
yet my state has no clue how to implement and pay for that
system without help from the Federal Government, which leads me
to my second question.
Dr. Fauci and Dr. Redfield, you have made news today by
warning us appropriately of the dangers of states opening too
early. But, as Senator Murray mentioned, this is infuriating to
many of us because it comes hours after the President declared
that we have prevailed over coronavirus, which I am just going
to tell you is going to make it much harder on state leaders to
keep social distancing restrictions in place. It comes days
after the President called on citizens to liberate their states
from social distancing orders.
I think you are all noble public servants, but I worry that
you are trying to have it both ways. You say the states
shouldn't open too early, but then you don't give us the
resources to succeed. You work for a President who is, frankly,
undermining our efforts to comply with the guidance that you
have given us, and then the guidance that you have provided is
criminally vague.
I want to ask my last question on this topic. Obviously,
the plan to reopen America was meant to be followed by more
detailed, nuanced guidance. Right? What does a downward
trajectory mean? What happens if the trajectory is downward in
some settings but upward in others? What happens if you reopen
and then there is a spike in one location or another setting?
And, of course, you knew this because you developed this
guidance, this additional guidance, that is site-specific,
that, frankly, is helpful. Some of this is on the CDC website,
but some of it is not, and we need it. My state needs it. We
don't have all of the experts that you have, and so we rely on
you.
Reporting suggests, Dr. Redfield, that this guidance that
was developed by you and other experts was shelved by the
administration, that it was withheld from states and the public
because of a decision made by the White House. So, my specific
question is, why didn't this plan get released? And, if it is
just being reviewed, when is it going to be released? Because
states are reopening right now, and we need this additional
guidance to make those decisions.
Dr. Redfield. Senator, I appreciate your question. Clearly,
we have generated a series of guidances, as you know. And, as
this outbreak response has evolved from a CDC to an all-of-
government response, as we work through the guidances, a number
of them go for interagency review and interagency input to make
sure that these guidances are more broadly applicable for
different parts of our society.
The guidances that you have talked about have gone through
that interagency review. There are comments that have come back
to CDC, and I anticipate they will go back up into the task
force for final review.
Senator Murphy. But we are reopening in Connecticut in 5
days, in 10 days. I mean, this guidance isn't going to be
useful to us in 2 weeks. So, is it this week? Is it next week?
When are we going to get this expertise from the Federal
Government?
Dr. Redfield. The other thing I will just say is that the
CDC stands by to be of technical assistance to your state and
any state upon any request. I do anticipate this broader
guidance, though, to be posted on the CDC website soon.
Senator Murphy. Soon.
Dr. Redfield. I can't tell you soon, but I can tell you
your state can reach out to CDC and we will give guidance
directly to anyone in your state on any circumstance that your
state desires guidance from.
Senator Murphy. Soon isn't terribly helpful.
Thank you, Mr. Chairman.
The Chairman. Thank you, Senator Murphy.
Senator Cassidy.
Senator Cassidy. Okay. Gentlemen, thank you very much for
your service, and I will have a set of questions. So, if your
questions can be brief, I appreciate your answers to be brief.
Dr. Hahn, in your testimony, you mentioned that the testing
for the populations in the vaccine trials now includes older
Americans. I guess my question, though, is what about children?
Does it include children? Does it also include the obese, the
diabetic, the immunocompromised, those who are at risk of
having a less--a non-response or a mitigated response to
vaccination? Can you comment on that, please?
Dr. Hahn. Yes, sir. Thank you, Senator Cassidy. When the
Phase 2, Phase 3 trials are in place, they will include our
most vulnerable populations, including the individuals that you
describe. We are working very closely----
Senator Cassidy. If I can interrupt. Phase 2----
Dr. Hahn. Yes, sir.
Senator Cassidy [continuing]. Would normally check for
safety. You would not have to do a separate Phase 2 in the
patient who was younger? Do you follow what I'm saying? Or can
you just assume the safety data from the adults applies to that
of the children?
Dr. Hahn. Sir, no, we would also want to assess safety,
sir, as well, in children.
Senator Cassidy. The current Phase 2 trials, do they
include children?
Dr. Hahn. They are in Phase 1 studies right now, sir.
Senator Cassidy. Well, I thought Dr. Fauci said we had a
Phase 2 going on.
Dr. Hahn. Well, I think it is about to start for the
Moderna vaccine.
Dr. Fauci. No.
Dr. Hahn. Perhaps, Dr. Fauci, you can answer that.
Dr. Fauci. Yes. I--no, Senator Cassidy. No. I did not say a
Phase 2. As I said, we are in a second dose of the Phase 1, and
we will proceed when we finish the Phase 1 to go into Phase 2.
Senator Cassidy. If this--so, I think I am hearing that
children will be included Phase 2 trials?
Dr. Hahn. That is a--so, that is under discussion between
FDA and NIH at this time, sir, because we do realize that it is
important----
Senator Cassidy. Sounds right.
Dr. Hahn [continuing]. For us to understand what this is in
children.
Dr. Redfield, to build back upon what Senator Murphy said,
the published guidelines for schools, school opening,
obviously, you are about to modify. But, I notice as I read
through them, there is nothing about testing. So, we speak
about testing, targeted testing and how we use testing, but the
guidelines for the school systems has nothing about how to
integrate testing. Will these be in those guidelines that are
being released?
Dr. Redfield. Senator, thanks for the question. Clearly,
there is going to need to be, as has already been stated, an
integration of a testing strategy. That is going to be
different for different school settings, as well as different
jurisdictions, where there is--setting, and that is going to
have to be integrated into each of those. There is general
overarching guidelines. And, then, as I say, I do think the
testing strategy, which is important, is--including the
surveillance strategy, needs to be an individualized----
Senator Cassidy. Now, let me comment on that, Dr. Redfield.
Dr. Redfield [continuing]. Guidelines.
Senator Cassidy. Dr. Redfield, in all due respect, I think
children, whether you are rural, frontier, suburban, or urban,
is the one setting in which there is a remarkable commonality.
And I will echo what Senator Murphy said. The resources that
the Federal Government has greatly exceeds all but the most
sophisticated, the populous, wealthy state. And even then, it
exceeds it by some extent.
I do think it would be good to have, okay, in a primary
school setting, this is best practices, or these are three
options and choose between one of these three. To say to each
school district or each private or parochial or independent
school, work with your state board of health, figure it out,
seems a wasted effort. I say that because children play such a
role in both protection of disease, the spread of disease, et
cetera.
Your thoughts on that? Because it really seems that is the
one setting where you can have, not cookie cutter, but
certainly a pattern which can be followed.
Dr. Redfield. Senator, I must have been misunderstood. When
I was talking about differences, I was thinking of the
difference between an elementary school, a high school, a
college in terms of how we--a trade school. There may be
differences in how you integrate a testing strategy. But, I do
think having a testing strategy with different options for
people to evaluate based on different principles will be
important in terms of guidance.
Senator Cassidy. Dr. Fauci, you persuasively argue that the
risk of reopening prematurely is great. But, I think the
frustration, if I think of children in particular, the risk-
benefit ratio of a child being at home, potentially away from
enhanced nutrition, without the parent able to work because the
school provides daycare, without the monitoring that sometimes
occurs for incidences such as child abuse, but perhaps most
importantly for all children, the opportunity cost of a brain,
which is forming, not having access to the information that
will help that brain form optimally.
Now, has there been any sort of kind of risk-benefit ratio
for the child? Yes, they are at risk for Kawasaki's, but there
are particular risks for missing out on a year of education,
particularly for those from less than rich backgrounds.
I guess I am very concerned about that tension. What are
your thoughts on that?
Dr. Fauci. No. You make a very good point, Senator Cassidy.
There are obviously very difficult of the unintended
consequences of trying to do something that broadly is
important for the public health and the risk of having a return
or a resurgence of an outbreak, and the unintended, deleterious
consequences of having children out of school. We fully
appreciate that. I don't have an easy answer to that. I just
don't. We just have to see on a step-by-step basis as we get
into the period of time of the fall about reopening the schools
exactly where we will be at the dynamics of the outbreak.
I might point out something that I think has been alluded
to throughout some of the questions. We have a very large
country, and the dynamics of the outbreak are different in
different regions of the country. So, I would imagine that
situations regarding school would be very different in one
region versus another, so that it is not going to be
universally or homogenous. And I don't have a good explanation
or solution for the problem of what happens when you close
schools and it triggers a cascade of events and could have some
complicated circumstances.
Senator Cassidy. Mr. Chairman, I will close by asking the
permission of the Chairman to submit for the record an article
that just came out in the Journal of Pediatric Nursing,
Children are at Risk from COVID-19.
The Chairman. It is so ordered and it will be included.
Thank you, Senator Cassidy.
[The information referred to was not submitted for the
Record.]
The Chairman. Senator Warren.
Senator Warren. Thank you, Mr. Chairman, and thank you to
our witnesses for being here today. I hope everybody is staying
safe and healthy.
In the past 16 weeks, over 1.3 million Americans have been
infected with coronavirus. We now know that about 80,000 people
have died, and 33 million people are out of work.
Dr. Fauci, you have advised six presidents. You have
battled deadly viruses for your entire career. So, I would just
like to hear your honest opinion. Do we have the coronavirus
contained?
