Oversight of the Trump Administration's Response to the COVID-19 Pandemic (Hearing, June 23, 2020)
Summary
Transcript of the hearing "Oversight of the Trump Administration's Response to the COVID-19 Pandemic" before the Committee on Energy and Commerce, June 23, 2020, Serial No. 116-115, with Chairman Frank Pallone presiding. In an opening statement Mr. Pallone said more than 2.2 million Americans had contracted COVID-19, more than 120,000 had died and more than 45 million had filed for unemployment over the last three months, and faulted what Pallone called a sluggish initial response from the administration. Ranking Member Greg Walden also gave an opening statement. Witnesses were Robert R. Redfield of the Centers for Disease Control and Prevention, Anthony S. Fauci of the National Institute of Allergy and Infectious Diseases, Admiral Brett P. Giroir, Assistant Secretary for Health, and FDA Commissioner Stephen M. Hahn.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
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“Oversight of the Trump Administration's Response to the COVID-19 Pandemic (Hearing, June 23, 2020).”
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[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
OVERSIGHT OF THE TRUMP ADMINISTRATION'S
RESPONSE TO THE COVID-19 PANDEMIC
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
__________
JUNE 23, 2020
__________
Serial No. 116-115
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
__________
U.S. GOVERNMENT PUBLISHING OFFICE
54-857 PDF WASHINGTON : 2024
-----------------------------------------------------------------------------------
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois GREG WALDEN, Oregon
ANNA G. ESHOO, California Ranking Member
ELIOT L. ENGEL, New York FRED UPTON, Michigan
DIANA DeGETTE, Colorado JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland PETE OLSON, Texas
JERRY McNERNEY, California DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice BILL JOHNSON, Ohio
Chair BILLY LONG, Missouri
DAVID LOEBSACK, Iowa LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon BILL FLORES, Texas
JOSEPH P. KENNEDY III, SUSAN W. BROOKS, Indiana
Massachusetts MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California RICHARD HUDSON, North Carolina
RAUL RUIZ, California TIM WALBERG, Michigan
SCOTT H. PETERS, California EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
C O N T E N T S
----------
Page
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 2
Prepared statement........................................... 4
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 7
Prepared statement........................................... 9
Witnesses
Robert R. Redfield, M.D., Director, Centers for Disease Control
and Prevention................................................. 10
Prepared statement \1\
Answers to submitted questions............................... 156
Anthony S. Fauci, M.D., Director, National Institute of Allergy
and Infectious Diseases, National Institutes of Health......... 12
Prepared statement \1\
Answers to submitted questions............................... 180
Admiral Brett P. Giroir, M.D., Assistant Secretary for Health,
U.S. Department of Health and Human Services................... 14
Prepared statement \1\
Answers to submitted questions............................... 196
Stephen M. Hahn, M.D., Commissioner, FDA......................... 15
Prepared statement \1\
Answers to submitted questions............................... 208
Submitted Material
Statement of June 23, 2020, from the American Society of
Microbiology, submitted by Mr. Pallone......................... 135
Statement of June 23, 2020, from the Alzheimer's Association,
submitted by Mr. Pallone....................................... 137
Letter of June 23, 2020, to Mr. Pallone, by Scott Frey, Director
of Federal Government Affairs, America Federation of State,
County and Municipal Employees, submitted by Mr. Pallone....... 141
Letter of June 23, 2020, to Mr. Pallone and Mr. Walden, from the
American Society of Hermatology, submitted by Mr. Pallone...... 144
Graph on COVID-19 cases in the Houston region, from Rep. Olson,
submitted by Mr. Pallone....................................... 148
Statement of June 23, 2020, from Rep. Burgess, submitted by Mr.
Pallone........................................................ 149
Letter of June 23, 2020, to Mr. Pallone, from Mr. Walden,
submitteed by Mr. Pallone...................................... 155
----------
\1\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF00/
20200623/110829/HHRG-116-IF00-Wstate-RedfieldR-20200623.pdf.
OVERSIGHT OF THE TRUMP ADMINISTRATION'S RESPONSE TO THE COVID-19
PANDEMIC
----------
TUESDAY, JUNE 23, 2020
House of Representatives,
Committee on Energy and Commerce,
Washington, DC.
The committee met, pursuant to call, at 11:00 a.m., in the
John D. Dingell Room 2123, Rayburn House Office Building, Hon.
Frank Pallone (chairman of the committee) presiding.
Members present: Pallone, Rush, Eshoo, DeGette, Doyle,
Schakowsky, Butterfield, Matsui, Castor, Sarbanes, McNerney,
Welch, Lujan, Tonko, Loebsack, Schrader, Kennedy, Cardenas,
Ruiz, Peters, Dingell, Veasey, Kuster, Kelly, Barragan, Blunt
Rochester, Soto, O'Halleran, Walden (ranking member), Upton,
Burgess, Latta, Rodgers, Guthrie, Olson, McKinley, Kinzinger,
Griffith, Bilirakis, Johnson, Long, Bucshon, Flores, Brooks,
Hudson, Walberg, Carter, Duncan, and Gianforte.
Staff present: Joe Banez, Professional Staff Member; Kevin
Barstow, Chief Oversight Counsel; Billy Benjamin, Systems
Administrator; Jacquelyn Bolen, Counsel; Jesseca Boyer,
Professional Staff Member; Jeffrey C. Carroll, Staff Director;
Sharon Davis, Chief Clerk; Kimberlee Espinosa, Professional
Staff; Austin Flack, Staff Assistant; Waverly Gordon, Deputy
Chief Counsel; Tiffany Guarascio, Deputy Staff Director;
Stephen Holland, Health Counsel; Zach Kahan, Outreach and
Member Service Coordinator; Saha Khaterzai, Professional Staff
Member; Chris Knauer, Oversight Staff Director; Una Lee, Chief
Health Counsel; Kevin McAloon, Professional Staff Member;
Aisling McDonough, Policy Coordinator; Meghan Mullon, Staff
Assistant; Joe Orlando, Staff Assistant; Kaitlyn Peel, Digital
Director; Alivia Roberts, Press Assistant; Tim Robinson, Chief
Counsel; Samantha Satchell, Professional Staff Member; Andrew
Souvall, Director of Communications, Outreach and Member
Services; Benjamin Tabor, Policy Analyst; Kimberlee Trzeciak,
Chief Health Advisor; C.J. Young, Press Secretary; Nolan Ahern,
Minority Professional Staff, Health; Jennifer Barblan, Minority
Chief Counsel, Oversight and Investigations; Mike Bloomquist,
Minority Staff Director; S.K. Bowen, Minority Press Secretary;
William Clutterbuck, Minority Staff Assistant; Diane Cutler,
Minority Detailee, Oversight and Investigations; Molly Jenkins,
Minority Press Secretary; Caleb Graff, Minority Professional
Staff Member, Health; Tyler Greenberg, Minority Staff
Assistant; Tiffany Haverly, Minority Communications Director;
Brittany Havens, Minority Professional Staff, Oversight and
Investigations; Peter Kielty, Minority General Counsel; Bijan
Koohmaraie, Minority Counsel, Consumer Protection and Commerce;
Ryan Long, Minority Deputy Staff Director; Mary Martin,
Minority Chief Counsel, Energy and Environment and Climate
Change; James Paluskiewicz, Minority Chief Counsel, Health;
Brannon Rains, Minority Policy Analyst; Kristin Seum, Minority
Counsel, Health; Kristen Shatynski, Minority Professional Staff
Member, Health; Alan Slobodin, Minority Chief Investigative
Counsel, Oversight and Investigations; Natalie Sohn, Minority
Counsel, Oversight and Investigations; and Everett Winnick,
Minority Director of Information Technology.
Mr. Pallone. [presiding]. The Committee on Energy and
Commerce will now come to order.
Today, the Committee is holding a hearing entitled,
``Oversight of the Trump Administration's Response to the
COVID-19 Pandemic.'' Due to the COVID-19 public health
emergency, members can participate in today's hearing either in
person or remotely via video conferencing.
As part of this hearing, the microphones of members
participating remotely will be set on mute for the purpose of
eliminating inadvertent background noise. Members participating
remotely will need to unmute your microphone each time you wish
to speak.
For members and witnesses participating in person, I
encourage you to wear your mask whenever you are not speaking.
Dr. Monahan stressed in the updated attending physician's
COVID-19 guidelines that the use of face coverings is meant to
protect other people in case the wearer is unknowingly
infected, but does not have symptoms. By wearing our masks when
we are not speaking, each of us is playing a vital role in
protecting all members and staff who are in attendance, as well
as the leaders of the administration's COVID-19 response who
will be testifying before the committee today.
Due to the anticipated length of this hearing, the
committee will take a 15-minute recess at 1:30 p.m. to provide
witnesses a restroom break.
And finally, documents for the record can be sent to
Benjamin Tabor at the email address we provided to staff. All
documents will be entered into the record at the conclusion of
the hearing.
And now, I recognize myself for 5 minutes for an opening
statement.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Today, the Energy and Commerce Committee continues its
important work overseeing the administration's response to the
COVID-19 pandemic. It is difficult to overstate this disease's
devastating impact. To date, more than 2.2 million Americans
have contracted COVID-19 and, tragically, more than 120,000
have died. At the same time, more than 45 million Americans
have filed for unemployment over the last three months. COVID-
19 has wreaked havoc on this country's physical, mental, and
economic well-being.
And the pandemic has been especially brutal to people of
color and low-income communities. Thousands of families can
tell stories of losing a relative without being allowed to
visit them in their final days or the social isolation felt by
seniors and others in long-term care facilities. Millions more
could tell us about losing their jobs or being forced to close
a small business.
On top of the raw devastation of this disease, this
committee must confront the fact that, had it not been for a
sluggish initial response from the Trump administration, and a
President in my opinion putting political considerations over
public health, we could have done much more to mitigate the
destructive impact of COVID-19. And we must learn from and
correct the administration's mistakes, so that we are prepared
to combat this disease as more outbreaks flare up this summer
and the potential second wave comes in the fall.
Now, testing has been a problem since the beginning, and
while it has improved, we are still falling far short of the
900,000 daily tests public health experts believe we need. We
are also hampered by the administration's refusal to develop
and implement a national testing and contact tracing strategy.
This cannot continue. I think we need federal public health
experts to take more of a leadership role, and this
administration is failing to allow that.
Public health must also be our first consideration as we
accelerate research into a vaccine and treatments for COVID-19.
We all want a vaccine to be developed as soon as possible.
Before any vaccine or treatment is distributed, our public
health experts must ensure that it is safe, effective, and
accessible.
And we must also take action to prepare our supply chain
with sufficient quantities of vials, needles, syringes, and
other products necessary to administer a vaccine. We also need
to improve testing supply and our supply of personal protective
equipment, or PPE, for our frontline workers and others
throughout the economy. And while our supply of some PPE has
improved, governors have told us that we are still far from
where we need to be.
Fortunately, last month the House passed the Heroes Act,
which provides our public health agencies with the mandate and
the resources to ensure we are prepared going forward. The bill
requires that HHS finally develop a national testing and
contact tracing plan and provides $75 billion to carry it out.
It also provides billions more to strengthen the Strategic
National Stockpile and to increase research, development, and
manufacturing of vaccines and treatments. And it ensures that
all Americans will be able to receive free coverage of
treatment, drugs, and an eventual vaccine with no cost-sharing.
This legislation is needed today, but the Senate has failed to
act and the Trump administration has threatened to veto it
without putting forward any policy vision of their own.
Now President Trump refuses to even acknowledge the
challenges we face and the difficult work that must be done to
prevent further destruction. Just this weekend, as outbreaks
flared up and public health leaders continued to urge social
distancing, the President put Americans at risk, in my opinion,
by holding a political rally in Oklahoma. And at the rally, he
suggested that his staff slow down testing to mask the true
level of infection across the country. In fact, this morning
the President said he wasn't kidding when he made those
comments. And I think this was extremely reckless, and
unfortunately, it continues the President's pattern of ignoring
the advice of his own public health experts and it also sends a
horrible message to some Americans that they, too, can ignore
public health experts.
As this vicious disease continues to harm our country, it
is extremely dangerous that the President, the Vice President,
and others in this administration continue to downplay the risk
we continue to face. All around the country, warning bells are
going off, with hospitals struggling to keep up with the rate
of hospitalizations and ICU beds filling up and emerging COVID
hot spots. And the administration's unwillingness to face these
hard truths I think is going to lead more deaths and more
needless suffering.
So, I am pleased that we have our nation's public health
officials with us today. Thank you all for coming. I have
admired your role and what you have done over the last few
months. I think you can help us answer questions about what has
gone wrong, what is improving, and how we can be prepared going
forward. And I look forward to your testimony.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
Today, the Energy and Commerce Committee continues its
important work overseeing the Administration's response to the
COVID-19 pandemic. It is difficult to overstate this disease's
devastating impact. To date, more than 2.2 million Americans
have contracted COVID-19, and tragically 120,000 have died. At
the same time, more than 45 million Americans have filed for
unemployment over the last three months. COVID-19 has wreaked
havoc on the country's physical, mental, and economic
wellbeing.
And the pandemic has been especially brutal to people of
color and low-income communities. Thousands of families can
tell stories of losing a relative without being allowed to
visit them in their final days, or the social isolation felt by
seniors and others in long-term care facilities. Millions more
could tell us about losing their job or being forced to close a
small business.
On top of the raw devastation of this disease, this
Committee must confront the fact that had it not been for a
sluggish initial response from the Trump Administration, and a
President putting political considerations over public health,
we could have done much more to mitigate the destructive impact
of COVID-19. We must learn from and correct the
Administration's mistakes so that we are prepared to combat
this disease as more outbreaks flare up this summer and a
potential second wave comes in the fall.
Testing has been a problem since the beginning, and while
it's improved, we are still falling far short of the 900,000
daily tests public health experts believe we need. We are also
hampered by the Administration's refusal to develop and
implement a national testing and contact tracing strategy. This
cannot continue - we need federal public health experts to take
more of a leadership role, and this Administration is failing
to allow that.
Public health must also be our first consideration as we
accelerate research into a vaccine and treatments for COVID-19.
We all want a vaccine to be developed as soon as possible, but
before any vaccine or treatment is distributed, our public
health experts must ensure that it is safe, effective, and
accessible. We must also take action to prepare our supply
chain with sufficient quantities of vials, needles, syringes,
and other products necessary to administer a vaccine.
We also need to improve testing supplies and our supply of
personal protective equipment, or PPE, for our frontline
workers and others throughout the economy. While our supply of
some PPE has improved, governors have told us that we are still
far from where we need to be.
Fortunately, last month the House passed the Heroes Act,
which provides our public health agencies with the mandate and
the resources to ensure we are prepared going forward. The bill
requires that the Department of Health and Human Services (HHS)
finally develop a national testing and contact tracing plan and
provides $75 billion to carry it out. It provides billions more
to strengthen the Strategic National Stockpile and to increase
research, development, and manufacturing of vaccines and
treatments. And it ensures that all Americans will be able to
receive free coverage of treatments, drugs and an eventual
vaccine with no cost-sharing. This legislation is needed today,
but the Senate has failed to act, and the Administration has
threatened to veto it without putting forward any policy vision
of their own.
President Trump refuses to even acknowledge the challenge
we face and the difficult work that must be done to prevent
further destruction. Just this weekend, as outbreaks flared up
and public health leaders continued to urge social distancing,
the President put Americans at risk by holding a political
rally in Oklahoma. At the rally he suggested that his staff
slow down testing to mask the true level of infection across
the country. This was an extremely reckless action, and
unfortunately it continues the President's pattern of ignoring
the advice of his own public health experts. It also sends a
horrible message to some Americans that they too can ignore
public health experts.
As this vicious disease continues to harm our country, it's
also extremely dangerous that the President, the Vice
President, and others in this Administration continue to
downplay the risks we continue to face today. All around the
country warning bells are going off, with hospitals struggling
to keep up with the rate of hospitalizations and ICU beds
filling up in emerging COVID hotspots. The Administration's
unwillingness to face these hard truths I think will lead to
more deaths and more needless suffering.
I am pleased we have our nation's public health officials
with us today who can help us answer questions about what has
gone wrong, what is improving, and how we can be prepared going
forward. I look forward to their testimony and I now recognize
the Ranking Member for 5 minutes for his opening statement.
I now recognize our ranking member for 5 minutes for an
opening statement.
Mr. Walden. Thank you, Mr. Chairman.
Before I begin, I have a parliamentary inquiry.
Mr. Pallone. Yes.
Mr. Walden. Mr. Chairman, Committee Rule 9(b)(1) says that,
``At full committee hearings, the chairman and ranking minority
member shall be limited to 5 minutes each for an opening
statement, and may designate other members to give an opening
statement of not more than 5 minutes.'' And pursuant to this
rule, I designated Dr. Burgess to give an opening statement.
And I raise this because I know in the past at times only the
chairman and ranking member have given opening statements. At
other times, we have allowed the minority--and you have I
believe as well--to designate another member for 5 minutes.
Given the importance of this hearing, I would hope that we
could work this out where the subcommittee chairmen and rankers
could also comment. And I wonder if you would be willing to
allow that.
Mr. Pallone. Well, I appreciate your comments, Mr. Walden,
but the answer is no. I mean, first, let me remind members
that, pursuant to committee rules, all Members' written opening
statements will be made a part of the record. But, according to
our rules, only the full committee chair and ranking member
must be provided 5 minutes for an opening statement at a full
committee hearing.
Now, you know, we don't have too many of these because, in
the tradition of the Energy and Commerce Committee, we try to
do all the hearings at the subcommittee level. But the problem
with doing that today is that I thought this was important
enough for a full committee hearing, but, plus, these witnesses
are going to be testifying in areas that cross the boundaries
of various subcommittees. And so, if we let the Health
Subcommittee ranking members, we would have to let the ranking
members of all the subcommittees, including Oversight and
Investigations, and that is just going to drag things on too
long. So, I decided that we would just have it for the full
committee members.
And I would point out--I don't want to go into it--I could
give you all the record about how, when you were chair when we
had full committee hearings, we just had it limited to the two
full committee members. And I know you are not saying that we
have to do it. You are just asking that we do it. But, given
the fact that I would have to open it up to all the
subcommittee chairs, and we would be here another hour, I
think, I have decided to just proceed with the two of us.
Mr. Walden. Sure. Reclaiming my--I guess I can reclaim the
time on a parliamentary inquiry.
But I know in the past we would even be willing to divide
that simple 5 minutes among both Mr. Guthrie and Dr. Burgess. I
would suggest you could do the same on that side and limit it
to 10 minutes.
Mr. Pallone. Do you want to use your time for them?
Mr. Walden. No, I would yield it, as allowed for under our
rules, the additional 5 minutes. Each side would have 10
minutes total.
Mr. Pallone. No, because you see my point. My point is, if
you just have the subcommittee chairs--and nobody is prepared
to do that at this point. So, let's just leave it the way it is
and you use your 5.
Mr. Griffith. Mr. Chairman, parliamentary inquiry.
Mr. Pallone. Yes.
Mr. Griffith. What part of Rule 9(b) do you think does not
give the ranking minority member the opportunity to delegate
another member to give an opening statement of not more than 5
minutes? When I read this language, it is pretty clear, it is
not a decision of the chair. It is, in fact, built into the
rules that that is a decision of the ranking member, the
ranking minority member, if he chooses to do so.
And as Jefferson's Manual opens up with very clearly--and I
didn't bring my copy down with me today--but the rules are
designed to protect the rights of the minority because the
majority can do whatever it wants to whenever it wants to. And
the rules that we adopted just at the beginning of this
congressional session reiterated the fact that the minority
ranking member not only gets his 5 minutes, or her 5 minutes,
but that they may designate another member to give an opening
statement of not more than 5 minutes.
So, while we have waived that in the past, I don't see
anything in here that actually gives that decision to the
chair. And while we are all friends--and I know you do the best
you can, Mr. Chairman; I am not criticizing that personally--I
am just saying the rules are pretty clear that the ranking
minority member gets to designate somebody, and it is not----
Mr. Pallone. Well, that is not the way I read it. According
to the rules, only the full committee chair and ranking member
must be provided the 5 minutes for an opening statement at a
full committee hearing. Anything else is discretionary with the
Chair and is ``may.''
Now, again, this interpretation is not unique to my term as
chairman. At the first full committee hearing during the
ranking member's term as chairman of the full committee, on
October 25th, 2017, a hearing entitled, ``Federal Efforts to
Combat the Opioid Crisis,'' then-Chairman Walden announced,
``At the conclusion of my opening statement, we now go to our
witnesses.'' Full committee hearing, only the chairman and
ranking member give opening statements just for our committee's
benefit. So now, we go to our witnesses.
And then, in the 116th Congress, we continued the same
practice of only providing the full committee chair and ranking
member with 5 minutes each for opening statements at full
committee hearings.
At both the May 22nd, 2019 full committee hearing entitled,
``Lift America: Modernizing our Infrastructure for the
Future,'' and the July 25th, 2019 full committee hearing
entitled, ``Member Day,'' only the full committee chair and
ranking member were provided time for an opening statement.
So, I am just continuing the same practice today that
existed both under Mr. Walden's chairmanship and mine, and it
is clearly discretionary. But the reason I am exercising
discretion to not do it beyond the 5 minutes for each of the
full committee chairs and rankers is because of the time
limits. I mean, I guess now we are wasting time. But, I mean,
look, I don't want to tell you what to do, but I am going to
insist on that.
And I would rather proceed and hear from everybody.
All right, you are recognized, Mr. Walden, for 5 minutes.
OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Well, Mr. Chairman, I am frustrated by that. I
know members on both sides, and in the past back to 2011 and
2013, chairs and rankers did work this out and did have others
participate.
So, I will move on to my opening statement at this point.
I want to thank our distinguished panel of witnesses who
are still working around the clock to understand this deadly
virus and to develop public health standards to confront it,
medicines to treat it, and a vaccine to end it.
COVID-19 laid bare how vulnerable we are and how much more
we need to do as a government. I comment the work of my
colleagues, Anna Eshoo and Susan Brooks, to modernize the
Pandemic and All-Hazards Preparedness Act. And I acknowledge
the incredible efforts of Fred Upton and Diana DeGette who
wrote the 21st Century Cures legislation.
But, even with all of that work, COVID-19 hit the world
like a tsunami, quick and deadly, leaving unprecedented
destruction and disruption. Our distinguished speakers are like
co-captains of America's rescue plane, a plane we are building
while we fly. Congress has supported those efforts with
historic levels of funding, resources, and flexibility.
Early on, President Trump stopped flights from China, and
then, Europe. He tightened up our borders, established a
presidential task force to coordinate efforts, and invoked
executive authority seldom used except in times of emergency or
war, including the Stafford Act and the Defense Production Act,
and harnessed the power of American innovation through projects
like Operation Warp Speed.
During this unprecedented response, the administration had
to operate with very limited, often conflicting, data. Even
with CDC guidance in hand, some governors chose to ignore that
guidance, and they actually forced sick nursing home patients
back to the nursing homes, committing the deadliness mistake of
the pandemic.
Meanwhile, backward-looking critics with unfair advantage
of 20/20 hindsight attacked you and the men and women who
worked alongside of each of you. I commend our witnesses today
for keeping focused on the challenges at hand and for doing
everything possible to beat this virus.
Six months ago, we had barely heard of this virus. During
our briefings, most thought that, like SARS and MERS before it,
we would get past this beast, which didn't even have a name
back then. We quickly went from knowing little about this virus
to creating a test for it and testing more than 25 million
samples, with recent averages of more than 500,000 tests a day.
But we all know there is more to be done.
Dr. Giroir is a distinguished admiral who became a self-
proclaimed ``swab guy,'' quote-unquote, because that is what
America needed. We discovered there were only two nasal swab
manufacturers in the world, one in Maine and one in Italy. And
the President invoked the DPA ordering Puritan to make the
swabs we needed, and then, provided funds made available
through Congress to dramatically increase production in a new
facility in Maine.
Meanwhile, the President launched Project Airbridge to fly
military planes to Italy to pick up swabs and to search the
globe for other supplies that we found in complete limited
supply here.
The State Department helped 101,386 Americans abroad get
back home, often on government-chartered planes when commercial
transportation was shut down.
With a potential increase of illnesses in the fall when
coupled with the flu season, I asked my team to research every
aspect of this health crisis and provide recommendations to
improve our preparedness going forward. Mitigating a second
wave of infections is critical, given the impact this virus has
had not only on public health, but also on people's livelihoods
and America's economy. We released the first recommendations on
testing and surveillance three weeks ago and are preparing to
release recommendations on therapeutics and vaccines very soon.
In less than six months, the United States has conducted
millions of tests, manufactured medical equipment in car
factories, used 3D printers to make personal protective
equipment, developed multiple vaccine candidates, authorized
use of more than 100 medical devices and drugs for emergency
use, weighing the known and potential benefits and risks at the
time--all at unprecedented speeds. These innovations have the
ability to serve us well and far beyond this pandemic.
We have seen remarkable coordination, flexibility, and
cooperation between the executive branch, private sector, faith
groups, volunteers, and lawmakers. America is strongest when we
work together to achieve common goals.
We are constantly learning how to improve our preparedness.
We must adjust our response based off of facts at hand and
focus on how to best move forward. We must unite in a common
fight against this virus.
Just as America mobilized in World War II to do whatever it
took, today our distinguished panelists have mobilized
America's finest scientists, logisticians, and entrepreneurs to
beat this deadly, microscopic enemy. Thank you for your
leadership, for your years of public service, and for your
dedication to this lifesaving mission.
Mr. Chairman, I yield back the balance of my time.
[The prepared statement of Mr. Walden follows:]
Prepared Statement of Hon. Greg Walden
I want to thank our distinguished witnesses who are still
working around the clock to understand this deadly virus and to
develop public health standards to confront it; medicines to
treat it; and a vaccine to end it.
COVID-19 laid bare how vulnerable we are and how much more
we need to do as a government. I commend the work of my
colleagues, Anna Eshoo and Susan Brooks to modernize the
Pandemic All Hazards Preparedness Act. And I acknowledge the
incredible efforts of Fred Upton and Diana DeGette who wrote
the 21st Century Cures legislation.
But even with all of that work, COVID-19 hit the world like
a tsunami: quick and deadly, leaving unprecedented destruction
and disruption.
Our distinguished speakers are like co-captains of
America's rescue plane -a plane we are building while we fly.
Congress has supported those efforts with historic levels of
funding, resources, and flexiblility.
Early on, President Trump stopped flights from China and
then Europe, tightened up our borders, established a
presidential task force to coordinate efforts, and invoked
executive authorities seldom used, except in times of war,
including the Stafford Act and the Defense Production Act, and
harnessed the power of American innovation through projects
like Operation Warp Speed.
During this unprecedented response, the Administration had
to operate with very limited, often conflicting, data. Even
with CDC guidance in hand, some governors chose to ignore
guidance and forced sick nursing home patients back to the
nursing home, committing the deadliest mistake of the pandemic.
Meanwhile backward-looking critics with the unfair
advantage of 20-20 hindsight attack you and the men and women
who work alongside you. I commend our witnesses today for
keeping focused on the challenges at hand and for doing
everything possible to beat this virus.
Six months ago, we'd barely heard of this virus. During our
briefings, most thought that like SARS and MERS before it, we'd
get past this beast--which didn't even have a name back then.
We quickly went from knowing little about this virus to
creating a test for it and testing more than 25 million
samples, with recent averages of more than 500,000 tests a day.
Dr. Giroir (JER--WA), is a distinguished Admiral who became
a self-proclaimed "swab guy" because that is what America
needed. We discovered there were only two nasal swab
manufacturers in the world: one in Maine and one in Italy. The
President invoked the DPA ordering Puritan to make the swabs we
needed and provided funds to dramatically increase production
in a new facility.
Meanwhile, the President launched Project Air Bridge to fly
military planes to Italy to pick up swabs, and to search the
globe for other supplies that were in limited supply here. The
State Department helped 101,386 Americans abroad get back home,
often on government chartered planes after commercial
transportation was shut down.
With a potential increase of illness in the fall when
coupled with the flu season, I asked my team to research every
aspect of this health crisis and provide recommendations to
improve our preparedness. Mitigating a second wave of
infections is critical given the impact this virus has had on
not only public health, but also on peoples' livelihoods and
the economy. We released the first recommendations on testing
andsurveillance three weeks ago, and are preparing to release
recommendations on therapeutics and vaccines very soon.
In less than six months, the United States has conducted
millions of tests, manufactured medical equipment in car
factories, used 3-D printers to make personal protective
equipment, developed multiple vaccine candidates, authorized
use of more than 100 medical devices and drugs for emergency
use, weighing the known and potential benefits and risks at the
time, all with unprecedented speed. These innovations have the
ability to serve us well and far beyond this pandemic.
We have seen remarkable coordination, flexibility and
cooperation between the executive branch, private sector, faith
groups,volunteers, and lawmakers. America is strongest when we
work together to achieve common goals.
We are constantly learning how to improve our preparedness.
We must adjust our response based off the facts at hand and
focus on how to best move forward. We must unite in a common
fight against this virus.
Just as America mobilized in World War II to do whatever it
took, today, our distinguished panelists have mobilized
America's finest scientists, logisticians and entreprenuers to
beat this deadly, Microscopic Enemy. Thank you for your
leadership, for your years of public service, and for your
dedication to this life-saving mission.
Mr. Pallone. Thank you. I want to thank the ranking member.
And I would like to now introduce our witnesses for today's
hearing. I keep calling it the White House Task Force on
Coronavirus, but I don't actually know whether that is still in
existence or whether you are all Members of it anymore.
So, first, we have Dr. Robert Redfield, the Director of the
Centers for Disease Control and Prevention. We have Dr. Anthony
Fauci, Director of the National Institute of Allergy and
Infectious Diseases at the National Institutes of Health. We
have Admiral Brett Giroir, Assistant Secretary for Health, U.S.
Department of Health and Human Services, who is probably tired
of hearing from me since I am call him all the time. And Dr.
Stephen Hahn, who is the Commissioner of the U.S. Food and Drug
Administration.
Thank you all for being here today, and I know it is going
to be worthwhile.
At this time, the chair is going to recognize each witness
for 5 minutes to provide their opening statement. Before we
begin, I would like to explain the lighting system.
In front of you is a series of lights. The light will
initially be green at the start of your opening statement. The
light will turn yellow when you have 1-minute remaining. And,
of course, you should try to wrap up your testimony at that
point. And the light will turn red when your time expires. You
probably know this already, but I will mention it again.
So, we are going to start with Dr. Redfield. You are
recognized for 5 minutes. Thank you.
STATEMENTS OF ROBERT R. REDFIELD, DIRECTOR, CENTERS FOR DISEASE
CONTROL AND PREVENTION; ANTHONY S. FAUCI, DIRECTOR, NATIONAL
INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL
INSTITUTES OF HEALTH; ADMIRAL BRETT P. GIROIR, ASSISTANT
SECRETARY FOR HEALTH, U.S. DEPARTMENT OF HEALTH AND HUMAN
SERVICES, AND STEPHEN M. HAHN, COMMISSIONER, U.S. FOOD AND DRUG
ADMINISTRATION
STATEMENT OF ROBERT R. REDFIELD
Dr. Redfield. Good morning, Chairman Pallone, Ranking
Member Walden, and distinguished members of the committee.
