Road to Recovery: Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain (Hearing, 2021)
Summary
The printed record of a virtual hearing before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, dated February 3, 2021 (Serial No. 117-2), on ramping up COVID-19 vaccines, testing and the medical supply chain. Opening statements are listed for Hon. Anna G. Eshoo, Hon. Brett Guthrie, Hon. Frank Pallone, Jr. and Hon. Cathy McMorris Rodgers; Eshoo calls it the first Health Subcommittee hearing of the 117th Congress. Witnesses are Luciana Borio, M.D., of In-Q-Tel, Julie Morita, M.D., of the Robert Wood Johnson Foundation, Michael O. Leavitt of Leavitt Partners and Greg Burel of Hamilton Grace. Submitted material includes a statement of the Association of American Medical Colleges dated February 2, 2021.
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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“Road to Recovery: Ramping Up COVID-19 Vaccines, Testing, and Medical Supply Chain (Hearing, 2021).”
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[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
ROAD TO RECOVERY: RAMPING UP COVID-19
VACCINES, TESTING, AND MEDICAL SUPPLY CHAIN
=======================================================================
VIRTUAL HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
----------
FEBRUARY 3, 2021
----------
Serial No. 117-2
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
45-081 PDF WASHINGTON : 2022
-----------------------------------------------------------------------------------
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois CATHY McMORRIS RODGERS, Washington
ANNA G. ESHOO, California Ranking Member
DIANA DeGETTE, Colorado FRED UPTON, Michigan
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 BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida DAVID B. McKINLEY, West Virginia
JOHN P. SARBANES, Maryland ADAM KINZINGER, Illinois
JERRY McNERNEY, California H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
PAUL TONKO, New York BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York BILLY LONG, Missouri
KURT SCHRADER, Oregon LARRY BUCSHON, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California TIM WALBERG, Michigan
DEBBIE DINGELL, Michigan EARL L. ``BUDDY'' CARTER, Georgia
MARC A. VEASEY, Texas JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire GARY J. PALMER, Alabama
ROBIN L. KELLY, Illinois, Vice NEAL P. DUNN, Florida
Chair JOHN R. CURTIS, Utah
NANETTE DIAZ BARRAGAN, California DEBBBIE LESKO, Arizona
A. DONALD McEACHIN, Virginia GREG PENCE, Indiana
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
DARREN SOTO, Florida JOHN JOYCE, Pennsylvania
TOM O'HALLERAN, Arizona KELLY ARMSTRONG, North Dakota
KATHLEEN M. RICE, New York
ANGIE CRAIG, Minnesota
KIM SCHRIER, Washington
LORI TRAHAN, Massachusetts
LIZZIE FLETCHER, Texas
------
Professional Staff
JEFFREY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
NATE HODSON, Minority Staff Director
Subcommittee on Health
ANNA G. ESHOO, California
Chairwoman
G. K. BUTTERFIELD, North Carolina BRETT GUTHRIE, Kentucky
DORIS O. MATSUI, California Ranking Member
KATHY CASTOR, Florida FRED UPTON, Michigan
JOHN P. SARBANES, Maryland MICHAEL C. BURGESS, Texas
PETER WELCH, Vermont H. MORGAN GRIFFITH, Virginia
KURT SCHRADER, Oregon GUS M. BILIRAKIS, Florida
TONY CARDENAS, California BILLY LONG, Missouri
RAUL RUIZ, California LARRY BUCSHON, Indiana
DEBBIE DINGELL, Michigan MARKWAYNE MULLIN, Oklahoma
ANN M. KUSTER, New Hampshire RICHARD HUDSON, North Carolina
ROBIN L. KELLY, Illinois EARL L. ``BUDDY'' CARTER, Georgia
NANETTE DIAZ BARRAGAN, California NEAL P. DUNN, Florida
LISA BLUNT ROCHESTER, Delaware JOHN R. CURTIS, Utah
ANGIE CRAIG, Minnesota DAN CRENSHAW, Texas
KIM SCHRIER, Washington JOHN JOYCE, Pennsylvania
LORI TRAHAN, Massachusetts CATHY McMORRIS RODGERS, Washington
LIZZIE FLETCHER, Texas (ex officio)
FRANK PALLONE, Jr., New Jersey (ex
officio)
C O N T E N T S
----------
Page
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 2
Prepared statement........................................... 3
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 4
Prepared statement........................................... 6
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 7
Prepared statement........................................... 9
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 10
Prepared statement........................................... 12
Witnesses
Luciana Borio, M.D., Vice President, In-Q-Tel.................... 13
Prepared statement........................................... 16
Answers to submitted questions............................... 329
Julie Morita, M.D., Executive Vice President, Robert Wood Johnson
Foundation..................................................... 23
Prepared statement........................................... 26
Answers to submitted questions............................... 340
Michael O. Leavitt, Founder and Chair, Leavitt Partners.......... 32
Prepared statement........................................... 34
Answers to submitted questions............................... 347
Greg Burel, President and Principal Consultant, Hamilton Grace... 42
Prepared statement........................................... 44
Answers to submitted questions............................... 359
Submitted Material
Article of January 31, 2021, ```It's a mess': Biden's first 10
days dominated by vaccine mysteries,'' by Tyler Pager, Adam
Cancryn and Joanne Keenen, Politico, submitted by Ms. Eshoo.... 104
Statement of the Association of American Medical Colleges,
February 2, 2021, submitted by Ms. Eshoo....................... 112
Letter of February 3, 2021, from Nancy A. LeaMond, Executive Vice
President and Chief Advocacy and Engement Officer, AARP, to Mr.
Pallone, et al., submitted by Ms. Eshoo........................ 120
Statement of the National Immigration Law Center by Ben D'Avanzo,
Senior Health Policy Analyst, February 3, 2021, submitted by
Ms. Eshoo...................................................... 123
Statement of the Asian & Pacific Islander American Health Forum
by Juliet K. Choi, Chief Executive Officer, February 3, 2021,
submitted by Ms. Eshoo......................................... 130
Letter of January 29, 2021, from Gary L. LeRoy, Board Chair,
American Academy of Family Physicians, to Ms. DeGette, et al.,
submitted by Ms. Eshoo......................................... 139
Statement of the American Psychological Association by Arthur C.