Dr. Fauci. Senator, thank you for the question. Right now,
it depends on what you mean by containment. If you think that
we have it completely under control, we don't. I mean, if you
look at the dynamics of the outbreak, we are seeing a
diminution of hospitalizations and infections in some places,
such as in New York City, which has plateaued and started to
come down, New Orleans, but in other parts of the country, we
are seeing spikes.
When you look at the dynamics of new cases, even though
some are coming down, the curve looks flat with some slight
coming down. So, I think we are going in the right direction,
but the right direction does not mean we have, by any means,
total control of this outbreak.
Senator Warren. Right direction. As I understand it, we
have about 25,000 new infections a day and over 2,000 deaths a
day. I think those are the right numbers. And some are
estimating we could be at 200,000 new cases a day by June. Is
that right, Dr. Fauci?
Dr. Fauci. I don't--I don't foresee that as 200,000 new
cases by June. I am hoping, in looking at the dynamics of
things starting to flatten off and come down, that we will be
much, much better than that, Senator. I mean, I think----
Senator Warren. Just so I understand, we are right now at
2,000 new infections a day and--25,000 new infections a day and
2,000 deaths a day.
Dr. Fauci. Right.
Senator Warren. That is where we are right now?
Dr. Fauci. Right.
Senator Warren. Is that----
Dr. Fauci. Yes.
Senator Warren. Let me just ask. We know that it is
possible to get this virus under better control. Other
countries have done it, like South Korea. But, we are now 3
months into this pandemic and basically we have continued to
set records for the number of people who are diagnosed and the
number of people who die.
Dr. Fauci, you recently said that a second wave of
coronavirus in the fall was ``inevitable,'' but that if America
``puts in place all of the countermeasures that you need to
address this, we should do reasonably well.'' And the
countermeasures you identified were things like continued
social distancing, significantly more testing, widespread
contact tracing. You also said that if America doesn't do what
it takes, and this is your quote, ``We could be in for a bad
fall and a bad winter.''
Right now we are about 16 weeks away from Labor Day. That
is about the same length of time since the virus was first
detected here in the U.S. Do we have enough robust
countermeasures in place that we don't have to worry about a
bad fall and winter?
Dr. Fauci. Right now, the projection, as you have heard
from Admiral Giroir, with regard to testing and other elements
that will be needed to respond, the projection is that by the
time we get to the end of the summer and early fall, that we
will have that in place. That is the projection that I get
from----
Senator Warren. We don't have it in place now, but we are
projecting that we will have it in place.
Let me just ask the other side of this. If we don't do
better on testing, on contact tracing, and on social
distancing, will deaths from coronavirus necessarily increase?
Dr. Fauci. Of course. If you do not do an adequate
response, we will have the deleterious consequence of more
infections and more deaths, and that is the reason why--you
quoted me, Senator, quite correctly, everything you said, and I
will stand by that.
If we do not respond in an adequate way, when the fall
comes, given that it is without a doubt that there will be
infections that will be in the community, then we run the risk
of having a resurgence. I would hope by that point in time in
the fall that we have more than enough to respond adequately.
But, if we don't, there will be problems.
Senator Warren. I appreciate your hope, and I wish we could
tell the American people that the Federal Government has this
pandemic under control, but we can't. In fact, you have said
that the virus is not under control in the U.S. We haven't yet
taken the measures necessary to prevent a second wave of death.
And, we all know that the people who are going to be most
affected are going to be seniors, essential workers, the people
who are out on the front lines.
The President needs to stop pretending that if he just
ignores bad news, it will go away. It won't. The time for
magical thinking is over here. President Trump must acknowledge
that the Federal response has been insufficient and that more
people are dying as a result. We are running out of time to
save lives, and we need to act now.
Thank you, Dr. Fauci, for all you are doing. We appreciate
it, but the urgency of the moment could not be clearer.
Thank you.
The Chairman. Thank you, Senator Warren.
Senator Roberts.
Senator Roberts. Thank you very much, Mr. Chairman, and
thanks to all the witnesses. You all are like the Fab 4. I
guess there it a Fab 5 back in the day. But, we are shining the
light of truth into darkness, with individual flashlights, for
sure. Thank you, Mr. Chairman, for emphasizing that we have to
be bipartisan in this approach or we are not going to get
anywhere, and that obviously is in the eyes of the beholder.
I am happy to say that we have a great relationship with
Governor Kelly, who happens to be a Democrat and obviously I am
a Republican, and her emergency management team is spot on. Dr.
Lee Norman is doing an outstanding job. This morning I talked
to Lee. The situation in Kansas is not very good. I am reading
here, ``Kansas Receives 7,000 New COVID Tests for Counties With
Food Processing Facilities.''
You see this mural behind me. That is a stagecoach coming
into Dodge and opposed to getting out of Dodge. That city is my
hometown, and we are the hot spot in regards to Kansas, mainly
because of two packing plants. We have five. That is 26 percent
of the cattle market. At any rate, Kansas is going through a
tough time, and it--we shouldn't be worrying about the safety
of the food, but the food supply chain, I think nationwide, is
under a great deal of stress. We see that in dairy. We see that
in poultry. We see that in pork. They are euthanizing pigs, and
obviously the livestock industry.
Sonny Perdue at the Department of Agriculture has stepped
up, so has the President, declaring that these packing plants
are a national asset. We have progress--Dodge City, when we
first started out, had five tests. Five. That is between four
and six. Five. It is not 50 million as we hoped to receive that
has been said by one of the witnesses.
The reason I am really harping on all of the problems we
are having in agriculture, on top of the fact that the
relationship with China is such that even the first
breakthrough with regards to trade to China seems to be on hold
now, and that is another price depressant. And this is going on
5 or 6 years where our prices have been below the cost of
production.
End result, our consumers are really figuring out that food
doesn't come from grocery stores, and I am very worried that
the harm to the food value chain is very real, not to mention
the financial situation that our farmers, ranchers, and our
growers all face.
Now, having said all that, I want to ask. Admiral Giroir,
you have spoken about the importance of having diversity in
kinds of tests that are available. Of the five packing plants
we have in Kansas, if we could get a rapid test and we could
get it as we hopefully ask for it because of the hot spots that
are developing not only in Kansas, but also doing great harm
for the food value chain, that would be absolutely wonderful.
Would you speak to that, sir?
Admiral Giroir. Yes. Thank you, Senator. Both Dr. Redfield
and I have been very actively involved in getting strategies
for the industry, particularly in Kansas. We are supplying very
heavily the public health labs with rapid diagnostics, as well
as surging them to areas like that. The one tradeoff, however,
is that the rapid--the ``rapid'' point-of-care diagnostics are
very slow. So, each machine can only do four per hour, and that
is very, very slow.
It is a mix of testing that you need at these kinds of
situations. On sort of the high-throughput tests that are
available at a major lab, a Quest lab right there in Kansas, as
well as a mix of the rapid testing, and that is what we are
supplying in order to provide a comprehensive, holistic
solution. And, I believe CDC is on the ground, as well, in
Kansas supporting that.
Senator Roberts. I appreciate that. If you are only doing
four an hour, that is not a rapid test. Maybe it is a rapid,
slow test. I am not quite sure how you define that.
But, I, for one, think that, as we reopen--and by the way,
Governor Kelly started the opening process the 1st of this
month. Then it is May 18, and then we go to June, and then the
hope is we open up.
But, we do have contingency plans that, if that doesn't
work as aptly described by Dr. Fauci, I think we will be
alright. But, this is going to be a tough go. I have to tell
you that, in terms of agriculture, we are not in good shape.
I appreciate everybody and the job that you are doing. I
will stand beside you when you are taking the boos and behind
you when you are taking bows.
The Chairman. Thank you, Senator Roberts.
Senator Kaine.
Senator Kaine. Thank you, Mr. Chairman, to the Committee
leadership, and witnesses for calling this important hearing.
The last time Dr. Fauci and Hahn were before us was March
3. I have a slide that I want to put up that shows what has
happened in America since then.
The chart, which is here, compares the experience of the
United States and South Korea on three dates.
On January 21, both nations experienced their first case of
COVID-19. At that time, the unemployment rates in both
countries were essentially identical.
On March 3, when the witnesses were last here, South Korea
had experienced 28 COVID-19 deaths and the U.S. had experienced
9. Again, the economies of both nations as measured by the
unemployment rates were nearly identical.
But, now the story changes. As of yesterday, more than
81,000 Americans have died, and the U.S. economy has
experienced job losses not seen since the Great Depression.
Meanwhile, the economy of South Korea has not changed
dramatically at all, and the death toll is now at 256.
South Korea is smaller than the United States, one-sixth of
our population. But, even if you bulk up the death toll to
reflect the difference, the per capita death toll in the U.S.
is more than 45 times the rate in South Korea. And, healthcare
carnage here is causing a near depression, while South Korea
has protected its economy by managing correctly.
I could have done this chart with other nations. The U.S.
has the seventh highest per capita death rate in the world. Our
death rate is off the charts higher than that in India,
Australia, New Zealand, Japan, and Mexico. It is nearly three
times the death rate in Germany; twice as high as Canada's
rate.
The question is, Why? If we want to open up our economy and
schools, we have to learn the lessons of nations that have
managed this well.
Here are some things that don't explain the difference:
Our hospitals are as good or better than those in South
Korea.
Our healthcare providers, heroes, are as good or better
than those in South Korea.
Our research capacity is as good or better than that in
South Korea.
We have more resources than South Korea. Our GDP is 12
times South Korea's, and our per capita income is 50 percent
higher.