Thank you for the opportunity to testify before you with my HHS
colleagues.
Today, the COVID-19 pandemic continues in the United States
and around the world. This pandemic is the greatest public
health crisis our nation and our world have confronted in more
than a century.
While overall case counts are going down, several
communities are seeing increased cases driven by multiple
factors, including increased testing, outbreaks, and evidence
of community transmission.
Right now, the most powerful weapon against this disease
are social distancing, face coverings, and hand hygiene. These
actions will help us contain transmission, along with readily
available testing; comprehensive, timely contact tracing;
timely isolation of known cases, and self-quarantine to break
the chains of transmission.
Once again, I call on the American people to remain
vigilant in our collective obligation to protect those who may
be at risk for severe complications of COVID-19 due to age or
underlying medical conditions. We must also lessen the burden
of COVID-19 among racial and ethnic groups disproportionately
impacted.
The CDC continues to improve its data collection of
comprehensive data of each case, race, and ethnicity from our
state, local, tribal, and territorial partners. Reporting from
hospital surveillance sites, for example, has increased in
completeness on race and ethnicity from 30 percent to now more
than 80 percent. CDC is also receiving more complete data from
our public health partners.
The recent CDC study examined more than 1.3 million COVID-
19 cases and found that the most underlying health conditions
were cardiovascular, diabetes, obesity, and chronic lung
disease. Hospitalizations were six times higher for these
individuals and death 12 times higher of those reporting these
conditions compared to those without.
The CDC is working to ensure the equity and health outcomes
and the social determinates are being addressed through the
COVID-19 response. CDC continues to provide communities with
technical expertise, tools, and information to confront the
virus.
The CDC has created more than 1500 specialized resource and
guidance documents that would have been consulted more than 1.5
billion times on the CDC website.
We have deployed over 5,000 personnel in the response. We
have more than 40 rapid response teams on the ground now
providing local health departments and health officials with
expertise in epidemiology, surveillance, infection control,
laboratory science, and community mitigation.
We are enormously grateful to the heroes of the response.
That is the public health and healthcare professionals, the
first responders, the critical infrastructure workers who have
served and sacrificed too much.
CDC and our nation's public health partners are actively
working on the front lines of this pandemic to remedy the
shortcomings in a public health system that has been
underresourced for decades. With your support, CDC has been
able to award nearly $12 billion to states, territories,
tribes, and localities to enhance their response capabilities.
When confronted by any disease threats, CDC and public
health departments must make real-time decisions based on real-
time data. Data is the backbone of any disease threat response.
With the resources that Congress has provided, data
modernization is underway. We also must ensure that our
laboratories have resilience. Advanced technology, personnel,
expertise, and supplies are being sourced.
Our public health workforce must grow exponentially to
address COVID-19 and future public health threats. Thousands of
contact tracers are onboard and being recruited by public
health departments across our nation. The bottom line:
sustained investment in the public health system is an
investment in the health and prosperity of our nation.
Last, CDC has begun to prepare for the months ahead when
the next season's influenza illness will occur simultaneously
potentially with COVID-19, increasing the challenges on
hospitals, healthcare professionals, and the public. This fall,
before the seasonal circulation of influenza increases, I
encourage the American people to be prepared and to embrace flu
vaccination with confidence for yourself, your families, and
the communities. This single act will save lives.
Thank you, and I look forward to your questions.
[The combined statement of Dr. Redfield appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you, Dr. Redfield.
Dr. Fauci?
STATEMENT OF ANTHONY S. FAUCI
Dr. Fauci. Thank you very much, Mr. Chairman, Ranking
Member Walden. Thank you all for giving me the opportunity to
discuss with you today the role of the National Institutes of
Health in research addressing COVID-19.
The approach to the NIH is very similar to what we do with
other emerging infections. It is a four-pronged approach.
First, to study the fundamental knowledge of the virus itself,
as well as the host response to the virus. The second is to
help develop diagnostics and assays. The third is to
characterize and test therapeutics, and the fourth is to
develop safe and effective vaccines.
Speaking of the first, fundamental knowledge of the virus
and what the virus is capable of doing, we have done a number
of studies now that have informed how we are approaching
therapeutics and vaccines. For example, the precise molecular
structure of the spike protein, which is that part of the virus
which actually gives it its name, coronavirus, because of these
spikes that stick out from the virus, that is the way the virus
binds to cells in the body. This has been precisely delineated
by NIH scientists and those that we fund. Second, the
demonstration of the precise receptors where by the virus binds
to cells in the body, allowing it to enter and cause disease.
In addition, we develop animal models. We do natural history
studies, such as understanding the virus in different
demographic groups.
Second is the development diagnostics and assays. We need,
and we will get within a reasonable period of time, based on a
major investment in the RADx program, diagnostics that are
point-of-care, simple, precise, sensitive, and specific. We
hope by the end of the fall and into the early winter we will
have these for wide distribution.
Third, the development and characterization of drugs. You
have all heard of the first successful randomized, placebo-
controlled trial of a drug called remdesivir, which was used in
hospitalized patients with lung disease. It showed a
statistically significant, but modest impact on decreasing the
time to release from the hospital; namely, faster recovery. In
addition, this drug is now being used in combination with
another drug that blocks the inflammatory response,
baricitinib. We are also looking at a variety of others:
convalescent plasma, hyperimmune globulin, other drugs,
monoclonal antibodies, as well as other immune-based therapies.
Fourth, the development of safe and effective vaccines, the
hallmark of all really defining responses that we have to virus
diseases. If you look at the history of viral diseases, it is
generally vaccines that put the nail in the coffin of these
types. We are now mounting a major effort in which we are
collaborating with industry in public-private partnerships to
get vaccine trials that are developed that harmonize with each
other. In other words, they have multiple trials in which we
have common questions that are being asked, common laboratories
that are being looked at, common data and safety monitoring
board, and common primary, secondary, and tertiary endpoints,
so that the data can be compared from one to another.
You have probably heard that one of those vaccines--and
there are more than one; there are several that are moving
along at various paces--one of them will enter phase 3 study in
July. This is one that has already shown in preliminary studies
some very favorable responses in the animal models that were
developed. There will be others that will follow one month, two
months, three months later.
Although you can never guarantee at all the safety and
efficacy of a vaccine until you actually test it in the field,
we feel cautiously optimistic, based on the concerted effort
and the fact that we are taking financial risks, not risks to
safety, not risks to the integrity of the science, but
financial risks to be able to be ahead of the game, so that
when--and I believe it will be when and not if--we get
favorable candidates with good results, we will be able to make
them available to the American public, as I said to this
committee months ago, within a year from when we started, which
would put us at the end of this calendar year and the beginning
of 2021.
I will stop there, Mr. Chairman, and be happy to answer
questions later. Thank you.
[The combined statement of Dr. Fauci appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you, Dr. Fauci, and thanks for all your
contributions to fighting this pandemic. And I will say the
same about Admiral Giroir, who I bother the most.
You are recognized for 5 minutes, Admiral.
STATEMENT OF BRETT P. GIROIR
Mr. Giroir. Thank you, Chairman Pallone, and I always enjoy
our conversations. You call me anytime.
Ranking Member Walden, distinguished members of the
committee, on March 12th, Secretary Azar requested that I lead
the coordination of COVID-19 testing efforts within the
Department of Health and Human Services. And I would like to be
clear that, although I am no longer full -time deployed to
FEMA, I am maintaining my role of coordinating testing.
To date, the nation has performed over 27 million COVID-19
tests, now averaging about 500,000 tests per day. Even without
any major technical advances, I estimate the nation will have
the capacity to perform between 40 to 50 million tests per
month by fall.
To address the public health challenges over the past
months, we implemented a phased approach to meet the testing
needs at each stage of the pandemic, especially now during
reopening when the need for testing is the greatest. In early
March, HHS and FEMA developed and implemented 41 community-
based drive-through testing sites in locations prioritized by
the CDC in collaboration with our state and local partners.
These sites have tested nearly 300,000 high-risk individuals
and served as prototypes that have been duplicated multifold.
Next, we leveraged trusted pharmacies to further implement
community testing, especially for minorities and the
underserved. This federal program is now providing testing at
611 locations in 47 states and the District, 70 percent of
which are in communities with moderate to high social
vulnerability. This program has tested over 688,000
individuals.
Federally Qualified Health Centers serve over 29 million
people across the nation. They provide care to 1 in 5 of those
uninsured, 1 in 5 rural Americans, 1 in 3 living in poverty,
and 1.3 million homeless. Again, to ensure we reach these most
vulnerable among us, 93 percent of FQHCs offer COVID-19
testing.
To further expand access, we authorized all licensed
pharmacists to order and administer COVID-19 testing under the
Public Readiness and Emergency Preparedness, or PREP, Act. Over
90 percent of Americans live within 5 miles of a pharmacy,
again assuring widespread availability.
On June 4th, using authorities provided to the Secretary
under CARES, HHS released new mandatory laboratory reporting
guidance, so that we can confirm that all groups are
benefitting equitably from COVID-19 testing. Lab reports must
include demographic information like race, ethnicity, age, and
gender.
And today, I am pleased to announce the selection of
Morehouse School of Medicine as the awardee for a new $40
million initiative to fight COVID-19 among racial and ethnic
minorities, as well as rural and other socially vulnerable
communities. This cooperative agreement with the Office of the
Assistant Secretary for Health's Office of Minority Health and
Morehouse School of Medicine will develop and implement a
strategic network of national, state, territorial, tribal, and
local organizations to deliver COVID-19-related information to
communities hardest hit by the pandemic. In the first year of
this agreement, Morehouse School of Medicine will receive $15
million.
This massive expansion of testing resulted in unprecedented
demand for supplies, reagents, and laboratory platforms. To
meet this demand, we secured the global supply chain through a
military airbridge. We worked directly with manufacturers to
increase domestic production. We collaborated with external
partners to validate new technologies. We secured and
prioritized scarce point-of-care tests for state public health
laboratories, the Indian Health Service, and other critical
needs. Finally, we used Title III of the Defense Production Act
to further invest in domestic manufacturing. These actions and
others have enabled our current efforts with states,
territories, and tribes to implement evidence-based diagnostic
and surveillance plans.
I would like to close by recognizing my fellow officers in
the United States Public Health Service Commissioned Corps, the
uniformed service that I lead. Four thousand four hundred and
eighty-two officers have deployed to support the pandemic
response, including to the Diamond Princess cruise ship in
Japan, to our military bases repatriating Americans, to our
community-based testing sites, to FEMA and task forces directly
inside nursing homes, and to field hospitals across our nation,
exemplifying the care and compassion that all of us feel for
those who have suffered during this pandemic.
I thank each and every one of these officers and their
families, and on their behalf, I would like to thank all of you
in Congress for supporting our training needs and the
establishment of a ready reserve corps to supplement our ranks
during inevitable future national emergencies.
Thank you again for the opportunity to provide these
remarks.
[The combined statement of Dr. Giroir appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you, Admiral, and thank you for
mentioning the--both military and civilians who are out front
and helping us during this crisis. We really appreciate all
that they do and we have to make sure that we help them as much
as possible.
So last, but certainly not least, because the FDA is just
as important, is Dr. Hahn, or Commissioner Hahn.
STATEMENT OF STEPHEN M. HAHN
Dr. Hahn. Chairman Pallone, Ranking Member Walden, and
distinguished members of the committee, thank you for inviting
me here today.
First, I would like to start by thanking all of you for
your support of the agency and U.S. government with the laws
that you've passed that become have law of the land. It has
helped a great deal in our response.
FDA has a critical role in the federal government's
response to the COVID-19 pandemic. We remain focused on our
mission of protecting and promoting the health and safety of
Americans.
President Trump has requested and we have provided
appropriate regulatory flexibilities to assure that the
American public have access to critical medical products, safe
foods, and the confidence that the government is taking
measures to address important public health issues.
FDA has used our emergency authority since the beginning of
this pandemic. We have issued more than a hundred emergency use
authorizations for diagnostics, personal protective equipment,
ventilators, and other devices, as well as for drug products.
Since the public health emergency was declared, we issued
more than 50 guidance documents to help ensure the continuity
of healthcare and safe food supply, and we put into place new
initiatives to accelerate the development of needed products.
Additionally, we have kept the American public up to date
on what they need to do to protect themselves and to contain
the virus from spreading.
We are now preparing for the next phase of addressing this
evolving crisis. It is mission-critical that the agency
continue to be diligent, assuring the safety of the products
that we regulate, and that we also put in place processes
needed to assure the protections that the public will need.
There are a number of experiences we have gained over the
past few months that will inform our plans. We recognize that
we must be bold in our decision-making and advance effective
solutions to achieve challenging public health objectives.
Therefore, we have begun a comprehensive real-time review
and assessment of our actions to date to address the COVID-19
pandemic.
The objective is to identify and address potential
organizational and programmatic changes that should be
implemented without delay to advance the ongoing response to
COVID-19.
We need to assure that we leverage what is working well
while at the same time review our framework and policies to be
positioned to effectively identify and respond to quickly
evolving public health situations.
A major focus of this effort will be to identify what
regulatory policies should be continued and accelerate it
consistent with Executive Order 13294, signed by the president.
Durable policy, organizational and programmatic changes
will be consistent with advancing the agency's public health
mission and will inform our strategic priorities moving
forward.
One of the challenges facing FDA during the COVID-19
pandemic is how to assure the timely review of medical product
applications despite an incredible surge in volume and
constraints on our ability to conduct onsite inspections.
I am pleased to announce today that FDA has maintained the
same pace of meeting its goals on applications for medical
products for the last six months it has maintained in recent
years.
We are on target to meet our user fee goals for the drugs
this year by reviewing and taking timely action on at least 90
percent of brand, generic, and biosimilar drug applications,
even during the pandemic. Additionally, this work has continued
at a time when the number of applications received in some
centers is substantially higher than the pre-COVID-19 times.
I want to thank the more than 17,000 employees of the FDA
for their incredible efforts, one that reflects the remarkable
dedication and commitment to the public health of all
Americans.
Finally, I would like to discuss what is top of mind for
all Americans, namely, the work that FDA is doing to facilitate
the development of safe vaccines and therapeutics. FDA launched
an emergency review and development program called the
Coronavirus Treatment Accelerated Program, or CTAP, and we
continue to work night and day to provide guidance and to
review proposals from companies, scientists, and researchers
who are developing therapies.
Let me be clear that data and science will dictate when we
will have safe and effective treatments and vaccines for COVID-
19, as Dr. Fauci just mentioned. Toward that end, FDA is using
every available authority and applying every appropriate
regulatory flexibility to facilitate the development and
testing.
We have not lost sight of our solemn responsibility to the
American people to ensure our decisions related to all medical
products are based on science and data, and that is a
commitment that the American public can have confidence in. And
I assure you that the FDA will provide leadership, expertise,
guidance, information, and whatever else is needed as we
continue to address this unprecedented challenge.
Thank you, and I look forward to your questions.
[The combined statement of Dr. Hahn appears at the
conclusion of the hearing.]
Mr. Pallone. Thank you, Commissioner Hahn.
That concludes our openings from the witnesses, and so now
we will move to member questions. Each member will have 5
minutes to ask questions of our witnesses and I will start by
recognizing myself for 5 minutes.
Now, you know that I am very critical of the president for
a lack of leadership from the start of this pandemic, which I
think continues. And, of course, it is difficult because you
work, in theory, for the president and I feel that many of you
on many occasions actually wanted to take more leadership and
be, as Dr. Hahn mentioned, or Commissioner Hahn, fully
cognizant of the data and the science.
So it is difficult because I am going to ask you questions
about the president's lack of leadership, and I know it is hard
for you to answer those. So we will see.
But I do believe the president is encouraging behaviors
that are not consistent with good public health such as
encouraging thousands to attend a rally and not mandate the
wearing of masks, and I can't imagine that NIH or CDC would
suggest this as a best practice in the face of this pandemic.
So it is sort of like there are two versions of reality
here. One is the president's and one is, hopefully, yours,
based on data and science. But I want to hear from the experts.
So let me start with Dr. Fauci. You are a trusted voice and
have always been candid with us and the American public.
Give us an unvarnished view of where we are at our fight
against COVID-19, quickly if you can.
Dr. Fauci. Thank you very much for that question, Mr.
Chairman.
It really is a mixed bag. We have a very large country,
very heterogeneous, major differences, for example, between the
New York metropolitan area and Casper, Wyoming.
If you look at how we have been hit, we have been hit
badly. I mean, anybody who looks at the numbers we have had now
over 120,000 deaths and we have had two and a half million
infections. So it is a serious situation.
In some respects, we have done very well. Right now, for
example, the New York metropolitan area, which has been hit
extraordinarily hard, has done very well in bringing the cases
down and using the guidelines that we have very carefully put
together in a step-wise fashion to try and carefully reopen
their city and their state.
However, in other areas of the country, we are now seeing a
disturbing surge of infections that looks like it is a
combination. But one of the things is an increase in the
community spread, and that is something that I am really quite
concerned about that and you know that.
This has been something that has been in the press over the
past couple of days. We were going down from 30,000 to 25,000
to 20,000, and now we sort of stayed about flat and now we are
going up. A couple of days ago there were 30,000 new
infections.
That is very troublesome to me. The way you address that,
and I have said this over and over again, is you have to have
the manpower, the system, the testing to identify, isolate, and
contact trace in an effective way so that when you see those
increases you can understand where they are coming from and you
can do something about them.
Right now, the next couple of weeks are going to be
critical in our ability to address those surgings that we are
seeing in Florida, in Texas, in Arizona, and in other states.
They are not the only ones that are having the difficulty.
Bottom line, Mr. Chairman, it is a mixed bag, some good and
some now we have a problem with.
Mr. Pallone. All right. Now, I am going to have to ask
about the president because you talked about testing and how
important it is, and I--you know, Admiral Giroir and I know how
important it is.
At his rally over the weekend the president said, and I
quote, ``When you do testing to that extent you are going to
find more people. You are going to find more cases. So I said
to my people, `Slow the testing down, please,' '' unquote, and
this morning he said he meant this.
So, Dr. Fauci, do you agree with that? Does it make sense
that to safely open our economy we should be limiting the
number of tests rather than ensuring that anyone who needs a
test can get one? And you don't have to mention the president.
I did. But tell us about the testing.
Dr. Fauci. I, as a member of the task force----
Mr. Pallone. Your microphone is on?
Dr. Fauci. Sorry. I, as a member of the task force, and my
colleagues on the task force, to my knowledge--I know for sure
that to my knowledge none of us have ever been told to slow
down on testing. That just is a fact.
In fact, we will be doing more testing. As you have heard
from Admiral Giroir, not only testing to specifically identify
people in the identify, isolate, and contact trace, but also
much more surveillance if you want to get your arms around and
understand exactly what is going on in community spread.
So it is the opposite. We are going to be doing more
testing, not less.
Mr. Pallone. And then let me just ask the same question of
Dr. Redfield. Do you agree with the president on this? Do you
think we should be testing more people? If you don't want to
talk about the president, just tell us if you think we should
be testing more people.
Dr. Redfield. As Dr. Fauci said, all of us have been and
continue to be committed to increasing readily timely access to
testing. We have made a marked improvement. We still have a
ways to go.
One of the key things, as Tony mentioned, is surveillance,
expanding surveillance because of the asymptomatic nature of
this infection, and in doing so we are looking at ways that can
really substantially enhance testing by potentially pooling
samples.
So right now, as Giroir said, we are doing 500,000, 600,000
tests a day. If we can pool samples five to one, that would
bring it to 3 million tests a day.
So we are continuing to try to enhance testing. It is a
critical underpinning of our response.
Mr. Pallone. Thank you, Dr. Redfield.
I recognize Mr. Walden now for 5 minutes.
Mr. Walden. Thank you, Mr. Chairman.
Let me--let me go straight to the question that my
colleague asked, and I will just ask each of you for a yes or
no answer.
Has President Trump ever directed you to slow down testing
for COVID-19 in the United States?
Dr. Redfield?
Dr. Redfield. No.
Admiral Giroir. No, sir.
Dr. Hahn. No, Congressman.
Mr. Walden. Thank you.
All right. Let us go to some other issues here.
Dr. Hahn, you created a website, I believe, on the FDA site
dealing with convalescent plasma and antibody-rich
investigational therapies that may help fight the virus.
What is the status of the research into the effectiveness
of convalescent plasma in fighting COVID-19? What do we know
right now?
Dr. Hahn. Thank you, Congressman Walden.
A really important question from a therapeutic point of
view. As everyone here knows, convalescent plasma is where you
take the natural immunity from a person who has recovered from
COVID-19--those antibodies--and then administer to a person who
is sick.
So we have partnered with BARDA and HHS as well as the Mayo
Clinic to develop what is called an expanded access program. We
have safety data from over 20,000 patients that show this is a
very safe therapy, and our preliminary assessment of the
effectiveness of this plasma is quite encouraging.
We continue to look at the information. If those data hold,
we will have potentially another weapon in the armamentarium
against COVID-19, pending those final results. This will also
allow us to have information that will feed the development of
monoclonal antibodies and something else called a hyperimmune
globulin, which we can pool that plasma and actually give it as
an injection to people.
So I think it's a good news story right now. We have to
wait for the final data to come in and we should know very
shortly about that.
There are also several randomized trials looking at this as
well that are ongoing across the country.
Mr. Walden. All right. Thank you very much.
Dr. Redfield, CDC has developed a new test to
simultaneously detect two strains of influenza and the COVID-19
and is seeking an emergency use authority.
How does the CDC envision its combined tests to be used?
Dr. Redfield. I think it is very important. As I mentioned,
as we get to the fall, we are going to have influenza and COVID
at the same time, and CDC is developing that test for the
public health system. But in parallel, the private sector now
has also got advanced development.
Maybe Dr. Hahn wants to comment on similar tests in the
private sector. So to facilitate timely diagnosis of these two
co-circulating pathogens.
Mr. Walden. Dr. Hahn, do you want to comment on that for 20
seconds?
Dr. Hahn. Yes, sir. In cooperation with Admiral Giroir, we
have been working with companies to actually look at that.
Admiral Giroir has been at the forefront of this. It has been a
great relationship.
Mr. Walden. Admiral?
Admiral Giroir. I would just agree with my colleagues. We
are all concerned about the possibly of co-circulation of
influenza A and B as well as COVID-19 when it comes to flu
season.
So we want to do everything we can to simplify the
diagnosis, and you can have a--if you have a single test and we
are working with multiple manufacturers. As is usual, the CDC
is usually in the lead. But there are multiple manufacturers
both at point of care and laboratory who will have this type of
test available.
Mr. Walden. All right. Excellent.
You all have been subject to a lot of criticism, as has the
president. Often that is leveled after we know facts we didn't
know at the time when things started, and so it is really great
if you have hindsight and 20/20 vision you can look back and
say you should have done that then.
I want to look forward. What is it you need from Congress
that you do not have now to have America ready for the fall?
What should we be preparing for now for the fall?
I don't care who wants to start but I am down to a minute
to answer. So Dr. Redfield?
Dr. Redfield. I think, first, I want to just express our
appreciation to Congress for the supplemental funding. I think
it is of note that CDC has been able already to disburse $12
billion to the states to help prepare their COVID responses
and, really, that is an unprecedented amount of resources.
I would only ask that we look to how to make this a
sustainable investment as opposed to a sporadic investment to
this particular challenge we have right now.
Mr. Walden. All right. Dr. Fauci, what do we need to worry
about? What don't you have?
Dr. Fauci. Well, just to reiterate what Dr. Redfield said,
we are extraordinarily grateful for the--you know, the
unprecedented amount of supplementary funded that the Congress
gave to us, which really make it totally possible for us to do
the kinds of things we need to do on an emergency basis.
But, again, to mention what Dr. Redfield said, we have to
establish some corporate memory. I have said to this committee,
literally, many times over the many years that we forget things
when we get distant from them.
We are going through a terrible ordeal right now. We need
to have in place the stable type of support for preparedness
for outbreaks.
We will get through this. This will end, hopefully, sooner
rather than later. But we need to establish a system so that we
are prepared for future outbreaks.
Mr. Walden. Thank you.
Mr. Chair, could the other two just answer that question
quickly?
Admiral, what do you need you don't have? What should we be
worrying about?
Admiral Giroir. I want to express my thanks again----
Mr. Walden. Right.
Admiral Giroir [continue]. To the committee. But let me get
to the point.
I think sustainability and commitment are very important. I
was involved in Ebola in 2015 in Dallas trying to lead some of
the policy options during that time, and you see over a five-
year period we sort of forgot all the lessons that we were
trying to get implemented, including PPE and other stockpiles.
I would say some of the biggest limitations, and I know
everyone is working on this, is the national data
infrastructure we need.
When we started out, I am calling up a hundred hospitals a
day trying to understand who is on an ICU bed, who is not, who
has a ventilator, how much you have left. And we got through
this early not by systems but by people working 24/7.
The third thing is--I am just going to pound it--the
vaccine infrastructure in this country, to promote vaccination,
to promote vaccine confidence, to make sure that people have
the right information about safety and efficacy, that we order
enough flu vaccine, because we really need to get everybody
vaccinated this winter.
One thing that minimizes our problems is if we get
everybody a flu vaccine. That is one less virus that could kill
20,000, 30,000, 50,000, 70,000 and, potentially, even be a co-
infection with COVID.
Mr. Walden. Dr. Hahn?
Dr. Hahn. Thank you. Again, thank you for the support.
One big point I want to make here is that what we have
learned during this epidemic is what Admiral Giroir said, is
that we have an access to information issue.
We have learned that we need to collect real-world evidence
in real time during an emergency, just like a doctor would do
during an emergency, to inform decisions and how we could
change them, moving forward.
So your support for real-world evidence generation would be
incredibly helpful.
Mr. Pallone. So now we are going to move to our members,
based on seniority, and I think our next few are virtual. So I
will just remind you to unmute. If you don't do so on your own
I will just keep reminding you.
So next we have Mr. Rush from Illinois.
Mr. Rush. I want to thank you, Mr. Chairman, for holding
this important hearing.
Last week, the Health Subcommittee held an informative
hearing on the racial and ethnic health disparities being
highlighted by the coronavirus.
The distinction of all of these disparities are very
troubling, even extremely outrageous. A Scientific American
article published earlier this month found that if Black people
were dying at the same rate as white Americans, at least 13,000
mothers, fathers, daughters, sons, and other loved ones would
still be alive.
Even more shocking is that among those 35 to 44, Black men
and women die from the coronavirus at least nine times the rate
of white Americans.
Dr. Fauci, wouldn't it become apparent that institutional
racism and structural discrimination are playing a part in why
certain racial and ethnic communities are suffering more than
white communities?
Dr. Fauci. I think I know what the--I didn't hear it quite
as clear as I want but I think I know what the Congressman is
referring to.
So when you are looking at the African American community
and the minority community in general as a demographic group,
there are two elements that make it much more difficult for
them and why they are suffering disproportionately.
One is the risk of infection. Because of economic and other
considerations, the jobs that the majority of them would find
themselves in does not allow them to protect themselves by
looking into a computer and doing telework. Most of them are
essential, on the outside, having to mingle in a society in
which the virus is circulating.
So right at the get-go, they have a greater risk of getting
infected. And then we know from a lot of experience now that
the situation regarding whether or not you have serious
consequences, hospitalizations, intubation, complications, and
death relate very strongly to the prevalence and incidence of
underlying comorbid conditions, which are, clearly,
disproportionately more expressed in the African American
population than in the rest of the population and that
particularly includes hypertension, diabetes, obesity, chronic
lung disease, and kidney disease.
So, unfortunately, we have a situation where it is sort of
a double whammy of a negative capability of them to respond
through no fault of their own because of underlying conditions
and the conditions in which they find themselves with.
Mr. Rush. Dr. Fauci, would you consider racism itself as
being one of the stresses that certainly impacts the African
American community more in an extraordinary way that
contributes to these comorbidities?
Dr. Fauci. I think the question was would I consider
institutional racism as contributing. I don't think there is--
--
Mr. Rush. Yes.
Dr. Fauci. Yes. Thank you, Congressman.
Well, I mean, obviously, the African American community has
suffered from racism for a very, very long period of time and I
cannot imagine that that has not contributed to the conditions
that they find themselves in economically and otherwise.
So the answer, Congressman, is yes.
Mr. Rush. Admiral Giroir, I applaud your announcement that
provides for $100 million--I mean, for $40 million to go into
the Morehouse College of Medicine for contact tracing and
testing.
I have introduced a bill, the TRACE Act, which calls for a
$100 million for testing and contact tracing. Shouldn't we be
seeing a larger amount, $100 million or more, for contact
tracing and for testing?
Admiral Giroir. Thank you, Congressman.
For testing and contact tracing, we are going to need
billions of dollars. I mean, that is the amount of investment
that we are doing partially through CDC.
This specific award is to have Morehouse lead a consortium
of organizations like 100 Black Men, UnidosUS, the National
Association of Community Health Workers, the National Council
of Urban Indian Health, et cetera, et cetera, to really focus
on the specific educational testing and linkage to the care
needs of underserved minorities and some of those also in the
rural population.
My personal opinion is $40 million is a start. It is going
to need to be a lot more than that in order to reach the people
that we need to reach.
Mr. Pallone. Thank you, Bobby. Thank you, Admiral.
Next is Mr. Upton from Michigan.
Mr. Upton. Thanks very much, Mr. Chairman, and I really
appreciate the testimony that we have heard thus far and the
interaction that we will have between all of our----
I guess the first question I have, Dr. Fauci--good friend,
thank you for your service for sure--in recent weeks, of
course, you made the statement [audio malfunction in hearing
room] have as many as a 100 million doses of [audio malfunction
in hearing room] vaccine before the [audio malfunction in
hearing room] year.
I have heard from a number of companies just in recent days
AstraZeneca, Pfizer [audio malfunction in hearing room] hopes
to have, perhaps, a billion doses before the end of next year,
calendar year '21.
So as [audio malfunction in hearing room] move through the
Phase II process [audio malfunction in hearing room] maybe even
get into some production, a little bit later by somewhat early
August. Not the approvals yet but [audio malfunction in hearing
room] the promise of getting it to the marketplace and, really,
saving the world. Let's face it.
What is your thought as to how early we may see an EUA, an
emergency use authorization, approved for any of these
vaccines, based on what you know today and under the scenarios
that we may see something in the next number of months in terms
of an approval? Lay out what you think is a real distinct
possibility where we might end up being.
Dr. Fauci. OK. Thank you for that. I didn't hear----
Mr. Upton. And Dr. Hahn as well.
Dr. Fauci. I didn't hear everything you said but I think I
got enough of it to answer your question, at least the last
part that I think is very important and I welcome the
opportunity to address this.
The idea about the doses that would be available, you know,
a couple of hundred million doses in the beginning of the year,
some companies saying that in a couple of years, a year or two,
they will have as many as a billion doses, I think that is
real.