Evans, Chief Executive Officer and Executive Vice President,
February 3, 2021, submitted by Ms. Eshoo....................... 141
Statement of the American Society for Microbiology, February 3,
2021, submitted by Ms. Eshoo................................... 147
Statement of Steven C. Anderson, President and Chief Executive
Officer, National Association of Chain Drug Stores, February 3,
2021, submitted by Ms. Eshoo................................... 149
Report of the National Institutes of Health, ``COVID-19
Vaccination Communication: Applying Behavioral and Social
Science to Address Vaccine Hesitancy and Foster Vaccine
Confidence,'' by Wen-Ying Sylvia Chou, et al., submitted by Ms.
Eshoo \1\
Statement of the American Nurses Association, February 3, 2021,
submitted by Ms. Eshoo......................................... 159
Comment, Docket No. CDC-2021-0002, Centers for Disease Control
and Prevention, by Leslie G. Sarasin, President and Chief
Executive Officer, FMI-the Food Industry Association, January
27, 2021, submitted by Ms. Eshoo............................... 162
Report of the Centers for Disease Control and Prevention,
``Demographic Characteristics of Persons Vaccinated During the
First Month of the COVID-19 Vaccination Program-United
States,'' February 1, 2021, submitted by Ms. Eshoo............. 166
Statement of the National Health Care for the Homeless Council by
G. Robert Watts, Chief Executive Officer, February 3, 2021,
submitted by Ms. Eshoo......................................... 170
Article of December 5, 2020, ``Trump's Operation Warp Speed
promised a flood of covid vaccines. Instead, states are
expecting a trickle.,'' by Christopher Rowland, et al.,
Washington Post, submitted by Ms. Eshoo........................ 172
Article of January 23, 2021, ``U.S. CDC says 41.4 million doses
of COVID-19 vaccines distributed, 20.5 million administered,''
Reuters, submitted by Ms. Eshoo................................ 176
Article of January 21, 2021, ```Pixie dust': Why some vaccine
sits on shelves while shortages intensify nationwide,'' by
Isaac Stanley-Becker and Lena H. Sun, Washington Post,
submitted by Ms. Eshoo......................................... 178
Article of February 1, 2021, ``Thousands of Vaccine Appointments
Canceled as Supply Lags,'' by Lucy Tomkins, New York Times,
submitted by Ms. Eshoo......................................... 182
Article of January 16, 2021, ``Frustrations Boil at Pace of
Vaccinations at Long-Term Care Facilities,'' by Rebecca Robins,
New York Times, submitted by Ms. Eshoo......................... 184
Article of January 31, 2021, ``Trump officials actively lobbied
to deny states money for vaccine rollout last fall,'' by
Nicholas Florko, STAT, submitted by Ms. Eshoo.................. 188
Artile of May 24, 2020, ``Administration leaves testing
responsibility to states in report to Congress,'' by Amy
Goldstein, Washington Post, submitted by Ms. Eshoo............. 194
Article of March 10, 2020, ```It's Just Everywhere Already': How
Delays in Testing Set Back the U.S. Coronavirus Response,'' by
Sheri Fink and Mike Baker, New York Times, submitted by Ms.
Eshoo.......................................................... 197
Report of the Department of Health & Human Services,
``Coronavirus (COVID-19) Testing Plans by State and
Jurisdiction,'' submitted by Ms. Eshoo \1\
Article of July 6, 2020, ``Months Into Virus Crisis, U.S. Cities
Still Lack Testing Capacity,'' by Sarah Mervosh and Manny
Fernandez, New York Times, submitted by Ms. Eshoo.............. 202
Report of the Government Accountability Office, ``COVID-19:
Urgent Actions Needed to Better Ensure an Effective Federal
Response,'' November 2020,bmitted by Ms. Eshoo \1\
Article of January 26, 2021, ``Health Workers Still Face
Shortages Of Critical Medical Supplies,'' by Yuki Noguchi, NPR,
submitted by Ms. Eshoo......................................... 207
Article of December 29, 2020, ``Oxygen supply shortages bedevil
hospitals already overwhelmed by COVID-19 patients,'' by Rong-
Gong Lin II, et al., Los Angeles Times, submitted by Ms. Eshoo. 212
Article of January 5, 2021, ``Warning of Shortages, Researchers
Look to Stretch Vaccine Supply,'' by Sheryl Gay Stolberg and
Sharon LaFraniere, New York Times, submitted by Ms. Eshoo...... 223
Report of the White House, ``National Strategy for the COVID-19
Response and Pandemic Preparedness,'' January 21, 2021,
submitted by Ms. Eshoo \1\
Announcement by the White House, ``President Biden Announces
American Rescue Plan,'' January 20, 2021, submitted by Ms.
Eshoo.......................................................... 229
----------
\1\ The information has been retained in committee files and is
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=111136.
Executive Order, ``Ensuring a Data-Driven Response to COVID-19
and Future High-Consequence Public Health Threats,'' by
President Biden, January 21, 2021, submitted by Ms. Eshoo...... 247
Executive Order, ``Sustainable Public Health Supply Chain,'' by
President Biden, January 21, 2021, submitted by Ms. Eshoo...... 250
Executive Order, ``Establishing the COVID-19 Pandemic Testing
Board and Ensuring a Sustainable Public Health Workforce for
COVID-19 and Other Biological Threats,'' by President Biden,
January 21, 2021, submitted by Ms. Eshoo....................... 255
Article of January 29, 2021, ``Biden Covid Team Derides Trump
Plan While Borrowing Playbook,'' by Josh Wingrove and Riley
Griffin, Bloomberg, submitted by Ms. Eshoo..................... 260
Editorial of January 29, 2021, ``No Good Vaccine Deed,'' Wall
Street Journal, submitted by Ms. Eshoo......................... 266
Commentary of February 1, 2021, ``Why Operation Warp Speed
Worked,'' by Arthur Herman, Wall Street Journal, submitted by
Ms. Eshoo...................................................... 269
Letter of December 18, 2020, from Chip Rogers, President and
Chief Executive Officer, American Hotel & Lodging Association,
to Governor Andrew Cuomo, Chair, and Governor Asa Hutchinson,
Vice Chair, National Governors Association, submitted by Ms.