To Dr. Fauci, the death roll in the United States, the
death rate in the United States, especially when compared with
other nations, is unacceptable, isn't it?
Dr. Fauci. Sorry, sir. Yes, of course. I mean, a death rate
that high is something that in any manner or form in my mind is
unacceptable.
Senator Kaine. Dr. Fauci, the experience of other nations
shows that the U.S. death rate is not only unacceptable, but it
is unnecessary. Isn't that correct?
Dr. Fauci. I don't know if we can say that, Senator.
Senator Kaine. But would you say that the U.S. has to do
better?
Dr. Fauci. Of course. You always have to do better. I mean,
as a physician and----
Senator Kaine. The experience of South Korea shows that how
a nation manages the healthcare crisis has a huge impact also
on its economic condition. Isn't that the case?
Dr. Fauci. That is the case, sir. I understand where you
are going with this, but I have to tell you, there is a big
difference between South Korea and the United States----
Senator Kaine. Let--and----
Dr. Fauci [continuing]. In the outbreak.
Senator Kaine. Let me get to that. I want to get to factors
that do explain the difference since we know it is not
resources or our health providers.
First is testing. South Korea began aggressive testing much
earlier than the U.S. Now, in the fifth month of the pandemic,
we have surpassed South Korea in per capita testing, but in the
critical month of March, South Korea was testing its population
at a rate of 40 times the testing in the U.S.
Admiral Giroir, Dr. Giroir, has set out the standard for
us. When we get to September, he says the United States needs
to do 40 to 50 million tests a month to be safe. That equates
to about 1.3 million to 1.7 million tests a day. Yesterday, we
did 395,000 tests. We have a long way to go.
A second factor is contract--contact tracing. South Korea
embraced a rigorous contact tracing program right from the
beginning. The United States still has not engaged in a
national contact tracing program. Isn't that right? Would that
be Dr. Fauci or Dr. Redfield?
Dr. Fauci. I think that question would best be directed to
the CDC and not the NIH.
Dr. Redfield. When the outbreak started, sir, we had an
aggressive contact tracing program, but unfortunately, as cases
rose, it went beyond the capacity and then we went to
mitigation. So, we lost the containment edge clearly before
that.
Senator Kaine. That was key to the economy, as well,
because South Korea did testing, contact tracing, protect,
serve, isolate the sick, and then they didn't have to do the
shutdowns, which helped their economy.
Social distancing is a third factor. We have talked about
it.
But finally, the last one, healthcare systems. Would you
agree with me that it helps keep people safer, even from
serious conditions or death from COVID-19, if they have access
to healthcare?
Dr. Fauci. Yes, of course.
Senator Kaine. Of course that is the case. In South Korea,
97 percent of the population have health insurance. In the
United States before COVID-19, millions did not have it and
lacked access to healthcare. The massive job losses in the last
months threaten to take health insurance away from millions
more. And, President Trump is doing all he can to dismantle the
Affordable Care Act, which would take health insurance away
from tens of millions more. Let us learn the lessons from those
who are doing this right.
Thank you, Mr. Chairman. I yield back.
The Chairman. Thank you.
Admiral Giroir. Can I make a clarification, please, Mr.
Chairman? This is Brett Giroir.
I just wanted to clarify that I did project that we will
have the ability to perform 40 to 50 million tests per month in
that timeframe, but I said if needed at that time. I am not
making a proclamation. We have to really understand what--where
the epidemic is, what the community spread is, before we can
estimate the number of tests that are needed. I was simply
stating the fact that our combination of testing capabilities
will be at that level even barring new input from the NIH.
The Chairman. Thank you very much, Senator Kaine.
Senator Murkowski.
Senator Murkowski. Thank you, Mr. Chairman. And, gentlemen,
thank you for being here this morning virtually, but also for
all you have been doing for these many, many months.
Alaska is doing okay right now from a numbers perspective,
and quite honestly, we want to keep it that way because we know
we have exceptionally vulnerable populations. We know we have a
geography that is challenging. We know that we have facilities
that are very limited.
Last hearing, we had an opportunity to hear from Dr.
Collins, and he shared where they are with the RADx, and also
spoke to RADx-UP, which was very interesting, about what we can
be doing in rural areas, but focusing on hot spots. And, as I
reminded him, we don't want to be a hot spot in Alaska, so
every effort that we make to keep the virus out of Alaska is--
are lives that are saved.
I educated him on the community of Cordova, that it is just
getting ready to open its Copper River salmon fishery in 2
days, and was able to share that they had one worker tested
positive as he was coming in from the Lower 48 to come to work.
The good news on that is that all of the protocols that we had
put in place seemed to be working: the quarantine, the
isolation, not only for that individual, but for others that he
had come in contact, were secured.
I want to recognize the assistance that we have received
from the administration. Dr. Eastman is in the state at this
moment, the chief medical officer for the Department of
Homeland Security, going out to rural communities to really
better understand our vulnerabilities, going to some of our
fishing communities to, again, understand how we can
successfully prosecute our fisheries when you have to bring
workers in from the outside. We thank you for the assistance
with regards to additional testing capacity.
I have been in contact with our chief medical officer of
the state this morning, and the mayor of Cordova, just better
understanding, again, do we have the tests that we need? What
do we need on the ground? And, one of the things that I would
like to have clarified, and this is probably to you, Dr.
Giroir, because you have been so helpful in kind of shining the
light on what we need to be doing in these rural areas.
But so much of the focus has been on hot spots and
responding to the hot spots, but how do you keep those rural,
remote, small communities from becoming the hot spots in the
first place? Are we doing enough? And, right now, the strategy
has been we just lock it off. The travel restrictions that are
in place are apparently working, but they are also devastating
our economy, whether it is tourism, whether it is our resource
industries, or whether it is the potential for our fisheries.
Admiral, if you might speak to that aspect of it, and then
I have a very important question as it relates to contract--
contact tracing that I would like to direct to either Admiral
Giroir or Dr. Redfield.
Admiral Giroir. Thank you, Senator. And, as you know, you
have an outstanding state health officer in Dr. Anne Zink.
Senator Murkowski. We do.
Admiral Giroir. I have had the privilege of working with
her, and you have a very good protocol in trying to keep Alaska
safe by isolation over a period of time when you come in.
As you know, we also work with the state to meet your very
challenging testing requirements because you can't really, send
labs out a thousand miles away. So, we put a real customized
mix of point-of-care and also the Cepheid machines--I think we
sent nine or 10 new to Alaska--and about 50,000 tests, which is
about four times than you have done to date collectively in
order to provide that support. So, again, I do think there is a
comprehensive strategy that you do have.
But, again, the mitigation, to the degree that you can
given the circumstances: the face masks, the hand washing, the
hygiene. We understand fully the challenges, particularly in
the fishing environment and the remote. But all of these have
to come together--the testing, the tracing, the mitigation, the
hygiene factors--to try to keep your community safe.
We really understand culturally that many of your
communities were almost annihilated in the 1918 influenza
pandemic, so--and that memory is still very sharp and very
hurtful to many of the citizens, so we want to do our best to
assure them that we are giving them all the protection we can.
Senator Murkowski. Admiral, let me turn to Dr. Redfield
because this relates to contact tracing.
I think this is a very, very key part of how we move
forward into getting people back to work, getting people back
to school. Right now, we have about 100 people that are
involved in contact tracing in Alaska. That is clearly not
sufficient. There has been talk about a national strategy, but
I think we recognize that we have teams in place, whether it is
AmeriCorps or whether it is Peace Corps or whether it is our
Public Health Corps.
What more do we need to be doing to make sure that once you
have been tested positive, then what happens after that? Who
else needs to be brought into this? And I am not convinced that
we are focusing enough on that aspect of how we move to
reopening if we have not done the contact tracing.
Dr. Redfield. Thank you very much, Senator. I want to just
re-emphasize what you said. I think contact tracing
capabilities is critical. It is going to be the difference from
succeeding in containing this outbreak from once again causing
wide-scale community transmission, or not. We are positioned,
as you know, to deploy, redeploy, the number of CDC--over 500
CDC individuals. We have another over--about 650 that we are
trying to put in through our foundation.
But most importantly, we are trying to work with your
health department. With the resources that we have been able to
give because of Congress. Also, as you mentioned, with these
other agencies, with Lab Corp--I mean with AmeriCorps, with the
Census Bureau, to work together and have the state develop
their contact tracing capacity. Some states have reallocated
state workers. Some states have reallocated National Guard
while they begin to do this.
But, I agree with you, and I said it is going to be a
significant effort to build the contact tracing capacity that
we need in this Nation. It will be state by state, but it is
going to need to be augmented. Probably in your state, from
what you just said, and increase five to tenfold, and we are
there to work with the states to help them get that
accomplished. That needs to get in place before September.
The Chairman. We need to move on to the next question.
Senator Murkowski. Thank you.
The Chairman. Thank you, Senator Murkowski. I don't want to
cut any Senator off, but we have eight more Senators who have
5-minute rounds and it is 12:30, so I would like to request
that the Senators and the witnesses, succinct questions and try
to stay within 5 minutes would be appreciated.
Senator Hassan.
Senator Hassan. Well, thank you, Mr. Chairman. Thank you
and the Ranking Member for having this hearing, and thank you
to our witnesses today. And, please pass our thanks along to
all of the hardworking women and men in your agencies, who I
know have been working virtually around the clock to try to
improve our response and keep Americans safe. And, Mr.