Most people would raise their eyebrows and think that how
is that going to happen, and it is because things are being
done at risk. People--companies are starting to plan to make
doses even before you know the vaccine works.
So the risk of the speed is not risk to safety. It is not
risk to scientific integrity. It is risk to money. So put that
aside.
The point that Congressman Upton made I think is very
important. We need to be careful that we don't jump because of
our need to get vaccines for those who need it that we do not
definitively prove safety and efficacy before we make decisions
about distribution.
We have heard a lot about emergency use authorization. An
emergency use authorization is important, but it has to be done
in a situation where you fulfill the criteria for the emergency
use authorization.
I would be very disappointed if we jumped to a conclusion
before we knew that a vaccine was truly safe and truly
effective because I wouldn't want the perpetual ambiguity of
not knowing whether or not it is truly safe and truly
effective.
That is the reason why we are doing several randomized
placebo-controlled trials with power enough that could give us
that answer.
I hope that answers your question, Fred.
Mr. Upton. Well, just one quick. What would be the earliest
that you think, under the best scenario, that we might be able
to see an EUA issued by [audio malfunction in hearing room]
along with--I guess it would actually be the FDA, right, that
would actually issue that?
Dr. Fauci. Yes. The answer is yes.
Let me just quickly answer that and hand it over to Steve
because he may want to answer that.
We are going into the first Phase I--Phase III efficacy
trial in July. It takes at least a month to get to the second
dose because it is a prime boost.
It will take another couple of months to accrue or enroll
enough people that if there is viral activity in the community,
and we have our sites not only in the United States but all
over the world, in Brazil and in South Africa.
So if we get an efficacy signal, you are going to get an
efficacy signal more quickly the more cases there are. Now, if
it turns out that there are not a lot of cases, it may take
longer and that is the reason why you can't give an accurate
prediction of when you are going to get those data.
Steve, do you want to take it from here?
Dr. Hahn. Yes, thanks, Dr. Fauci.
So just a couple of issues to your point, Congressman
Upton. One is we are--we are working with the sponsors across
the board--private industry, Operation Warp Speed, et cetera--
those who are developing vaccines, and we are providing
technical assistance regarding clinical trial design, the
number of participants in the clinical trials, as well as the
endpoints that we want to see to make an adjudication about
safety and effectiveness.
And I want to emphasize what Dr. Fauci said and that is the
acceleration is really around taking financial risk around the
development process. The acceleration is not cutting corners
with respect to the assessment of safety and effectiveness.
The American people can rely upon the fact that FDA has
many experts in the vaccine area. We have been doing this for
years, and we will rely upon the science and data when it is
available to us to make that adjudication and decision
regarding an EUA. I cannot prejudge when that will happen.
Mr. Pallone. Thank you. Thank you, Fred.
Next, we have the gentlewoman from California, Ms. Eshoo.
Ms. Eshoo. Thank you, Mr. Chairman. And morning, everyone.
I would like to start with Dr. Redfield.
Doctor, we had a conversation over the weekend, and I
expressed to you, really, my pain, my disappointment about you
as CDC director, the most prestigious institution in the world,
infectious disease intervention.
The United States today is number one--number one in the
world in infections and in deaths. This is not anything that
any of us can be proud of. The American people are in pain.
They are grieving. There is a great deal of struggle in
communities. There is confusion because for many reasons, and I
urged you as head of CDC to speak directly to the American
people.
I know the agencies are talking to each other. I consider
that a whisper because the American people are not hearing you
speak out. They deserve to hear the truth. We have heard Dr.
Fauci time and time again putting out pertinent information to
the American people. The American people are divided on this
issue of the virus. Imagine that.
So I continue to urge you to speak out. You are a doctor.
Put your white jacket on and speak weekly to the American
people. They want to know what is coming, what is ahead. My
constituents ask me on a consistent basis, what is next? What
is our government doing? That is a haunting question. And so
while we are doing the nice back and forth this morning, good
questions on the part of members, I really remain dismayed and
deeply disappointed.
We need leadership coming out of the CDC, real leadership.
It was an outrage that there was a gathering in Tulsa. Six of
the President's advanced people were infected and it is my
understanding that two Secret Service agents were. How can the
CDC allow this pandemic, this virus to be something political?
You have to push back. You are a scientist. You are a doctor.
Now to Dr. Hahn, I am sure you have read several articles
regarding hydroxychloroquine. Every study states it doesn't
work in any setting. In fact, it has known side effects,
cardiac issues being one, so there is a danger in terms of the
side effects. As Commissioner you see all the data. Are you
going to inform the American people, doctors across the
country, about these facts?
Dr. Hahn. Thank you, Congresswoman, for that question. And
indeed, we are. I can refer the committee to several documents
that we have put out over the last several weeks regarding
hydroxychloroquine. With respect to the issues, we issued a
safety alert, particularly around the combination of
hydroxychloroquine within other drugs that might affect the
heart. And as you know we have taken recent action regarding--
--
Ms. Eshoo. Have you specifically spoken directly to the
American people so isn't this notion about hydroxychloroquine?
Dr. Hahn. Yes, ma'am. There is an FDA Voices piece that is
authored by me as well as a piece that is directly to the
American people about the status of hydroxychloroquine.
Ms. Eshoo. This isn't paper. I want to know if you have
spoken out verbally to the American people, to doctors across
the country. People don't hear paper, with all due respect.
Dr. Hahn. Yes, ma'am, and I appreciate the question. But
every opportunity I have had to be in the media I have been
asked that question and I have communicated that same
information about the current status----
Ms. Eshoo. You aren't answering the question, Dr. Hahn.
There have been several disturbing articles expressing concerns
related to political pressure being placed on the FDA by the
President. Can you state unequivocally that if any political
pressure is applied to you and the FDA that you will
immediately report that to this committee?
Dr. Hahn. I will certainly unequivocally state that if I
receive political pressure I will report to this committee. I
can tell you that I have not felt political pressure nor has
the FDA to make any decisions in any specific direction.
Mr. Pallone. Thank you.
Ms. Eshoo. Well, it is not about decisions, it is about a
direct political pressure. So thank you for your response and I
yield back.
Mr. Pallone. Thank you, Ms. Eshoo.
Next is Mr. Latta from Ohio.
Mr. Latta. Well, thank you, Mr. Chairman. And thanks to our
witnesses and all the hard work that you have been doing over
the last several months for not only the United States but for
individuals from around the world. I really appreciate it.
Dr. Fauci, if I could start my questions with you. And I
know that our leader, Mr. Walden, had brought some of this
stuff. Would you further explain how an infected individual
develops antibodies and how long those antibodies remain
effective in fighting off the virus and are you seeing
different levels of antibodies in people who have been infected
and what that means in terms of immunity?
Dr. Fauci. Thank you very much for that question,
Congressman Latta. So we need to start off by saying that we
want to assume that you are dealing with an antibody test that
has been validated by the FDA or by the NIH. That is important
because a lot of the confusion out there. There are tests that
are not validated. But let's assume you have a good test.
Whenever the body gets confronted with a virus and
recovers, even when they don't recover, the body is stimulated
to make antibodies. In general, for viruses that we have a lot
of experience with, those antibodies serve to protect you
against exposure and infection after you are exposed to the
same virus. So that is what we call immunological memory and
these proteins block the virus.
The one thing we do not know yet with COVID-19 is the
relationship between the type of antibody, because the best
antibody is called neutralizing antibody, namely if this were
the virus and this is where the virus binds to the cell, the
neutralizing antibody blocks the virus from binding to the
cell. There are antibodies against other parts of the virus
that are called binding antibodies; they don't mean much. So
you have got to make sure you get the right antibody.
The second thing is, what we still don't know is what the
relationship between the titer of the antibody is, namely the
level of the antibody and the degree of protection. The third
thing we don't know is how long or what the duration of that
antibody is going to be. We are going to find these things out
as we study these individuals over months and a year or more,
but remember, we are only a few months into this.
So, A, we know they make antibody; B, it is likely they are
protected for some period of time, but we don't know how long
that is going to be. So the question I always get asked, which
is a subtext, does that mean if you are exposed and you have
antibody that you are protected? Likely you are, but we don't
know how long you are protected.
Mr. Latta. All right, thank you.
Dr. Redfield, when a vaccine or treatment is developed, how
will it be distributed to Americans?
Dr. Redfield. Thank you for the question. It is a critical
issue that is currently under discussion within the team to
look at what the appropriate prioritization for distribution. I
want to just comment that it may be very dependent on what the
product is. Each of these vaccine products that are currently
being developed may in fact, have differential utilization for
different populations.
So there are serious considerations to try to develop those
prioritizations and it is going to be important to develop them
dependent upon the product that they are going to applied to.
Mr. Latta. Thank you.
Dr. Hahn, and thanks very much for all your work and thanks
for taking my calls especially on Friday nights and on
Saturdays. I appreciate it. The FDA provided an emergency use
authorization for remdesivir. Do you expect or envision the FDA
to issue anymore EUAs for potential treatments in the fall?
Dr. Hahn. Congressman, for potential therapies? Is that
what you asked, sir?
Mr. Latta. Right.
Dr. Hahn. Yes. Yes, sir. So we are working very closely
with sponsors regarding the development of therapeutics
including with Operation Warp Speed. A hundred and thirty one
clinical trials ongoing right now. I anticipate that we will
receive data regarding several therapies in the future, plasma
being one of them that we just discussed with Congressman
Walden, and potentially also with some anti-inflammatory agents
as well as for monoclonal antibodies. Those are being
accelerated through the pipeline and then on potential
therapeutics as well as prophylaxis moving forward.
Again, can't prejudge the EUA process because we have to
see the data. But I do anticipate that we will be receiving
data.
Mr. Latta. Thank you very much.
Mr. Chairman, my time has expired and I yield back.
Mr. Pallone. Thank you.
Next we have Ms. DeGette from Colorado.
Ms. DeGette. Thank you so much, Mr. Chairman.
I want to thank the panel and welcome all of you. Many of
you have appeared in front of my subcommittee, the Oversight
and Investigation Subcommittee, a number of times. And just to
let you know, the Oversight and Investigations Subcommittee is
going to be continuing its investigations both about how we
responded to this and where we go in the future, so you can
expect to hear from us.
I have some brief questions for each witness and I would
like to start with you Admiral Giroir. The Chairman talked
about comments last weekend saying that double testing because
when you do testing, quote, you are going to find more people.
And then again this morning, the President tweeted cases are
going up U.S. as we are testing far more than any other country
and ever-expanding. With smaller testing we show further cases.
This is what he says and he also said this morning that he
doesn't talk about it. So I know the chairman asked Dr. Fauci
and Dr. Redfield they have been expected to test less, I am
going to ask you since you are now in charge of overseeing the
tests, has the President asked you to do fewer tests?
Admiral Giroir. Thank you. And again I want to clarify that
neither the----
Ms. DeGette. Yes or no will work. Yes or no will work,
Admiral. Has the President asked you to do fewer tests?
Admiral Giroir. No, the President--neither the President
nor anyone in the administration has instructed that we should
do less testing, have said that to me, and we are proceeding in
just the opposite.
We want to do more testing----
Ms. DeGette. OK.
Admiral Giroir [continue]. Of higher quality.
Ms. DeGette. I want to ask--so I want to ask you, Admiral,
do you think that it is a good or a bad idea to do less testing
so it will look like fewer cases?
Admiral Giroir. My purpose in leading is to increase the
number of testing. The only way that we will be able to
understand who has the disease, who is infected and can pass
it, and to do appropriate contact tracing is to test
appropriately, smartly, and as many people as we can.
Ms. DeGette. Thank you so much.
Dr. Fauci, I wanted to ask you, I have seen some data the
last few days that while cases are going up in this country,
deaths are going down. And I have seen some reporting in the
media that in part that is because younger people who tend not
to die from COVID are the ones being infected. Should we see
this as a positive sign or should we still be worried?
Dr. Fauci. I think it is too early to make that kind of
link, Congresswoman. Deaths always lag considerably behind
cases. You might remember that at the time that New York was in
their worst situation where the deaths were going up and yet
the cases were starting to go down, the deaths only came down
multiple weeks later.
So you are seeing more cases now while the deaths are going
down. The concern is if those cases then infect people who wind
up getting sick and go to the hospital, it is conceivable you
may see the deaths going up. So I think it is too early to say
because the deaths are going down.
Ms. DeGette. Thank you, Doctor. And I have another
question, Dr. Fauci, for you. We have seen--and I think you and
I have talked about this. Most vaccines take years, if not
decades, to be approved and to be proved efficacious and
sometimes we don't find a vaccine at all. I have two questions
for you.
Number one, do you believe that we will find a vaccine for
the coronavirus; and number two, do you still stand by the
prediction you gave us some months ago that we could actually
have a vaccine by early 2021?
Dr. Fauci. I feel cautiously optimistic, Congresswoman,
that we will be successful in getting a vaccine. There is never
a guarantee of that, but the early data that we are seeing
regarding the immunogenicity and the induction of good
responses makes me cautiously optimistic, always knowing that
there is never a guarantee. You remember I told your committee
a few months ago that a vaccine would be available from a year
to 18 months. I said that in January of 2019--2020. A year from
January to December. I still think there is a reasonably good
chance that by the very beginning of 2021 that if we are going
to have a vaccine that we will have it by then.
Ms. DeGette. Thank you very much, Doctor.
Mr. Chairman, I will yield back.
Mr. Pallone. I thank the gentlewoman.
Next we have Mrs. Rodgers from Washington State.
I hope.
Mrs. McMorris Rodgers. I am coming. Cathy McMorris-Rodgers
is here. Am I here?
Mr. Pallone. You are recognized for 5 minutes.
Mrs. McMorris-Rodgers. Thank you, Mr. Chairman. I want to
thank the Chair and the ranking member for holding this hearing
and appreciate our witnesses for testifying today.
COVID-19 is the challenge of the century as others have
said. It is a health and economic crisis of our lifetime. We
mourn the deaths of over a hundred thousand Americans and we
must remember that we are not out of the woods yet. I want to
especially express my heartfelt gratitude for the healthcare
workers, the first responders, the emergency and essential
workers who have been working around the clock to fight this
virus, save lives, and keep our families safe. As our experts
work tirelessly to develop a vaccine and treatment, I am
confident that there is no country in the world who is better
equipped to lead for a medical breakthrough than America. We
can't trust China to lead.
And that is why the Trump administration has created
programs like Operation Warp Speed for bringing together the
very best in the public and private sector to develop
countermeasures that will fight the virus. We are leveraging
the power of artificial intelligence, super-computing, and
machine learning to speed up discoveries and enhance our
knowledge base of the virus. In Washington State we have top
researchers as well as biotech and pharmaceutical innovators
who continue to be at the forefront of these breakthroughs.
I look forward to learning more and appreciate all of you
being here to help us understand what the administration is
continuing to do to lead in the development of these tests and
treatments that America needs so that we can usher in a new era
of innovation and healthcare cures. To win the future, keep our
families healthy and save lives, and to ensure our economy
booms again, we must get this right.
Dr. Fauci, as you know, adjuvants maximize the
effectiveness of vaccines. Would you just explain a little bit
further what an adjuvant is and are there any novel synthetic
adjuvants in the pipeline and, if so, how will they play a role
in the administration's pursuit of a COVID-19 vaccine?
Dr. Fauci. Thank you very much for that question,
Congresswoman. An adjuvant is a product distinct from the
vaccine itself, but when given in conjunction with the vaccine
it enhances the power of the immune response, so if you have a
vaccine that gives a level of response that here when you get
an adjuvant together with it you often boost it to a much
higher level.
We use adjuvants in several vaccines. The NIH has a major
program in the pursuit and development of novel adjuvants of
all different types. And, in fact, that is part of the program
right now, to accelerate our vaccine development capability. So
it is a good question but it is a very important part of what
we do. Thank you.
Mrs. McMorri-Rodgers. Thank you. Thank you for that.
Dr. Hahn, as you know, FDA's decentralization of diagnostic
test oversight has been very helpful in expanding the
availability of diagnostic tests for COVID-19 but it is
temporary. Would you just speak to how this flexibility has
benefited the general public and how you think it would be
helpful in the future for outbreaks or novel viruses?
Dr. Hahn. Thank you very much, Congresswoman, appreciate
the question. As you have pointed out, the flexibilities have
allowed us to work with test developers. This has been
throughout the COVID pandemic with all of our medical products
a balance between the oversight so that we have tests that are
valid, reproducible, accurate, but at the same time allow the
developers the ability to have the freedom to develop those
tests.
And we have developed this partnership that I think has
been very fruitful moving forward. I particularly like it with
respect to the flexibility given the states, your state in
particular which has excellent public health laboratories, as
well as the University of Washington, and New York State is
another example of this.
Those are the sort of things that we are looking at now as
we talk about how we want to move forward that we could
potentially put in place on a permanent basis to facilitate
test development. Hopefully, we will never be in a position
again where we have to develop tests over such a short period
of time like we have remarkably done during this time. But we
really do need to talk about how these flexibilities could
stimulate innovation and development of tests.
Mrs. McMorris-Rodgers. Great. Well, thank you all. Thank
you all for your leadership, your commitment during this time,
the long hours, and I especially appreciate the way that we are
looking forward to make sure that we are prepared in the future
for whatever we may face. Thank you. Good to be with you.
Mr. Pallone. Thank you.
Now we go to Mr. Doyle coming to us from Pittsburgh.
Mr. Doyle? Is Mr. Doyle----
Mr. Doyle. Sorry, Mr. Chairman. I forgot to unmute.
Mr. Pallone. Thank you.
Mr. Doyle. Can you hear me now?
Mr. Pallone. Yes. You are recognized for 5 minutes.
Mr. Doyle. Thank you, Mr. Chairman, for holding this
hearing and to the ranking member also and to our witnesses for
your service on behalf of the American people.
This committee has continued to conduct oversight of the
Trump administration's shortcomings related to procuring and
distributing personal protective equipment, or PPE. When states
and hospitals were faced with critical shortages of PPE such as
masks and gowns, President Trump passed the buck and said the
federal government was, quote, not a shipping clerk. We saw the
result of a failure of leadership.
Without a national strategy, states have had to fend for
themselves and even compete against each other for critical
supplies. It has become so desperate out there that one former
U.S. disaster official referred to this scramble as, quote,
Lord of the Flies: PPE Edition. At a recent hearing before the
Oversight and Investigation Subcommittee, Michigan Governor
Gretchen Whitmer testified, quote, the lack of centralized
coordination at the federal level created a counterproductive
competition between the states and federal government to secure
limited supplies, driving up prices, and exacerbating the
existing shortages.
Admiral Giroir, let me ask you. Do we have enough PPE for
every front-line worker who needs it whether they be healthcare
workers, first responders, or thousands of others whose job
puts them at risk? Are people still having to reuse N95 masks,
for example, and if we don't have enough, why hasn't the
administration invoked DPA to greatly expand the manufacturing
of these supplies?
Admiral Giroir. Well, thank you for the question and I will
do my best to answer that. Admiral Polowczyk is certainly
running the supply chain with also Dr. Kadlec from ASPR. But
being a member of the Unified Coordination Group at FEMA for
the past three months, I am pretty familiar with this.
I think as Admiral Polowczyk testified before and I think
we all know is that there was an absolute shortage of
everything when this started. Everyone in the world was looking
for the same supplies and we tried to manage that both from
increasing the supplies and using the DPA multiple times. For
example, there were three investments, DPA Title 1 for N95s--
3M, Honeywell, and Owens & Minor--to improve production.
We estimate that the country in the fall, if there were a
COVID outbreak to this degree, would need about a 140 million
N95s per month. We should have 180 million per month being
produced domestically by that time. This was not available when
we started in March. The industry was not here. This was all
offshored.
And I will just say, cumulatively, between March 1st and
June 19th, the government distributed or enabled the commercial
distribution through the air bridge of 160 million N95 masks,
638 million surgical and procedural masks, 281 million gowns,
and over 16 billion pairs of gloves. So this was really an
enormous effort.
We need to better prepared. This all needs to be onshore.
We are working with S&S 2.0 to have a 60- to 90-day supply. We
talked to governors in every state. Many of the states are also
doing their own supplies for 60 to 90 days. So I am confident
moving from here on as we ramp domestic manufacturing that we
are going to be in a much better position than we were three
months ago.
Mr. Doyle. Thank you, Admiral.
Dr. Hahn, let me ask you. Since demand for PPE increased
this spring, we have seen many actors with little previous
experience in the supply field enter the market. Reports have
indicated that some are selling counterfeit or low-quality
products that don't meet safety requirements or are unable to
fill agreements. What steps is the FDA taking to ensure that
companies are not circumventing federal oversight and injecting
potentially substandard PPE into the United States market?
Dr. Hahn. Thank you, Congressman. This is a really
important issue. During the height of this epidemic and the
increased demand, we provided regulatory flexibility for
companies but insisted that they provide certification, often
foreign FDAs, if you will, certification that the PPE met the
requirements that we have in place and that the foreign
governments had in place.
But we did something else with respect to that and that is
we also partnered with CDC and NIOSH, for example, with N95s to
test, to verify that in fact that self-certification over the
validity of the efficacy of the PPE was in place. And you have
correctly identified that for a variety of reasons subsequent
product that was shipped into the country did not meet those
specifications.
We immediately took action to make sure that those were off
of the market and continue to do that and monitor it very
closely.
Mr. Doyle. Thank you, Mr. Chairman. I see my time has
expired. I yield back.
Mr. Pallone. Thank you, Mr. Doyle.
Next we have Mr. Guthrie coming to us from Kentucky.
Are you muted? Do you want to unmute?
Mr. Guthrie. I thought I did that. I apologize.
Hi. Brett Guthrie. I apologize.
I Dr. Hahn, I am interested in the COVID-19 counterfeit
testing. And I have a bill that would bring--it's called the
Safeguarding Therapeutics Act that would assure FDA has the
authority to destroy the counterfeit testing devices. And I
will follow up with a question with this.
What I am interested in, and what the people that I talk to
every day are interested in, is what is going on in the future?
How are we going to protect ourselves moving forward?
We need the lessons learned from the past. We need to look
forward. And Dr. Hahn kind of answered on--I mean, excuse me,
Dr.--Admiral Giroir answered on the PPE kind of moving forward.
But if I can just go with Dr. Redfield, Dr. Fauci, and then Dr.
Hahn, if you will talk about pool testing and how that might be
effective.
What--the people that I've talked to want to know what is
it going to look like in March--I mean, excuse me, what is it
going to look like in August? Are kids going to be getting back
in school? Are our nursing homes going to be safe? That is what
people are looking for.
So, Dr. Redfield, I know we are going to have flu, we are
going to have COVID. What is the testing going to be like? Dr.
Fauci, what do we need to be looking for? And Dr. Hahn, pool
testing?
And I will just open it up for you three to talk about,
what is it going to look like in August, and are our kids going
to be able to go back to school.
Thank you. And I will start with Dr. Redfield.
Dr. Redfield. Thank you, Congressman. I think, first and
foremost, it is really important that we continue to take this
time to continue to accelerate our capacity to diagnose,
obviously, readily available, timely test results. Build that
capacity for isolation and contact tracing, and self-
quarantine.
That is fundamental. We are working hard to do that. As I
mentioned in January, we had about 6,000 contact tracers in
this country. The beginning of June it was up to around 27,
28,000. It needs to continue to increase in my view towards
100,000, if we get that operationally functional. That is going
to be critical for what we're doing.
Secondly, we do have to reinforce in the American public
the importance of the social distancing interventions that we
have discussed, particularly face coverings, six feet
distancing, and hand washing.
I anticipate that the states will begin to open up higher
education and K through 12. It is going to be on a
jurisdiction-to-jurisdiction decision. CDC will be issuing
additional guidance on this topic in the days ahead as we
continue to try to work and to give guidance on how to open up
these, particularly the school systems, how to open them up
safely.
I will end with nursing homes. I think we have made
enormous progress in the long-term care facilities, enhancing
infection control. Admiral Giroir may want to comment about the
commitment that FEMA made to provide all nursing homes with
protective equipment for a period of time.
And we are continuing, I think, to have aggressive
surveillance in the nursing homes across this country where we
have recommended that all residents get tested so that we can
start with a clean baseline of understanding where the epidemic
is.
I will just end with the fact that although they only make
up 0.6 percent of our population, nursing home residents have
made up more than 35 percent of our mortality.
Dr. Fauci. Let me very briefly----
Mr. Guthrie. Thank you, Dr. Redfield.
Dr. Fauci.
Dr. Fauci. Yes, let me briefly address the question you
asked about schools, because we get asked that all the time.
I think the important thing to point out is that, as you
well know, we live in a very big country that is certainly not
a unidimensional country. It is very, very different whether
you are in a New York metropolitan area or Casper, Wyoming. So,
when you are asking about schools, you have to say where are
you talking about, because we have different regions, different
states, different cities, towns, and countries.
So, some counties may have such a low level of infection
that schools can open in a way that is exactly like normal.
Others may be in a situation where it isn't really bad where
you want to close the school, but you might want to make some
modifications, alterations of scheduling, things like morning/
afternoon, one day or another day.
So, it is up to the local officials to evaluate where you
are in the particular region, what the recommendations that we
really very carefully put out about the guidance of opening
schools.
So, you don't want to make one-size-fits-all for the United
States. You want to tailor it to the degree of viral dynamics
in the particular location that you are talking about.
Mr. Guthrie. So, looking forward, we are really only going
to know when we get closer to that point so we can make those
decisions. That is unfortunate, but obviously that is the
reality.
I am about out of time, Dr. Hahn. I will submit a question
for the record for pool--for pool sampling.
Thank you very much. And I yield back.
Mr. Pallone. Thank you, Mr. Guthrie. It sounded like there
was a monster that was going to envelop you at some point
there.
Next we have Ms. Schakowsky from Illinois.
Ms. Schakowsky. Thank you, Mr. Chairman. And I want to
thank the witnesses.
I have to disagree with you, Dr. Redfield. I think nowhere
has the Trump administration's lack of leadership been more
apparent than in our nation's nursing homes and long-term care
facilities where we have lost 50,000 residents and workers to
COVID-19.
So, let's review some of the deadly failures.
You delayed data collection on cases and deaths in nursing
homes.
You have not required--required--states to conduct testing.
You are not giving workers adequate PPE--and I agree with
Congressman Doyle on that--to protect themselves.
You are allowing facilities to literally kick residents out
of--out onto the street if there is a more profitable COVID
patient to take their place.
And since CMS Administrator Verma who is responsible for
the safety of our nursing home residents has declined Chairman
Pallone's invitation to speak, let me refer then to Dr.
Redfield.
The CDC website explains that your mission is to save lives
by providing health information that protects our nation. So,
why didn't you require nursing homes to report any data on
COVID-19 cases and deaths until May, four months after--you may
remember, you told me about the first case in Illinois--January
30th? And to report the case of human-to-human transfer.
On July 4th--on June 4th, you testified before the House
Appropriations Committee and apologized for CDC's inadequate--I
quote--response to COVID-19 race and ethnicity data. Yet, the
same day CMS and CDC finally published COVID-19 data from
nursing homes, and failed to include race and ethnicity
information.
So, when--when my office asked CMS about the exclusion, we
were told to ask the CDC.
So, will you promise to include race and ethnicity
information moving forward so that we can identify the
address--and address the racial disparities in nursing home
COVID-19 cases?
Dr. Redfield. Thank you, Congresswoman, for your question.
First, I want to stress that since the early beginning of
the pandemic that we have initially encouraged all nursing
homes to report the cases through their health departments and
through our National Healthcare Safety Network as of May 8th.
Ms. Schakowsky. If I--if I could--if I could just briefly
interrupt on the word encouraged. That, I think, is a problem,
that there has been guidance, there has been encouragement, but
what about mandating?
Dr. Redfield. As I said, that as of May 8th now it is a
requirement that this be reported in through CDC, as CMS has
made that required. And we are working to make sure this
reporting is comprehensive to include ethnic and racial data.
As well as I would argue--put forth that we have worked
hard to really accelerate training and retraining of infection
control procedures in these nursing homes to, to try to
mitigate the situation that, unfortunately, we did experience,
as you pointed out, where the nursing home residents have taken
a high burden of this initial outbreak.
We will continue to work to get this reporting. This
reporting is going to be forward-facing. CDC will forward the
data to CMS. CMS will forward face it so families can make
decisions based on their understanding of how different nursing
homes are performing.
We have recommended that the nursing homes, as you
mentioned, that they screen all residents. And we have
recommended that they screen all workers in nursing homes on a
weekly basis because we do believe this is an important area
that we have to do more as a nation to protect infections.
Ms. Schakowsky. Let me just say, this kind of suggesting
and recommending has clearly not been enough, in my view. This
is the view of many observers, families, workers, that there is
a crisis in our nursing homes that persists, and that we insist
that the government do more to help.
And I yield back.
Mr. Pallone. Thank you, Ms. Schakowsky.
Mr. Olson of Texas.
Mr. Olson. Thank you, Chairman Pallone and lead Republican
member Greg Walden for having this very important hearing.
Welcome to our four expert witnesses. You all have been on the
frontlines fighting the COVID-19 virus for about half a year
now. We greatly appreciate all your efforts to make our country
safer.
And a special howdy to a former Rice Owl like myself,
Commissioner Hahn. Go Owls.
First of all, all of you know that Texas and Greater
Houston have seen a spike in COVID-19 cases over the last week.
Our state is at stage 3 of reopening and the trend is not good.
To Dr. Tony Fauci of Houston, of Texas, Dr. Steve--Peter Hotez
put out a tweet, and I quote what he said, if this trajectory
persists, Houston will be the worst affected city in the United
States, maybe rival what we are seeing right now in Brazil, end
quote. And that is damn scary.
The spike in the Greater Houston region is due to one
country, Harris County, which is the county--the third largest
county in America in the county seat of Harris County--I am
sorry, Harris County and Houston, county seat of Houston, the
fourth largest city.
Mr. Chairman, I would like to have a graph added for the
record about the spikes in Houston, in Harris County, and Fort
Bend County.
Mr. Pallone. Without objection, so ordered.
[The information follows:]
Mr. Olson. Thank you.
There are many factors why we have this spike right now in
Texas and in Houston. But what scares me the most is the
increase in infectious cases in people aged 20 to 39, the so-
called youngsters. In the last week they are one-third of the
new cases in my hometown of Sugarland, in my own county of Fort
Bend, in the Greater Houston region. This is because of their
attitude.
To sum up their attitude my former boss Phil Graham said it
best about these people, how they've--how they view this
crisis. Bending the COVID-19 curve and ending the pandemic is
like going to heaven: everyone wants to go there but fewer and
fewer want to do the hard work to make it happen. I call this
the bad attitude curve.
And, Dr. Fauci, if you were king for a day, how could we
change this bad attitude curve and make these people address
this issue for the threat it truly is?
Dr. Fauci. Well, Congressman, you bring up a very good
point. One of the very perplexing things about COVID-19--and I,
as some of you know, have been dealing with viral outbreaks for
the last 40 years--I have never seen a single virus that is one
pathogen have a range from 20 to 40 percent of the people have
no symptoms, to some get mild symptoms, to some get symptoms
enough to put them at home for a few days, some are in bed for
weeks and have symptoms even after they recover, others go to
the hospital. Some require oxygen. Some require intensive care.