Eshoo.......................................................... 273
Letter of January 14, 2021, from Chip Rogers, President and Chief
Executive Officer, American Hotel & Lodging Association, to
Jeffrey Zients, Biden-Harris Transition Team, submitted by Ms.
Eshoo.......................................................... 275
Letter of January 27, 2021, from Chip Rogers, President and Chief
Executive Officer, American Hotel & Lodging Association, to Dr.
Jose R. Romero, Chair, Advisory Committee on Immunization
Practices, Centers for Disease Control and Prevention,
submitted by Ms. Eshoo......................................... 277
Blog post of January 5, 2021, ``American Pharmaceutical
Resilience,'' by Scott Lincicome, Cato Institute, submitted by
Ms. Eshoo...................................................... 279
Blog post of January 20, 2021, ``Global Supply Chains and
Economic `Resilience': (More) Evidence from the Pandemic,'' by
Scott Lincicome, Cato Institute, submitted by Ms. Eshoo........ 282
Report of the Department of Defense, ``Coronavirus: Operation
Warp Speed Timeline,'' submitted by Ms. Eshoo.................. 287
Letter of February 2, 2021, from Mary R. Grealy, President,
Healthcare Leadership Council, to Ms. Eshoo and Mr.
Guthrie,bmitted by Ms. Eshoo \1\
Article of January 26, 2021, ``Operation Warp Speed Staffers
Refute Claim Biden Is Starting from Scratch on Vaccines,''
National Review, submitted by Ms. Eshoo........................ 301
Article of January 25, 2021, ``Proud of vaccine success, Warp
Speed's ex-science head talks politics, presidents, and future
pandemics,'' by Jon Cohen, Science, submitted by Ms. Eshoo..... 308
Statement of Premier Inc., February 3, 2021, submitted by Ms.
Eshoo.......................................................... 319
----------
\1\ The information has been retained in committee files and is
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=111136.
ROAD TO RECOVERY: RAMPING UP COVID-19 VACCINES, TESTING, AND MEDICAL
SUPPLY CHAIN
----------
WEDNESDAY, FEBRUARY 3, 2021
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:00 a.m., via
Cisco Webex online video conferencing, Hon. Anna G. Eshoo
(chairwoman of the subcommittee) presiding.
Members present: Representatives Eshoo, Butterfield,
Matsui, Castor, Sarbanes, Welch, Schrader, Cardenas, Ruiz,
Dingell, Kuster, Kelly, Barragan, Blunt Rochester, Craig,
Schrier, Trahan, Fletcher, Pallone (ex officio), Guthrie
(subcommittee ranking member), Upton, Burgess, Griffith,
Bilirakis, Bucshon, Mullin, Hudson, Carter, Dunn, Curtis,
Joyce, and Rodgers (ex officio).
Also present: Representatives Schakowsky and O'Halleran.
Staff present: Jeffrey C. Carroll, Staff Director; Kimberly
Espinosa, Professional Staff Member; Waverly Gordon, General
Counsel; Tiffany Guarascio, Deputy Staff Director; Perry
Hamilton, Deputy Chief Clerk; Stephen Holland, Health Counsel;
Mackenzie Kuhl, Digital Assistant; Aisling McDonough, Policy
Coordinator; Meghan Mullon, Policy Analyst; Kaitlyn Peel,
Digital Director; Tim Robinson, Chief Counsel; Chloe Rodriguez,
Deputy Chief Clerk; Kimberlee Trzeciak, Chief Health Advisor;
C.J. Young, Deputy Communications Director; Sarah Burke,
Minority Deputy Staff Director; Theresa Gambo, Minority
Financial and Office Administrator; Nate Hodson, Minority Staff
Director; Peter Kielty, Minority General Counsel; Bijan
Koohmaraie, Minority Chief Counsel; Clare Paoletta, Minority
Policy Analyst, Health; Kristin Seum, Minority Counsel, Health;
Kristen Shatynski, Minority Professional Staff Member, Health;
Michael Taggart, Minority Policy Director; and Everett Winnick,
Minority Director of Information Technology.
Ms. Eshoo. The Subcommittee on Health will now come to
order.
Good morning, everyone. Due to COVID-19, today's hearing is
being held remotely, obviously, so all Members and witnesses
will be participating via video conferencing. As part of our
hearing, microphones will be set on mute to eliminate
background noise. Members and witnesses, you will need to
unmute your microphone each time you wish to speak. So keep
that in mind.
Documents for the record will be sent to Meghan Mullon at
the email address that we have provided to your staff, and all
documents will be entered into the record at the conclusion of
the hearing.
The Chair now recognizes herself for 5 minutes for an
opening statement.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
I want to welcome everyone to our first Health Subcommittee
hearing of the 117th Congress. It is entitled ``Road to
Recovery: Ramping up COVID-19 Vaccines, Testing, and Medical
Supply Chain,'' all issues that the Members are very familiar
with.
A very warm welcome to all of our new Members, both sides
of the aisle. We look forward to the contributions that you are
going to make. And a very special welcome to Congressman Brett
Guthrie, who is the new ranking member of our subcommittee, and
I look forward to working with him. We all look forward to
working with you, Brett.
Over the past year, our country has undergone truly
profound changes due to COVID-19. I think that the veil has
really been torn off every system and laid bare, what I call
our country's many preexisting conditions, including inequities
of care in communities of color and the inability of too many
Americans having a lack of access or can afford healthcare.
This subcommittee, I think, needs to move quickly and
purposefully to correct these wrongs and do the right thing.
We are in a race against death. We have lost nearly 450,000
of our fellow Americans due to the virus, and as deaths
continue to climb, Native, Black and Latino Americans face the
highest risk. According to the CDC, these communities are
nearly three times more likely to die from COVID-19 than White
Americans.