Chairman, I hope you and all the witnesses are healthy and safe
today, as is everybody on your team.
I wanted to start by echoing the comments my colleagues
have made about needing leadership from the CDC and our public
health experts on how we are going to use facts and evidence as
guidance so that our schools and our daycares and our
businesses have the information they need to create safe and
sustainable plans to reopen. And, of course, that means, too,
that our testing capacity not only has to be enough, but it has
to be flexible enough to meet our needs.
The key distinction between South Korea and the United
States is not how many tests per capita over a certain amount
of time we have done, but the fact that at the onset of this
pandemic, South Korea was much more able to do a lot more tests
per capita than we were. And then, follow that with all the
other measures you have talked about. So, that--we continue to
need to identify the need, and then build our capacity toward
the need, not the other way around.
I wanted to start with a question to you, Dr. Fauci. First
of all, thank you for your work and your expertise. I wanted to
talk about nursing homes for a minute. In New Hampshire and
across the country, a huge number of the deaths from COVID-19
that we are seeing have been in nursing homes. We all know
people who have lost a friend or a family member in nursing
homes, and the grief compounded by the fact that people
couldn't be at their loved ones' bedside if they died.
Yesterday, Dr. Birx said that all one million nursing home
residents should be tested within the next two weeks, as well
as all nursing home staff.
Dr. Fauci, as a short-term goal, that makes sense to me,
but after that, what will the ongoing Federal recommendations
look like? How frequently do we need to test patients and staff
on a continuing basis, and what other measures will be
necessary to keep our loved ones in these facilities safe?
Dr. Fauci. Thank you for that question, Senator Hassan. The
general plan, as you mentioned, that was recommended by Dr.
Birx, is a sound plan, as you said, in the immediate. The
question is in the long range. We will have to have infection
control capabilities in nursing homes that are really pristine
and really unassailable. We have to do the kinds of
surveillances and have to have the capability of when you
identify someone, you get them out of that particular
environment so that they don't spread the infection throughout.
General testing for all I think is a good start. But, when
you look where you are going to go in the future, there has to
be a considerable degree of surveillance capability.
Senator Hassan. Thank you, Doctor. The White House is now
requiring all staff to wear masks, and anyone in regular
contact with the President to be tested daily. Do you think
nursing homes should implement those same measures to help make
sure that our seniors can get the same level of protection?
Dr. Fauci. I think there should be a certain--a system in
place for the optimal protection of people in nursing homes,
and that would be not necessarily testing every person, every
day. That is one approach that might not be practical when you
think of all the nursing homes in the country. But very strict
regulations and guidelines about who is allowed to go into the
nursing home. And the staff, I believe, needs to be monitored
very carefully with intermittent testing to make sure that we
don't have introduction into the nursing home of infected
individuals. I am not sure you can practically do testing every
day. That, I don't think would be feasible. But something that
is much more aggressive than has been done in the past, I
believe, should be done.
Senator Hassan. Well, thank you. I have one last question
for Dr. Fauci and Dr. Redfield. I would also just say that if
we are able to get masks to everybody in the White House, I
hope we can get masks to every nursing home employee who needs
it.
Dr. Fauci and Dr. Redfield, the U.S. needs to be preparing
now to ensure that we have capacity to manufacture and
administer vaccines, something you have both touched on, both
for an eventual COVID-19 vaccine, as well as other illnesses,
such as the flu. The failure to ramp up production of testing
and personal protective equipment early on during this crisis
made things worse here. Those mistakes cannot be repeated when
it comes to vaccine production and distribution. We are already
seeing reports that some children are not receiving routine
immunizations as it becomes more difficult to access in-person
care.
Dr. Fauci, what steps should we take now to ensure that we
have sufficient manufacturing and distribution capacity for a
COVID-19 vaccine without putting at risk our capacity to
manufacture and distribute other important products, such as
the flu or measles vaccine? And my follow-up question to Dr.
Redfield would be, What efforts are underway at CDC to ensure
that all routine vaccines are accessible during the COVID-19
public health emergency?
Dr. Fauci. Yes. Thank you for that question, Senator
Hassan. I will answer it as quickly as possible.
I alluded to this in my introductory remarks when I was
talking about vaccines for COVID-19. And, what we said, that as
we do the testing on these vaccines, we are going to make
production at risk, which means we will start putting hundreds
of millions of dollars of Federal Government money into the
development and production of vaccine doses before we even know
it works so that when we do--and I hope we will and I have
cautious optimism that we will--ultimately get an effective and
safe vaccine, that we will have doses available to everybody
who needs it in the United States, and even contribute to the--
what is the needs globally because we are partnering with a
number of other countries.
The other part of your question about making sure that when
we get into a situation like the so-called shutdown that we
might be in now that we make sure that children get the
vaccinations that they need. That would be an unintended
consequence of shutting down, as we are right now. It is a very
good point, and we want to make sure we don't fall behind on
that, also. Thank you.
Senator Hassan. Thank you very much. And I will take my
answer from Dr. Redfield offline. Thank you so much for
allowing me to go, Mr. Chairman.
The Chairman. Thank you, Senator Hassan.
Senator Scott.
Senator Scott. Thank you, Mr. Chairman, and to the panel.
Thank you all for being here virtually. Without any question,
we find ourselves in a situation that we wish we were not. And
I am very thankful for folks like Dr. Birx, Dr. Fauci, and many
others for your dedication 24/7. Without any question, our
Nation is safer because of your hard work.
I am going to direct my questions toward Dr. Fauci. Really
one specific question, Dr. Fauci. I am thinking about the
reopening of America, and specifically the reopening of South
Carolina.
I am taking into consideration the fact that South
Carolina, I think, overall, our cases are moving in the right
direction. We have a little less than 8,000 cases;
unfortunately, 350 deaths. Our hospital capacity is actually
better now than it was when the pandemic started. Our ability
to isolate hot spots and mitigate the spread of the virus is, I
think, where it needs to be.
With that in mind, I flew into Washington from South
Carolina yesterday. We had plans to test additionally 220,000
more residents by the end of this month, focusing on at-risk
populations. By the end of this month, we will have tested 100
percent, 100 percent, of nursing home residents and the staff
that takes care of them.
And, after increasing our contact tracing workforce 20 fold
in a matter of weeks, our state's health department announced
yesterday that we are going to increase it by an additional
1,400 contact tracers.
We have built, and we continue to build, the tools
necessary to better detect and isolate cases, to map their
exposure, and to prevent substantial spikes moving forward.
Most importantly, our healthcare system, thanks in part to
flexibilities from this administration, has the beds and the
equipment necessary to address the most serious cases when they
arise.
Now, with these tools in hand, we have begun to reopen. To
be clear, we continue to scale up testing and to make--to take
measures to protect the most vulnerable, and the data points
are increasingly clear. For older Americans and for those with
chronic conditions, like diabetes and high blood pressure, this
virus remains a threat--a dangerous threat.
A recent report suggests that in New York, roughly 90
percent of the fatalities had underlying issues. Two-thirds of
fatalities were 70 years or older; 95 percent over the age of
50.
In South Carolina, the median age of patients who have died
from the virus, 76.5. Nearly two-thirds of fatalities have been
patients older than 71; and nearly 90 percent were over the age
of 60; and roughly 98 percent in South Carolina are over the
age of 50. Contrast that with those age 20 and younger where we
have seen no deaths. Fewer than 1 percent of deaths in my state
have been under the age of 40. Every single death is a tragedy,
every single one, and we mourn with our family members who have
lost their loved ones. We are taking every measure to protect
our older South Carolinians, as well as those with underlying
conditions.
When we set out to flatten the curve by taking aggressive,
unprecedented measures, like staying-at-home orders and mass
small business closures, we did not set out with the goal of
preventing 100 percent of fatalities. That would be
unrealistic. It is impossible. And we did not set out to keep
quarantines in place until we found a safe and effective
vaccine. That would take too long.
Dr. Redfield, your agency put out a helpful graphic showing
two curves. One, which spiked quickly and peaked high,
reflected daily cases without protective measures. The other,
flatter curve, show cases with those measures in place. And the
whole point, which the graphic illustrated, was to make sure
that we did not exceed hospital capacity. So, while I respect
the need for caution, we are too often presented with a false
dichotomy: either saving our economy or saving lives.
We have seen the goalposts around flattening the curve
move, and I think that is unfortunate. Because at the same time
we are doing that, businesses have collapsed, mental and
physical health have declined, deaths and despair escalate,
educational outcomes nosedive, as we wait in our living rooms,
praying for some good news around therapies and around
vaccines. We set out to flatten the curve, and I think we have
done a pretty good job with that. We need to do better and we
will do better.
My question, Dr. Fauci, is, as we start the process of
moving toward reopening South Carolina, what else would you
suggest that we could do to protect our most vulnerable
populations?
Dr. Fauci. Thank you, Senator Scott. You gave a really very
eloquent description of what I think is one of--would be a
model way, the way you approach this. I mean, you have put
things in place that I think would optimize your capability of
reopening. And as--I was thinking as you were speaking, I
almost want to clone that and make sure other people hear about
that and see what you have been doing.
The issue of your direct question to me about the
vulnerable populations is that, as we have said in our
guidelines--and it looks like you were ready to progress
carefully because you have put into place a very good system--
that the vulnerables, the elderly and those with underlying
conditions, should be those who at the very last lifting of
mitigations, should be those who are left in a situation where
they might be in danger of getting infected. In other words,
protect them right up until the very end of the relaxation of
your mitigation.