Some get intubated, and some die.
So, you have a situation that is very confusing to people
because some people think it is trivial, it doesn't bother me;
who cares? And that is one of the reasons why what we do have
is a lack of appreciation, that you have a dual responsibility.
You have a responsibility to yourself, because I think thinking
that young people have no deleterious consequences is not true.
We're seeing more and more complications in young people.
But even though the majority--the overwhelming majority of
them do well, what you can't forget is that if you get infected
and spread the infection, even though you do not get sick, you
are part of the process of the dynamics of an outbreak. And
what you might be propagating inadvertently, perhaps
innocently, is infecting someone who then infects someone who
then is someone who is vulnerable. That could be your
grandmother, your grandfather, your sick uncle, or whom have
you who ends up dying.
So, it is a very difficult messaging when people say, I am
young, I am healthy; who cares? You should care, not only for
yourself but for the impact that you might have on the dynamics
of the outbreak.
Mr. Olson. The bad attitude syndrome.
I am out of time. I have a question for the record for Dr.
Redfield about hurricane evacuation of COVID-19 people from
nursing homes.
I yield back. Thank you very much.
Mr. Pallone. Thank you, Mr. Olson.
Next we go to Mr. Butterfield from North Carolina.
You might have to unmute, G.K.
Mr. Butterfield. Thank you, Mr. Chairman. I made a note to
do that and failed to do it, yes.
But thank you, Mr. Chairman, and thank you to all of our
witnesses today.
Mr. Chairman, in response to COVID-19, Congress has
appropriated significant funding through the CARES Act. And it
looks like some of that money is finally getting into
underserved communities. The Congressional Black Caucus Health
Braintrust, led by Congresswoman Robin Kelly, has met with some
or all of you. And we've written you to urge funding for
minority institutions and communities to fight the pandemic.
Admiral, Mr. Secretary, you announced this morning that HHS
has formed a partnership with the Morehouse School of Medicine.
That's good. A partnership to coordinate a strategic network of
organizations to deliver COVID-19--related information to
minority communities hardest hit by the pandemic.
Does the Morehouse funding give the medical school
discretion to engage in aggressive contact tracing and other
testing and education? We need more than information. What is
their mandate?
Admiral Giroir. So, thank you for that question, sir.
The intent of this award is really not to empower Morehouse
to physically do contact tracing themselves but to be a lead
institution to build partnerships throughout the nation so that
public health organizations, et cetera, can use the well over
$11 billion that the CDC sent out.
So, we are not funding Morehouse to be the boots on the
ground, we are funding them to be the brains behind the
operation, to really extend our network throughout the minority
and underserved----
Mr. Butterfield. Yes. Thank you for that. But how broad is
their discretion, or are they restricted?
Admiral Giroir. They--I would be happy to get into this,
but they--they assembled really a remarkable group of partners
using digital technologies, all types of network technologies.
They have very broad discretion. This is out of my office----
Mr. Butterfield. That's what---that's what---
Admiral Giroir. And look, what I want to do--I want to do
is make sure that the underserved get the information, get
testing, and get links to care.
Mr. Butterfield. Yes. You're saying broad discretion. Yes.
That is what I wanted to hear, broad discretion.
Dr. Fauci, the Washington Post reported this morning that
Arizona is seeing a troubling spike, the State of Arizona. And
as we all know, President Trump is in Phoenix today for a
campaign rally at Dream City Church. And I suspect he will not
be wearing a mask. I know that will disappoint you. It will
certainly disappoint me.
The Washington Post also reported that Arizona got its
positive rate down to seven percent, but now it is up to 20
percent after a 3-week rise.
In my state of North Carolina we had got it down to seven
percent. And now in North Carolina, it is up to ten percent.
So, ten percent in North Carolina, up from seven; and 20
percent in Arizona. What is the Administration specifically
doing to slow the spread in states like Arizona and North
Carolina that are seeing a rise? It can't--it just can't be
explained away by more testing.
Dr. Fauci. Well, Congressman, the percentages that you are
speaking of are clearly indications that there are additional
infections that are responsible for those increases. Because
when you get an increase in the percentage of your tests that
are positive, that is an indication that you do have additional
infections.
So, one of the issues that we have spoken about that is
very clear is that when you have those kinds of increases, you
must implement on the ground as effectively as possible the
manpower, the system, the tests to do identification,
isolation, and contact tracing to try and blunt that surge of
cases in the two states that you are speaking of. Hopefully,
that will be successful in the blunting of those cases because,
if not, then you have the danger of having a gradual insidious
increase in community spread, which will be much more difficult
to contain as the community spread amplifies itself.
Mr. Butterfield. Well, it just seems to me in closing, Dr.
Fauci--and you don't need to respond to this--but it seems to
me that the President seems to think that COVID is over and he
can just push it all to the states.
The data that is coming out of the states shows the
necessity, the absolute necessity for a national strategy.
Because while the virus may seem contained in some areas, it is
conceivable that we can see a resurgence everywhere. This
frightens me and should frighten the American people.
Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you, Mr. Butterfield.
So, now Dr. Burgess is here, and we will recognize him for
5 minutes.
Mr. Burgess. Thank you, Mr. Chairman. In fact, I was with
you virtually earlier, so I heard all of the discussion back
and forth. And I would ask unanimous consent that my opening
statement be made part of the record.
[The information appears at the conclusion of the hearing.]
Mr. Burgess. And I do want to thank our panelists for being
here today. Outside of a tiny little bit that we tacked onto a
budget hearing on February 27th, we really have not heard from
this group enough in this committee, and certainly the Health
Subcommittee. So, I want to thank you for your willingness to
be here today and testify.
I would also observe that we are about the one-year
anniversary of the passage and signing of the Pandemic and All-
Hazards Preparedness Act. We had a wonderful opportunity in
January, February, perhaps early March of this year to do some
real-time introspection as to whether or not that bill had
gotten things right. Did we do what we--was it performing as
intended? Was it going as expected? And for whatever reason, we
chose to talk about flavored tobacco, horse racing, and ticket
stubs instead.
So, we can be critical of the Administration, Mr. Chairman,
but this committee--this committee bears some of that
responsibility as well.
Since we have been talking about community spread and
increase in community spread, I also, Dr. Fauci, have been
talking to some of my counterparts, physicians in the Lower Rio
Grande Valley. And spread in that part near the border of
Mexico--community spread has been apparently significant over
the last week to ten days.
I guess a question I would have for you and for Admiral
Giroir is since we recognize community spread is increasing,
and we recognize that there is still going to be the
vulnerabilities of congregate living facilities, what are we
doing to make certain that the appropriate amount of personal
protective equipment is available to our congregate living
facilities, extended care facilities, and nursing homes, not
just in the Valley but any place where we see this community
spread increasing?
Admiral Giroir. So, thank you, Dr. Burgess. Good to see you
again.
Mr. Burgess. Good to see you.
Admiral Giroir. Again, I am familiar with the PPE situation
from my work on the UCG at FEMA. And I think you--I think you
know that it was decided by the UCG very early that when we
were able to secure the PPE, we would send directly to every--
and we are sending PPE directly to fifteen thousand--I believe
the number is four hundred--nursing homes. And the numbers are
really staggering. Millions of face shields, masks. Thirteen
million pairs of gloves are already there.
So, that is being distributed right now. And there are
going to be multiple tranches of that.
Again, Admiral Polowczyk is running this through the Supply
Chain Task Force. I've got all the swabs and all the tests. He
runs the PPE, and we interact a lot. So that is going to be
going all the way through August and September, through all
15,400 nursing homes, with multiple shipments of that.
Mr. Burgess. Do you agree that that is on the immediate
horizon ahead, that is one of the big vulnerabilities,
community spread is increasing in some places, but we also know
we have got areas where there is congregate living people with
multiple risk factors?
Admiral Giroir. So, I think as has maybe been said by the
colleagues, we are clearly seeing community spread in a number
of areas. If you look at counties, I think Dr. Birx detailed
yesterday, there are about 110 counties of real concern
throughout the country.
Mr. Burgess. Well, I guess, Admiral--excuse me for
interrupting, but my time is short. I guess what I am really
asking is are we preparing and do our administrators and
executives in nursing facilities--nursing home facilities know
how to access the vast amounts of personal protective equipment
that is being made available through Airbridge and through the
work that you have done? Because if we don't get it to the end
user, then it is a vulnerability and it will affect all of us.
Admiral Giroir. Very briefly because I know the time, I am
going to say the answer is yes, because we decided to ship door
to door because we couldn't necessarily rely on the state
distribution systems, you know, because you just can't get that
deep. So, the only way to do it is get the address and ship it.
And then, secondly, the testing regimens that are now
mandated through CMS, recommended by CDC, are pretty excellent.
Right? Every nursing home resident gets tested. Every worker
gets tested every week. This is a very robust testing regimen--
--
Mr. Burgess. Sure.
Admiral Giroir [continue]. That we think is going to put
high protection.
Mr. Burgess. Certainly has been in Texas.
Dr. Redfield, in just the very brief amount of time I have
remaining, let me just ask you a question.
I heard some things, and of course people are concerned
about--about China, the impact that China has had on our
ability to fight this virus. Are there people working in the
CDC in Atlanta who are Chinese nationalists? Do you have such
people on loan from Chinese labs in the agency?
Dr. Redfield. Well, CDC does have an office--CDC has an
office in Beijing that is right next to the China CDC, and we
work collaboratively on a series of things, particularly
respiratory viruses and particularly influenza.
We haven't been brought in into the overall Chinese
investigation of this current coronavirus epidemic. That's
something I requested back on January 3rd and then formally on
January 6th.
Mr. Burgess. I want to be helpful to you on that, so I will
follow up with you. And I have some ideas of some other things
that we might think about as well. But I think that is a
critical part of our discussion going forward and being
prepared into the future.
Thank you all. Thank you to the panelists.
Mr. Pallone. Thank you, Dr. Burgess.
Next we go to Ms. Matsui from California. You may have to
unmute.
Ms. Matsui. Thank you. I have unmuted. Thank you, Mr.
Chairman. I want to also thank the witnesses for being here
today. You have been on the clock 24/7, and we really
appreciate it.
Now, while a lot of our questions today have focused on how
we found ourselves in the midst of this pandemic, I would like
to focus my questions on the future and how we are preparing
for the coming weeks and months and the possibility for another
dramatic surge in cases of a second wave this fall,
particularly during flu season.
Dr. Fauci, it's nice to see you there. You have said that
we are still in the first wave, and I understand that it's
difficult to predict what a second wave would look like while
we are still seeing high counts, high case counts and deaths
currently. However, we must effectively prepare our
communities, our healthcare workforce, and constituents for
what could come as we make decisions about returning to work,
going to school, and trying to readjust to what we consider
somewhat normal life.
Dr. Fauci, I want you to put your kind of prognosticator
cap on right now. What are the projected infection mortality
rates for the second half of 2020 and for early 2021?
Dr. Fauci. Thank you for the question, Congresswoman. It is
really impossible to give any projection about what the
fatality rate or case rates are going to be. It's going to
depend on so many factors. I think you alluded to that in the
beginning of your question.
When people talk about second waves--and I have said
multiple times publicly that we are still in the middle of the
first wave. So, before you start talking about what a second
wave is, what we'd like to do is to get this outbreak under
control over the next couple of months, so that when we enter
into the fall, early/late, and then early winter, that we have
such a low baseline that when you do have the inevitable
situation of cases appearing as you try to gradually reopen the
country, which we are all trying to do to varying degrees,
depending upon what state, city, town, or county you are in,
that if you get a level that's very low, when you get new
cases, you can contain.
And contain means identify, isolate, and contact trace,
rather than have such a high level that when you get increases
you have to mitigate right from the beginning. So that really,
as you can imagine, complicates the situation and makes it
impossible to predict what the case or fatality rate is going
to be until you know where you are.
Do you get down to baseline? And, if so, can you keep it
there as you enter into the complicating situation that will
inevitably occur when we get into the winter and inevitably we
will have a flu season? And that is the reason why we are
saying, all of us, why it is so important to really get as many
people vaccinated with influenza as you possibly can, so that
you can at least take off the table, for many people, one of
the confounding issues that we are going to face this winter of
two respiratory-borne infections simultaneously confounding
each other.
Ms. Matsui. And what would you say, Dr. Fauci,
understanding that we don't know yet, but we have a sense that
we are going to have a second wave, what should the public know
so they can be prepared for this? And what, as a country, can
we all do to reduce the potential for this second wave and
somehow or another manage it? Because I think that all of us
believe something is going to be happening, and we need to know
what we can do now.
Dr. Fauci. Thank you for that second part of the question.
There are a lot of things that can be done. We know what the
failings were early on: a lack of enough PPE, a lack of enough
N95s, hospital bed issues, ventilator issues. All of that is
right now being stored up in the Strategic National Stockpile
in preparation for what we hope never occurs, but which very
well might occur.
So, it's the preparation. Also, as Admiral Giroir had
mentioned, as we go into the fall, we likely will have the
capability of doing 40 to 50 million tests per month, which
means we can get a much better grasp of what the situation is
of the dynamics of virus in the community. So, hopefully, we
will be much better prepared if, in fact, we do get this second
surge than we were months ago.
Ms. Matsui. OK. Thank you very much, Dr. Fauci. And I yield
back.
Mr. Pallone. I thank the gentlewoman.
Next we move to Mr. McKinley.
Mr. McKinley. Thank you, Mr. Chairman. I'm going to direct
my first question to Dr. Fauci. The New York Times, CNN, and
The Washington Post have relentlessly criticized President
Trump's response to COVID-19, calling it a failure. You heard
today, a lack of leadership. But, wait. As you know, nearly
750,000 people have died in America from drug overdose, and we
still don't have a solution. AIDS has killed over 700,000
people in America, and we don't have a cure for that either.
But, look, the first case of COVID was diagnosed in America
just 155 days ago. And, according to testimony we had earlier
this spring, the pharmaceutical experts say that we could have
a treatment by fall and a vaccine by January, keeping in mind
it took almost ten years to come up with a vaccine for the
influenza and four years for mumps. Nevertheless, the media and
the left simply can't help but criticize President Trump.
So my question to you is: do you think that President Trump
is being judged fairly?
Dr. Fauci. Actually, that's an unfair question, because you
are asking me to pass judgment on the press's treating of the
President of the United States. That's----
Mr. McKinley. It may be unfair, but you've had--numerous
times you've commented and criticized--or contradicted what the
President said. So do you think he is being judged fairly?
Dr. Fauci. Well, it depends on what you mean. I mean, I
work in the White House, and I believe that everyone there is
doing everything they possibly can----
Mr. McKinley. Thank you.
Dr. Fauci [continue]. To do what they need to do.
Mr. McKinley. That's it. So, Dr. Fauci, you said as late--
and I've got a newspaper article here--that as late as March
31st, there was no consensus on wearing masks. And the
President, as you know, relies on your expertise. Do you now
regret not advising people more forcefully to wear masks
earlier?
Dr. Fauci. OK, we're going to play that game. Let me
explain to you what happened back then.
Mr. McKinley. It should be a yes or a no.
Dr. Fauci. No, there's more than a yes or no, by the tone
of your question. I don't regret that, because let me explain
to you what happened. At that time, there was a paucity of
equipment that our healthcare providers needed, who put
themselves daily in harm's way of taking care of people who are
ill. We did not want to divert masks and PPE away from them to
be used by the people.
Mr. McKinley. OK. I have----
Dr. Fauci. Now that we have enough, we recommend----
Mr. McKinley. Reclaiming my time, I've got two more
questions. So, thank you for that, Dr. Fauci.
So, Dr. Redfield, I am going to be directing this to you.
Nursing homes, as we've talked about here earlier, make up
nearly 40 percent of all of the COVID deaths. And the CDC
issued guidance on proper protocol for these facilities, yet
states like Michigan, New York, New Jersey, and California
apparently--apparently disregarded that guidance. So, Dr.
Redfield, do you think the decisions of these governors led to
unnecessary deaths in these nursing homes?
Dr. Redfield. Thank you for your question. I think the
critical issue here is--two things. One, our guidance is just
that: guidance. Two, areas that we could impact the nursing
homes, particularly infection control, working together with
CMS, very aggressively early on, after the Seattle outbreak was
recognized in that nursing home, really rechanneled energy into
looking at the effectiveness of infection control in those
nursing homes, then restricted visitors to make sure----
Mr. McKinley. Do you think that the decisions led to
unnecessary deaths by not--by allowing infected residents to
come back into the nursing home?
Dr. Redfield. I think, again, all of these decisions that
have been made in the early days are subject to hindsight. We
gave clear guidance on how people should be handled if they
come into these nursing homes.
Mr. McKinley. OK. Now, the third question--back again to
you, Dr. Redfield--we know in the foreseeable future that we're
not going to have a zero risk of transmission. We're not going
to get to that. So if we want our economy to recover, we know
our schools have to reopen. So, going back to the school
question, in addition to tracing, distancing, wearing masks,
what rate of infection is needed, in your mind-set, for
children to go back to school? What's the rate of infection?
One percent?
Dr. Redfield. Yes, I'm not prepared to give you that
definitive answer. I am prepared to say that one of the most
important things we need to look at is not the number of
infections but the consequences of these infections. And there
are two really big consequences. One is hospitalization and
mortality, and the other is our economy, right?
And I think we are clearly seeing that, in many parts of
our nation, that one can open our economy safely, but it is
going to require more vigilance than some of us see right now
with the social distancing. We're going to continue to try to
emphasize the importance of social distancing, face masks, and
hand-washing as we continue to do it.
It's my expectation that many jurisdictions will be opening
schools. We're going to try to give the guidance to help them
do it safely. I think you're right, as Dr. Fauci alluded to
before, it is going to be influenced by the kinetics of the
outbreak in the jurisdiction at the time. I'm not prepared to
give you that number, but I think we're going to see
progressive jurisdictions move to open schools in the fall.
Mr. McKinley. I yield back. My time's up.
Mr. Pallone. We now go to Ms. Castor, the gentlewoman from
Florida. I'd ask everybody to unmute before they begin.
Ms. Castor. Great. Thank you so much. Thank you to our
witnesses today.
When you compare the number of confirmed cases and the
number of deaths in the United States with countries across the
globe, it's really shocking. And it makes me angry and it makes
me sad at the same time. We have 2.3 million confirmed cases.
We have just over 120,000 Americans who have lost their lives
just in a few months' time. And it appears that other countries
have done a better job controlling the spread. They've done a
better job on testing and tracing. Every advantage that the
United States of America has with our scientists, our public
health experts, something has gone wrong here, and I think it
starts at the top. I think the President's behavior and
comments have undermined our public health professionals every
step of the way.
Dr. Redfield, I would like to know, how often do you
interact with the President and talk to him about public health
guidelines and bringing all of your expertise to bear? How
often do you interact with the President?
Dr. Redfield. Well, I have regular interactions as part of
the White House Task Force, as a member to it, and participate
in each and every one of the task force meetings. And as
relates to my interactions directly with the President, I'm
going to keep those between myself and the President.
Ms. Castor. Well, you know, every time the President
contradicts scientists, every time he contradicts our public
health experts, whether it's the wearing of masks or mass
gatherings or drinking bleach or taking hydroxychloroquine, it
costs lives. And I agree with my colleagues that we really
expect you to be more outspoken when it comes to these public
health advisories. It will cost lives, it has cost lives, and--
but I'll change direction now.
For Dr. Fauci, you know, Floridians are very concerned with
the latest spike in cases. The Florida Department of Health
announced, just a little while ago, we've got another 3,300
cases and 64 deaths just since what was announced yesterday.
Twenty-five percent of the total cases in Florida have been
confirmed in just the past ten days, and we have a positivity
rate of now up to 13 percent in the past week.
So, what message do you have for the State of Florida, and
other hot spots across the country, as we have so many more
young people who feel invincible that are testing positive and
our economy is opened up? What is your advice to Floridians and
others in hot spots?
Dr. Fauci. You know, my advice to the Floridians is the
advice I would give to anyone and everyone: to follow the
guidelines that we have very carefully thought out and put out
on how one can reopen or open America again. And that is to
stay within the framework of the particular phase of reopening
you are in and to not throw caution to the wind.
I think what happens, related to the comment I made a
little while ago about the confusion there must be,
particularly among young people who have a pent-up urge to go
out, which is understandable, but what they need to appreciate
is that they are part of a process of the dynamics of an
outbreak. And although they themselves may perceive that they
are at very low risk for something that would be deleterious to
them, by propagating the process of the outbreak they may be
indirectly hurting people by infecting someone, who then
infects someone, who then infects someone who is vulnerable.
So they need to understand that. If we could get that
message across, that it is not an all-or-none phenomenon;
getting back to normality is going to be a gradual step-by-step
process, and not throwing caution to the wind.
Ms. Castor. And what about masks for young people? There's
a lot of--you know, they look at national leaders who are not
modeling your advice and your behavior. What do you say?
Because you're a trusted scientist and expert. What do you say
directly about wearing masks and mass gathering?
Dr. Fauci. I will be very consistent, and I will say it yet
again, that you should not congregate in crowds. You should
keep your distance. And even though many people, for a variety
of reasons, do not listen to the--not suggestion, but plea to
not congregate in crowds, some people are going to do that
anyway.
If you do, please wear a mask. And as you wear a mask, and
you are in a situation where you are getting animated, in a
demonstration or in a rally or wherever you are, avoid as best
as possible the urge to pull your mask down and shout.
So, Plan A, don't go in a crowd. Plan B, if you do, make
sure you wear a mask.
Mr. Pallone. Thank you, Ms. Castor.
Ms. Castor. Thank you, Dr. Fauci. I yield back.
Mr. Pallone. Next, we go to Mr. Kinzinger in Illinois. And
unmute.
Mr. Kinzinger. Thank you, Mr. Chairman. I'm unmuted. Thank
you, Mr. Chairman, and thank you to all of the guests for being
here. It's a weird time, and very important, so thank you.
I think, you know, one of the discussions is this
communication's important. So, whether it's between Federal
Government, state governments, local governments, nonprofits,
businesses, but also international governments. And I think we
need a lot more information, eventually, on what the Chinese
Communist Party knew, what they withheld, and what real impact
they had, and I look forward to that being more investigated.
We have all seen the stories about people who are testing
positive for the virus and they show no symptoms at all. And,
in some cases, it was able to spread through entire communities
of people without ever knowing that they have been infected.
So, Dr. Fauci, let me ask you, given the significant rate of
these asymptomatic infections, how can antibody tests improve
our understanding of the transmission of COVID-19 and to help
identify populations at risk?
Dr. Fauci. Well, one of the things that we need to do, and
I think that's very important, related to a previous question
about getting the kinds of surveillance studies that allow you
to get a much better handle on, A, the real percentage of
asymptomatic carriers; B, the rate at which they infect others;
and a variety of other things, I mean, things that are really
important questions.
We learned, interestingly--actually, to my surprise,
Congressman--that when you look at asymptomatic individuals and
people who are symptomatic, the level of virus in their
nasopharynx is almost the same, which is almost
counterintuitive, but it is a fact which tells you that the
danger of transmissibility is such that it is very important to
understand the penetrance of asymptomatic infected people.
And when you do get them, you need to identify them,
isolate, and contact tracing. And questions that were asked, I
don't know, an hour or so ago to the testing issue, we need to
do much, much more surveillance testing. And so the 40 to 50
million tests per month that would be available as we get into
the late summer and early fall are going to be able to ask some
of the questions you're appropriately asking.
Mr. Kinzinger. Thank you. And----
Admiral Giroir. If I could just build on that for a second.
The 40 to 50 million tests I said assume no advances in
technology, and that's not even including pooling. I do say
pooling because the FDA just put up standards for validating
pooling. So we would expect, based on preliminary data we have,
that on many tests we can at least pull 5 to 1, and maybe up to
10 to 1.
So when you do that math that I think will be validated
very quickly by academic institutions and by large
organizations, that number of 50 million is going to go up by
five-fold, at least, per month.
Mr. Kinzinger. Great. Thank you. And that's what's amazing,
frankly, is American ingenuity, when we put our minds to it and
seeing the advances and hopefully when we get to a vaccine.
So, at the beginning of the pandemic, both my wife and I
actually experienced what we thought were symptoms of COVID-19,
and we recently decided that we would go in and get an antibody
test. I had that done, and I found out that I was actually
negative for the antibody.
So, Dr. Redfield, in your testimony, you stated that, at
this point, we don't know whether the presence of antibodies
provides immunity to the virus. So, with this in mind, how does
antibody testing help, if we don't know if it provides immunity
to the virus? And what are the benefits of an antibody test
from an individual patient's perspective?
Dr. Redfield. Thank you very much for the question,
Congressman. I think right now, at this stage, I think
important at the individual patient level, we don't know what
it means, particularly, in terms of immunity, as Dr. Fauci said
earlier. What it does mean--again, assuming it is a reliable,
approved-FDA test--that you have been infected in the past. We
don't know, though, what that means in terms of immunity.
Its value to us at CDC is its surveillance advantage. Right
now, we continue to do surveillance throughout the United
States through a variety of different systematic collections we
are doing, and it allows us to see the full extent of the
infection.
Right now, the data at a national level suggest that for
every documented infection that we have as a case report,
there's actually about ten other individuals that actually had
been infected. That data will continue to be refined as we
continue to expand our antibody testing, but I really think its
major role right now is an important surveillance tool.
Mr. Kinzinger. Thank you. And I'll just add another
question, I'll submit it for the record, about this virus
lasting on surfaces.
But, with that, I will yield back. Thank you.
Mr. Pallone. Thank you. And, thanks, I remind everyone that
you can submit questions for the record, to the task force and
the witnesses, and that all opening statements will be entered
into the record.
So, next we go to Mr. Sarbanes from Maryland.
Mr. Sarbanes. Thank you, Mr. Chairman. Can you hear me?
Mr. Pallone. We can.
Mr. Sarbanes. Terrific. I want to thank the panel. Last
month, the Trump Administration announced the launch of
Operation Warp Speed to support rapid research and development
of COVID-19 vaccines, therapeutics, diagnostics, and so forth.
It's a project that is supposed to coordinate efforts across
the Federal Government and engage the private sector, including
at least five pharmaceutical companies that are developing
vaccines.
So, I'm trying to understand a little bit better how that
works. First off, there's been some concerns raised about the
venture, including potential conflicts among its leadership,
conflicts of interest.
Dr. Fauci, you have had decades of experience leading
public-private partnerships with pharmaceutical companies to
develop the vaccines. Transparency is important, is it not, in
these collaborations?
Dr. Fauci. Thank you for the question. The Operation Warp
Speed is an endeavor that is a Department of Defense/HHS, led
by Secretary Esper and Secretary Azar, to try and get
diagnostics, therapeutics, and vaccines done in a way that is
coordinated, with the maximum speed possible without
sacrificing scientific integrity.
It is divided up into three groups. The leader of this is
Moncef Slaoui, a person with great experience in industry; as
well as General Perna, who is an Army General who is very well
versed and very experienced in supply chain processes of
getting vaccines, when we do get it, to be produced to the
level that is needed, as well as to be distributed equitably
throughout our society.
So it's a----
Mr. Sarbanes. Let me ask--let me jump in, because I wanted
to ask Dr. Hahn. I understand that a senior FDA official was
initially tapped to lead the vaccine development under
Operation Warp Speed, but then left the project out of concerns
about political pressures to approve vaccines.
I assume you agree that the role FDA plays in this has to
be one that's not impacted by political pressure, and that your
agency is ready to adopt the highest standards in approving any
vaccine that's developed under this initiative?
Dr. Hahn. Congressman, thank you for the question. Your
point is very well taken, and I can assure you that we will
retain our regulatory independence. We will use the science and
data that come to us, and we will use our high standards to
assess the safety and efficacy of a vaccine. We have world-
class experts who will continue to maintain that.
One point I do want to make clear, sir, is that we drew a
very bright line between Operation Warp Speed and all of our
sponsors. We do not engage in decisionmaking, neither I nor Dr.
Marks nor Dr. Cavazzoni, with respect to those decisions. We
provide technical assistance, as we do to all sponsors, but
we've made it clear that we do not participate in those
decisions because we absolutely must maintain regulatory
independence and make the right decision for the American
people based upon science and data.
Mr. Sarbanes. Thank you. And, again, I'm trying to
understand sort of the boundaries or reach of the Operation
Warp Speed effort. So, my initial sense is that it was focused
on these five selected companies that are pursuing vaccine
candidates. I'm not entirely clear--and maybe that's not
right--but I'm not entirely clear on what this means for
vaccine exploration/development beyond that.
For instance, I've been reading just over the last week or
ten days or so about this oral polio vaccine opportunity, maybe
that it has promise, maybe it doesn't, but some inquiry there,
I guess, may be warranted.
I'd like to get the panel's perspective on whether you
consider those kinds of inquiries outside of Operation Warp
Speed, or is Operation Warp Speed broad enough to accommodate
those kinds of things in addition to whatever is happening with
the five companies? And sort of from where your different
agencies sit, what's your perspective and understanding of
that?
So let me just, I guess, go down the line. Dr. Redfield,
why don't we start with you, and then Dr. Fauci, and I guess
Commissioner Hahn would be the other one.
Mr. Pallone. Brief responses, gentlemen, because his time
is up.
Dr. Redfield. Yes, very quick. The only thing I would say
is it's intriguing in terms of the potential, what we call
viral interference with these live-virus vaccines, whether it's
polio or measles, that they may impact another RNA virus from
being able to establish infection. So, really, that's the
hypothetical. I think it's intriguing, not for just this
pathogen, but for other RNA viruses.
Dr. Fauci. Yes. Very quickly, I think your question was, is
there room for other vaccines? The answer is yes, through
multiple mechanisms. Anything is on the table. It could be
through Operation Warp Speed. It could be through a number of
mechanisms that we have in our research institution at NIH. So,
I can understand your concern, but the doors are not closed to
other candidates. You can be assured of that, sir.
Dr. Hahn. Congressman, from FDA's perspective, we
absolutely--the doors are open there as well. We are working
with multiple different sponsors, pharmaceutical companies, as
well as Operation Warp Speed. We will look at all data that
comes across the door. We will provide technical assistance to
all who want to develop a vaccine and therapeutics.
Mr. Sarbanes. Thank you.
Mr. Pallone. Thank you. Mr. Griffith?
Mr. Griffith. Thank you very much, Mr. Chairman. I greatly
appreciate it.
Dr. Fauci, and then Dr. Redfield, I'm going to put you all
a little bit on the spot, because I want to talk about schools.
And as you might imagine, a lot of constituents are very
concerned about what's happening in the schools.
And, Dr. Fauci, you earlier made some statements which led
me to believe that you believe that, not only nationally, but
even within a state the size of Virginia, we probably ought to
be looking regionally, and maybe even locally, as to how we do
it and how we go forward. Did I understand that correctly?
Dr. Fauci. You understood me correctly, Congressman. And
that's the point I want to make, because it's really a source
of confusion. It's not one-size-fits-all. I think you have to
look at it at the local level, the county level, the regional
level, the city level, the state level.