The previous administration lacked a national strategy to
end the pandemic and administer vaccines to Americans
efficiently, equitably, and effectively. And without effective
Federal coordination for the vaccination campaign, we clearly
are not going to make any progress. I think we are actually
tripping at the starting block, and there are many
manifestations of that in our States and our local communities.
With a new administration, and a new Congress, and a new
commitment, we can optimize a new beginning. The President has
put forward his American Rescue Plan, which recognizes that we
are in a battle to save American lives. It responds to this
crisis with an all-of-government approach, and an all-of-
America wartime plan.
First, the American Rescue Plan provides $20 billion for
national vaccination strategy to increase the supply and the
vaccination sites to fully vaccinate 300 million Americans by
the end of this summer. The plan also creates a public health
core of 100,000 newly hired public health workers to conduct
individual outreach in local communities to address the vaccine
hesitancy and misinformation.
Secondly, it invests $50 billion to scale up testing by
buying rapid tests, expanding lab capacity, and coordinating
the genetic sequencing that is needed to detect the concerning
new variants of the virus.
Third, it invests $3 billion in innovative COVID-19
treatments. While we have effective vaccines to prevent people
from getting the virus, we don't yet have accessible medicines
to treat patients who are sick with it. This plan funds the
research and large-scale clinical trials needed to develop
therapeutics, such as antivirals and antibodies, to help people
recover from the virus.
Fourth, it buys a strong supply of American-made personal
protective equipment. I think that is music to all of our ears.
The plan invests $10 billion to ensure we have sufficient
protective gear by expanding domestic manufacturing.
So together, these public health efforts to crush the virus
will cost $160 billion. The health benefits of this plan are
abundantly clear, but the measures will also aid our economic
recovery.
Last month, President Trump's White House Council of
Economic Advisors estimated that every day our country speeds
up vaccinations saves $10 billion in health and economic costs.
Moody's Analytics found that the American Rescue Plan would
create 7.5 million jobs and add 8 points to the GDP this year.
So I think we have the moral and economic duty to invest in
this plan for the sake of our country, the people that we
represent, and, obviously, our national economy. I hope our
subcommittee is prepared--I believe that we are--prepared to
hit the ground running to move these emergency actions through
our deliberative process.
So I want to thank our very distinguished panel of
witnesses today, including a former Governor, a former top
scientist of the FDA, a former Director of the Strategic
National Stockpile, and the former public health director of
the third-largest American city. Each of you are going to
enlighten and guide our subcommittee on the urgent tasks before
us.
[The prepared statement of Ms. Eshoo follows:]
Prepared Statement of Hon. Anna G. Eshoo
Welcome to the first Health Subcommittee hearing of the
117th Congress and a very warm welcome to the new Ranking
Member Brett Guthrie and the new Members of the Health
Subcommittee.
Over the past year our country has undergone profound
changes due to COVID-19.
The veil has been torn off every system and laid bare the
many ``pre-existing conditions'' in our country. including
inequities of care in communities of color and the inability of
many to access or afford needed healthcare.
This subcommittee must move quickly and purposefully to
correct these wrongs and do what's right.
We're in a race against death. We've lost nearly 450,000 of
our fellow Americans to COVID-19.
As deaths continue to climb, Native, Black, and Latino
Americans face the highest risk. According to the CDC, these
communities are nearly 3 times more likely to die from COVID-19
than white Americans.
The previous administration lacked a national strategy to
end the pandemic and administer vaccines to Americans
efficiently, equitably, and effectively.
Without effective Federal coordination for the vaccination
campaign, we've seen seniors spending hours in line for
vaccinations or wealthier, whiter communities accessing
vaccines ahead of communities of color.
We're tripping at the starting block.
With a new administration and a new Congress, we can
optimize this new beginning. The President has put forward his
American Rescue Plan which recognizes that we're in a battle to
save American lives.
It responds to this crisis with an all-of-government and
all-of-America wartime plan:
First, the American Rescue Plan provides $20 billion for a
national vaccination strategy to increase supply and
vaccination sites to fully vaccinate 300 million Americans by
the end of this summer. The plan creates a public health corps
of 100,000 newly hired public health workers to conduct
individual outreach in their local communities to address
vaccine hesitancy and misinformation.
Second, it invests $50 billion to scale up testing by
buying rapid tests, expanding lab capacity, and coordinating
the genetic sequencing needed to detect the concerning new
variants of the virus.
Third, it invests $3 billion in innovative COVID-19
treatments. While we have effective vaccines to prevent people
from getting COVID-19, we do not yet have accessible medicines
to treat patients who are sick with COVID-19. This plan funds
the research and large-scale clinical trials needed to develop
therapeutics such as antivirals and antibodies to help people
recover from COVID-19.
Fourth, it buys a strong supply of American-made personal
protective equipment. The plan invests $10 billion to ensure we
have sufficient protective gear by expanding domestic
manufacturing.
Together the public health efforts in the American Rescue
Plan will cost $160 billion.
The health benefits of the American Rescue Plan are
abundantly clear, but these measures will also aid our economic
recovery.
Last month, President Trump's White House Council of
Economic Advisors estimated that every day the Nation speeds up
vaccinations saves $10 billion in health and economic costs.
Moody's Analytics found that the American Rescue Plan would
create 7.5 million jobs and add 8 points to the GDP in 2021.
We have the moral and economic duty to invest in the
American Rescue Plan.
I hope this subcommittee is prepared to hit the ground
running to move these emergency actions through our
deliberative process.
I thank the distinguished panel of witnesses who are with
us today, including a former Governor, the former top scientist
of the FDA, the former Director of the Strategic National
Stockpile, and the former public health director of the 3rd
largest American city.
Each of you will enlighten and guide this subcommittee on
the urgent task before us.
Ms. Eshoo. So the Chair now would like to recognize our new
ranking member. We are very proud of you, Brett. Brett has
been--Brett, for new Members, you need to know that Mr. Guthrie
has been a high-value member of our subcommittee. So I will now
call on him in his new capacity as ranking member for 5 minutes
for his opening statement.
Please remember to unmute.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Guthrie. I did, I think so.