Because, as you said very correctly, those are the
individuals that are the most vulnerable for the morbidity and
the mortality. So, those individuals, particularly I might say,
sir, those in the minority group, the African American and
Hispanics, who, for a variety of situations that are the social
determinants of health, have a greater likelihood of not only
getting infected, but of also having the underlying conditions
that would make their risk for a higher degree of morbidity and
mortality higher.
It looks like you are doing things very, very well, and I
would encourage you to continue and to follow the guidelines as
you get closer to normalizing your state.
Thank you.
Senator Scott. Thank you, Dr. Fauci, and I will just simply
close with this since I am out of time. Thank you for the many
conversations that you and I have had about those vulnerable
populations to include minorities, as well as our senior
citizens. I will say that, without any question, when you look
at nursing homes, that it is typically African Americans,
Hispanics, are the certified nursing assistants who are
providing care for the elderly population. So, your focus on
those two very vulnerable groups is much appreciated, and thank
you for your expertise.
The Chairman. Thank you, Senator Scott.
Senator Smith.
Senator Smith. Thank you so much, Chairman Alexander and
Ranking Member Murray. And thanks to all of you for being here
today and for your service.
Dr. Fauci, I have to say, you are in the unenviable
position of being a person that so many Americans and
Minnesotans trust to give us the straight scoop and tell us
what is really happening. You are about the facts and not about
the politics, and that is a really good thing.
I have to start by asking you a question that I think a lot
of Americans want to know, which is, how are you doing? How are
you holding up? You have--it has been an unbelievable effort.
Dr. Fauci. I am doing fine, Senator. Thank you very much
for asking. This is such an important problem. It transcends
all of us individually and has to be working as a team, and I
enjoy very much working with your Senators and the Governors
because it is at the local level that we are going to make this
thing work. So, I am fine. I appreciate your concern.
Senator Smith. Well, a lot of people are thinking about you
and are grateful for your service, as we are for all of you.
We are gathered today to think about what we need to do to
reopen our economy, and I think first about what is happening
in my home State of Minnesota, where agriculture is such an
important part of how our state works. It is a part of our
history and our culture.
Pork processors right now are looking at the reality of
euthanizing thousands of hogs a day because there is no place
to process them because of what is happening in the processing
plants. The working people, who do the hard work in those
processing plants, are getting sick.
Here is one story. This is one worker--the Star Tribune
wrote about this--named Jomari de Jesus. She is an asylum
seeker and a mom who works for a contractor that does the
cleaning in the processing plants, and she works for $14 an
hour, 7 hours a day, 5 days a week, and her job is to sanitize
the machines that process the meat into ground meat.
She started feeling sick on April 11th, but she kept going
to work. And, on April 21st, when one of her coworkers fainted,
she told her supervisor that she felt sick. And, so, she was
told to go home, but that if she didn't show any signs of
illness, she should come back.
She went to the doctor and she paid $115 to get a test and
found out a few days later that she was COVID positive, and she
is still at home. She is still--she is not getting paid, and
she doesn't have health insurance.
Nearly 2 weeks ago, President Trump deployed the Defense
Production Act to keep these processing plants open, but the
USDA gave really limited guidance about what would be safe for
those workers. It said, for example, in response to testing,
which has been such a big part of what we have been talking
about today, they said--this is a quote. ``Facilities should
consider the appropriate role of testing and workplace contact
tracing of COVID-19 positive workers in a worksite risk
assessment.''
Dr. Fauci, as we think about how we move forward, we all
want to open up the economy, what guidance would you give us in
a situation like this here in Minnesota?
Dr. Fauci. Well, I can give you my commonsense guidance,
although this is not the area of my expertise. It is more in
others.
But, it would seem that if you want to keep things like
packing plants open, that you have really got to provide the
optimum degree of protection for the workers involved, the
ability to allow them to go to work safely; and if and when
individuals get infected, to immediately be able to get them
out and give them the proper care.
I would think when you are calling upon people to perform
essential services, you really have almost a moral
responsibility to make sure they are well taken care of and
well protected. And again, that is not an official
proclamation. That is just me speaking as a physician and as a
human being.
Senator Smith. Well, thank you, Dr. Fauci. And I think that
you speak as a human being, but you also speak as the chief
epidemiologist of our Country and the person that we all trust.
This is the point that I want to make and drive home with
everybody, which is this is the kind of guidance that we should
be getting and following. And then, this is the kind of--these
are the tools that we have got to have in our Country if we are
going to reopen our economy, as we all want to do. And, this--
we move forward with reopening our economy, and yet we still
have circumstances like we have in these processing plants and
in other places around the state. We are going to be--we are
going to be right back where we started, and--except even in a
worse place, as I think you have pointed out, Dr. Fauci.
Dr. Fauci. Thank you, Senator. And again, it really does
relate to one of the questions that one of your colleague
Senators asked me before and one of the things that I keep
emphasizing. And I will just repeat it again because it is
important, that when you are in the process of opening up and
pulling back on mitigation, you really must have in place the
capability of responding when you do have the inevitable
upticks in cases. That will absolutely occur. It is how we deal
with it and how successful we are in putting the clamps on it
that will prevent us from getting the kind of rebound that, not
only from the standpoint of illness and death would be
something that is unacceptable, but it would set us back in our
progress toward reopening the country.
Senator Smith. Thank you.
The Chairman. Thank you very much, Senator Smith.
Senator Romney.
Senator Romney [continuing]. this hearing and the
participants in it.
Admiral Giroir, I am going to take off where Senator Hassan
spoke. I understand that politicians are going to frame data in
a way that is most positive politically. Of course, they don't
expect that from admirals. But, yesterday you celebrated that
we had done more tests and more tests per capita even than
South Korea, but you ignored the fact that they accomplished
theirs at the beginning of the outbreak, while we treaded water
during February and March. And, as a result, by March 6th, the
U.S. had completed just 2,000 tests, whereas South Korea had
conducted more than 140,000 tests. So, partially as a result of
that, they have 256 deaths, and we have almost 80,000 deaths.
I find our testing record nothing to celebrate whatsoever.
The fact is, their test numbers are going down, down, down,
down now because they don't have the kind of outbreak we have.
Ours are going up, up, up as they have to. I think that is an
important lesson for us as we think about the future.
On a separate topic, my impression is that, with regards to
vaccines, that--where I am critical of what we have done on
testing, on vaccines, we have done a pretty darn good job of
moving ahead pretty aggressively. And yet, the President said
the other day that President Obama is responsible for our lack
of a vaccine.
Dr. Fauci, is President Obama, or by extension, President
Trump, did they do something that made the likelihood of
creating a vaccine less likely? Are either President Trump or
President Obama responsible for the fact that we don't have a
vaccine now, or in delaying it in some way?
Dr. Fauci. No. No, Senator, not at all. Certainly President
Obama, nor President Trump, are responsible for our not having
a vaccine. We moved, as you said--because I described it in my
opening statement--rather rapidly. No one has ever gone from
knowing what the virus was to a Phase 1 trial as fast as we
have done. So, I don't think that is something that one should
say anybody is responsible for doing anything wrong on that. I
think that is right. That is the correct way to do it.
Senator Romney. Thank you. That was my impression. I was
surprised by the comment, but that was my impression.
Dr. Redfield, Senator Sinema and I wrote a letter to you
expressing our dismay at the lack of real-time data at the CDC.
I am talking about granular, demographic, hospitalization,
treatment data. How is it possible in this day and age that the
CDC has never established such a real-time system with accurate
data? And what can Congress do to rectify that so we never have
to look at something like this again?
Dr. Redfield. There we go. I am sorry. Senator, thanks for
the question. I think you hit one of the--important they are.
The first one I focus on is data modernization, data analytics,
and predictive data analysis.
Clearly, Congress has come forward in providing funding for
data modernization, and we are in the process of implementing
it. The reality is there is an archaic system, a non-integrated
public health system. Each public health department has their
own systems. The Nation needs a modern, highly capable data
analytics system that can do predictive analysis. I think it is
one of the many shortcomings that had been identified as we
went through this outbreak, and I couldn't agree with you more.
It is time to get that corrected.
Senator Romney. Thank you. Please help guide us as to what
we need to do to make sure that happens. And I presume it is
not build it ourselves, but work with companies that have that
capacity and use that capacity in our favor.
Dr. Fauci, one last thing, which relates to the virus, and
I know I am asking you the impossible question. But, we are all
hoping for a vaccine, obviously. It is the objective of our
administration to get it as soon as they can. And, from what I
can tell, they are pulling out all the stops to do exactly
that.
Given our history with vaccine creation for other
coronaviruses, how likely is it? I mean, is it extremely likely
we are going to get a vaccine within a year or two? Is it just
more likely than not? Or, is it kind of a long shot?
Dr. Fauci. It is definitely not a long shot, Senator
Romney. I would think that it is more likely than not that we
will because this is a virus that induces an immune response,
that people recover. The overwhelming majority of people
recover from this virus, although there is good morbidity and
mortality at a level in certain populations. The very fact that
the body is capable of spontaneously clearing the virus tells
me that, at least from a conceptual standpoint, we can
stimulate the body with a vaccine that would induce a similar
response. So, although there is no guarantee, I think it
clearly, much more likely than not, that somewhere within that
timeframe, we will get a vaccine for this virus.
Senator Romney. Thank you. Mr. Chairman, I yield.