So, we often say, in America, should you or should you not
be open? I mean, that is almost a non-question, because we're
such a large country, and so heterogeneous, and such a range of
involvement of this virus in different parts of the country.
Mr. Griffith. And, Dr. Redfield, I'll move to you because
in the Commonwealth of Virginia they often are citing, and for
various things related to schools and others, they cite the
CDC. Do you agree with Dr. Fauci in his assessment?
Dr. Redfield. Yes. It needs to be a very targeted,
jurisdictional decision.
Mr. Griffith. And I greatly appreciate that, because my
district is four hours from D.C., even though people often
think I am right next door. And then the district stretches
from the very edge of it, which is four hours away, another
four-and-a-half hours, so that it ends up going further west
than Detroit, Michigan. And the district, just my district, is
larger than the State of New Jersey. So, even within the
district, we may need to have some additional regional
approaches. Would you all agree with that?
Dr. Redfield. Yes.
Mr. Griffith. And Dr. Fauci indicates that, as well.
All right. Commissioner Hahn, in a statement on March 30th,
2020, you recognized the importance of facilitating access to
viral samples in order to speed up the development of tests.
You noted that, in the future, making virus samples available
earlier to commercial developers will be crucial to deploying
tests quickly.
This certainly will not be the last time we face a rapidly
spreading novel virus strain. How can the process for obtaining
viral samples, especially inactivated viral samples, be
improved in the future for quicker access?
Dr. Hahn. Congressman, thank you for that question. And I
think that is one of the lessons learned from this situation
with COVID-19, is that access to those samples is very
important. We would work with NIH, with academics, with the
CDC, to make sure that those are available.
And just to make a point, we, for serology tests, have made
a reference panel now available to developers to actually
facilitate that. That's an example of what U.S. government,
FDA, NIH, and CDC could do.
Mr. Griffith. I thank you. And I apologize, Admiral Giroir?
Did I say it close to correct?
Admiral Giroir. That's good enough.
Mr. Griffith. All right. Earlier this year you informed
this committee that enough testing supplies would be
distributed so that the states could test the recommended two
percent of their populations per month. Yet, according to Johns
Hopkins coronavirus testing trend tracking center data, only
about 20 percent of the states are testing the recommended two
percent of their population per month, while another 20 percent
are testing less than one percent of their population per
month.
Has the Administration been distributing supplies to
states? And, if so, why do you believe some states that have
testing supplies are not testing more of their population?
Admiral Giroir. So, thank you for that. Again, before the
full state plans were just received--and this was part of the
PPP funding that we've reviewed, and we've reviewed them
extensively with the CDC--we set preliminary targets for every
state by phone calls with every single state, every single
state health officer, epidemiologist.
Overall, in May, the target was about 12.9 million tests
throughout the country and about 12 million were done. This is,
really, very good considering many of the states try to do
three or four times as many tests as they had done cumulatively
during that time.
Mr. Griffith. So you think we are on track.
Admiral Giroir. I think we're really on track right now. It
looks very good. Some states have underperformed, especially in
May. Most of them have improved their performance in June. And
our preliminary view of all of the state plans, the great
majority of them, I mean, the overwhelming majority, were very
good to excellent. So, everyone is getting the message, and I
look forward to that.
Mr. Griffith. I thank you. And, Dr. Fauci, if I can come
back to you. When we first started this, you know, we knew it
was going to be tough, and that we were probably never going to
get rid of this particular virus, but we talked about bending
the curve and making sure our hospitals were ready. Based on
your comments on PPE and face masks and so forth, I believe
that you think that we're probably ready, maybe not perfect,
but we're ready. And have we not bent the curve?
I understand it's not over. It's not going to be over
anytime soon. We've got to wear our masks and do what we're
supposed to do, but don't you think we've bent the curve and
that our hospitals are now ready? Is your mic on?
Dr. Fauci. Sorry, sir. Yes. We've been through a terrible
ordeal. We've learned a lot. The preparedness now is clearly
logarithmically different than it was in the beginning.
Mr. Griffith. And so we've bent the curve and our hospitals
are ready.
Dr. Fauci. Right.
Mr. Griffith. I yield back.
Mr. Pallone. Thank you. Next we go to Mr. McNerney, coming
from California. Would you unmute?
Mr. McNerney. I thank the Chairman, and I thank the
witnesses for your work and your expertise. Are you able to
hear me there, Chairman?
Participant. We can hear you.
Mr. McNerney. OK. Thank you. So, I am deeply concerned
about President Trump's decision to terminate the United
States' relationship with the World Health Organization. And
I'm not alone in this concern. The head of the American Medical
Association has called the President's move a senseless action
that will have significant harmful repercussions now and far
beyond this perilous moment. It appears that the President is
not acting on sound public guidance, but is instead
scapegoating the WHO to deflect from his Administration's
failure in responding to the COVID-19 pandemic.
According to a report in Vanity Fair, key U.S. agencies
that work with the WHO on critical public health programs were
not consulted or asked for an impact analysis before the
President's decision to withdraw.
Dr. Fauci, were you consulted about the potential public
health impact of the United States withdrawing from the WHO?
And, if so, what were your recommendations?
Mr. Pallone. Jerry, I apologize. We said we were going to
take a break at 1:30 so everyone can go to the restroom or
whatever for 15 minutes, and Dr. Fauci had to step out.
So I'm going to ask you to start over again. We will take a
15-minute break so everybody can use the restrooms, and then
we'll start again with Jerry and you'll have to repeat your
question.
This committee stands adjourned for 15 minutes.
[Recess.]
Mr. Pallone. All right. The committee will reconvene. We
will try to go as quickly as we can. And I appreciate everybody
bearing with us. And if you have to step out, please come back.
And we left off with Congressman McNerney. Jerry, you are
going to have to repeat your question, and unmute.
Mr. McNerney. OK. Thank you, Mr. Chairman. I am assuming I
am live now.
I want to remind the chairman that your video from the
committee is coming in and out, so I am not sure if I am in
sync or not.
But I am truly concerned by President Trump's decision to
terminate the United States' relationship with the World Health
Organization. And I am not alone in that concern. The American
Medical Association, for example, has called the President's
move a senseless action that will have significant harmful
repercussions now and far beyond this perilous moment.
It does appear that the President is not acting on sound
public health guidance, but is instead scapegoating the WHO to
deflect from his administration's failure in responding to the
pandemic. Again, according to the Vanity Fair, key U.S.
agencies that work with the WHO on critical public health
programs were not consulted or asked for impact analysis before
the President's decision to withdraw.
Dr. Fauci, were you consulted about the potential public
health impact of the United States withdrawing from the WHO?
And, if so, what were your recommendations?
Dr. Fauci. Thank you, for the question, sir. I was not
specifically consulted about the withdrawal or the attempt to
withdraw.
The situation with many of us is that we have longstanding
relationships with the WHO. The NIAID is a collaborating
center. I have a memorandum of understanding with Dr. Tedros.
Many of our bits of information that we get, Dr. Redfield and I
are on a weekly call that is supervised by the WHO where we get
the opportunity to speak to the medical leaders in the various
countries.
So, with regard to what policy comes from the White House
is not--I have not been consulted on. And it hasn't really
impacted the kind of interaction----
Mr. McNerney. I am going to interrupt you, Dr. Fauci. I
can't--it's like watching--listening to a cell phone that is
coming in and out. So I am going to go to my next question,
which is really the same question for Dr. Redfield.
Were you consulted about the potential public impact of the
U.S. withdrawing from the WHO? And if so, what were your
recommendations?
Dr. Redfield. As with Dr. Fauci, no, not directly.
CDC has a long history with working with WHO. We continue
that collaboration. We are working on both polio eradication,
the Ebola outbreaks in the DRC, influenza surveillance across
the world. So, we continue working at the technical scientist-
to-scientist level. And so, we continue to do that.
Mr. McNerney. Again, I couldn't hear the response, and I
hope the Committee improves the situation.
According to Dr. Ashish K. Jha, Faculty Director of the
Harvard Global Health Institute, pulling this critical global
health investment while the world is in the middle of battling
a pandemic will have outsized consequences, and it will
certainly make all of us less safe. And this will put more of
lives at risk, not only globally but here in the United States.
Dr. Fauci, do you have concerns with the President's
decision to withdraw from the WHO?
Dr. Fauci. Yes, I do. And that is the reason why I am sorry
that you did not hear my explanation.
What I was saying is that despite any policy issues that
come from higher up in the White House, we at the operational
level continue to interact with the WHO in a very meaningful
way, literally on a day-by-day basis.
Mr. McNerney. Thank you.
Dr. Redfield, if the United States formally withdraws from
the WHO, how will that impact the CDC's ability to protect
Americans?
Dr. Redfield. Yes. We will--as I said, we are continuing to
work with WHO in our public health efforts in a number of
different programs. And, again, the implication will become,
you know, where there is colleagues and able to collaborate,
clearly there can be limitations on our ability to provide
direct funding to the WHO, but we have the ability to provide
funding to the operations through different mechanisms, so we
continue the public health work that we need to get done.
Mr. McNerney. Thank you, Dr. Redfield.
Well, as a member of Congress with a science background, I
am concerned that science is being ignored for political
purposes. We must be certain that consequential decision, like
withdrawing from the WHO, are based on sound public health
guidance and not on pursuit of a scapegoat. Science must have a
voice at the table. Whether it is regarding treatments for the
current and future pandemics, climate change, or other issues
of public concern, we must include science in decision-making.
Ignoring science is dangerous and a disservice to the American
public.
Mr. Chairman, I yield back.
Mr. Pallone. Thank you, Mr. McNerney.
Next, Mr. Bilirakis.
Mr. Bilirakis. Thank you, Mr. Chairman, I appreciate it.
And I want to thank the presenters for their testimony today
and all the work you do on behalf of our constituents.
Dr. Fauci and Dr. Hahn, in the scientific community's
COVID-19 responses, we have seen unprecedented scientific
collaborations and research information sharing at a pace
unlike anything before in history. Clinical trials are approved
in record time, while laser focus remains intent on patient
safety.
Regulators and drug manufacturers are learning from each
other from joining together in the critical fight against
COVID-19.
In line with that innovation, is the COVID-19 Evidence
Accelerator, which is a public/private partnership initiative
launched by the Reagan-Udall Foundation for the FDA, in
collaboration with Friends of Cancer Research, to advance
understanding of COVID-19 through focus on analysis of real-
world diagnostic and clinical data.
Question: do you believe these scientific collaborations
will lead to lasting changes in how we innovate for drugs and
vaccines--for drugs and vaccines? How will the innovation
changes affect research into diseases like ALS and Alzheimer's
disease?
Dr. Fauci, if you--OK. All right, Commissioner Hahn.
Dr. Hahn. Congressman, thank you for highlighting this
really important endeavor and partnership with the Reagan-Udall
Foundation and the Friends of Cancer Research. This effort is
an attempt to really accelerate, as the name implies, the use
of real-world evidence in our decision-making from a
development and a research point of view.
A couple of points I would like to make, sir. And I do
thank you. One is, we have to be really careful that we do this
in a robust and careful way because the gold standard remains
clinical trials, randomized clinical trials. That is important
that we understand that level of evidence.
However, in a rapidly moving situation like we have now
with COVID-19, where we make decisions based on the data that
is available to us at the time, having additional data
afterwards, as those decisions play out, as we gather evidence
of how tests work in the real world, about how treatments are
administered, very pragmatic data that allow us to then go back
and revisit the decision, to me there is nothing wrong with
that, that is actually a really good thing. As the doctors in
the room know, when you are taking care of a patient and you
get more data, you bring that back to the table. In fact, you
must incorporate that in your decision-making.
Mr. Bilirakis. Absolutely.
Dr. Hahn. So, I think this is a great opportunity. I would
love to see us do more. But as I mentioned earlier when asked
that question, I would love to continue the conversation with
Congress.
Mr. Bilirakis. Very good.
Dr. Fauci, would you like to respond?
Dr. Fauci. Yes. I totally agree. I think that what Dr. Hahn
has mentioned is something that spills over into what we do at
NIH and NIAID, is the clinical trial process, which is really
the gold standard of those types of decisions.
Mr. Bilirakis. Very good. Thank you.
The next question is for Dr. Redfield. Has CDC coordinated
with agencies, such as the Administration on Community Living,
to improve efforts to protect the elderly?
What steps has CDC taken to foster increased collaboration
between the public health sector, and aging services sector, to
meet the needs of older adults during this pandemic?
Dr. Redfield. Thank you, Congressman.
Mr. Bilirakis. Thank you.
Dr. Redfield. CDC has a long, established relationship with
the ACL to continue to work on health and well-being,
particularly the elderly, but also people with disabilities. We
work together in trying to cross-clear information from other
agencies, and their materials.
Also, CDC has reached out to, obviously, AARP to help to
provide tools for older adults that we can get out and take
advantage of their distribution. And we will continue to do
that.
Obviously it is a critical group. It was highlighted in
terms of the morbidity and mortality in this particular
pandemic, as you know. So, again, I think we will continue to
cross-collaborate with the ACL and try to help facilitate their
mission.
Mr. Bilirakis. Excellent.
Next question, again Dr. Redfield. Given the fact that we
continue to learn about the virus in real-time, how often is
CDC updating its testing guidelines?
Dr. Redfield. Well, it is intermittent. We recently posted
our updated testing guidelines last Friday. And I know, as
we've gotten some feedback from the states, there's an interim
week posting that is going to come to clarify a few issues this
week probably.
And then, on top of that basic guideline, we are posting
specific guidelines for specific situations. So, we did
infrastructure, critical infrastructure, we did nursing homes,
we did medical. This week I suspect we are going to do K
through 12 and higher universities. And then I suspect shortly
thereafter we are going to do non-critical infrastructure,
businesses.
So, we are trying to add specific testing guidelines to
specific situations. And, obviously, when there is new science
and new situations we update them in that setting. But I think
you will see there is going to be a series of targeted testing
guidelines for unique situations that will be posted over the
next several weeks.
Mr. Bilirakis. Very good. I appreciate that.
I yield back, Mr. Chairman. Thank you.
Mr. Pallone. Thank you.
Next member is the gentleman from Vermont, Mr. Welch.
Unmute, please.
Mr. Welch. Thank you very much. Thank you very much, Mr.
Chairman and our Ranking Member Walden. Thank you for your
patience and for your extraordinarily good work.
I think it is fair to say that not a single member of this
committee, Republican or Democrat, as of December of last year,
or even January or February, had any notions that there was
this emerging threat from the coronavirus. But, on the other
hand, my understanding is that public health officials always
anticipate, and there are two things that are essential to be
ready. One is preparation, and two is communication.
I want to ask a few questions about preparation. My
understanding is that the National Security Council had a
playbook for early response to high-consequence emerging
infectious diseases. And that indicated that we should, in
preparation, move swiftly to fully detect outbreaks, procure
PPE, secure supplemental funding, use the Defense Production
Act.
Are any of the witnesses aware of that report having been
followed in 2019, or January or February of 2020? Just a yes or
no.
It sounds like the answer is no.
Dr. Fauci. No, I am not exactly sure what you are referring
to. I think you are referring to a document that was put out
prior to the outbreak about what the response should be.
Mr. Welch. Right.
Dr. Fauci. Yes. You know, if you look substantively, much
of what is put--that was in that document, actually was
implemented with the exception, as I think you are alluding to,
is that the amount of stockpiled PPE and other items that were
needed were not at the level that we were able to respond in as
efficient way as possible.
Mr. Welch. Right.
Dr. Fauci. Right.
Mr. Welch. And there was a real delay in the use of the
Defense Production Act.
Also, there had been a White House Global Pandemic Response
Team that was eliminated in May of 2018. Anyone think that that
was a good decision, to eliminate that?
I am not there to see your responses. I take it the answer
is no.
In the travel ban that the President did implemented
January 31, as I understand it, that only applied to foreign
nationals coming from Wuhan, but it did not include permanent
residents or family members or nationalized American citizens.
Did that significantly limit the benefit of that travel ban?
Dr. Redfield. Thank you for the question, Mr. Congressman.
This is Redfield, CDC.
Mr. Welch. Yes. Very briefly, if you would, because I don't
have more time.
Dr. Redfield. Yes, those individuals, those individuals as
American citizens were qualified to come into America when
allowed. They went into 14-day quarantine.
Mr. Welch. But the quarantine wasn't enforced, is my
understanding.
Let me ask a few other questions about communication. I am
sure that every one of you, who is very careful about your
communications, knows how important that is. When the President
said on February 23, 2020, that the stock market is starting to
look very good, and the coronavirus looks very much under
control, if any one of you agrees with that, can you raise your
hand?
And on February 27th----
ADM Giroir. I am sorry, we didn't, none of us heard that
question. Could you just repeat that?
Mr. Pallone. Peter, could you repeat the question again?
Mr. Welch. What I said is that communication is extremely
important. And we have before us extremely good and careful
communicators, for which I thank them.
On February 23, 2020, President Trump indicated that the
stock market is, quote, starting to look very good, and the
coronavirus is, quote, very much under control.
Does anyone at the table agree with that statement? If so,
raise your hand.
And another statement was that----
Mr. Pallone. Peter. Peter, listen to me.
Mr. Welch. Yes.
Mr. Pallone. You have got to give them a chance to respond,
because you are not here.
Did you hear his question? If you don't want to respond,
that is fine. But I just ----
Dr. Redfield. He asked us to raise our hands.
Mr. Pallone. Oh, I see.
Dr. Fauci. Nobody raised their hand.
Mr. Pallone. OK. So nobody raised their hands. OK.
Next.
Mr. Welch. All right. On February 27th President Trump said
that COVID-19 will disappear like a miracle. Do any of you--did
any of you agree with that statement by President Trump at that
time? If so, raise your hand.
Mr. Pallone. OK. No hands were raised, Peter.
Next.
Mr. Welch. And, finally, President Trump indicated on March
9 that COVID was comparable to the common flu. I heard your
testimony, Dr. Fauci, and you are fearful about the flu making
the situation worse. But do you agree that there is any
comparison between COVID and the common flu? That is for Dr.
Fauci.
Mr. Pallone. You have to put your mike on, Dr. Fauci.
Dr. Fauci. Sorry.
It is not the common flu.
Mr. Welch. OK, thank you. I see my time is up. I yield
back.
Mr. Pallone. All right, thanks a lot.
Mr. Johnson of Ohio is recognized for 5 minutes.
Mr. Johnson. Well, thank you, Mr. Chairman and Ranking
Member Walden, and to our witnesses. Especially our witnesses,
for taking your critical time. The work that you are doing is
so very important. Obviously we are not out of the woods with
this virus yet, so you are still on the front lines of it.
You know, I want to shift gears a little bit and talk about
something I don't think I have heard anybody else talk about.
You know, during this COVID-19 pandemic and the associated
lockdowns and distancing orders, many vulnerable Americans, for
the first time, became isolated and, in many cases, too fearful
or unable to get essential healthcare.
In eastern and southeastern Ohio where I live, and across
rural America, unfortunately this can be the reality even in
normal times. A specialist could be a three-hour-plus drive
away, or a symptom could go unchecked for days because an
elderly person might not have a loved one close by to drive
them to their doctor.
Increased use of telehealth could help alleviate this
problem. Telehealth has been a priority of mine for a long
time, and it has taken on a new sense of urgency with so many
elderly and medically-compromised people finding it potentially
hazardous to leave their homes due to COVID-19.
I am really pleased that President Trump and his
administration used the emergency authority that Congress gave
them to remove the regulations and red tape that had previously
hindered robust deployment of telehealth. And as a result,
countless vulnerable Americans now have access to their doctors
from the safety of their home, ensuring continuity for
essential medical care.
I have heard patient after patient, and provider after
provider, who have taken advantage of these safe, new services.
They love the convenience of it and the immediate access to
care. They tell me they don't want to go back to the way that
it was before.
It is time for Congress to make robust access to telehealth
permanent for all Americans, especially the most vulnerable
among us.
So, Dr. Fauci, I would like to start with you.
Do you believe that telehealth practices, virtual doctor
visits, could be an effective tool in helping to promote--or,
protect vulnerable individuals in the event of a second wave of
COVID-19, or even in a future infectious disease pandemic?
Dr. Fauci. Yes, I do, sir. I believe that telemedicine is a
very important component. It should have been even more
implemented. But as we look forward in the future, I think you
are going to see a lot more of that, not only for the reasons
that you bring out, given the specific situation we are in now,
but for a variety of other situations.
And I think Admiral Giroir has a very keen interest in
this.
ADM Giroir. Thank you. I would just like to emphasize that,
as well, is that I think we have learned tremendous lessons
about the utility of telemedicine, lessons that most of us
thought that would be there.
But for example, just to understand the uptake, the week of
January 15th there were only 500 telehealth visits by Medicare.
The week of April 15th, there was 150,000 of them. We have seen
telehealth visits be instrumental in combating our burgeoning
SUD issues, particularly with opioid use disorder,
teleprescribing, increasing access to buprenorphine.
So, I think all of us with M.D.s behind our name understand
that the whole key is getting healthcare to people where they
are, and not making them come to a major tertiary or quaternary
center, unless they really need to be there. So, we are all
very anxious to increase the use of telemedicine going forward.
Mr. Johnson. OK. Well, Dr. Redfield, you know, during the
last several months we have seen situations where at risk,
elderly, and isolated individuals have missed regular doctor
appointments and preventative health screenings. As one of
America's leading public health experts, can you speak briefly
to the dangers to public health if patients looking to continue
mental health treatment, to check in with their specialists, or
even to consult with their doctor, are not able to do so over
an extended period of time?
Dr. Redfield. Thank you very much, Congressman.
I think it is important to emphasize that, you know, as we
did limit healthcare, largely the purpose was to keep certain
jurisdictions from overwhelming their health systems when we
were working towards the peak.
Unfortunately, with healthcare being broadly limited
across the nation, as you point out, there were real health
consequences. Clearly, an individual's mental health services,
individual's substance abuse services, but also, you know,
individuals, we have a marked decline in childhood
immunization. Many people missed their preventative medicine
visits for mammograms or pap smears or colonoscopies.
So, it is really important that we get the health system
back and operational. And I do think the introduction of
telemedicine is a critical component and something that needs
to stay as part of the innovation, as we work more and more to
move from a disease-based system to a health system. So, I
think it is critical.
We have seen an increase in suicides. We have seen an
increase, obviously, in drug use disorder. It is important to
get these health services back and operational in a manner
which the American public can access.
Mr. Johnson. Well, thank you very much.
And my time has expired. So, Mr. Chairman, I yield back.
Mr. Pallone. Thank you, sir.
Next is the gentleman from New Mexico, Mr. Lujan.
Unmute your connection, there.
Mr. Lujan. Thank you, Mr. Chairman.
Dr. Redfield, under federal statute the CDC is required to
treat tribal epidemiology centers as public health authorities,
and share all data and data sets. Dr. Redfield, last week your
staff indicated in writing that the data sharing issue--what is
that, Mr. Chairman?
Mr. Pallone. Commenting on your artwork. I apologize.
Mr. Lujan. Oh.
Dr. Redfield, last week your staff indicated in writing
that the data sharing issues reported in Politico were merely a
miscommunication with a single tribal epidemiology center. But
that isn't true.
My office has confirmed that this problem goes beyond a
single center and the center's report that they have
encountered problems obtaining other data sets from CDC, beyond
COVID-19.
Dr. Redfield, do I have your commitment to work with each
of the 12 tribal epidemiology centers to sure they get access
to all the data they are entitled to under law?
Dr. Redfield. Yes. The initial episode that you brought up
was obviously a significant miscommunication. But you are
right, that there is still issues to be worked out. Our team is
currently working with the tribal epidemiology center, and we
are committed to correcting that for all tribes.
Mr. Lujan. So, Dr. Redfield, you could direct your staff
right here and now to release that data. Is that something you
are prepared to do?
Dr. Redfield. I didn't hear. I'm sorry, I didn't hear the
question.
Mr. Lujan. Dr. Redfield, you could direct your staff right
here and now to release that data to the tribal epidemiology
centers. Is that something you are prepared to do?
Dr. Redfield. We are working with them as we speak. One of
the keys, Congressman, is to make sure that we have secure data
systems to transport the data. And that is in fact, what our
teams are working to--to finalize that. And as soon as that is
finalized, to maintain the security of the data, it will be
transferred.
I have been told that that is going to be completed,
hopefully, this week or within the next one to two weeks for
all 12 tech directors.
Mr. Lujan. Thank you, Dr. Redfield. And please report to
the Committee when that is done. Thank you.
The Trump administration failed to bring COVID-19 testing
to scale in the early months of the pandemic. Even now, five
months later, testing capacity is nowhere near where America
needs it to be.
On January 31st, Secretary Azar declared COVID-19 a public
health emergency. Five weeks later, on March 6th, President
Trump infamously declared that, quote, anybody that needs a
test can have a test. They are all set. They have them out
there, close quote. Yet, on the same date, fewer than 3,300
tests were completed in the United States.
On April 28th, President Trump said testing in the United
States would surpass five million per day.
Admiral Giroir, yes or no, are we currently in the United
States conducting five million tests per day?
ADM Giroir. No, we are not. We are doing about 500,000
single tests per day.
Mr. Lujan. That's my understand, about half a million
tests.
Now, nearly every leading public health expert agrees that
the centerpiece of reopening the country is robust testing,
tracing, and isolation strategy. One public health expert has
said, quote, the lack of testing has been not only a public
health catastrophe in the U.S., but is also a direct cause of
our economic suffering, close quote.
Admiral Giroir, we have been hearing both proclamations and
promises on increased testing for months now, and every time
they come up short. What is going to be different moving
forward? And how does the United States get to the 50 million
tests promised, particularly in light of the President's
evident lack of concern over the need for testing?
ADM Giroir. Thank you, Congressman, but I disagree with
your question. I don't believe we have come up short every time
we have said something. Since March 12th I have been very
forthright about what we are going to provide, what the
imitations are, what some of the constraints are, and that we
are doing everything possible to increase that.
Right now we are doing about 15 million tests per month.
Although we have need for more testing, our national positivity
rate is about 6.5 percent, so we are certainly getting in the
range. Right now six or seven states are above ten percent. We
have to really surge into those areas.
When I tell you 40 to 50 million tests that is because I
know every single lab producer, what they are doing, when they
are providing it, how they are going to distribute it, and how
many swabs are going to be there. So, the capacity will be
there for 40 to 50 million tests, at least, in the fall. And I
have that provider by provider, material by material.
And, hopefully, it will be much greater than that when we
have pooling, and hopefully some of the new technologies from
the NIH, from BARDA, that we can move into that realm.
Mr. Lujan. Thank you, Admiral Giroir. And I appreciate your
leadership and respect you very much.
The one area where I disagree though, is that President
Trump promised 5 million tests per day very soon, on April
28th, and we are still at only half a million tests each day.
That appears that we have fallen short. So, I continue to look
forward to working with you.
And with that, I yield back, Mr. Chairman.
Mr. Pallone. Thank you, Mr. Lujan.
Next we have Mr. Long, from Missouri.
Mr. Long. Thank you, Mr. Chairman.
And, Dr. Hahn, there are a number of initiatives between
the federal agencies and private industry to accelerate the
entire process for the development, manufacture, and
distribution of COVID-19 therapeutics. The administration
recently established Operation Warp Speed, and FDA has set up a
Coronavirus Treatment Acceleration Program, or CTAP, as they
call it.
Could you talk about the FDA's role in the development of
therapeutics under Operation Warp Speed? And how does the FDA
integrate its work and its own initiatives, like CTAP, with
Warp Speed?
Dr. Hahn. Thank you, Congressman, for the question.
Approximately ten weeks ago, FDA stood up what we call
CTAP, Coronavirus Treatment Acceleration Program, as you
mentioned, and that was for a variety of reasons. One is we
indeed wanted to accelerate the development of therapeutics on
behalf of the American people but do it in a very robust way
that looked at the science and data.
We also, because we had gotten a significant number of
applications and at this point our best estimate is double the
normal of applications that we have during a regular time pre-
COVID, because of that we had to prioritize applications based
upon science and the highest priorities of science. So across
the spectrum of our medical products CTAP allowed us to
prioritize the science and then address those applications,
because what we wanted to do is make sure that we in real-time
with those applications address any questions that developers
had.
I think the other important point here is that we had
people come to the FDA who had never before applied to the FDA
for an application of any sort, whether it be an emergency use
authorization or an IND, and so we really had to hold hands
with industry, with sponsors, with academia, to try to help get
through the process.
I think a great example of what can be done is the work we
did within IND to get the remdesivir protocol up and running
and the speed with which I think it was completed that
ultimately led to a EUA. We are working with all sponsors, sir,
not just Operation Warp Speed, but we are providing all
sponsors, but and including Operation Warp Speed technical
assistance.
What are the trials that we think need to be done, what are
the end points that need to be looked at, how can we accelerate
those clinical trials and the design, and we will continue to
do that as we continue to go through this pandemic.
Mr. Long. OK, thank you.
And Dr. Fauci, could you speak to the HHS's role as part of
the Warp Speed and its efforts to accelerating manufacturing
capacity and ensuring the manufacturers can invest early and
aggressively in vaccine and therapeutic development?
Dr. Fauci. Thank you very much for that question, a very
important question. Congressman, and that was one of the things
I refer to earlier on in the discussion. That as part of the
process of developing the vaccines in Operation Warp Speed that
there is employment of contracting organizations to already
start scaling up development of vaccines, particularly the
first one that I mentioned that will go into a Phase 3 trial in
July has already had contracted through HHS and BARDA, for the
production by a contracting organization of hundreds of
millions doses, ultimately, the first group of which would be
delivered at the end of the year and the rest in the first
quarter of 2021.
Mr. Long. OK, yes. Thank you. I was a little confused in
your opening remarks. Of course, we have been here a long time
today and I can't remember exactly everything that I have
heard, but I was wondering about that so thank you for
clarifying.
And, Dr. Hahn, I will go back to you. Looking long term,
what do you think the FDA and Congress could do to promote
domestic manufacturing of drug therapy?
Dr. Hahn. Congressman, this is a very important issue and I
appreciate you bringing it up. We have seen across the medical
products that we regulate issues related to redundancy in
manufacturing and our dependence particularly in the foreign
sphere where during a public health emergency we might have a
lot of difficulty given the increased demand of having access
to those supplies, both precursor products such as
pharmaceutical precursors as well as final finished form of the
drugs and PPE.
So very much we have been working on our technical
assistance because manufacturers depend upon our technical
assistance to help them develop the manufacturing procedures
that lead to a quality product. We very much are leaning in on
this. It is one of our major initiatives for advanced
manufacturing but also domestic manufacturing. It would be very
good to work with Congress further on this.
I think this is a particularly important lesson learned and
the more we can bring manufacturing home and provide that
redundancy to the supply chain, I think the better off we will
be in the future. Thank you.
Mr. Long. OK. I am getting the red light so I do yield
back. Thank you all.
Mr. Pallone. Thank you, Billy.
Mr. Tonko of New York. Unmute.
Mr. Tonko, are you muted?
Mr. Tonko. Can you hear me?