Thank you, Chair, for those very kind words. I really
appreciate it very much, and welcome to all the new Members. On
our side of the aisle, you are going to get to know John
Curtis; Neal Dunn, who's a physician; Dan Crenshaw; and John
Joyce, who is a physician as well. So I welcome them to the
committee and all the new members, and all the members.
I want to thank you for holding this important hearing.
My earplugs keeping popping out. Sorry.
Over 441,000 people have died from the COVID-19 pandemic in
the United States, which is greater than the number of American
servicemembers we lost in World War II. I know that all of us
on this committee are committed to stopping this horrible
virus. Specifically, I think we must fully evaluate our
country's response efforts on what has worked and what lessons
we have learned thus far during the COVID-19 pandemic. Our
focus needs to be forward looking in order to make continuous
improvements that will stop this virus. Each of us has a choice
to make. We can stay in our camps and focus on ideological
battles, or we can sit at the negotiating table and get work
done that the American people expect us to do during these
challenging times.
We need to examine ways to further expand testing, use of
therapeutics, and increase vaccine confidence. We also need to
prioritize quick and efficient distribution of vaccines.
Let me be clear: We are not starting from scratch. Without
Operation Warp Speed, we would not have two vaccines that are
currently being administered to Americans, nor potentially
additional vaccines that may be authorized by the FDA in the
near future. The Biden administration has taken credit for a
pathway to 100 million vaccines in 100 days. However, 2 weeks
into the Biden presidency, there have been around 52 million
vaccines distributed and more than 32 million vaccines
administered, thanks to the previous administration's efforts.
As we move forward with vaccine distribution, we will find
ways to improve, and we should explore those. Let us not forget
this is the fastest we have ever had a vaccine move through the
development pipeline and come to market. We never cut any
safety corners, despite the extraordinary speed, and that is
success that should be celebrated.
Additionally, I have I have heard from Kentucky and many
other States that the lack of additional Federal funding for
States who distribute vaccine has been the biggest hiccup. We
had two vaccines authorized, authorized prior to the latest
funding package that was signed into law at the end of
December. Let us not forget that this package was stalled for
months. Valuable time was lost. When we did move forward,
Speaker Pelosi said she moved forward because of a new
President and a new vaccine. The money being sent to the States
2 weeks late, when it needed to be weeks if not months before,
has cost us valuable time.
From my background in manufacturing, I know it takes time,
hard work and detailed planning to get a manufacturing line up
and going. Operation Warp Speed's tireless work on supply
chains and simultaneous manufacturing during clinical trials
meant safe and effective vaccines that were administered to our
healthcare heroes and vulnerable populations within a matter of
days, rather than months, after receiving FDA authorization.
Each State and some large jurisdictions have been given the
opportunity to run their vaccine distribution as they believe
is best for their residents.
I am not sure if anyone here is familiar with Utica,
Kentucky. It is a rural community in my district that I am
proud to represent. I think Frankfurt, our State capital, and
Davis County, can do a better job of taking care of Utica than
being run out of Washington, DC, which is a person who has
probably never stepped foot there. While some States may need
to reevaluate their strategy, there are many States that are
doing quite well with vaccine distribution.
In addition, I think it is key to remember the work the FDA
has done to authorize 320 COVID-19 tests. According to the
COVID-19 tracking project this Monday, we had more than 1.6
million new tests reported in a day. On March 3lst of last
year, we had less than 116,000 new tests reported. Over the
past year, we have seen the development and authorization of
rapid point-of-care diagnostics to reduce instances of delayed
results, tests using saliva samples to eliminate the need for
swabs in short supply, and even a test that is sold over the
counter.
While challenges remain, we have demonstrated that these
type of private industry partnerships and the innovative
products that are a result are essential to successfully
responding to the pandemic.
Lastly, as the Republican leader of the Oversight and
Investigations Subcommittee in the last Congress, I believe
that oversight is a very important aspect of our response. We
have passed around $4 trillion in COVID-19 aid alone. I have
supported much-needed relief for American families, workers,
and small businesses. We must ensure it is being used
effectively and wisely.
And I agree, Madam Chair, that we have an esteemed panel of
witnesses. I look forward to hearing their testimony, along
with my colleagues, hoping my colleagues will join me in
finding solutions and acknowledging how far we have come and
work to get even farther as we go forward.
I yield back.
[The prepared statement of Mr. Guthrie follows:]
Prepared Statement of Hon. Brett Guthrie
Thank you, Chair Eshoo, for holding this important hearing
about the COVID-19 pandemic.Four hundred and forty-three
thousand people have died from the COVID-19 pandemic in the
United States which is greater than the number of American
servicemembers that we lost during World War ll. I believe that
all of us who serve on this committee are committed to stopping
this horrible virus.
Specifically, I think we must fully evaluate our country's
response efforts on what has worked and what lessons we have
learned thus far during the COVID-19 pandemic. Our focus needs
to be forward looking in order to make continuous improvements
that will stop this virus. Each of us have a choice to make--we
can stay in our camps and focus on ideological battles or we
can sit at the negotiating table and get work done that the
American people expect us to do during these challenging times.
We need to examine ways to further expand testing, use of
therapeutics, and increase vaccine confidence. We also need to
prioritize quickly and efficiently distributing vaccines. Let
me be clear: we are not starting from scratch. Without
Operation Warp Speed, we would not have two vaccines that are
currently being administered to Americans, nor potentially
additional vaccines that may be authorized by the FDA in the
near future. The Biden administration is taking credit for the
pathway to 100 million vaccines in 100 days However, two weeks
into Biden's presidency, there have been around fifty million
vaccines distributed and thirty-two million vaccines
administered, largely thanks to the previous administration's
efforts. As we move forward with vaccine distribution, we will
find ways to improve, and we should explore those. Let us not
forget this is the fastest we have ever had a vaccine move
through the development pipeline and come to market. We never
cut any safety corners, despite the extraordinary speed, and
that is a success that should be celebrated.
Additionally, I have heard from Kentucky and many other
States that the lack of additional funding for States to
distribute vaccines has been the biggest hiccup. However, let
us not forget, Pelosi obstructed additional COVID funding for
months. We had two vaccines authorized prior to latest funding
package that was signed into law at the end of December.