The Chairman. Thank you, Senator Romney.
I want to thank the witnesses for their patience. We have
four more Senators, and we would like to give them a chance to
ask their questions.
Senator Jones.
Senator Jones. Thank you very, very much, Mr. Chairman, and
thanks to all our witnesses for your being here virtually, and
also for your incredible service during this time.
I want to follow-up real quick with an additional statistic
that Senator Romney talked about with regard to South Korea,
and that is the fact that we are a Nation that has about six
times the population of South Korea, but yet we have about 310
times the number of deaths from this pandemic. So, I think we
have to be very careful in making comparisons around the world,
comparing the United States to other countries.
Dr. Redfield, I want to follow-up just a little bit with
what Senator Murkowski and I think Senator Kaine talked a
little bit about, contact tracing and where we are going. I
understand that you are working with states to try to develop
plans for reopening. The testing is important. The contact
tracing is important. But, using that data, as well, is also
going to be important in terms of the quarantine plans that
Senator Murphy talked about. Childcare facilities to have--
allow people to put their kids in a facility while they are
still--go back to work. All of those issues, including maybe
even facilities like vacant hotels or motels that may be used
for self-isolation.
How is this plan being developed within the CDC? Are those
plans going to be individualized by state? Will we, as a Member
of Congress, be--have access to those plans? And how are states
going to pay for these? I say that because my state is already
using the money that we have already given them as a wish list.
I mean, they are talking about building a few hundred million
dollar statehouse as opposed to developing the test and doing
the contact tracing.
I would like for you just to drill down a little bit on how
these plans are going to develop, what access we will have to
have those plans and be able to see them.
Dr. Redfield. Thank you very much, Senator. This is
obviously, as I said before, this is a critical component of us
taking this time now to get prepared for next fall and winter
and building that comprehensive contact tracing capacity. We
are working individually with the leadership of the state
health departments, the local health departments, territorial
and tribal, to try to let them get us to understand what they
think their capacity needs are. And, those discussions have
already happened. As Admiral Giroir said, there has been a
variety of Federal agencies together on testing and contact
tracing.
CDC is in position that we have reprogrammed our
individuals that we have across the country, over 500, begin to
help each of these states. We have augmented that with some
additional personnel that we are bringing onboard state by
state through our foundation. We have put about $106 billion of
the money that Congress has appropriated into the states so
they can begin to start thinking about whether they want to
hire--contact tracing capability. And, then, of course, it was
mentioned that we are--well, other government programs, like
AmeriCorps, Peace Corps so that each group is going to
construct their contact tracing piece to what they think their
needs are. And I do think it is going to be similar to what we
heard from the Senator from South Carolina. These are
significant increases. He said he increased 20 fold, and then
they are going to increase again.
But the point you brought up is also critically important.
And we found that as we already struggled through the
repatriation of different Americans from around the country,
where we had to put many of these in quarantine, as you know,
ended up using military bases because many of the state and
local health departments really have not developed that system.
Where do they put somebody who should be in isolation who is
homeless? How do you develop those systems? So, this has to be
part of it, too. Is it--there a certain capacity that is
intrinsic? Or, is it hotels, as you mentioned?
I think the point that was made by one of the other
Senators is so important about individuals that--particularly
like the meatpacking individual that has to go home and self-
isolate, but maybe they don't have the ability to go home and
self-isolate because they live in a multi-generation house with
about 12 other people.
There needs to be mechanisms to be brought in to have an
effective way to identify cases, identify contacts, and then do
the appropriate public health measure, and that these have to
be comprehensive. It is going to be developed one jurisdiction
at a time.
I see no reason why these are not transparent documents as
they get completed. And, it really is a tribute to what the
congressional support that you all have given so far. As I
said, $1.6 billion got into the states for them to begin to do
this, in addition of the resources that we have gotten.
But, it is fundamental. People underestimate how important
it is that we have a highly functional, comprehensive,
aggressive contact tracing programs so that the next--for this
outbreak, we still contain them. We don't have to switch to
mitigation.
Senator Jones. Alright. Thank you, Dr. Redfield. I
appreciate it. It sounds to me like we have still got a lot of
work to do. So, thank you.
The Chairman. Thank you very much, Senator Jones.
Senator Braun.
Senator Braun. Thank you, Chairman. There has been so much
discussion about testing in general. Listening to Senator
Romney earlier; I think Senator Kaine mentioned it; everybody
has.
Dr. Hahn, if you remember when we first met, I said, Is the
FDA going to be more entrepreneurial? Is the FDA going to kind
of not be as stodgy? Talking then about how we fix the
healthcare system in general. Now this has brought it into
clear focus.
I have a timeline that I am going to submit for the record
that shows from January 24th through March 5th. And I want to
emphasize what Senator Burr asked earlier, has the
administration ever put an impediment in front of trying to get
to testing?
And, Dr. Hahn, this will end up in a question in a moment.
But, there was a span of time, from January 24th through March
5th, that I hope the American public looks at. It gets back to
what is wrong with our healthcare system in general. Early
testing, from what I am seeing, was created by the fact that
the CDC said it was going to do its own test. The South Korean
test that gets cited so often was not going to be looked at; we
had to do our own. I know the FDA worked with the CDC.
But the long and short of all of this is that for nearly a
month, this was in that bureaucratic swirl. The FDA prevented
private and academic development of tests for weeks. The CDC
denied access to functioning tests, as I cited, in South Korea.
This created, through all the red tape and bureaucracy, to
where we had to come up with a one-size-fits all approach due
to the uncertainty of the virus, and we are stuck with that
now. I don't want to dwell on that necessarily because I think
those are mistakes that we have made. I am tired of having it
heard that it is the administration's fault.
Dr. Hahn, I would like to ask you this question in that
spirit of what we talked about during your nomination process.
Here going forward, will we shed some of that stodginess? Will
we look to get therapeutics and vaccines through the system in
a quicker method? Because I fear if we don't, and if we treat
through bureaucracy how we did the early period of testing, we
can belabor this into the distant future. And, at that point,
there is going to be not only the carnage from the disease
itself, but from the economy to deal with.
I would like your comment on that 1-month stretch, what
accountability the FDA and the CDC have, and then whether it
looks better in terms of moving more quickly into the future.
Dr. Hahn. Thank you, Senator Braun, for the question. Our
timeline of that period demonstrates that we began working with
test developers beyond CDC on January 24th and had double digit
number of test developers working with us. One of the issues
that we identified was in fact availability of the virus and
other supplies to actually get that test development done in a
timely fashion.
Senator, I completely agree with you that this is an
opportunity for us to take a look and determine how we can do
things better, and I think that is a really important thing for
all of us to do, and certainly the FDA, I can promise you, will
do that.
Looking forward, sir, I can commit to you that we will look
at every one of our regulatory authorities. We have done so
during this outbreak. We have provided significant flexibility
and have tried to provide the right balance between regulatory
flexibility and enabling of the great test developers and
therapeutic developers in this country with the need to ensure
that our gold standard of safety and efficacy is in place.
We have leaned in with manufacturers. We have learned a lot
from them, as well as the other stakeholders, and we will
continue to learn. And we will, I commit to you, sir, implement
the changes that are necessary to make sure that we can act in
a more nimble way but still protect the safety and efficacy of
medical products.
Senator Braun. Thank you.
Dr. Fauci, taking a page from your anti-AIDs playbook that
implemented a formal, clearly defined treatment review pathway,
can we do that for COVID-19 in a similar parallel track that
you put into place back then in the 1990's? In fact, I have a
bill called the Promising Pathways Act that is based upon that
protocol you put into place. Can we do that to more quickly get
through to therapeutics and vaccines here with COVID-19?
Dr. Fauci. Well, it is a different story, but some
similarities if you are referring to the parallel track that I
put into place back in the late 1980's, which was when there
was no availability of drugs at all for HIV. And when we were
testing drugs within a protocol, that we would make it
available outside of the protocol in what has ultimately turned
out to be compassionate use.
What we did is we didn't want to interfere with the
integrity of the protocol to determine in a controlled way what
was safe and what was effective, but there was a dire need for
some sort of accessibility to those drugs outside of a clinical
trial for those who might even have some chance of having it.
And, in fact, that was really in many respects the birth of the
really firm concept of compassionate use.
And, in fact, there is a version of that, which I will hand
over to Commissioner Hahn, that is, when you have expanded
access and Emergency Use Authorizations for drugs that have not
yet been fully proven in a clinical trial. So, there is
somewhat of an analogy and similarity between what I did in the
1980's and what is actually being done by the FDA now.
Steve, if you might want to comment on that?
Dr. Hahn. I think that is right, Dr. Fauci. The Emergency
Use Authorization process by statute allows us to have
flexibility and assess the risk-benefit ratio in a public
health emergency, and we have done that on the therapeutic side
in three separate occasions and continue to look at those
requests as they come in.
The Chairman. Thank you very much.
Senator Braun. Thank you.
The Chairman. Thank you, Senator Braun.
Senator Rosen.
Senator Rosen. Here I am. Thank you, Mr. Chairman, for
bringing this hearing. And I want to thank the dedicated
doctors today for their lifetime of work and study and passion.
We are a grateful Nation for all of your lifelong commitment in
fighting disease. And not just the United States, but around
the world.