Mr. Pallone. Yes. Now we can.
Mr. Tonko. OK. Hey, thank you, Mr. Chairman, and thank you
to our panelists for all the information exchange.
Last week, while participating in a telephone town hall
with my constituents, I got a simple question from Ruby in
Schenectady for which I had no good answer. She asked me
straightforwardly, if the government is telling everyone to
wear a mask in public, why does President Trump refuses to wear
one?
So, Dr. Fauci, please help us set the record straight. What
does the evidence tells us about the benefits of face masks or
face coverings when it comes to transmitting or contracting
COVID-19?
Dr. Fauci. Thank you for the question, Congressman. So
although we don't know the exact percentage; we can say very
clearly that wearing a mask is definitely helpful in preventing
acquisition as well as transmission. The data for your wearing
a mask and if you are inadvertently not knowing you are
infected, protecting you from infecting someone else, is
stronger data than the data that says that you will be
protected.
However, everyone agrees in the public health sector that
wearing of masks is beneficial. It may not be perfect, as we
often say wear it and don't let the perfect be the enemy of the
good, it is always better to have a mask on than to not have a
mask on both for acquisition and for transmission.
Mr. Tonko. Thank you. And I listened earlier in the hearing
to my friends and colleagues talk about this spike in numbers
in Texas, and I couldn't help but think that precautionary
efforts come to prime importance. They can be defined and
written or they can be shared by example. And so I,
unfortunately, witness as the President seems to believe he is
above this evidence-based recommendation you just described and
has rejected, or injected, rather, politics into public health.
Not only as he refused to be seen on camera wearing a face
mask, but last week he claimed that some Americans are wearing
masks as a way to signal disapproval of him.
Now I think that, you know, leadership as a form of
precautionary instruction is required of the President and any
of us in elected office. We should be setting the right
example. Does the President's refusal, Dr. Fauci, to wear a
face covering and his efforts to politicize the wearing of face
masks send the wrong message about the advice coming from
public health experts like yourself and others who are at that
expert table?
Dr. Fauci. No, I don't think I can comment on what the
President, the multiple factors that go into the President not
wearing a mask. Certainly, I wear a mask in public all the time
not only because I want to protect others and to protect
myself, but also to set an example. So I guess that answers
your question.
Mr. Tonko. Yes. And have you had any time to advise the
President to wear a mask in public? If so, what was the
response that you received?
Dr. Fauci. I have not directly recommended to the President
to wear a mask, but I think it is very clear to anybody in the
country, because I talk about it so often, of the importance of
having physical distance with a mask and if you are going to be
either beyond your control or by your own choice in a crowd
that it is imperative to wear a mask at all times.
Mr. Tonko. Thank you.
And, Dr. Redfield, let me turn to you. On April 3rd, I
believe, CDC released guidance recommending the use of face
masks or face coverings in public settings such as grocery
stores, and more recently CDC issued recommendations suggesting
that employees that were [audio malfunction in hearing room]
face covering as well as promoting their use when someone is
likely to raise his or her voice such as at a protest for
racial justice or at a political rally.
So what prompted the need for these recommendations and
what does the American public need to know about the use of
face masks and whether and when they should wear them?
Dr. Redfield. Thank you very much for the question,
Congressman. I want to echo the comments Dr. Fauci made. You
know, our recommendations are clear. One of the most powerful
weapons we have against this virus remains as it was before and
that is social distancing, face coverings, and our ability to
practice rigorous hand hygiene.
Clearly, when we recognize that asymptomatic transmission
or pre-symptomatic transmission was significant, that is when
it was clear that we wanted to recommend that all individuals
wear a face covering in order to, you know, protect other
individuals in case they were asymptomatically infected. We
continue to recommend that. Our recent guidance on mass
gatherings, we again tried to illustrate the importance of
trying to maintain social distancing and to wear face
coverings.
And as Dr. Fauci said, in the event that you are not going
to maintain that distance, it is critical that you wear a face
covering.
Mr. Tonko. Well, I think it is unfortunate that like so
much of the administration's response, the message coming from
the White House undermines the message coming from public
health experts [audio malfunction in hearing room] support the
health of the American people.
With that I yield back, Mr. Chair, the balance of my time.
Mr. Pallone. Thank you, Mr. Tonko.
Next is Mr. Flores from Texas.
Mr. Flores. Thank you, Mr. Chairman. I want to thank each
of our witnesses for appearing today. My internet access is a
little bit spotty today, so hopefully you will be able to hear
me.
I want to brag on the Trump administration and the team
witnesses that are here today for the response to the SARS-CoV-
2 spread. First of all, we have several new therapeutics
underway. We have several vaccines under development. We have
had a huge expansion in the supply of testing materials, PPE,
ventilators. The regulatory response to deal with clearing out
the roadblocks that would typically impede the development of
these items has been impressive.
The great example is the huge expansion in telemedicine
which has happened just in the last few weeks despite some of
us trying to promote that for years. Dr. Fauci made a pretty
pointed statement earlier in this hearing talking about the
reason that things are different region by region, and I would
like to talk a little bit about the responses that were done
region by region, so here are some state level statistics on
COVID-19 as of yesterday.
New York State has six percent of the population, but it
has twenty-two percent of the total U.S. deaths. Michigan has
three percent of the U.S. population but it has about five
percent of the total U.S. deaths. If you look at my home state
of Texas, we have nine percent of the population but only two
percent of the deaths.
Now, again, these are all spot values as of yesterday. Of
the top seven states that represent sixty percent of the
deaths, all of those are led by Democratic governors. When you
look at the cases' number of deaths, New York State's fatality
rate is six percent and Michigan's is nine percent, whereas
Texas is three percent.
So what concerns me are the stark differences in fatality
rates and some states' percentage of deaths compared to their
percent of the population. It is obvious that some governors
made big mistakes, but we are not hearing much about that today
in addressing the spread of SARS-CoV-2. It is interesting that
while those governors were complaining about President Trump,
they were ignoring their own populations.
So, specifically, I think we ought to talk about our
elderly at-risk population who contracted COVID-19 and let's
start with these stats. In Michigan, 1,947 patients in long-
term care facilities died from COVID-19. In New York that
number was 6,200. In Florida that number is only 1,637 and this
is despite the fact that Florida has a long-term care
population that is far higher than both Michigan's and New
York's.
In Michigan, state officials declined a proposal to use
new, vacant, unlicensed facilities to house patients who tested
positive for COVID-19. Instead, Michigan put those patients in
nursing homes with other uninfected patients. And as we have
heard previously in this hearing, in New York the health
department ordered nursing homes and rehab centers to accept
COVID-19 patients who were discharged from hospitals. This led
to more than 4,500 patients who tested positive for COVID-19
being put back into long-term care facilities.
Now compare these policies to Florida where state officials
set up isolation centers that focused on treating patients with
COVID-19.
So my questions for Dr. Fauci and Dr. Redfield are as
follows: As I noted, there have been fewer deaths reported in
Florida's long-term care facilities compared to either
Michigan's or New York's despite the long-term care population
of Florida being significantly higher. So can you talk
specifically about these approaches to elderly care and whether
putting COVID-19-positive patients in nursing homes with non-
infected patients was good policy and were the decisions in the
best interest of our seniors?
So, Dr. Fauci?
Dr. Fauci. Well, obviously, if you put someone who is a
potentially infected patient into a nursing home there is a
risk of their being spread. I think you gave a lot of data and
a lot of situations in which there really was a moving target
and whether or not there really was a facility to put
individuals in, so I really feel uncomfortable in commenting
about that because I was having trouble following each and
every one of the data points that you were giving.
But, Bob, do you have any further insight into that one?
Dr. Redfield. Thank you very much, Congressman. Two points.
First, and we are working to try to understand the
multivariance, as you have pointed out, that at least on the
cases there has been differential mortality both in different
jurisdictions as well as within the long-term care facilities
in different jurisdictions and really looking at the
multifactors to see that if they are controlled for whether
there is any difference and that we really don't know at this
point, but we are looking at it.
Mr. Flores. I want to ask you and Dr. Fauci a simple
question. Which state had a better approach to dealing with
elderly patients, Florida or New York?
Dr. Fauci?
Dr. Redfield. He wants to know which state had the----
Dr. Fauci. I don't think I am in a position to evaluate
that. That is not in my purview of anything that I am
responsible for.
Mr. Flores. Dr. Redfield?
Dr. Redfield. I would just say that, clearly, Congressman,
if you look at, as I have said before, consequences and impact,
for me, consequences and impact is obviously morbidity and
mortality. And as you pointed out that the mortality rates in
nursing homes were clearly better in Florida than opposed to
New York, but the causation is what I am not willing to
speculate on, and without doing controlling for the different
variables that we have individuals with the same extent of
comorbidities in those two nursing home settings.
So I think that investigation will be complete and we will
get an understanding of why there is differential mortality in
nursing homes as well as why there is differential mortality in
different jurisdictions as you pointed out.
Mr. Pallone. Thank you, Mr. Flores. Thank you.
Mr. Flores. I ask you to provide that information
subsequently. Thank you. I yield back.
Mr. Pallone. Now we go to Iowa, Mr. Loebsack. Unmute.
Mr. Loebsack. All right, thank you. I should be unmuted. Am
I unmuted?
Mr. Pallone. Yes. You are good.
Mr. Loebsack. OK, thank you. Thank you, Chairman Pallone
and Ranking Member Walden, for this important hearing today and
I want to thank all these witnesses for their expert testimony.
I know it has been a tough several months here for you folks
trying to lead the way through this.
I had hoped also that Administrator Verma would be here
today willing to join the panels. I believe that Congress needs
a fuller understanding of how the administration is meeting the
resource needs of hospitals and nursing homes, but since she is
not here, I do have a few questions for Admiral Giroir as the
Assistant Secretary for Health.
I think that Dr. Fauci kind of answered this question
already, very briefly, but Admiral Giroir, do you believe that
our healthcare providers that are serving on the front line
within our hospitals have the personal protective equipment,
the supplies, the resources that they need today at this
particular moment?
Admiral Giroir. Today at this particular moment, I do
believe they have the supplies that they need. And let me tell
you, when we get a report of a nursing home or another facility
that says they don't have the supplies, literally, we call
those places individually to understand what their needs are.
So at this point in time, I think we are meeting those needs.
Again, the challenge is if the first wave gets worse or we
have a second wave, are we going to be able to meet those
challenges and that is what the S&S 2.0 is, to make sure we
have at least 90 days. Yes, sir.
Mr. Loebsack. No, that is--no. Thanks, I appreciate that.
I want to move on to the future, if you will, but before I
do that I do want to ask every one of the panelists whether he
agrees that it is likely that we will, in fact, see a second
wave. I know there is a lot of controversy, right, as to
whether we are still in the first wave, if you will, and it is
sort of disproportionately--the different regions are kind of
dealing with it in just in different ways and are feeling
different effects as well. But if I could just go down the
panel beginning with Dr. Redfield and truly a simple yes or no
answer, do you believe that it is likely that we will see a
second wave in the fall or the winter?
Dr. Redfield, you first.
Dr. Redfield. Yes, it is simple. I am not sure I would call
it a wave, but I want to make it clear we are going to
experience significant coronavirus infection in the fall and
winter of 2020 and 2021.
Mr. Loebsack. OK. Thank you.
Dr. Fauci?
Dr. Fauci. Yes, certainly there will be coronavirus
infections in the fall and winter because the virus is not
going to disappear. It is too----
Mr. Loebsack. OK, thank you. I appreciate that.
Dr. Hahn?
Dr. Hahn. Congressman, I agree with Drs. Fauci and
Redfield.
Mr. Loebsack. Thank you.
And I left you to last, Dr. Giroir. I am a little bit out
of place there, I apologize, because I do want to ask you about
going forward and in particular what steps is the Department
taking to help hospitals and healthcare providers prepare for a
potential or perhaps likely, if you will, second wave of
surging cases in the coming months?
Dr. Giroir?
Admiral Giroir. OK, thank you. I don't want to take up all
your time because it is really everything from understanding
what the needs are to understanding the supply chains down to
the individual hospital levels. Because, like I said, when we
started out it was impossible to know what supplies were being
used objectively, what ventilators were being used objectively.
We have gone through that--all the way to the therapeutics
that Dr. Fauci has talked about and Dr. Hahn, of course--
remdesivir, steroids, hopefully plasma--all these things and
everything in between. It is really all hands on deck and all
our task forces are still operational including the Hospital
Resilience Task Force, that is not only dealing with COVID, but
if this happens again, we don't want our immunization rates to
plummet. We don't want our mammograms to plummet. We don't want
our colon cancer screenings to plummet.
All of these things were really victims of the COVID
response just like COVID patients were, so we need to fix all
of that.
Mr. Loebsack. All right.
OK, one last question, Dr. Giroir. As you know, hospitals
have struggled dramatically, financially, through all this,
especially when they could no longer perform elective surgeries
because they had to be ready for the COVID patients. And we did
pass legislation here in Congress, obviously, to provide $175
million in direct funding to providers for expenses and lost
revenue.
What is the status, Dr. Giroir, of the next allocations of
the remaining funding that is yet to be distributed from the
provider fund?
Admiral Giroir. Yes. I am sorry. I am going to have to take
that one for the record because the Secretary and the people on
that side are really controlling that but we will be happy to
supply that answer to you from----
Mr. Loebsack. I look forward to that. My time has expired,
anyway, but thank you all. Thank you, Dr. Giroir, and thank
you, Chairman Pallone, and I yield back.
Mr. Walden. Mr. Chairman, before you proceed----
Mr. Pallone. Yes.
Mr. Walden [continue]. There is quite an uproar on social
media about the fact Dr. Fauci has changed face masks and the
implications thereof. Do you have any comment?
Dr. Fauci. I am an avid Washington National fan, so I
thought I would break up this a little bit by putting on my
Washington National face mask.
Mr. Pallone. OK. Thank you.
Next we have Mrs. Brooks.
Mrs. Brooks. Thank you, Mr. Chairman, and thank you all so
very much. We got going thinking about the Nats a little bit.
We miss all of them playing baseball.
I would like to talk a little bit about what you all
suggested with respect to sustainability of funding. Dr.
Redfield, I think for decades we have underinvested in our
nation's public health infrastructure. Can you tell us what is
it we need to do? You all mentioned sustainability, but if you
could, you know, talk with us about what steps would be
necessary. Not just federal government, state and local, what
do we need to do to really think about our public health
infrastructure in this country?
Dr. Redfield. Thank you very much, Congresswoman. It is so
important and I have said this that this now is the time,
because for decades we have underinvested in what I call the
core capabilities of public health, day-to-day analytics that
have predicted data analysis, laboratory resilience, public
health workforce, emergency response form, and then our global
health security around the world.
Mrs. Brooks. And those are all the different things that
you think everyone--state, local, and federal--ought to be
investing in at higher levels.
Dr. Redfield. And we need to do it. And when you look at
it, if you didn't quite palpate it before we are going to
probably spend close to seven trillion dollars, all right,
because of one little virus that came which we recognized very
early. We used the capacity that we have and, you know, I said,
you know, the critics will be there, but we will do the
postmortem when we are done.
We have all done the best that we can do to tackle this
virus and the reality is it brought this nation to its knees.
And I would say now is the time. It requires a sustained
investment in terms of the core capability. Many of you may not
know the nuances of, say, funding for the agency I run, CDC,
but there is no core funding. It is all through different PPAs
that are provided by Congress.
We need core public health funding and many people don't
know that CDC provides up to 70 percent of the public health
funding for every state, local, territory, and tribal health
department in this nation. So we have got to invest in that in
a sustainable way with a purpose that that is core-based
funding.
Mrs. Brooks. And might the states also invest at higher
levels and local governments as well.
Dr. Redfield. I think you said it right there. This needs
to be a partnership.
Mrs. Brooks. Right.
Dr. Redfield. It is not all the burden of the federal
government to invest in public health at the local level. And
the reality, if the public, if your funding of CDC was to go
away tomorrow public health infrastructure across this nation
would just crash. We are right now the backbone of it and it
should be a partnership.
Mrs. Brooks. Thank you.
I want to talk, Dr. Hahn, a little bit about Operation Warp
Speed. It really sounds like an exciting effort. It is a great
project. We are, the United States is the global leader in
vaccine development. But I have to tell you, because we are
working at warp speed and your companies that you are working
with and all of the government agencies and everyone is working
at warp speed, there are many who have concerns about vaccine
safety and efficacy.
And when we get to that point which hopefully is at the end
of this year or early next year where one of these products
breaks through and gets there, what do you want to tell the
American people and the world in many ways about the safety and
the efficacy and the steps that we are taking to make sure that
when that vaccine does break through that it, you know, it will
be safe for everyone to use?
Dr. Hahn. Thank you, Congresswoman Brooks. I really
appreciate the question. And Dr. Fauci, certainly, as a world's
expert can speak to vaccine development, I can tell you from
the regulatory perspective of FDA we have world-leading experts
in the assessment of vaccine safety and efficacy. The world
looks to FDA. The world looks to the U.S. to actually make
those assessments. What I can promise the American people, we
will work with companies. We will work with Operation Warp
Speed to provide the assistance so the right studies are done
with the right information.
But we will independently look at those data and we will
make a decision in the best interest of the American people
with respect to safety and efficacy. We will use science and
data to do that.
Mrs. Brooks. So, Dr. Fauci, maybe I should have started
with you before going to the regulatory side. So what would you
like to say to the American people?
Dr. Fauci. Yes. I think that Dr. Hahn said it very well.
But I just want to emphasize, you know, I think there were some
good intentions about using the word ``Warp Speed,'' but I,
myself, flinched a little because I know that people might
think it is reckless because it is warp speed. It isn't. There
are risks, but the risks are all financial risks and that is
what people need to understand.
They are not compromising the safety at all nor is there
compromise of scientific integrity. When you do a vaccine under
non-emergent conditions there are various steps. And because
companies make investments in this, what they do is they don't
make an investment in this step until they are pretty sure this
step works, and then they go to the next step. And one of the
most important steps is when you start, you know, gearing up to
make many, many doses. You are not going to make an investment
of a half a billion or more dollars to produce doses unless you
know it works.
So what this particular program says, we are going to
assume it is going to work so we are going to put investment in
preparing the sites for Phase 3 even before we knew that the
Phase 1 was successful. We are going to be making doses even
before we know it is effective. So what you are doing is you
are cutting down on time but you are not cutting down on the
process of safety and science, so if you lose, the only thing
you lose is a lot of money.
Now nobody likes to lose a lot of money, but we feel we
would rather lose a lot of money and gain 4, 5, 6, 7 months
than have a result and have to wait 4, 5, 6, 7 months to get
the vaccine.
Mrs. Brooks. Thank you. Thank you. I yield back.
Mr. Pallone. Thank you, Mrs. Brooks.
And now we go to Mr. Schrader from Oregon.
Mr. Schrader. Thank you, Mr. Chairman.
I want to thank everybody here for all the hard work you
are doing.
But I am concerned, very concerned, that the American
people are laboring under some gross misapprehensions as a
result of some of the information that is out there.
Dr. Fauci, what is the average time to develop a vaccine?
Dr. Fauci. It depends on the vaccine and the situation in
which you are doing it. If you are developing a vaccine in the
middle of an outbreak----
Mr. Schrader. I am just asking, what is the average?
Dr. Fauci. About seven years.
Mr. Schrader. All right. And what was the fastest we have
ever done? What is the quickest a vaccine has been developed to
date?
Dr. Fauci. Well, it is probably, I think, the Zika vaccine,
which we developed, was about a year and a half, but it was
never brought to full fruition because Zika kind of
disappeared.
Mr. Schrader. And say there is a vaccine. What is the
probability that a vaccine comes to market actually?
Dr. Fauci. Oh, if it is successful, it is a high
probability.
Mr. Schrader. Well, I am just saying, all these vaccines we
have got out there being developed, what is the probability
they are going to make market entry?
Dr. Fauci. There are more failures than there are
successes.
Mr. Schrader. It is about six percent.
Dr. Fauci. Right.
Mr. Schrader. What is the chance that, even with a vaccine,
this virus will be eradicated? And I would look to flu for a
little bit of an example, influenza. How effective is that
vaccine?
Dr. Fauci. The influenza vaccine is variable because the
virus changes rapidly.
Mr. Schrader. Much like this virus?
Dr. Fauci. We don't know that yet.
Mr. Schrader. Well, we already know it has mutated, right?
Dr. Fauci. Yes. That doesn't make any difference. All RNA
viruses mutate. That doesn't mean they change.
Mr. Schrader. If I was a mother, or a hard-working American
citizen, and I am trying to bank on my family's future, how
long do I wait? I am very worried that many, many Americans are
waiting until there is a vaccine, maybe a year and a half at
best, out there, and that is going to be the panacea, and they
are all going to be OK. I think that is a terrible
miscalculation. I am not blaming anybody here, but it is a
terrible miscalculation on the part of many Americans. So, I am
going to stay home, not go to work, not send my kid to school,
and I am going to hunker down and I am going to be OK. I will
just wait for that vaccine. I think we have to start talking in
terms of vaccine as one of many tools in the toolbox, so we
don't end up in particular problems. Dr. Redfield----
Dr. Fauci. I agree with you completely.
Mr. Schrader. Well, that needs to get out there a little
bit more.
Dr. Redfield, to that end, I am very concerned with the
school year coming up. The CDC never recommended closing
schools this spring. And yet, many, many, many school districts
across the country closed. Right now, the CDC guidance talks
about different considerations. How likely is it that a second-
grader or, frankly, even a teenager, is going to maintain
social distancing of six feet all the time?
Dr. Redfield. I think you know the answer to that,
Congressman.
Mr. Schrader. All right. Thank you. That is a rhetorical
question. I appreciate that.
How about a school bus where you are supposed to have one
child per row? School districts maybe in some states, are much
more flush with money than mine. We can barely afford the
school buses we have now. What is the chance of having three
foot or less----
Dr. Redfield. Yes, I mean, I think you raise the reality.
As we look at----
Mr. Schrader. I am just concerned--I am sorry to interrupt;
I have limited time. And some of these are rhetorical. But I am
just worried that we are making all these pie-in-the-sky public
health perfection recommendations that have no chance in hell
of actually happening at the local level. They don't have the
money. They are dealing with human nature, especially children.
Look, adults aren't much better, from what we can see around
the country. But for children, we have to have recommendations,
I think, that are realistic.
What is the incidence rate of this disease in children?
Dr. Redfield. We still don't know the infection rate in
children, but we do know, when you say ``disease''----
Mr. Schrader. Well, we do know internationally it is less
than two percent.
Dr. Redfield. When you say ``disease''----
Mr. Schrader. And Dr. Fauci makes a correct comment that,
oh, but they can infect others.
It would seem to me a smart use of our precious dollars--I
mean, you talk $7 trillion. We don't have $7 trillion, Doctor.
We spent over $3 trillion, which is twice what we spend in a
year, and we did that in one bloody month, for good reason. And
you guys are showing us good results, and I appreciate that.
But we need to make sure that citizens out there aren't
withholding Johnny and Suzie from going to school because they
think this is all going to be over in a month and a half or two
months. That is what the President tells--that is what we are
telling them, or they are getting that impression. That is
wrong. And if we have kids not going to school, we run the huge
risk of the wealthy kids get a great education online with
their nice moms and dads; the lower-income kids get no
education.
Dr. Redfield. The comment I would like to make is that--it
is so important--the inference of what you are saying is, we
need to use the knowledge that we have now, which we didn't
have then. As you know, CDC did not recommend closing schools.
OK?
Mr. Schrader. Yes, sir. Thank you for that.
Dr. Redfield. And we didn't recommend it because we didn't
think it was a one-size-fits-all. We close schools jurisdiction
by jurisdiction when we see issues in the schools.
So, I do think we have to focus, as we move forward in the
fall. And now--what I said before, on the consequences of this
virus, and those consequences are mortality and hospitalization
and the economy. Right? And I think when you see that, you will
see that different recommendations for the jurisdictions will
come to rise. And as you said, I am pretty confident we are
going to be opening our schools. And your comments are true; we
need to open our schools with the reality of how we expect
those schools to act, based on the consequences of what we
think this virus is going to pay for those individuals in
school. That doesn't mean we don't have to be vigilant about
protecting the vulnerable. We need to work on that in those
families, but no longer does that mean we have to shut down
schools, shut down the economy. It means we have to focus on
how to prevent the consequences of this virus.
Mr. Schrader. Thank you very much. I am sorry for the line
of my questioning.
Mr. Pallone. Thank you.
Mr. Schrader. I yield back.
Mr. Pallone. All right. Now we go to North Carolina, Mr.
Hudson.
Mr. Hudson. Thank you, Mr. Chairman. Thank you for holding
this hearing today and for convening such an esteemed witness
panel.
Admiral Giroir, it is a pleasure to see you. I appreciate
all the work we have done together, particularly on the opioid
epidemic. I want to thank you and all of the distinguished
witnesses for taking time out of your very busy schedules to be
with us here today.
I, first, want to give a lot of credit on our coronavirus
response to President Donald Trump and to the individuals on
this panel who worked tirelessly to get us to where we are. The
Trump administration has taken decisive action early and often
to combat this virus and keep us safe. Eleven days after the
first confirmed case in the United States, President Trump
declared a health emergency and restricted travel from China
and any foreign national who posed a risk of infection. And a
little less than two months after the first confirmed case,
President Trump declared a national emergency.
The same goes for our testing capacity. The Trump
administration has gone from a few thousand tests a day in
March to close to half a million tests a day in June, and
anticipates being able to perform 40 to 50 million tests a
month by September. That is a staggering improvement for a
virus we knew nothing about last year. This is not to mention
the Herculean efforts made on PPE with Project Airbridge and
ventilators with all the public-private partnerships to grow
our capacity.
As we all have grappled with the coronavirus outbreak, we
have all had to acknowledge how little was known about it. Even
months after its arrival, we are still grappling with questions
such as how and if it will mutate, if our immune system can
develop appropriate antibodies, and what, if anything, our
genetic makeup says about our vulnerability to the virus.
What has become clear, though, through all this
uncertainty, is our need for data. Getting the full picture
from the data is important to my district because of racial
disparities. If you look at cases reported by race in
Cumberland County in my district, there were 71 white
individuals, 202 African American individuals, but, then, 638
unknown. I noted in our health hearing last week the disparity
in COVID-19 cases in my district. Fifty-seven percent of the
COVID-19 cases at Cape Fear Valley Hospital in Fayetteville are
in African Americans, despite being just 34.9 percent of the
county population. It is paramount that we have as much data as
possible, so that we can address this issue.
Congress recently required new reporting requirements under
the Paycheck Protection Program and Healthcare Enhancement Act.
Labs are required to submit data to the CDC on a number of
factors to help us understand how and where the virus is
spreading, such as race, ethnicity, age, sex, geographic
region, and other relevant factors. It is important to note,
though, that in most cases lab employees are not actually
interacting with the patient. This makes it important to ensure
that all providers are fully engaged on collecting this data to
obtain the most complete demographic information.
Admiral Giroir, what actions can we take so that all
providers, including those in physician offices and hospitals,
know to collect all of this demographic data?
Admiral Giroir. Yes, we feel very comfortable, but we are
going to continue our efforts to make sure that everyone does
know this. It was guidance that was put out. And again, as you
said, it is essential.
One thing--although the PPP did authorize the Secretary to
make this, there were no enforcement mechanisms in PPP. So we
are enforcing this through emergency use authorization
enforcements of the laboratory tests. So, I just want to put
that just for your information.
But, yes, I am absolutely committed to aggressively getting
this information. It is not only African Americans. African
Americans have suffered horribly with this disease. Latino
Americans are also at very high risk, and the highest risk are
Native Americans and Alaska Natives who suffer even higher
rates. So all these are critically important to us.
Mr. Hudson. Yes, sir. Thank you.
As I noted earlier, the Trump administration has greatly
increased our testing capacity. One area that has had
uncertainty, though, is the serology testing, something that
could help us tremendously as we reopen the economy and people
move back to work.
Commissioner Hahn, in recent months, we have seen a large
number of serology tests enter the market, some decisively not
as accurate as others. The FDA has since taken action to remove
several of these. How is the FDA ensuring that only high-
performance serology tests are available in the U.S. market?
Dr. Hahn. Congressman, thank you for the question. As I
think you know, when we issued our original regulatory
flexibility around serology testing, it was not known
completely how these tests would be used and what the operating
characteristics of them were. Our guidance allowed these to be
used in a real-world setting. At that time, we required the
manufacturers to certify that the tests had been validated. We
found that in some cases that certification was not correct.
And so we developed a partnership with the National Institutes
of Health, NCI, to actually do a U.S. Government independent
validation. And as you probably know, sir, over 20 of those
tests have been taken off the market. We have subsequently
required that all manufacturers provide us with that
manufacturing data, and if they don't, they have to be removed
from the market. We continue to look into that, and we will
continue to follow that policy, sir.
Mr. Hudson. Thank you.
Mr. Chairman, I see my time has expired. So, I will yield
back.
Mr. Pallone. Thank you.
Next, we go to Mr. Kennedy in Massachusetts. Joe, are you
there? Did you unmute? Joe, you have to unmute. I think he is
there, but you are still muted, Joe. Mr. Kennedy, you are
speaking, but we can't hear you. Are you there?
All right. We are going to go on. We will come back to Mr.
Kennedy.
Next is Mr. Cardenas. Mr. Cardenas, unmute. Maybe there is
a technical problem; I don't know.
Mr. Cardenas. Can you hear me now?
Mr. Pallone. Yes. You are recognized for 5 minutes.
Mr. Cardenas. OK Thank you so much. Thank you, Chairman
Pallone and Ranking Member Walden, for holding this important
hearing.
And thank you to the expert witnesses that we have before
us, and we all appreciate all the work that you are able to do
when you are allowed to do it.
This February, there has been a steady flow of reports of
the Centers for Disease Control and Prevention, otherwise known
as the CDC, being sidelined. Its experts have been overruled.
And in the midst of a pandemic, this is unacceptable.
Dr. Redfield, earlier this month you expressed concern that
the CDC's public health messages on COVID-19 weren't resonating
with the public. Dr. Redfield, why hasn't the CDC held regular
media briefings during the pandemic, as the CDC has done during
past public crises, where it can provide clear evidence-based
information directly to the public and where the media can ask
questions? Is it possible the lack of regular and direct
communication from CDC has been contributing to the public's
confusion about how to best protect themselves in this health
pandemic crisis?
Dr. Redfield. Thank you very much, Mr. Congressman.
The CDC has communicated in different ways. Clearly, first
and foremost, we have put out over 1500 guidances or----
Mr. Cardenas. Excuse me, Doctor. Dr. Redfield, the
President has proven very, very clearly that when you get in
front of a podium and you actually have a press conference, you
have a higher likelihood that you are going to reach more
people.
My specific question is, why aren't you having more of
those press conferences like the CDC has done previously?
Dr. Redfield. And I was trying to add that, through our
things, we have had about or we have reached 1.5 billion people
so far. We have regular conferences with the local, state,
territorial, tribal health departments every week almost, and
every day we have special conferences reaching out to special
interest groups, whether it is business, faith communities, et
cetera. We have also had conferences, as you know, and we have
re-instituted our now biweekly press conference with the open
press. And so, I do think that CDC does continue to
communicate, but more at the local level than, let's say, at
the national level.