From my background in manufacturing, I know it takes time,
hard work, and detailed planning to get a manufacturing line up
and going. Operation Warp Speed's tireless work on supply
chains and simultaneous manufacturing during clinical trials
meant safe and effective vaccines were being administered to
our healthcare heroes and vulnerable populations within a
matter of days rather than months after receiving FDA
authorization.
Each State and some large jurisdictions have been given the
opportunity to run their vaccine distribution as they believe
is best for their residents. Is anyone here familiar with
Utica? It's a rural community in my district that I'm proud to
represent, and I think Frankfort and Daviess County can do a
better job taking care of Utica than a bureaucrat in
Washington, DC, who has probably never stepped foot there.
While some States may need to reevaluate their strategy, there
are many States that are doing quite well with vaccine
distribution.
In addition, I think it is key to remember the work FDA has
done to authorize 320 COVID-19 tests. According to the COVID
Tracking Project, this week, we had more than 1.6 million new
tests reported. At the end of March last year, we had less than
116,000 new tests reported. Over the past year we have seen the
development and authorization of rapid point-of-care
diagnostics to reduce instances of delayed results, tests using
saliva samples to eliminate the need for swabs in short supply,
and even a test that is sold over-the-counter. While challenges
remain, we have demonstrated that these types of private
industry partnerships and the innovative products that result
are essential to successfully responding to this pandemic.
Lastly, as the former Republican Leader of the Oversight
and Investigations subcommittee, I believe that oversight is a
very important aspect of our response. We have passed around $4
trillion in COVID-19 aid alone. I have supported much-needed
relief for American families, workers, and small businesses. We
must ensure it is being used effectively and wisely.
I look forward to the testimony from these esteemed
witnesses and welcome them to this hearing. I hope my
colleagues will join in me in helping find solutions and
acknowledging how far we have come from just a year ago. I
yield back.
Ms. Eshoo. The gentleman yields back.
The Chair now recognizes the chairman of the full
committee, Mr. Pallone, for his 5 minutes for his opening
statement.
And, Frank, you need to unmute.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairwoman Eshoo. And I want to, as
you did, welcome everyone back for our first Health
Subcommittee hearing of the 117th Congress.
There is no more pressing issue to begin with than the
ongoing COVID-19 pandemic and our response so far and our need
to increase vaccinations, testing, and mitigation of building a
robust supply chain.
This pandemic has taken a devastating toll on communities
all around the country. As Members of Congress, we have to do
everything we can to ensure that this new administration has
all of the tools and resources it needs to crush the virus.
With President Biden in the White House, I am confident
that we can move forward with comprehensive actions to stem the
tide on the virus. One of the first orders of business will be
jump-starting and sustaining a robust vaccination program.
After the scientific breakthrough of two safe and effective
COVID-19 vaccines, and hopefully more on the way, we must do
more to confront the challenge of getting the vaccine into
people's arms.
Unfortunately, the Trump administration failed to prepare
and provide reasons for a national vaccination campaign, and
never developed a comprehensive national vaccine plan. Instead,
the administration pushed all responsibility for distributing
and administering vaccines to the States, and then they made
that job nearly impossible when they opposed providing the
States with additional resources to do so. And this failure of
leadership led to only 3 million Americans being vaccinated by
the end of the year, far short of the 20 million that the Trump
administration had promised.
Yesterday, we heard at our O&I Subcommittee, we heard from
States on the front lines about these vaccination challenges.
While we were pleased to hear about how they have improved
vaccination rates in recent weeks, they underscored the need
for additional resources and clear, consistent communication as
they work to get the vaccines in people's arms. And their
insight is critical as we chart a better path forward.
In December, Congress stepped up and provided $8.75 billion
for vaccine distribution activities, including $4.5 billion to
States in the final omnibus and COVID relief package. And so,
vaccination rates are increasing, but if we are to accelerate
both production and vaccinations, more resources are needed,
especially resources dedicated to the most vulnerable, hard-to-
reach Americans.
And the same can be said for ongoing needs related to
testing and contact tracing. From the early days of the
pandemic, public health experts and House Democrats were
calling for a comprehensive national testing strategy that
would ensure testing supplies were allocated efficiently, and
tests were available to all who needed them. But,
unfortunately, just like with vaccines, the Trump
administration never created a comprehensive national testing
strategy, and turned over virtually all responsibilities to the
States, with little support or guidance.
Now, I want to emphasize testing again. Testing reagents
and supplies, like pipettes, have continued to face shortages,
and as new outbreaks have occurred, new bottlenecks in testing
have followed. And while we work to vaccinate all Americans,
access to reliable, efficient, and speedy testing, contact
tracing, and mitigation support will continue to be critical if
we are to reduce transmission and community spread.
And we also need a more robust and reliable medical supply
chain. While States are administering more COVID-19 vaccines,
they are running up against supply shortages of doses, but also
the ancillary medical supplies, such as syringes that are used
to extract every available dose, and while some early
therapeutics have been authorized by the FDA, their limited
availability has also curbed their impact. And so, we also
continue to face supply challenges for administering tests,
like reagents and swabs, and supply challenges remain for
critical personal protective equipment for medical personnel,
including in nursing homes, vaccinators, and the public health
workforce.
So I am pleased that President Biden has taken swift and
decisive action to improve our response to the pandemic, as you
mentioned, Madam Chair, but crushing the virus requires more
action from Congress.
President Biden has proposed the American Rescue Plan,
which includes $20 billion in funds for vaccine distribution
administration, public awareness, and additional resources for
improving our supply of vaccines. It invests $50 billion for
testing and contact tracing, including expanding community-
based and mobile testing sites, and it includes $10 billion to
help support expansion of medical supply manufacturing
capacity.
So, Congress needs to move President Biden's American
Rescue Plan as quickly as possible. I know their process is
beginning on the floor this afternoon, and I look forward to
hearing from our witnesses about their thoughts on the Nation's
response to the pandemic so far and how we can improve going
forward.
So thank you again, Madam Chair, for this important hearing
of the Health Subcommittee.