As I talk to Nevadans about safely reopening the economy,
one question that frequently comes up is, so, when are we going
to have a vaccine like everyone has talked about? In Nevada,
travel and tourism, of course, the lifeblood for us, and the
jobs associated with those industries, can only fully come back
if we know it is safe to travel and visit or work in our
hotels, casinos, restaurants, and attractions.
Ultimately, to make this happen, we have to build
confidence in our visitors that it is safe. We need a vaccine,
and that research is extremely important. However,
understanding that this takes time to develop and ensure both
safety and efficacy, I would like to hear more about what
research is happening regarding preventative medication
research that could be helpful in the timeframe before a
vaccine, and especially before one is widely available. So, I
would like to ask if this could be part of a path in helping us
begin to reopen our economy safely and bring visitors not only
back to Nevada, but across our Country.
Dr. Fauci, what research is currently happening to identify
potential monoclonal antibody preventative treatments or other
therapeutics? If the right antibody is identified or can be
identified, could this be used as a preventative medication to
block COVID-19 virus from latching onto those host cells, much
like the treatments for rheumatoid arthritis, severe asthma, or
other diseases? And second, would preventative medication
options like this help complement the effectiveness of a
vaccine once it is available?
Dr. Fauci. Yes. So, thank you for that question, Senator
Rosen. That is an excellent question. And, in all of the
therapeutic interventions that we are developing, and you
mentioned several of them, they could be direct antivirals
along the line of Remdesivir, but that is just one of a number
of possibilities since there are several viral targets in a
replication cycle.
Using convalescent plasma in a preventive modality, as well
as monoclonal antibodies in a preventive modality, are in fact
all feasible and will be pursued in parallel with the
development of a vaccine. The model of using drugs and other
interventions that are effective for treatment is really a
great success story in the issue with HIV-AIDS because many of
the interventions that were developed for the full treatment of
an infected person are exquisitely effective in preventing
infection of HIV.
That is the kind of model that we work out in parallel with
treatment for disease. It is using treatment as prevention. I
believe that will be a part of our effort at the same time as
we are putting a full court press on trying to get a vaccine.
So, it is an excellent question. Very relevant.
Senator Rosen. I know I have a short time left, so I am
just going to kind of abbreviate this.
The second most important question that I get, not just
from our first responders and people worried about work, but
generally, what does the next generation of PPE need to look
like for all of us as we go about our lives? Not just as
workers. Depending on your work, you may need something
stronger, more specific, but as all of us--as we want to go out
and shop or out to eat or whatever those things are, get on an
airplane. Should masks be made of a certain material? Gloves?
Are handkerchiefs effective? Can you talk about PPE for the
general public?
Dr. Fauci. Well, the best PPE for the general public, if
possible, right now is to maintain the physical and social
distancing. But, as we have said, and I think all of us would
agree, there are certain circumstances in which it is beyond
your control when you need to do necessary things, like go to
the drug store and get your medication, go to the grocery store
and get your food, that in fact you need some supplementation
to just physical distancing.
That is the reason why some time ago, the recommendation
was made--I believe it was Dr. Redfield at the CDC who first
said that--about getting some sort of a covering. We don't want
to call it a mask because back then we were concerned we would
be taking masks away from the healthcare providers. But, some
sort of mask-like facial covering, I think for the time being,
should be a very regular part of how we prevent the spread of
infection. And, in fact, the more and more as you go outside
right here where I am sitting in Washington, DC, you can see
many people out there with masks on, which gives me some degree
of comfort that people are taking this very seriously.
Senator Rosen. Thank you.
The Chairman. Thank you, Senator Rosen.
Senator Loeffler.
Senator Loeffler. Thank you all for being here and for your
service.
Admiral Giroir, before I start my questions, I want to
recognize your new role as the U.S. Representative to the World
Health Organization. Mitigating a resurgence of this pandemic
will take global cooperation. In order to do that, we need
accountability and transparency at the WHO. This organization
was established to ensure the timely flow of accurate, unbiased
information on global health emergencies, just as this. Reforms
must be made in order to restore the trust that we need here. I
hope you will work with our allies to push for these reforms.
This question--I have two questions. The first one is for
Dr. Redfield. And, Dr. Redfield, Georgians are wondering how we
got here today. Fourteen hundred deaths, one-third of Georgia's
workforce out of work. I am incredibly concerned about the
cover-up and the misinformation coming from China and their
efforts to suppress lifesaving information at the outset of
this outbreak.
As we can sit--as we continue to reopen our economy safely,
we have to take steps to ensure that another outbreak cannot
take hold of the world in this way. I understand CDC has worked
with the Chinese CDC on global health security for decades. Can
you comment on the level and the timing of the information that
you received and relied upon from your Chinese counterparts as
this virus emerged?
Dr. Redfield. Well, thank you very much, Senator, and I
want to echo how important global health security is as a
national security priority for this Nation. We are going to
need to be able to be able to respond to that as long as we are
a Nation.
CDC has had relationships with different countries from
around the world. We have offices in over 45 countries right
now, people in over 60, and one of those happens to be China,
where we have a U.S. CDC that is with the Chinese CDC. And we
have worked together for decades, particularly on influenza and
emergent infectious diseases, and that has been a very
productive, collaborative, scientific interaction.
When this original outbreak of pneumonia of unknown
etiology came from the original seafood market, there were
obviously discussions with U.S. personnel in Beijing, with the
Chinese CDC. I personally had discussions as early--I think CDC
did as early as January 2d, and myself, January 3d with my
counterpart to discuss this. So, at a scientific level, we had
very good interactions. I think, that is different than the
broader Chinese government level.
Senator Loeffler. Thank you, Dr. Redfield. I have a final
question for each of our great witnesses today, and it is one
that my constituents often ask me.
The mainstream media, and indeed some of my colleagues in
the Senate, seem to want to paint each of your relationships
with our President during this wartime effort as
confrontational and lacking consensus. Can you categorically
say here to the American people today whether this is true or
untrue?
From your testimony today, I have seen a very coordinated
effort to address this with the administration to combat this
pandemic. Can you give me a sense of whether this
characterization--what the characterization is--whether it is
true or untrue? Thank you. And I ask Dr. Fauci to answer that
first.
Dr. Fauci. Yes. No, there is certainly not a
confrontational relationship between me and the President. As I
mentioned many times, I give advice and opinion based on
evidence-based scientific information. He hears that. He
respects it. He gets opinions from a variety of other people.
But, in no way in my experience over the last several months
has there been any confrontational relationship between us.
Senator Loeffler. Thank you. Dr. Redfield, Dr. Hahn.
Dr. Redfield. Again, I would echo what Dr. Fauci said, that
we are there to give our best public health advice, and that is
what we do, and it is grounded in data and science. And I have
always felt free to give the best public health advice that I
think needs to be given at the time, and it has always been
done in a very professional----
Dr. Hahn. Senator Loeffler, this is Steve Hahn. I do not
have a confrontational relationship, have not had a
confrontational relationship with the President. He asks
questions. I have given him my honest answers rooted in data
and science, and he has listened respectfully to those,
incorporating that into his decision making.
Admiral Giroir. I have nothing else but to echo my
colleagues. We work very closely together, all the scientists,
all the physicians, of course Ambassador Birx, other scientists
within our group. We have a very productive working
relationship with each other and also with the President and
Vice President. It would not be confrontational, and I
certainly feel that we have the ability to honestly state our
opinions and recommendations, and that has been that way since
the beginning.
The Chairman. Thank you, Senator Loeffler.
Senator Murray, do you have closing comments?
Senator Murray. I do, and if it is alright, I have a couple
of--two quick questions.
The Chairman. Sure.
Senator Murray. Well, thank you.
You know, Dr. Fauci, while President Trump claimed
otherwise, there is no question that an essential part of
reopening our economy safely is successfully developing and
distributing a vaccine for COVID-19. We need to plan now to
deploy a vaccine once it is proven safe and effective, but it
is absolutely crucial this planning process, from the clinical
trial to distribution and administration, recognizes and
addresses racial and ethnic disparities in our healthcare
system that, as we all know, for too long have been overlooked
and unacknowledged in this country. And we have to ensure
equitable access to this vaccine for everyone.
Dr. Fauci, let me start with you. What steps is NIH taking
to make sure that clinical trials for COVID-19 vaccines and
therapeutics account for racial and ethnic disparities?
Dr. Fauci. Yes. Thank you very much. That is a very
relevant question, Senator Murray. And, in fact, the design of
our clinical trials and the sites that we have chosen in our
clinical trial network is going to be very representative of
being able to get minority populations and populations at most
risk to be part of the trial so that we know during the trial
what the relative efficacy, as well as potential adverse
events. It is something we started back in the days of HIV when
we tried to get good demographic representation, and we are
going to do that with these trials. Thank you.
Senator Murray. Thank you. And Dr. Hahn, tell me what steps
the FDA is taking now to make sure the United States is
prepared to produce a sufficient number of vaccines, including
the necessary manufacture and supply chain capacity, for
supplies like vials and stoppers and syringes.
Dr. Hahn. Thank you, Senator. This is an effort that
started as a partnership with the vaccine developers and the
NIH in their efforts.
One of the most important things, ma'am, has been the data
transparency, sharing of data, both with the agency, NIH, and
with the manufacturers so we can understand what the capacities
are; what the needs are from the supply chain; and then how to
actually share that so that if one manufacturer's vaccine does
not go forward, we can use the capacity of that manufacturer
for another manufacturer's vaccine.