Mr. Cardenas. Thank you, Dr. Redfield. You actually
answered my question, and I appreciate all the local work you
have been doing. But in the past, the CDC has been more of a
national presence and a voice in previous issues where we have
had health crises. And I hope that you are able to change that
and continue doing your local, but actually be more present on
the national, as the biggest voice on the national stage has
been President Trump. And there is no question that he has
misled the public, certainly with his actions and his words, by
not wearing masks and refusing to do so, and actually telling
the public that he is not going to do that.
In February, Dr. Messonnier with the CDC warned us that the
virus could possibly cause severe disruption to our everyday
life. She was right. Yet, she was contradicted by both the
President and Secretary Azar. And in April, Dr. Redfield, you
confirmed that a second wave of the virus in the fall could be
difficult, and President Trump immediately contradicted you in
real-time. And I will quote him. The President said, ``You may
not even have corona coming back.'' End quote.
Dr. Redfield, do you believe the public would have been
better prepared, and state and local public health officials
better supported to face this pandemic, had CDC and other
public health experts not been ignored or contradicted at the
national level, like the President contradicted you in real-
time?
Dr. Redfield. Well, I think, Congressman, obviously, we
continue to try to get our message out. And I thought Dr.
Messonnier obviously did a service in sharing her perspectives
at that time, in letting people understand what could be on the
horizon, which obviously eventually was on the horizon. I have
tried to do the same in making the American public prepared
that this fall and winter is going to be difficult and we need
to be prepared for it.
Mr. Cardenas. Thank you, Dr. Redfield, and thank you for
complimenting Dr. Messonnier for her bravery and her
willingness to speak up at the moments as necessary.
I am concerned, gentlemen, that we have a problem right
now, that over 120,000 lives have been lost in the United
States due to COVID-19. And yet, the public is still not on the
same page as they should be when it comes to how to protect
themselves, and they are getting mixed messages at the national
level from our leaders. So what I hope and pray is that the CDC
make its presence more aware and more clear with evidence-based
advice to the American people.
And then, also, I have got to hope and pray that--and I am
going to ask some questions to be forwarded back to the
committee as to the misleading statements such as touting the
fact that PPEs have been provided to the American people to the
tune of a few million here and there, when, in fact, some of
you have actually reported that, ideally, we should be in the
billions of PPEs. And I am going to ask those specific
questions, so that the full public can hear the answers and we
can have it on the record of this committee.
My time has expired. I yield back. Thank you.
Mr. Pallone. Thank you.
Next, we go to Mr. Walberg from Michigan.
Mr. Walberg. Thank you, Mr. Chairman.
And thanks to the panel for sticking with us for this
lengthy period of time. And thank you for your work. Whether we
agree or disagree, we are kind of learning this all together,
aren't we, and building it on the fly to some degree.
As we have discussed already, and as you know, there were a
handful, five states to be exact, including my State of
Michigan, where my governor ordered, required through an
executive order, nursing homes to admit COVID-19--positive
patients back into their facilities. This proved to be a
terrible policy, as we found out, with the consequences for our
seniors, with almost 2,000 nursing home residents in Michigan
having died. That is accounting for one-third of our State's
COVID-19 deaths.
Dr. Redfield, some officials in the five states that issued
these executive orders have indicated they were following
guidance from the administration. What guidance? And you used
that term expressly earlier on, and I appreciate that, because
I do think that is what we do give at the federal level when we
talk to the states. But what guidance did HHS and CDC release
as it relates to admitting COVID patients in the nursing homes?
And secondly, what obligations are states under to follow that
guidance?
Dr. Redfield. Thank you very much, Congressman, for the
question, an important question.
CDC did, in fact--and does, in fact--have guidance for
nursing homes. The guidance that you are referring to was
guidance that was grounded in the fact that there were some
situations where the nursing homes were refusing to take any
COVID patients at the time. So, CDC did issue a series of
important prerequisites that the nursing home had to have in
place in order to accept these patients that they had admitted
to the hospital back, when they came back.
Fundamental to that was that they had the appropriate
facilities to isolate that individual; they had the appropriate
infection control capacity to maintain that. So, it really was
not saying you have to take somebody back. It is that you have
to be open to taking care of COVID patients, provided that you
have the capacity to do it correctly.
Mr. Walberg. And correctly is the key thing?
Dr. Redfield. And correctly--and so that that patient
doesn't spread the infection to other individuals. And I think
some of the speeches that we have heard in the press fail to
understand that it is to do it correctly. As you know, over
half of the nursing homes in this nation right now, over 7,000
nursing homes in this nation, have a COVID patient in them. The
question is how to do it correctly and safely.
Mr. Walberg. And save the lives, yes.
Dr. Redfield. And save the lives.
Mr. Walberg. Well, it gets down to data as well. So, let me
ask you, what are the obstacles to collecting and reporting the
data that you are now requiring--and my governor has finally
started to put out--what are the obstacles to collecting and
reporting this data, particularly among seniors living in
nursing homes? And what steps has CDC already taken to improve
data collection from the states?
Dr. Redfield. CMS says now required. As you know, the
nursing homes are reporting their data, and they report it to
CDC, and then, CDC reports it on to CMS. And CMS has it as
actionable.
Right as we sit here today, a majority, over 90 percent of
nursing homes--I think it is north of 80; I think we are
between 80 and 90 percent--are actively reporting through our
system already since that request was required a couple of
weeks ago. And we are working to get all 100 percent of the
nursing homes to be reporting, as required by CMS.
And that data also is complemented--I mentioned earlier
about the ethnic groups and data. That data actually comes in
originally with now all testing. You all have helped us in
that. Now any test that is done for COVID has to come and has a
series of key data points, to include ethnicity and race, so
that we can maintain that for all cases across the country,
independent of if they are a nursing home or not.
Mr. Walberg. Thank you. We hope it helps.
Dr. Fauci, three questions that I have for you relative to
yesterday--the University of Michigan announced its plans for
the fall semester, to consist of a mixture of in-person and
remote classes. As schools prepare for the fall semester, what
factors should they be considering? And I am thinking of higher
education here. What do we know about the transmission of COVID
in young adults that would help inform the decision to reopen
colleges and universities? And thirdly, should reopening look
different for a school like the University of Michigan versus a
school like Hillsdale College in my district with 1500 students
in a rural community?
Dr. Fauci. Yes, all good points. Again, one answer could
probably spill over into each of the questions. You really have
to consider what the state of the epidemic is in the particular
place that you are at. Now, if you have very, very few cases,
like in a small college in a county, I think you can be really
very liberal in the opening.
What schools are doing--and they are doing it in a very
creative way--is to try to make sure that there is separation
enough that you have situations, where, first of all, masks
should be done at all times without exception. You have got to
protect the vulnerables. You have got to allow both faculty as
well as students who are in that category of underlying
conditions to be able to have the capability of either teaching
or learning online. You have to have the capability of, when
you get an infected student, which you invariably will, no
doubt, to be able to remove that student to a safe, comfortable
place for the period of time until they can go back. If you
leave them in the community, you are going to wind up having a
situation that could make the whole thing fall apart. That is
just a few of the things we need to do. But, importantly, you
have got to look at what the status is in your particular
situation.
The other thing is, people who work with the students--
namely, people who feed them, people who clean--they need to be
also paid attention to, because often, be it in a cruise ship
or be it in a nursing home, it is the staff who might bring in
an infection, and then infect the individuals who are in a much
larger group.
Mr. Walberg. Thank you. I yield back.
Mr. Pallone. Thank you.
We are going to go back now to Mr. Kennedy.
Mr. Kennedy. Hopefully this time it works. There you go.
Mr. Pallone. We can hear you.
Mr. Kennedy. All set, Frank? Beautiful.
Mr. Chairman, thank you. Apologies for the interruption
beforehand.
I want to thank our witnesses for being here. And Chairman,
thank you for calling this hearing. And to the witnesses, thank
you for your service and your willingness to stay so long into
the afternoon.
I want to start--this is now about a month ago. I had been
in Chelsea, Massachusetts, a community just outside of Boston
that has a rate of infection roughly six times higher than the
State average. And I was delivering meals at a nonprofit, local
nonprofit there, with food lines longer than I have ever seen
anywhere in the world.
On my way out of the community, I called one of the heads
of the local community health center and I asked what else they
needed for help. The individual I spoke with said that they had
recently received some mapping software and they were looking
for cool spots in the community. I asked him, why cool spots?
Aren't you looking for the hot spots? And he said, no, we know
that everybody is being exposed. What those cool spots will
tell us is where we haven't been testing. You know what the
biggest cold spot was? The public housing facility where, in a
population of 900 people, four had been tested--four.
This administration has failed so completely to prepare our
nation for this pandemic that working communities largely made
up of people that our government and our society have deemed to
be essential, that we require to be essential, they were left
in their wake with no help and nobody.
Just days ago, President Trump stood up before the American
public and told us that he asked his administration to slow the
tests down because what they were viewing was that tests were
accelerating and it was instrumental to his political survival.
And I know that we received testimony today that his statements
here were not true, although the President has also
contradicted that again, saying he does not joke.
But to my people in Massachusetts and our people in
Chelsea--maybe they are predominantly Black and brown, men,
women, and children--this administration's failure to test was
no joke. It has been deadly.
We have nearly 120,000 people that have died, over 2
million that are sick, and 45 million Americans that are out of
work. We are four months into this crisis, and the
administration's best plan to confront the racial inequities
that we are talking about is collecting long-overdue
demographic data. Yes, we need that data.
We know that Black and brown people across this country are
more than twice as likely to die as those who are white from
this virus, and more than six times as likely if you are Black
and in Washington, D.C. In Massachusetts, the positive rate
among Black and brown residents is three times higher than for
white residents.
So, yes, we need more data, but only because the
administration spent months ignoring what advocates had tried
to warn us about in those first months. So, let's talk about
the actions that this administration is taking to confront
these inequities.
Dr. Redfield, I will start with you. The CDC finally
released guidance requiring demographic data from commercial
testing companies earlier this month, but it does not take full
effect until August 1st. Do you believe that that lag time is
acceptable, as thousands are diagnosed still every day?
Dr. Redfield. Thank you very much, Congressman, for your
question.
I can say that we are committed to making sure that we get
comprehensive data, particularly on race and ethnicity, as well
as data on these underlying comorbidities, so we can better
understand----
Mr. Kennedy. I appreciate that. Doctor, we are talking
about collecting it on August 1st for a virus that arrived on
our shores in January and February. I have limited time, but
that wait seems to be quite substantial.
I want to move on because there is news that I think broke
today that indicates that the federal government is going to
stop supporting testing sites in Texas and other states. We see
skyrocketing numbers of cases. Actually just stopping this
federal support for those testing sites, is that going to be
effective at helping to mitigate the spread of the virus?
Admiral Giroir. So, I will take that question. Thank you
very much.
So, the first set of testing sites were 41 sites that were
completely federally run under federal contracts. The retail
sites have now been over 600, and then, the retail sites on
their own are over 1400. There are tens of thousands of testing
sites. The only sites that we sunsetted, with the full
agreement of the governors because I spoke to all of them, were
13 remaining sites, seven that were in Texas that were the 1.0
variety that were ready to go, because there were so many other
sites around them. We matched each site to FQHCs surrounding
them, to retail sites. So we are not withdrawing the support
for well over 2,000 sites. We are just transitioning those 13.
Mr. Kennedy. And very quickly, briefly, because I don't
have much time here, but we have seen 45 million Americans lose
their jobs. Yet, we have an administration that continues to
push the need for work requirements for individuals on
Medicaid.
Yes or no? I will go down the list, starting with Dr.
Fauci. Do you believe that implementing work requirements is
going to be an effective measure to stop the spread of
coronavirus?
Mr. Pallone. We are going to have to just limit you to the
response, Dr. Fauci.
Dr. Fauci. I didn't get the question. I am sorry.
Mr. Pallone. He asked about work requirements.
Mr. Kennedy. Now that 45 million Americans have lost their
jobs, is implementing work requirements an effective way to
stop the spread of coronavirus?
Dr. Fauci. I am not sure I am qualified to answer that
question. I really have not been involved in that.
Mr. Kennedy. I believe you are very qualified to answer
that question, Doctor, respectfully.
Dr. Fauci. I didn't even hear--sir, I am sorry, but I
really didn't even hear the question or understand it. So I am
not trying to evade.
Mr. Kennedy. No, no, no, no. OK. Let me clarify, if the
Chairman would give me one minute.
Given that 45 million people have lost their jobs, and the
administration still continues to move forward in trying to
implement work requirements, will the implementation of work
requirements be helpful at stopping the spread of coronavirus?
Dr. Fauci. Right, yes, I think that would be a problem. I
agree with you.
Mr. Pallone. All right. Your microphone wasn't on, but you
said it would be a problem.
Mr. Kennedy. Thank you. Thank you, Doctor.
Mr. Pallone. All right. We are going to go now from
Massachusetts to Savannah. Mr. Carter?
Mr. Carter. Thank you, Mr. Chairman. And thank all of you
for being here. I appreciate it.
The administration has done an exceptional job, in my
opinion, of increasing testing capacity over the past several
months. And I know that it is our desire and our goal to get
testing to 40 to 50 million tests per month by September. And
in order to do that, we greatly need to expand testing.
I have said that, in order to roll out our economy, we need
two things. First of all, we need robust testing. Secondly, we
need personal responsibility. That is, following the advice of
members of the Coronavirus Task Force in making sure we are
washing our hands, wearing masks, et cetera, et cetera.
Admiral Giroir, earlier you said that 90 percent of
Americans live within 5 miles of a pharmacy or a pharmacist.
And I don't mean to correct you, but it is actually 95 percent
of Americans live within 5 miles of a pharmacist, making them
the most accessible healthcare professionals out there.
I wanted to ask you--and, Admiral Giroir, you and I have
talked about this many times before--do you think the
administration should utilize the pharmacy personnel and the
profession for expanded testing, especially community
pharmacists who can help rural and medically underserved
communities? I know that we have made it to where pharmacists
can provide these tests, but not all pharmacists. And what I am
getting at is if we could get to where in the rural and the
medically underserved communities, the pharmacists there would
be able to do it as well.
Admiral Giroir. So, thank you, Congressman.
Mr. Carter. Admiral, can you respond?
Admiral Giroir. Yes. Thank you, Congressman.
And you know how I feel about this. I think pharmacists are
one of the most underutilized professions in the country, for
their training and their expertise, and also their trust from
the population. And I would just like to put an exclamation
point behind everything you have said.
In order to work with the independent pharmacist even more
than the retail pharmacist--and I am sorry, I know this is your
world--but there is an organization that is sort of an
intermediary between that, that we are working with to make
sure that we could bring more and more of the independent
pharmacists under contract through our community-based testing
program.
But I am all onboard. Whether it is telehealth,
pharmacists, community health workers, we need to get health
into the community, and pharmacists are a great way to do that.
Mr. Carter. Thank you, Admiral.
And I actually have submitted bill text that would do just
this, that all the pharmacists are onboard with. And it is over
at HHS right now. And I would just like to ask all of the
members here of the task force, if you could help me to get
that review completed, so we can move forward, I would
appreciate it.
Also, I wanted to talk--you know, I have been sitting here
listening to colleagues on the other side of the aisle who have
been saying that the administration and this task force has not
done enough to save lives. And as you know, we have talked
about the fact that 42 percent of the COVID have been from .6
percent of the population, and that has been nursing home
residents.
Now I do not in any way consider myself to have more
expertise on communicable diseases than any of the four of you
who are sitting here today. However, I will tell you that, in
my professional career as a pharmacist, I was a consultant
pharmacist and I worked in nursing homes. I spent almost 30
years in nursing homes. So I do know nursing homes, and I know
that is the last place that you want a positive patient to be
at.
And I just want to point out, in fact, I can remember
servicing a 100-bed facility years ago that, for whatever
reason, did not get the flu vaccine, and we lost almost 20
percent of our population in that nursing home as a result of
the flu outbreak, because we didn't get the flu vaccine that
year. So, I have seen this firsthand and I have experienced it.
And that is what upsets me so much about the decision of
some of these governors to put these patients in the nursing
home, which would have been the worst place they could have put
them in. Now I say all of that to say that, you know, I still
believe in humanity, and I don't think any of those governors
who made that decision did it intentionally. And I don't think
they would have done it if they had known what it would have
resulted in.
And I say that to point out to all of us on this committee
and to everyone in Congress that I think the administration has
done an outstanding job, and I think they have saved us. Well,
have they done everything right? No. No, they haven't. And
would they do things differently if they could? Yes. And I
believe that these governors would have done things differently
if they could. But to point fingers and say that no one cared
about saving lives, I think that is despicable, and I don't
think that is fair whatsoever.
Dr. Redfield, I know that you seem to have had a bullseye
on your chest today, for whatever reason. But I know that the
CDC has done some great things and made some great, positive
comments. Can you just tell us some of the useful materials
that you have released from the CDC?
Dr. Redfield. Well, we have put out the guidances really in
a variety of different areas, as you know, and obviously,
focusing on nursing homes; focusing on obviously individual
mitigation steps to limit the spread; focusing on first
responders, healthcare settings.
I will say something about the nursing homes that I really
hope we consider. As we are looking to the fall, I think there
needs to be more serious consideration in jurisdictions that
have multiple nursing homes to look at whether certain nursing
homes are prioritized for COVID patients, just because of the
situation we went through before.
But we continue to put guidance out on them, but going back
to school, going to camp, daycare centers, K through 12--
wherever the American public seems to have a need for guidance,
we either put out a guidance document or we put out what we
call a consideration document, which gives people some better
understanding of the impact of COVID and how they can protect
themselves safely in those particular environments.
Mr. Pallone. Thank you. Thank you, everybody.
Mr. Carter. Thank you, and thank all of you.
And I yield back, Mr. Chairman.
Mr. Pallone. And I just want you to know we have got ten
left. So hopefully, if you have to take a restroom break or
something just go out and come back.
Are you going to be able to stay with us for these ten? We
will try to make it brief.
All right. Mr. Peters of California is next.
You want to unmute, Scott?
Mr. Peters. Yes. I was just getting it.
Thank you, Mr. Chairman. I appreciate the witnesses coming
today. You know, the monumental challenge that our country is
facing has come in large part due to the failure to develop and
deploy sufficient diagnostic testing in time to monitor and
control the spread of the virus.
In February, on the 29th after it became clear that CDC's
tests would not be able to perform, FDA began authorizing the
emergency use of molecular diagnostic tests, and since then FDA
has authorized more than 110 emergency use authorizations--has
issued more than 110 authorizations for diagnostic tests, and
that has done a lot to increase our overall testing capacity.
Unfortunately, we still don't know much about the accuracy
of these tests, and while we might typically expect the tests
to undergo large patient studies to determine the level of
accuracy, the emergency use authorizations require a much lower
standard, so only a small number of validation steps.
While most screening tests will never be 100 percent
accurate, false negatives can lead to devastating consequences.
For example, there have been reports that the White House tests
that they use to screen individuals before they visit the Oval
Office may produce false negatives 20 percent of the time.
So, Dr. Hahn, FDA has said that it has asked test
manufacturers to conduct follow-up accuracy studies on tests
that have received emergency use authorization.
Can you tell us how many of these tests--how many of these
tests have you requested follow-up accuracy testing on and of
that number how many have been shown to be accurate?
Dr. Hahn. Thank you, Congressman, for that question, and I
just want to emphasize the point that you made, which is that
in an emergency situation our EUA authorities allow us to look
at the risk benefit, and early on in a pandemic with limited
numbers of supplies on our--or not supplies, but reagents to
test the actual diagnostic accuracy, we rely upon a certain set
of data to make that decision initially.
We have actually required in the post-marketing setting the
collection of data for a number of companies and they have come
back to us with those data, and we have made adjustments to the
EUAs for those tests.
But even in those situations where we haven't required a
formal post-marketing assessment of the tests, we have
collected on our own and with the companies and with academics
real-world data.
We incorporate all those data into our assessment of the
tests. And I will just take, sir, for a moment, serology tests
where we have taken over 20 off the market based upon our own
independent evaluation in U.S. government.
We will continue to make those efforts and we will continue
to look at those data and adjust our recommendations and tell
end users, be very transparent about the operating
characteristics of the tests so that they can use them in the
best way possible.
Mr. Peters. About how many adverse events reports have you
received on diagnostic tests so far?
Dr. Hahn. Sir, I will have to get back to you with the
exact number. We have received a number, and I mean double-
digit numbers, of reports about all of these tests. But I would
be glad to get those data for you, sir.
Mr. Peters. OK. And just to confirm, if a follow-up
accuracy study comes back and it is shown to be inaccurate, you
have moved and you will continue to move to take those tests
off the market?
Dr. Hahn. Absolutely, sir, and we promise to be transparent
and post that on our website.
Mr. Peters. Thank you very much.
I want to ask Dr. Redfield a question about digital contact
tracing. Do you agree that digital contact tracing tools can
enhance our traditional contact tracing efforts, particularly
proximity tracking tools that use Bluetooth technology to
identify people at risk of COVID-19 infection?
Dr. Redfield. Thank you very much for the question.
Clearly, these new digital technologies that are--have been
developed for contact tracing are important to be evaluated and
to see how they will contribute.
I want to emphasize, though, that first and foremost, the
most important component we believe of contact tracing is the
human capacity to do that, and this is why we are working to
aggressively increase the number of contact tracers.
But we currently are in the process of evaluating it to see
if it is value added.
Mr. Peters. Dr. Redfield, let me just--let me just point
out, because I only have 45 seconds.
Dr. Redfield, let me just point out, I would really think
it would be a shame if we took the technology from the 1980s
and didn't employ the technology that we have today.
Bluetooth technology can tell you who you have been around
within a certain proximity with great accuracy and with great
speed. It can be anonymized so that no one knows who the
particular person is.
But if you have your Bluetooth on, you don't have to know
who you were standing next to at the protest or in the
restaurant or in the bar. If the person's test is positive, it
can go into a system. And Google and Apple, MIT, UCSD are
working on these things.
So, in fact, you could be automatically almost in real-time
warned that you have been in proximity to someone who has
tested positive, and can behave accordingly.
For speed and for accuracy, I hope you will give a good
look to Bluetooth technology because it could be private and it
is certainly more accurate and certainly faster than the
technologies we used back in the 1980s.
We can do better, and I yield back.
Dr. Redfield. Yes. I just want to just emphasize,
Congressman, that we are aggressively evaluating that
technology with Google, Facebook, to actually see how it
impacts it.
So I agree with you, it is really important. We have
programs evaluating each of it in partnership with Google and
Facebook right now, and we will continue.
The question is just to see exactly the best way for this
technology to be used. It is not a question of not seeing it as
something that potentially could be very important.
Mr. Peters. Thank you.
Mr. Pallone. Thank you.
We are going to go to Montana now, Mr. Gianforte.
Unmute, please.
Mr. Gianforte. Thank you, Mr. Chairman. I appreciate the
recognition.
I want to thank all the witnesses for their time today. The
people of Montana appreciate you and all the health
professionals who are working so hard to keep us safe and deal
with this virus.
As we mourn the lives of those lost to COVID-19, we must
also think about how to continue to safely reopen our nation.
Testing is critically important to both help limit the spread
and restore confidence to the public.
Montana has seen an uptick in positive test results but not
a large uptick in hospitalizations. This could be seen as
indicating that increased testing is finding more mild and
asymptomatic cases.
I have heard from hospitals and private labs across Montana
that they would like to provide their own testing services to
help their communities and provide certainty to large employers
as well as rapid response capability for tourists that are
coming to see our national parks and great public lands in
Montana.
Admiral Giroir, there has been an enormous increase in
availability of diagnostic testing since the early stages of
the pandemic. Test manufacturers rapidly scaled up their
production capacity to meet the unprecedented need for testing.
Could you describe for us the administration's
collaboration with the private industry in establishing this
massive diagnostic and serological testing infrastructure and
the availability of supplies for state health agencies as well
as the commercial supply chains?
Adm. Giroir. So thank you, and I will try to be brief
because I know your time is limited.
It has really spanned--as you said, it is a public-private
partnership and we have been working very tightly with FDA as
well because innovation has been key to that.
Just to give you an example, when we opened our first 41
testing sites using nasopharyngeal swabs, which would require a
full PPE and full PPE changes, if we ran those 41 sites full-
blown we would have exhausted 80 percent of the stockpile for
PPE within the first week.
So it was really vital that the FDA was able to work with
sponsors to validate other types of equipment to span our--to
expand our supplies.
Let me just say that the public-private partnership,
whether it is working with the ACLA labs--that is the Quest,
LabCorp, Mayo, BioReference--they have done over half the tests
in the country to date. It has been absolutely critical.
Every laboratory manufacturer that supplies test kits for
these laboratories are working with us. We have a relationship
manager with every one so we know what their limitations are,
can we get around it with the DPA, can we help them with their
supplies, what can we do to maximize the number of tests,
moving forward.
And, again, I will just say with Montana it has been a real
special case because although we have lots and millions and
millions and millions of tests, there are only a few that are
really geared to rural areas and they are in very short supply.
So we have been working very closely to get, for example,
the Sofia test and the point of care to Montana, because you
are not in the middle of New York City where you have the
umpteen million-dollar machines. You are really in a rural area
like in Alaska.
So it's not just the numbers. It's the type and it is mixed
with innovation.
Mr. Gianforte. Great. Thank you, sir. And it sounds like
the public-private partnerships have really been central to
your strategy to scale up testing capacity.
What efforts are ongoing in that area to further develop
public-private partnerships?
Adm. Giroir. They really have been critical because the
public health laboratories are an essential first line of
defense. But as of now, they have only done about 7.5 percent
of the overall testing. So the majority--you know, overall, it
is the hospitals and academic institutions and about half with
the commercial sector.
The swabs--you've jested about swabs--when I dropped into
this on March 12th I thought we had ten manufacturers, 12
manufacturers.
There was one in Italy and one in Maine, and everybody
repackaged the same product and it, you know, was the most--is
the hardest to make, most difficult to get was the only one
that was authorized.
I never thought I would send a C-17 over to Italy, to pack
a C-17 full of swabs. But that is what we needed to do. So the
public-private partnerships, whether it is the manufacturers,
the retailers, and the pharmacists, have been absolutely
essential.
It is really the only way to scale what we need. If you
have a small outbreak you could do it within the traditional
infrastructure. But like in World War II, you know----
Mr. Gianforte. Thank you, sir.
Adm. Giroir [continue]. Everybody has to participate.
Mr. Gianforte. Yes. Thank you, sir.
Commissioner Hahn, in the limited time I have here, a
health professional in Montana wanted me to ask if you have
confidence in the accuracy of the antibody test currently
available, and what steps are being taken to ensure we avoid a
supply crunch for those tests as well?
Dr. Hahn. Thank you, Congressman.
We have authorized over 20 serology tests. My
recommendation to users across the country in, particularly,
public health, is to use those tests that are authorized under
the EUA process with the FDA.
We are undergoing an independent validation of data that
manufacturers have sent to us to ensure that we can actually
corroborate what the manufacturers have sent.
If we are not able to do that, we are asking those and
taking those off the market. We are being very transparent on
our website, and I am very happy to have a conversation with
the health professionals in your state, sir.
Mr. Gianforte. Thank you.
Mr. Pallone. Thank you.
Mr. Gianforte. Mr. Chairman, I yield back.
Mr. Pallone. Thank you.
We are going to go now to Michigan, Mrs. Dingell. We are
coming to you from the Dingell Room there.
Mrs. Dingell. Thank you. Thank you, Mr. Chairman, and I
want to thank all of our witnesses for being here today and
your patience in dealing with all of us.
Believe it or not, there is widespread agreement on
something, which is that we are not going to be able to safely
return to anything resembling what we once knew as normal until
we have a safe and effective vaccine.
In Congress we have moved quickly to facilitate development
of such a vaccine, investing billions of dollars of funding in
BARDA and NIH.
Public and private researchers have taken those resources
and run with them, speeding through the Phase I and Phase II
trials, clinical trials, with multiple companies now announcing
that they are about to begin Phase III trials as soon as next
month or soon after.
This speed is unprecedented, and I want to be very clear as
I ask these questions I am not an anti-vaxxer. Vaccines have
eliminated disease and expanded life spans--extended life
spans.
But as members of this committee have been told many times,
Phase III trials are where the rubber meets the road in
developing a new drug.
It is where you test a new drug in human patients on a wide
scale, evaluating constantly for side effects and, ultimately,
determining the effectiveness of a vaccine.
One of the vaccine candidates which is working with NIH has
announced that their Phase III clinical trial will enroll
30,000 patients and another Operation Warp Speed candidate
company has said it will enroll 8,000 patients.
These are much lower than historical vaccine trials, which
have enrolled 60,000 to 70,000 patients in the past. And I know
that there can be consequences.
I was one of those unlucky people that got Guillain-Barre
after the swine flu shot decades ago. But to this day, I know
the benefits of the swine flu shot far outweighed the risks and
that we must develop this vaccine.
But we have got to talk about important issues so people
believe in this vaccine.
Dr. Fauci, will you explain the importance of testing
larger populations in Phase III clinical trials?
Dr. Fauci. Yes. Thank you very much for that very important
question.
The size of the trial is calculated, really, on a
statistical basis of the number of infections that you might
need to get a certain percentage of efficacy.
So you figure out do you need this level of efficacy or
this level, and how many hits or how many events do you need in
the trial, and it was based on that that the statisticians came
up with a 30,000-person.
I want to point out something that I think you were hinting
at, and I agree with you completely. You want to make sure,
particularly when you have a new vaccine for a brand new
disease, that not only can you get a signal of efficacy but you
really feel good about safety.
And the more people you get in the trial before you release
that vaccine to the public, the more confident you are in the
safety. We are going to have a different kind of an approach,
Congresswoman Dingell, to the Phase III trial.
We are going to have subsets of that that will be looked at
much more carefully for safety, particularly for the concept
and the phenomenon of enhancement, because that is one of the
things we are concerned about that, paradoxically, if you get a
suboptimal response to the vaccine and you do get infected, you
could actually have an enhancement.
So I hear you very, very loud and clear. Safety is a very
important issue and we are going to be paying very close
attention.
You may not have heard, or not, my comment earlier on in
the hearing when I said I wanted to make sure that before we
let a vaccine out to the general public, we are as confident as
to the efficacy as we are of the safety. And I promise you that
I will be an advocate for that very, very strongly.
Mrs. Dingell. I did hear you, and I do trust you. But I
still had to ask the question.
I want to ask Dr. Hahn a question, very quickly. A number
of observers have said that we won't know the vaccine's long-
term safety and effectiveness if we move forward with these too
quickly.
I hear what Dr. Fauci is saying and I know the importance,
but what steps will FDA take to ensure effectiveness in
evaluating data from the clinical trial and will you commit to
receiving that full effectiveness data from Phase III before we
authorize or approve the vaccine?