I yield back.
[The prepared statement of Mr. Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
I want to welcome everyone back for our first Health
Subcommittee hearing of the 117th Congress. There is no more
pressing issue to begin with than the ongoing COVID-19
pandemic, our response so far, and our need to increase
vaccinations, testing, and mitigation, and building a robust
supply chain.
This pandemic is taking a devastating toll on families and
communities all around our Nation. More than 440,000 Americans
have died from this terrible virus, and the Centers for Disease
Control and Prevention has projected that number will grow to
more than 500,000 before the end of the month. As Americans, we
mourn every loss. As Members of Congress, we must do everything
we can to ensure this new administration has all the tools and
resources it needs to crush COVID-19.
With President Biden in the White House, I am confident
that we can move forward with comprehensive action to stem the
tide on this virus, bring relief to struggling families, and
rebuild our economy.
One of the first orders of business will be jumpstarting
and sustaining a robust vaccination program. After the
scientific breakthrough of two safe and effective COVID-19
vaccines, and hopefully more on the way, we must do more to
confront the challenge of getting the vaccines into people's
arms.
Unfortunately, the Trump administration failed to prepare
and provide resources for a national vaccination campaign, and
never developed a comprehensive national vaccine plan. Instead,
the administration pushed all responsibility for distributing
and administering vaccines to the States and then they made
that job nearly impossible when they opposed providing the
States with additional resources to do it. This failure of
leadership led to only 3 million Americans being vaccinated by
the end of the year--far short of the 20 million the
administration had promised.
Yesterday, we heard from States on the front lines about
these vaccination challenges. While we were pleased to hear
about how they have improved vaccination rates in recent weeks,
they underscored the need for additional resources and clear,
consistent communication as they work to get vaccines in arms.
Their insight is critical as we chart a better path forward.
In December, Congress stepped up and provided $8.75 billion
for vaccine distribution activities, including $4.5 billion to
States in the final omnibus and COVID relief package.
Vaccination rates are increasing but if we are to accelerate
both production and vaccinations, more resources are needed,
especially resources dedicated to the most vulnerable, hard-to-
reach Americans.
The same can be said for ongoing needs related to testing
and contact tracing. From the early days of the pandemic,
public health experts and House Democrats were calling for a
comprehensive, national testing strategy that would ensure
testing supplies were allocated efficiently and tests were
available to all who needed them. Unfortunately, just like with
vaccines, the Trump administration never created a
comprehensive, national strategy and turned over virtually all
responsibilities to the States, with little support or
guidance.
Testing reagents and supplies like pipettes have continued
to face shortages, and as new outbreaks have occurred, new
bottlenecks in testing have followed. While we work to
vaccinate all Americans, access to reliable, efficient, and
speedy testing, contact tracing, and mitigation support will
continue to be critical if we are to reduce transmission and
community spread.
We also need a more robust and reliable medical supply
chain. While States are administering more COVID-19 vaccines,
they are running up against supply shortages of vaccine doses,
but also the ancillary medical supplies such as syringes that
are used to extract every available dose. And while some early
therapeutics have been authorized by the FDA, their limited
availability has curbed their impact. We also continue to face
supply challenges for administering tests, like reagents and
swabs. And supply challenges remain for critical personal
protective equipment for medical personnel, including in
nursing homes, vaccinators, and the public health workforce.
I am pleased that President Biden has taken swift and
decisive action to improve our response to the pandemic, but
crushing the virus requires more action from Congress, as well.
President Biden has proposed the American Rescue Plan, which
includes $20 billion in funds for vaccine distribution and
administration, public awareness, and additional resources for
improving our supply of vaccines, therapeutics, and ancillary
supplies. It invests $50 billion for testing and contact
tracing, including expanding community-based and mobile testing
sites. And it includes $10 billion to help support expansion of
medical supply manufacturing capacity.
Congress needs to move President Biden's American Rescue
Plan as quickly as possible. I look forward to hearing from our
witnesses about their thoughts on the Nation's response to the
pandemic so far and how we can improve going forward.
Ms. Eshoo. The gentleman yields back. We thank him for his
opening statement.
The Chair now recognizes Representative Cathy McMorris
Rodgers, our new ranking member of the full committee, for her
5 minutes for an opening statement.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Good morning, everyone. Thank you, Madam
Chair and Republican Leader Guthrie, for holding this important
hearing.
Exactly one year ago today, news outlets were reporting
that the global death toll from the coronavirus was 362, with
all but one of those deaths occurring in mainland China. A year
later, this heartbreaking number has surpassed 2 million, with
over 425,000 of these tragic deaths occurring in the United
States. This pandemic has wreaked havoc on our way of life. The
loss of life has been devastating.
Our previous booming economy has been decimated. Our mental
health crisis has only worsened, and the long-term impact of
our children being kept out of the classroom is incalculable.
Last Congress, we put our political differences aside to
make extraordinary investments in the fight against COVID-19
through five separate bipartisan relief packages. These
included providing over $30 billion for the States,
territories, and Tribes for testing, vaccine distribution,
contact tracing, and public health infrastructure improvement;
and over $23 billion to the Biomedical Advanced Research and
Development Authority for the research, development, and
manufacture of novel vaccines, tests, and treatments; and $178
billion for healthcare providers on the front lines of taking
care of patients with COVID-19.
This investment and partnership with the private sector has
led to unprecedented development of innovative vaccines and
treatments coming to market faster than we ever thought
possible. Operation Warp Speed is one of the most ambitious and
successful undertakings in American history, with two
lifesaving vaccines now authorized by FDA and a third hopefully
soon to follow. There is light at the end of this dark tunnel.
However, our hard work is not yet complete. Vaccine
distribution is ramping up, but we must ensure States have the
resources and the flexibility they need to immunize
successfully as many people who want it and meet the unique
healthcare needs of their individual population.
We heard yesterday in the Oversight and Investigations
Subcommittee from West Virginia, which has relied on community
pharmacists to get the vaccines to people. Unfortunately, other
States, like my own Washington State, have not been as
successful. Governor Inslee and others in Olympia have spent a
great deal of time pointing fingers at Washington, DC, for the
State's slow distribution, instead of figuring out strategies
to get people vaccinated.