I am very happy to report that the work of Dr. Marks and
Dr. Fauci has led to that sort of effort. We have developed, as
I mentioned before, this Gantt chart that describes all the
steps that go forward with vaccination, including those
supplies you described. It is somewhat complicated, ma'am, in
that we may very well have hopefully five to seven different
candidate vaccines that may need different supplies associated
with them. But, we have been up front identifying those
supplies, where they are available, and then working with the
manufacturers to make sure that they are available.
Senator Murray. Okay. Thank you. Thank you very much. And,
Mr. Chairman, thank you, and thank you to all of our witnesses
for joining us today.
It is really clear to me that we have more work to do
before we can safely get back to work and school and some
semblance of normal life in our Country.
We still need testing to be fast, free, and everywhere. And
we need the White House to lay out a detailed, national plan to
make that happen.
We still need adequate personal protective equipment, both
for our healthcare workers and for workers at our businesses
and at schools when the time comes.
We still need guidance from our experts so our communities
have the information that they need to reopen schools and
businesses safely, confidentially--confidently, and complete--
competently; and so public health workers and healthcare
providers have the information they need to keep their patients
and communities safe.
While experts have been clear that the day we can safely
reopen may be a ways off, there is plenty for us to do in the
meantime, both to plan ahead--for example, to make sure that
once we have a safe and effective vaccine, we can produce and
distribute it to everyone quickly, equitably, and at no cost.
To address the immediate challenges. For example, making
sure there are appropriate mental health resources for everyone
who is coping with the challenges that are prevented--presented
by this virus. From the stress of physical isolation, loss of
income, to the trauma and anxiety of patients and workers who
have been on the front lines.
I am going to keep pressing Congress and the White House to
provide the action and the leadership that our communities
need.
And, I hope, Mr. Chairman, that we will continue to have
the opportunities like this to hear directly from the experts
and ask pressing questions about how to get our Country through
this crisis. It has clearly got a lot further to go, a lot more
to do.
And, so, I hope that as our efforts continue, we will be
able to bring any of you back, our witnesses, for another
hearing soon.
Again, thank you to all of you for joining us today.
The Chairman. Thank you, Senator Murray.
I have a clarification question and a couple of quick
comments, and then we will thank the witnesses and wind up our
hearing.
My clarification is, I want to make sure I did not create
some confusion by the way I asked the question about going back
to school. I asked Dr. Fauci first about treatments and
vaccines, and doctor--and Admiral Giroir second about testing.
What I thought I heard was that Dr. Fauci said that
vaccines are coming as fast as they ever have, but it will be
later in the year at least--at the earliest before we see that;
but there are some treatments that have--that are modest, but
are promising--there could be more; but that doesn't mean you
should not go back to school. That would be more for a testing
strategy. Am I right, Dr. Fauci? You didn't say you shouldn't
go back to school because we won't have----
Dr. Fauci. No.
The Chairman [continuing]. a vaccine by the fall?
Dr. Fauci. No. Absolutely not, Mr. Chairman. What I was
referring to is that going back to school would be more in the
realm of knowing the landscape of infection with regard to
testing. And, as Admiral Giroir said, it would depend on the
dynamics of the outbreak in the region where the school is. But
I did not mean to imply at all any relationship between the
availability of a vaccine and treatment and our ability to go
back to school. You are quite correct.
The Chairman. Thank you. And what I heard from Admiral
Giroir was that you are ramping up current technologies. You
are hopeful for Dr. Collins' Shark Tank and the National
Institutes of Health. But, in any event, you would expect to
have the capacity in the fall of 40 to 50 million tests a
month, and that ought to be adequate for the principal of a
middle school, or even the chancellor of a campus, to design a
testing strategy that could provide, for example, an antigen
quick test to screen all the students in the school if
necessary. Is that correct?
Admiral Giroir. Yes, sir, Mr. Chairman. And again, we want
to make as many tests available as absolutely possible. What I
said is, what I feel comfortable with, knowing the production
schedules, being in the position of being able to work with the
FDA and CDC, that we should have 40 to 50--we will have 40 to
50 million tests available per month that need to be deployed
in a smart, strategic way, depending on the dynamics, in that
area and in that region.
Still, having testing even widely does not nullify the need
that we are going to have to change our practices in terms of
sanitation, personal cleanliness, distancing, face masks,
things like that, given what the dynamics could be.
The Chairman. Well, thank you for those comments, because
given the--given that number of tests that will be available
in, say, 3 months, or as we ramp up to that number 3 months
from now, that should give every principal, every chancellor of
every college campus--and again, we have about 5,000 campuses
and 100,000 schools--some reassurance that testing, as well as
the commonsense hygiene practices you talked about, could be
used to develop a strategy for reopening school for school in
August.
And, then, two quick comments. One is, Senator Murray
talked about the national plan, which was in the legislation
that we all voted for. There is a little bit of a push and tug
between what is national and what is Federal, what Washington
should do and what the states should do.
I have always thought it is a mistake to say Federal equals
national. In other words, COVID-19 is clearly a national
problem, but that does not mean the Federal Government is
supposed to do everything.
For example, in testing. The law actually requires states
to tell you, Admiral Giroir, what their plans are, what their
needs are. And, then, you said that during the month of May,
you had a series of state plans that identified 12.5 million
tests, and you thought you could help meet that.
On the other hand, you have also noticed inefficiency in
the marketplace for some supplies, so the Federal Government is
buying those and allocating them to the states.
We don't want to get in a situation where Admiral Giroir is
telling all the states what to do. Governor Lee in Tennessee
does not really want you to tell him what to do. He wants to
tell you what he is doing and let you comment on it. I don't
think Governor Cuomo wants President Trump telling him what to
do. So, a push and tug between what Washington does and what
the states do.
I think we have a testing, contact tracing, isolating
national strategy and plan led by the Governors, designed by
the Federal Government, as a national effort. And then the
national effort, clearly, is to do the research for the
treatments and the vaccines, and what we have heard today is
that is coming along on a faster track than we have ever seen
before.
Finally, I want to reiterate, I thought this was a very
helpful hearing. I thank the Senators for their questions. I
think anybody who took the time to watch would be impressed by
the diversity of opinion and the honest answers we got from
four really remarkable experts who are in the midst of this
every day.
I want to reemphasize what I said earlier, that I intend to
make sure that we focus. Senator Murray suggested we need to
have more hearings. I agree with her.
And, as we deal with this pandemic, we need to make sure we
are ready for the next one. What can we learn about faster
treatments and vaccines for the next one? What can we learn
about the stockpile, what ought to be in it, who ought to
manage it for the next one? Or, what can we learn? Can we learn
anything about having hospital beds so we don't have to shut
down hospitals and bankrupt them and push patients out in order
to create beds for sick people from the pandemic? What about
states and hospitals that sell off their PPE in between
pandemics?
How do we keep our focus in between pandemics when we are--
have so many important things to be worried about in this
country? How do we make sure that we, in Congress, sustain and
fund all the things that we need to do? And, I want to make
sure that we do that this year. I mean, our collective memory
is short. So, while we are all worried about this, we need to
not only deal with this crisis, but get ready for the next one.
I thank the witnesses for their extra time. I hope they get
a sense that our job, we see, is to create an environment in
which you can succeed. Because if you succeed, our Country
succeeds, which is what we desperately want.
The hearing record will remain open for 10 days. Members
may submit additional information for the record within that
time if they would like. Thanks to everyone for being here
today.
The hearing is adjourned.
ADDITIONAL MATERIAL
food & beverage issue alliance
Hearing on COVID-19: Safely Getting Back to Work and Back to School
The Food and Beverage Issue Alliance (FBIA) represents fifty-eight
allied U.S. based Food and Beverage Trade Associations. FBIA, through
collaboration with regulatory authorities, ensures that any regulations
and guidance are justified by verifiable, peer reviewed, published
science that is accessible through an open and transparent process and
enhance consumer understanding. In addition, FBIA works to ensure
regulation implementation timelines are reasonable, achievable and
economically feasible for both small and large food and beverage
manufacturers. Find out more about FBIA and its members at
www.feedingUS.org.
Critical Infrastructure Access to Testing
In March, the food and agriculture, consumer packaged goods (CPG)
and retail industries respectfully requested that--as testing
capabilities expand--the food and agriculture, CPG manufacturing and
retail operations have prioritized access to testing in those
situations where it helps protect workers. The current inconsistencies
in testing approaches from State to State and between localities have
resulted in the need to downscale or shut down operations altogether.
Since their initial request, the number of food operations that
have closed due to illness within their worker communities has
increased, and at the same time, testing has become more accessible.
Now more than ever, it is critical to keep the Food and Agriculture
sector, CPG and retail industries operations functional to feed
American families. What work is the agency doing to prioritize the
testing resources for these sectors directly behind healthcare and
first responders?
State and Local Re-opening Testing Requirements
State and local health officials throughout the country are asking
for 100 percent testing prior to allowing businesses to reopen. While
testing has become more accessible, but is still not readily available,
do you believe that this is an appropriate request?
Access to Personal Protective Equipment
In March, the Food and Agriculture industries, including retailers,
requested prioritization for PPE directly behind the healthcare sector
and first responders. It is vitally important to protect these
essential workers as businesses strive to stay operational, produce
food and to keep grocery store shelves stocked for American families.
What is being done to assist these sectors in securing needed supplies?
Thank you for considering our questions. If you need any additional
information, please contact me at [email protected].
______
[Whereupon, at 1:30 p.m., the hearing was adjourned.]
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