Dr. Hahn. Congresswoman, thank you very much for the
question, and I just want to reiterate one thing I said earlier
and that is that the science and the data will guide our
decisions.
We have world-class experts at the FDA. We are working on
right now guidance for sponsors and developers of vaccines to
exactly address the question that you are asking.
We will be transparent about that guidance and forward
leaning, and we will work with the sponsors to ensure that the
data we need to make those decisions are available.
And I promise you, ma'am, that we will wait for the data
that we need to make that adjudication around safety and
efficacy.
Mr. Pallone. Thank you, Mrs. Dingell.
Mrs. Dingell. Thank you both.
Mr. Pallone. OK. Now we are going to move to Mr. Veasey of
Texas. Unmute, please.
Marc, are you there?
Mr. Veasey. Can you hear me?
Mr. Pallone. Yes. You are recognized for 5 minutes.
Mr. Veasey. OK. Mr. Chair, thank you very much.
I wanted to ask a question about something disturbing that
I saw in Politico this morning, and it is concerning the data
collections that are underway at CDC.
It was implied in the article that there were attempts to
downplay true statistics, and I was wondering how is CDC
determining the death count that is updated daily?
If you could touch on that, Dr. Redfield, that would be--I
would sure appreciate it.
Dr. Redfield. Thank you very much, Congressman.
There was a report. There was--cases are reported to CDC
from state and territorial local health departments either as
confirmed cases or probable cases.
They come in through different data streams and then they
are verified to get the final numbers. There was a coding
glitch on June 19th from the State of New York where there was
approximately 5,000 cases that were probable cases that the
coding glitch assumed that they were counted in the confirmed
case list.
So that one day there was a 5,000 confirmed case
undercounting, which was--it occurred on the 19th of June. It
was identified on the 19th of June and it was corrected. And
there were no coding glitches that affected deaths.
Mr. Veasey. So let me ask you, so if a patient that--if a
patient has COVID and they die of sepsis, is that still a
COVID-related death? Are you still going to count that as a
COVID-related death?
Dr. Redfield. It depends on how it is coded by the state
health department or the city health department or the county
health department, whoever has jurisdiction for that, because
it is coded at the local level.
Mr. Veasey. So then--so the death count could be a lot
higher than what we are seeing right now on the news?
Dr. Redfield. Yes, I think each coder--each physician tries
to understand on the death certificate what the primary cause
of death was.
Was it COVID that then caused complications that leads to
sepsis, or is it somebody who had an asymptomatic COVID
infection who got hospitalized for, say, a contaminated
infection in their arm and led to sepsis.
So these are individual clinical decisions that are made on
the death certificate.
Mr. Veasey. So based on that, what do you think the actual
COVID death rate is? Would you have the--would you have----
Dr. Redfield. I would continue--yes, I would continue to
rely on the data that we have that is basically reported
through the current reporting system where it is then based on
the death certificate--the actual death certificate that is
defined by the clinician responsible for making that
determination, and that is the numbers that we use.
Mr. Veasey. OK. Thank you very much.
And I wanted to ask Dr. Fauci a quick question with my
remaining time.
Dr. Fauci, there was a grant that was--it was a
coronavirus-related grant that was not renewed and I wanted to
talk with you to make sure that we just get the facts straight
about this because I was really concerned about this.
Does the--do you know why this grant was canceled or if
anyone at the White House or HHS pressured your colleagues to
do so and, specifically, I wanted to talk with you about the
National Institutes of Health.
There was a decision made by the Trump administration to
cancel research on a grant that was specifically focused on
coronavirus emergence while we are in the midst of this
coronavirus pandemic, and it just didn't make any sense to me
why this grant would be canceled.
Dr. Fauci. Is the question you are asking, why was it
cancelled?
Mr. Veasey. Yes. Why was this--why was this grant cancelled
when we are in the middle of this pandemic? It seems like it
would have been very helpful for us to have this research,
considering we know very little about COVID-19.
Dr. Fauci. Right. OK. It was canceled because the NIH was
told to cancel it.
Mr. Veasey. And why were they told to cancel it?
Dr. Fauci. I don't know the reason. But we were told to
cancel it.
Mr. Veasey. OK. Thank you very much, Mr. Chairman. I have
no further questions.
Mr. Pallone. Thank you.
We are going to now go to New Hampshire.
Ms. Kuster, unmute please.
Ann, you got to unmute. Ann, are you there?
Ms. Kuster. I am, and I did unmute, Frank. Can you hear me?
Mr. Pallone. Yes, we can. You are recognized for 5 minutes.
Ms. Kuster. It is so embarrassing. I am sorry. I had
already unmuted and started.
So thank you, Chairman Pallone, for holding this hearing,
and to all our witnesses for your patience today.
In addition to efforts related to the research,
development, and manufacturing of a COVID-19 vaccine, there
will also be work needed to ensure that the vaccine is widely
adopted and equitably distributed, specifically, decisions
about the allocation of the vaccine, efforts to support
provider training, public education, and coverage
considerations to ensure that the vaccine is not only available
but available to everyone in every community, including
communities of color, among immigrants and refugees, those
living in rural areas, and of course, our elders.
In the absence of a vaccine plan from the administration, I
am concerned that attention to this necessary work is being
overlooked and we will repeat the errors and mistakes that were
made earlier in the pandemic.
Admiral Giroir, the framework and documents HHS has
released do not address these details and other factors that
will be critical to reaching COVID vaccination rate goals.
Could you comment on that and the bipartisan letter that
this committee called on the administration to create a
national COVID-19 vaccine plan?
Adm. Giroir. Thank you, ma'am. A very important question.
I am not on that work group. That is Dr. Redfield and, I
believe, Dr. Fauci, and they can answer that question for you.
Ms. Kuster. Great. Thank you. I would appreciate it.
Dr. Redfield. Thank you very much, Congresswoman.
This is a critical area. Just as Dr. Fauci has commented
how important it is that we have begun to take the financial
risk to have these companies be able to start manufacturing----
Ms. Kuster. And I am sorry to interrupt. Our time is short
and the day is long.
Admiral Giroir, what I am asking about is not the creation
of the vaccine. It is a national vaccine plan to equitably
distribute the vaccine.
Dr. Redfield. Right. I was----
Ms. Kuster. I have legislation to require the
administration to create a plan on the equitable distribution.
That is the focus of my question.
Dr. Redfield. Yes. The quick answer is that is part of the
overall working plan and it is in development.
Ms. Kuster. It is not available at this time? When can we
expect it will be available?
Dr. Redfield. I will have to defer that to the Secretary of
Health and the Secretary of Defense that are in charge.
But I can tell you that is an essential part of the current
plan to develop the distribution strategy that will also
address the equitability issue.
Ms. Kuster. My understanding from when Dr. Eric Wright came
before our committee is that it could take up to a couple of
years to manufacture the materials to administer the vaccine
and that those plans had not developed. Do you know about the
manufacturing of the supplies to deliver the vaccine?
Dr. Fauci. That is currently a plan that is under the
purview of a combination of General Gustave Perna, who is one
of the co-leaders of the Operation Warp Speed.
He has been specifically brought in by the Secretary of
Defense to work with the Department of Health and Human
Services to make sure that not only the vaccine itself is
equitably distributed but also that all of the material that is
needed for the proper distribution.
So this falls under his purview and he was specifically
brought in by the Department of Defense to address that issue.
Ms. Kuster. And do you know if there is a plan to promote
public health messaging----
Dr. Fauci. Yes.
Ms. Kuster [continue]. And materials to counter vaccine
hesitations in the country?
Dr. Fauci. Yes. That is a very good question. I am glad you
asked it and I have the opportunity to answer it.
What we are doing is a combination of a couple of things.
We are employing our community activist groups that we had
originally put together during the days when we had the HIV
group and they are now an important part of all of our clinical
trials networks.
So we are going to employ the community outreach mechanisms
that we already have. But also the CDC traditionally over the
years has been very heavily involved in making the
prioritization which usually is the most vulnerable people
first.
But I will let Bob talk about that since----
Dr. Redfield. I will just say, very quickly, that we are
very involved in the critical area you brought up in developing
the communication strategy.
It is going to be fundamentally critical, as well as I
mentioned already we are working on developing the distribution
strategy for--but the communication strategy is very important
and it needs to--it will be beginning to be operationalized
soon, just like we are getting ahead on the manufacturing.
Mr. Pallone. Thank you, Ann.
Ms. Kuster. Thank you. My time is up and I yield back.
Thank you, Mr. Chair.
Mr. Pallone. Thank you.
Now we go to Illinois, Ms. Kelly--Robin Kelly. Please
unmute.
Ms. Kelly. Thank you. Yes, I am. Thank you, Mr. Chair, and
thank you to the witnesses for all their patience.
I also wanted to thank Dr. Redfield and Dr. Fauci for the
extra meetings with the CBC and the Tribal Caucus.
As we have heard, data has been revealed across the
country, including in my district and in the city of Chicago,
minority communities shoulder a disproportionate burden of
COVID-19 cases and fatalities.
The virus has exposed centuries of health inequities
stemming from historically racist policies affecting the social
determinants of health.
As chair of the Congressional Black Caucus Health Brain
Trust, I am concerned by this tragic reality. The most recent
CDC data showed that American Indians and Alaska Natives have a
hospitalization rate approximately five times that of whites.
Black people are hospitalized at four and a half times the
rate of whites, and those who are Hispanic or Latino are
admitted to the hospital approximately four times more often
than white people.
Despite these disparities, CDC's racial and ethnic
demographic data is still extremely lacking. It is my
understanding that 52 percent of reported coronavirus cases in
the U.S. are still missing information on race or ethnicity.
That is why we included a number of requirements in the
HEROES Act that the House passed in May that would require the
federal government to better track and publicly report COVID-19
racial, ethnic, age, sex, and gender data as well as require
the various federal agencies to modernize their data collection
methods to account for inequities.
Dr. Redfield, you have admitted publicly that the
Administration's four-page COVID-19 demographic report was
inadequate, and while you announced that CDC will require all
lab tests to include information about a patient's race,
ethnicity, age, and zip code, the most recent report from CDC
shows that more than half of the data you have is missing
racial and ethnic information.
Consequently, I worry that this is a little too late, and
this new rule lacks a clear enforcement mechanism. What further
actions is CDC taking to address these data gaps? How is the
CDC working with state, local, territorial, and tribal public
health departments and labs to support their efforts to collect
this information across the country?
Dr. Redfield. Yes. Thank you very much, Congresswoman. As
we discussed I think last week, we are continuing to make
progressive progress and to ensure that the requirement to
include the race and ethnicity issue on all tests submitted for
COVID is completed.
There is a progressive improvement, as you--I think you
have noticed. The same with the hospitalizations. I think we
are up to 80 percent now. That is still not where we need to
be. We are working to get to 100 percent, and we are going to
just continue to work with our state, local, territorial,
tribal leaders to get that accomplished, as well as the
laboratories and the hospitals and the long-term care
facilities, because it is critical that we do have that
information, as you point out.
Ms. Kelly. Thank you.
And, Admiral Giroir, what steps is the Administration
taking to gather missing data, including data for minority
neighborhoods and congregate facilities like nursing homes,
jails, and prisons?
Admiral Giroir. I think I caught about half of that, ma'am.
But let me just say that I am sorry. It is the internet
connection.
Mr. Pallone. Robin, repeat it.
Ms. Kelly. What steps is the Administration taking to
gather missing data, including data for minority neighborhoods
and congregate facilities like nursing homes, jails, and
prisons?
Admiral Giroir. So all kind of different very, very
important subgroups that we are working with. I don't think it
is possible on the testing data to reconstruct what the racial
and ethnic makeup is of the tests that were done in March and
April and May. I don't think that is a possibility. Looking
forward, we are absolutely going to mandate that.
On the enforcement mechanisms that you talked about, we
might want some help with that because the authorization did
not have an enforcement mechanism. So we looked very deeply to
do that. We were not able to do criminal/civil monetary
penalties, et cetera, but we are working through the EUA
mechanism.
And I don't want to put too fine a point on it, but I would
like to turn the switch and have this tomorrow. I would have
liked to have had it two months ago, because it really is
critically necessary. We are targeting our resources to those
areas, but not getting all of the feedback of the numbers that
we need.
But one thing, for example, the major reference
laboratories, just to give you an idea of the complexity, they
have done over half the tests. They don't collect any of those
tests. That comes from tens of thousands of individual
physicians, pharmacists, others. So we are working with this
very complex system to make sure each of those tens or hundreds
of thousands of people provide that data, so we can get it.
But you have my personal commitment as a person whose job--
my day job is working on health disparities to make sure we get
this as quickly and as accurately as possible.
Ms. Kelly. Thank you. And my office will be in touch, so we
can work together and we can give you the help that you need.
Thank you so much.
And I yield back.
Mr. Pallone. Thank you.
Ms. Barragan is here. You are recognized for 5 minutes.
Ms. Barragan. Thank you. Thank you, Mr. Chairman, for
having this hearing.
This pandemic is still raging. Over 119,000 Americans have
died, and cases are still rising in 29 states, with over 20,000
new infections per day. In fact, 12 states set records for the
most daily cases in the past week, and we know that Black,
Latinx, and Native Americans are bearing a disproportionate
burden of the Administration's failures to address this
pandemic.
Meanwhile, the Trump Administration seems to have moved on.
The last time the White House task force held a full press
briefing was April 27, and the task force is now winding down.
Admiral Giroir is stepping down as the Administration's testing
czar, despite the fact that we still need to greatly expand
testing.
We still don't have enough tests. We still don't have
enough PPE. We don't have a vaccine, and this fall, we could
see another wave of infections, yet President Trump last month
declared, and I quote, ``We have met the moment, and we have
prevailed.''
Dr. Fauci, do you believe we have prevailed? Has the fight
against COVID-19 been won?
Dr. Fauci. I wouldn't use the word ``prevail.'' I would say
that we are still in the middle of a serious outbreak. There is
no doubt about that.
Ms. Barragan. Instead of devoting his time and effort to
taking this pandemic seriously, President Trump is hosting
campaign rallies, packing thousands of people tightly together
without masks, in direct opposition to the guidance of all
public health experts, just so that he can hear the crowds
chant his name.
Clearly, this President has decided the best strategy to
deal with the greatest threat against this country during his
presidency is to bury his head in the sand and wish it went
away.
Dr. Redfield, as the director of the CDC, your advice to
the President is important now more than ever. Dr. Redfield,
when was the last time you spoke to the President about the
country's response to this pandemic?
Dr. Redfield. Thank you, Congresswoman. As I mentioned
before, the interactions and discussions I had with the
President I will keep to myself. But I do meet with the task
force every----
Ms. Barragan. Dr. Redfield, I am not asking for the content
of your conversation. I am asking when you talked to him last.
Has it been a week? A day? A month?
Dr. Redfield. Again, I am going to stay with my same
answer, that I continue to talk with the task force whenever
the task force meets. And I think----
Ms. Barragan. Thank you, Dr. Redfield. I think the fact
that you won't tell this committee when the last time you spoke
to him, whether it was days or months ago, is a real concern.
Dr. Fauci, when is the last time you spoke to the
President?
Dr. Fauci. About two and a half weeks ago.
Ms. Barragan. Thank you, Dr. Fauci.
Admiral Giroir, when is the last time you spoke to the
President?
Admiral Giroir. It was about two and a half weeks ago as
well, maybe three weeks ago. If you don't mind just me
clarifying, because I do think it is really important. I am
remaining the testing lead. A lot got misconstrued because I
said I was not going to be 100 percent of the time at FEMA,
because my current position also works on ending HIV, substance
use.
So I am still going to maintain the testing lead, but I am
also integrating back into some of my other office functions.
Ms. Barragan. Thank you for clarifying that.
Honorable Hahn, when is the last time you spoke to the
President about the pandemic and the response?
Dr. Hahn. It has been some time since I spoke about the
pandemic response. I did have a conversation in the last couple
of weeks.
Ms. Barragan. Would you say that it had been more than a
month ago?
Dr. Hahn. No, ma'am.
Ms. Barragan. OK. Dr. Fauci, you have been candid in the
past about the shortcomings of the Federal Government's
response and what more is needed. Dr. Fauci, as painful as
these spring shutdowns have been, if we don't put in the effort
now--expand testing, prepare for a second wave, develop
national strategies for contact tracing and vaccinations--could
we see our progress reverse? And could we be forced to shut
down again if cases again get out of control?
Dr. Fauci. In describing what is going on, it is a very
complicated situation and a mixed bag. There are certain parts
of the country, certain areas, cities, states, that have
actually done very well and are following the guidelines that
we put together--the gateway, phase 1, phase 2, phase 3. New
York City is one of them. Actually, Washington, DC., is
another.
There are other areas, other states, other cities, that
have not done so well. I have a considerable concern about
those because I want to make sure that we get everything under
control. It is not there yet. I hope as the weeks and months go
by we will be able to do what you are referring to and mobilize
the identification, isolation, and contact tracing in those
states, the ones that have recently been in the news--Florida,
Arizona, Texas--and those states that are now having a serious
problem.
So it really is a mixed bag. We have some doing really well
and some really in trouble.
Ms. Barragan. Right. But, Dr. Fauci, just to clarify, in
the areas where it may get out of control--and we certainly
know there are states that are doing that now--would you say
that we might have to go backwards and some of the progress may
be taken away and we may have to shut down?
Dr. Fauci. Yes. I wouldn't necessarily--first of all, I
agree with what you are saying. I wouldn't necessarily say an
absolute shutdown/lockdown.
Ms. Barragan. Right.
Dr. Fauci. But if someone is going from gateway to phase 1
to phase 2, and they get into trouble in phase 2, they may need
to go back to phase 1. I don't think they necessarily need to
go back to lockdown.
Ms. Barragan. Thank you. Thank you all.
With that, I yield back.
Mr. Pallone. Thank you.
Now we go to Delaware, Ms. Blunt Rochester. Please unmute.
Ms. Blunt Rochester. Thank you, Mr. Chairman. And thank you
so much to the panel. We know that under normal circumstances
uninsurance, health insurance, the lack of that, as well as the
underinsurance of individuals, is a big problem for our
country. But right now with the current pandemic and the high
unemployment rate, it is an absolute crisis.
I don't want to turn this into a debate about the
Affordable Care Act or Medicaid expansion or any other policy
disputes that we may have. The fact remains that millions of
people in our country are either without health insurance or
they can't afford to use it. And they are especially vulnerable
right now.
There are close to 30 million people without health
insurance in this country. And for those people, it will
undoubtedly be harder to receive testing and treatment. And
when a vaccine is developed, they will likely struggle to
access that vaccine.
Dr. Fauci, as a matter of public health, would you agree
that during a pandemic such as COVID-19 it is in everyone's
interest for people to be quickly tested, treated, and
ultimately vaccinated?
Dr. Fauci. I agree.
Ms. Blunt Rochester. And, Dr. Fauci, if approximately 30
million people in this country can't easily access treatment
and vaccines because they lack health coverage, doesn't that
present a public health risk?
Dr. Fauci. I feel as a physician, a scientist, and a public
health official that everyone should have access to the kinds
of things that we are talking about--testing, as well as
accessibility to a vaccine and healthcare.
Ms. Blunt Rochester. Admiral Giroir, the Administration has
suggested that money from the Provider Relief Fund, which is
supposed to help struggling providers, is how it will pay for
care for the uninsured. When can we expect a comprehensive plan
from this Administration for how it plans to provide treatment
and vaccines to people regardless of insurance status?
Admiral Giroir. The vaccine plan I think is currently
underway, as you heard Dr. Redfield do that. There are--I work
very closely with HRSA on making sure that everyone can get
free testing. That program is underway, and the claims
reimbursement for treatment is up to about $186 million now. So
I know that is ongoing and would be glad to have HRSA or anyone
else answer any specific more questions that you would have.
But I do agree with the premise again that it is absolutely
critical, not only in a pandemic but under any other times,
that people who need testing get the testing, that they get the
healthcare that they need, and most importantly there are no
impediments whatsoever to getting vaccinated.
Ms. Blunt Rochester. I don't know if anyone on the panel
could answer this question, but were there conversations about
expanding Medicaid or opening up enrollment for the ACA to
actually mitigate the risks?
Admiral Giroir. So I am just going to say that I am not a
member of the task force but am at most of the meetings as an
invited guest for obvious reasons. And I think there were
discussions across the board about all options. All options
were looked at and discussed in order to make--it was clear
that the objective needed to be that no one should be waiting
at home in need of care because of a lack of coverage.
And I would say that every option was really looked at, and
the leadership of the Administration at the White House decided
on this way to move forward.
Ms. Blunt Rochester. I will reserve my comment to just say
that I think those options would have been no-brainers.
I championed legislation included in the Heroes Act that
would require insurers to cover COVID-19 treatment with no
cost-sharing, and the Heroes Act also included a provision that
would provide coverage of COVID-19 treatment and vaccines
through Medicaid for everyone who is uninsured.
I sincerely hope our colleagues in the Senate will take up
the Heroes Act, so that we can make sure that everyone in this
country can access the treatment and vaccines they need.
I yield back the balance of my time.
Mr. Pallone. Thank you.
Next is Mr. Soto of Florida. Please unmute.
Mr. Soto. Thank you, Chairman. I want to go through a
little bit of a timeline. On January 23 through 28, President
Trump received two intelligence briefings on the coronavirus
according to White House officials. From early January well
into mid-March, President Trump deliberately misled the
American people into believing the coronavirus was, quote,
``well under control.'' He declared on several occasions,
quote, ``It will disappear.'' And as late as March 12, he
stated, quote, ``It is going to go away.''
The very next day, on March 13, he finally declares the
national emergency. Approximately 50 days passed from the time
President Trump received his first coronavirus intelligence
briefings until he finally declared the national emergency.
Add in six weeks we lost in ramping up testing at the CDC
due to contamination and the results of President Trump's
disastrous response have been deadly, the United States has
more COVID-19 deaths and more cases than any country in the
world. Over 120,000 Americans are dead, 2.4 million Americans
contracted the virus, and the economic fallout has left 43
million Americans out of work.
To argue that President Trump's response has somehow been a
success is really quite astounding. It is our job to conduct
oversight and hold the Administration accountable, regardless
of the American--regardless of your party.
So moving forward, Dr. Fauci, the House has already passed
the Heroes Act, which includes $75 billion in additional
coronavirus testing, contact tracing, and isolation measures.
How important is this funding to our continued efforts to
combat COVID-19 in the United States?
Dr. Fauci. Thank you for that question, Congressman. As we
have said throughout this hearing, clearly testing, even more
widespread testing on a surveillance basis, is absolutely
essential for us to really get a full understanding of the
penetrance of this, particularly among individuals who are
asymptomatic.
So the short answer to your question: it is very important.
Mr. Soto. Thank you. And, Dr. Fauci, how important is this
additional funding to stop recent increases in COVID-19 cases
as seen in my home State of Florida?
Dr. Fauci. Again, in attune with what I just mentioned, the
more that you understand the dynamics of the infection, the
more that you understand the distribution, the more chance you
have of better control for identifying, isolating, contact
tracing, and concentrating the resources in those areas where
you have the most problems. You won't know that unless you know
exactly what the penetrance is in your community.
Mr. Soto. Thank you.
Commissioner Hahn, there is a shortage of remdesivir in
Central Florida in and around my district. Will the FDA be able
to assist us with this shortage? And have we seen other
shortages of remdesivir across the country?
Dr. Hahn. Congressman, really appreciate the question. We
are working closely with HHS, as well as the White House
Coronavirus Task Force, who are responsible for the
distribution of the remdesivir. We do know that we have a
supply in this country, and I am very happy to work with you
and with others.
So I would be glad to have our folks get in touch with
yours to make sure that there is adequate supply for Central
Florida.
Mr. Soto. Thank you, Commissioner Hahn.
Dr. Redfield, we saw after the [audio malfunction in
hearing room] we lost [audio malfunction in hearing room] in
ramping up testing. And now do you think that the United
States' relationship with the World Health Organization is
important to the future of combating the coronavirus, both in
the United States and worldwide?
Dr. Redfield. Thank you very much, Congressman. We continue
to have an important public health relationship with the WHO.
We have had a long history of partnership with them. We are
currently involved in a number of very important public health
efforts--the eradication of polio, responding to the Ebola
outbreak in the DRC, developing our influenza surveillance
system across the Nation, so we continue that partnership at
the scientific and public health level.
Mr. Soto. Thank you, Dr. Redfield. And so it is going to be
very important not to defund the World Health Organization,
since it so important to our national interest.
And with that, I yield back.
Mr. Pallone. Thank you.
And last but certainly not least is Mr. O'Halleran.
Mr. O'Halleran. That always bring a smile to everybody's
face, Mr. Chairman.
Members of the panel, thank you for being here today.
I am going to start out with the forest fire. I have been
at three of them the last week, because my district has eight
going on right now. And when I get to an incident control
meeting, the commander of that incident control team is there,
and then the division managers for that fire are all there,
too, or on the phone and being able to address the issue, as
are all of the community organizations--police, fire, emergency
response groups.
They are all on those meetings, and there are multiple
meetings during the course of the week with the citizens of
those communities at risk. And now I am in a process where I am
trying to figure out how this whole process is working from the
standpoint of we are here now. What has happened happened; we
can't change that. But going forward, how are we going to
address that we have enough of the testing equipment and
training--not training--equipment, the tracing equipment, in
order to address the issues potentially in October, November,
and into the winter?
How are we going to, or will we have, a command and control
system that doesn't include 50 people doing whatever they want
to do, and not any ability to react to hot spots as they occur
as quickly as they should maybe? And are we going to be ready?
Hot spots--Navajo is my district. I have White Mountain
Apache in my district. White Mountain Apache, over 1,500 have
gotten the virus. That is out of 12,000 people. Navajo--the
whole Nation knows what happened on Navajo. It took us weeks to
get enough help up there to be able to address that problem,
and White Mountain Apache is still calling me all the time
saying, ``Where is this? And where is that?''
So it is obvious that we have a shortage right now. How can
we be guaranteed that we are going to have the necessary
equipment and materials to be able to address it coming up
during a flu season and the pandemic at the same time?
And then transparency and accountability. I don't know how
right now you trace transparency and accountability in the
system because it is almost impossible, because nobody takes--
nobody says, ``That was my fault.''
So, and I think every one of your groups has done an
outstanding job. I just can't find out what you are doing on a
regular basis. I hear something on the news, but that doesn't
mean that I really end up knowing what it is.
And so, Dr. Fauci, could you explain to me where we are at
now and how are we going to attack these hot spots and address
all of the issues I just talked about by the fall? And will we
be prepared?
And I guess most of all, is the entire process of--how do
we educate the public that has different ideas and concepts
right now to be able to understand the complicated nature that
all of you have addressed here today and the overwhelming need
to cooperate with one another as America always has?
Dr. Fauci?
Dr. Fauci. You asked a lot there. I will try to be succinct
in my answer. So where we are now, as I mentioned a little bit
ago, that it really is a mixed bag. It is a big country, it is
very heterogeneous, and you can't have essentially a
unidimensional approach to the difference between Arizona and
the things you are responsible for and New York City
metropolitan area.
Some areas have done very well, are well controlled; they
are going through the guidelines to open America. Others that
we have discussed in detail today are doing poorly, and we are
very concerned about them. So you are talking about what about
as we get into the fall, into winter?
The first thing that we would need to do is to try as best
as possible to get the complete outbreak under control, so that
everything is at such a low level that when there are cases
that come up, you can contain them as opposed to mitigating,
where you are essentially chasing after a forest fire that you
just mentioned. Hopefully, we will get that under control soon.
The other thing we need to do is to get the material, which
we are doing--and Admiral Giroir, I am sure, will comment on
that because he has done a phenomenal job of doing that--
getting the PPE, getting the ventilators, getting the equipment
that we need, and have them in store, so that if--and I hope it
is if and not when--but if we ever need them, we will have them
and not be in the situation that we were in in February and
March.
Mr. O'Halleran. Will we have them by October and November?
Dr. Fauci. I believe we will. We certainly will have the
testing that we did not have early on. We will have it by
October.
With regard to the other things, the PPEs and the others,
perhaps Admiral Giroir can help you with that.
Mr. O'Halleran. Thank you.
Admiral Giroir. Thank you. And, again, this is what we
spend all of our time working on under the cooperation with
Department of Defense, FEMA, HHS. We have already talked about
testing. And if you want a person with accountability, it is
me. If we don't have it, you look at me, it is my problem.
But the whole testing infrastructure is really working
together. The laboratory supplies, the laboratory testing, the
NIH program, the BARDA program are all working in synergy, and
I am coordinating all of that to make sure it happens.
In terms of PPE, we have a long--we had a long way to go
because almost nothing was made in the United States. I mean,
literally, almost nothing was made in the United States. I
mentioned earlier that a good example would be the N95 masks,
and Admiral Polowczyk tells me as a result of everything we are
going to have about 180 million per month made in the United
States by the fall. That is ramping up very quickly, so we feel
pretty good about that.
And ventilators were just a good success story. I worked a
lot on the ventilator problem early on. I am an intensive care
physician. That is probably the only thing I do best is work
with children on ventilators. But we were very concerned about
that, and by July we will have about 50,000 in the stockpile.
We only had 19,000 to begin with, but we will have 50,000. So
we think--we know we are going to be in good shape for that.
And I am going to use a word of Dr. Fauci. I am cautiously
optimistic, but I am very cautious, and I still don't sleep
well at night because we have a long way to go.
And I just want to make the point that everyone has made.
It is not like this is all going to happen to us. The American
people have a lot to say about this, and we want to emphasize
following the guidelines, following the phases, avoiding mass
gatherings, wearing these things, using hand hygiene.
We have a lot to say about where this is going to go, but
we all need to continue to work together to make that happen.
Mr. O'Halleran. Thank you, Admiral.
And I yield.
Mr. Pallone. Thank you. Let me thank all of you for bearing
with us for six hours I guess, and a really thorough analysis
of what is going on. So I want to emphasize again, we really
appreciate your being here and your thoughtful responses to
everything. Thank you so much.
And I am going to let you go because I have a long list
here of documents to read for the record, so you don't have to
stay for that, but thank you again.
I want to remind members that, pursuant to committee rules,
they have ten business days to submit additional questions for
the record to be answered by the witnesses who have appeared.
And I ask each witness to respond promptly to any such
questions that you may receive.
And we would like to insert in the record by unanimous
consent the following documents: a letter from the American
Society of Microbiology to the committee dated June 23, 2020; a
letter from the Alzheimer's Association to the committee dated
June 23, 2020; a letter from AFSME to the chairman dated June
23, 2020; a letter from the American Society of Hematology
dated June 23, 2020; graph from Representative Olson on COVID-
19 cases in the Houston area; a statement from Representative
Burgess dated June 23, 2020; and a letter from Ranking Member
Walden on Committee Rule 9(b)(1) dated June 23, 2020.
[The information appears at the conclusion of the hearing.]
Mr. Pallone. And I will repeat again that any member that
wishes to submit an opening statement for the record is
certainly encouraged to do so.
And with that, at this time, the committee is adjourned.
Thank you to everyone.
[Whereupon, at 4:47 p.m., the committee was adjourned.]
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