Clearly, some States were better prepared and used the
advice of the CDC career scientists to implement locally
targeted strategies more successfully.
While vaccine distribution is critical to safely and
responsibly reopening our economy and our schools, we also
learned additional challenges during the response to COVID-19.
We learned that our medical supply chain is incredibly
vulnerable and that we rely too heavily on adversarial
countries like China for critically important products, such as
protective equipment.
We need to consider policies that will improve our domestic
manufacturing without impacting cost and consumer access. Our
Strategic National Stockpile and medical supply distribution
logistics also need to be strengthened.
While we have met this unprecedented crisis with an equally
unprecedented response, our resources are not unlimited.
Congress has a responsibility to oversee the money we have
spent, understand how it is being distributed and used, and
learn what is working and what hasn't.
As Chairman Pallone said during our organizing committee
just last week, this committee has a rich history of bipartisan
cooperation and hard work, perhaps more than any other
committee in Congress.
Between the pandemic, the economic crisis, the social and
political unrest, last year was one of the most difficult in
our Nation's history. Despite these incredible hurdles,
Congress was able to come together on five separate occasions
to give the American people the relief they needed. This
pandemic and our Government's response is bigger than any
single administration or political party.
As we discuss these important issues in our path forward
with our distinguished witnesses today, I hope our focus will
not be about pointing fingers on shortcomings, but the
opportunity to learn what bipartisan steps we can take over the
next several months to win the fight against COVID-19, restore
our way of life, rebuild the greatest economy in our history,
and prepare for future pandemics so that a public health
emergency of this magnitude never happens again.
I thank the witnesses for joining us today, and I yield
back the balance of my time.
[The prepared statement of Mrs. Rodgers follows:]
Prepared Statement of Hon. Cathy McMorris Rodgers
Thank you, Chair Eshoo and Republican Leader Guthrie for
holding this important hearing.
Exactly one year ago today, news outlets were reporting
that the global death toll from the coronavirus was 362, with
all but one of those deaths occurring in mainland China.
A year later, and this heartbreaking number has surpassed 2
million, with over 425,000 of these tragic deaths occurring in
the United States.
This pandemic has wreaked havoc on our way of life. The
loss of life has been devasting.
Our previously booming economy has been decimated.
Our mental health crisis has only worsened.
And the long-term impact on our children being kept out of
the classroom is incalculable.
Last Congress, we put our political differences aside to
make extraordinary investments in the fight against COVID-19
through five separate bipartisan relief packages.
These included providing over 30 billion dollars for
States, territories, and Tribes for testing, vaccine
distribution, contact tracing, and public health data
infrastructure improvement.
And over 23 billion dollars to the Biomedical Advanced
Research and Development Authority for the research,
development, and manufacture of novel vaccines, tests, and
treatments.
And $178 billion dollars for healthcare providers on the
front lines of taking care of patients with COVID-19.
This investment and partnership with the private sector has
led to the unprecedented development of innovative vaccines and
treatments coming to market faster than we ever thought
possible.
Operation Warp Speed is one of the most ambitious and
successful undertakings in American history, and with two
lifesaving vaccines now authorized by the FDA, and a third
hopefully soon to follow, there is light at the end of this
dark tunnel.
However, our hard work is not yet complete.
Vaccine distribution is ramping up, but we must ensure
States have the resources and flexibility they need to immunize
successfully as many people who want it.
And meet the unique health needs of their individual
populations.
We heard yesterday in the Oversight and Investigations
Subcommittee from West Virginia, which has relied on community
pharmacies to get the vaccines to people.
Unfortunately, Washington State has not been as successful.
Gov. Inslee and others in Olympia spend a great deal of time
pointing fingers at Washington, DC, for the State's slow
distribution instead figuring out strategies to get people
vaccinated as West Virginia is doing.
Clearly some States were better prepared and used the
advice of the CDC career scientists to implement locally
targeted strategies more successfully than he has done.
SUPPLY CHAIN
While vaccine distribution is critical to safely and
responsibly reopen our economy and our schools, we also learned
additional challenges during the response to COVID-19.
We learned that our medical supply chain is incredibly
vulnerable and that we rely too heavily on adversarial
countries such as China for critically important products, such
as personal protective equipment.
We need to consider policies that will improve our domestic
manufacturing without impacting cost and consumer access.
Our strategic national stockpile and medical supply
distribution logistics also need to be strengthened.
While we have met this unprecedented crisis with an equally
unprecedented response, our resources are not unlimited.
Congress has a responsibility to oversee the money we have
spent, understand how it is being distributed and used.
And learn what's working and what hasn't..
As Chairman Pallone said during our organizing meeting last
week, this committee has a rich history of bipartisan
cooperation and hard work.
Perhaps more so than any other committee in Congress.
Between the pandemic, the economic crisis, and the social
and political unrest, last year was one of the most difficult
in our Nation's history.
Yet, despite these incredible hurdles, Congress was able to
come together on five separate occasions to give the American
people the relief they needed.
This pandemic, and our Government's response, is bigger
than any single administration or political party.
As we discuss these important issues and our path forward
with our distinguished witnesses today, I hope our focus will
be not about pointing fingers for our shortcomings.
But an opportunity to learn what bipartisan steps we can
take over the next several months to win the fight against
COVID-19, restore our way of life, rebuild the greatest economy
in history.
And prepare for future pandemics so that a public health
emergency of this magnitude never happens again.
Thank you to our witnesses for joining us today and I yield
back the balance of my time.
Ms. Eshoo. The gentlelady yields back.
The Chair would like to remind Members that, pursuant to
committee rules, all Members' written opening statements are
going to be made part of the record.
I now would like to introduce our witnesses, first Dr.
Luciana Borio, vice president of In-Q-Tel, an organization that
I am very familiar with, former Acting Chief Scientist, FDA,
and former Director for Medical and Biodefense Preparedness of
the National Security Council.
Dr. Julie Morita, Executive Vice President of the highly
distinguished Robert Wood Johnson Foundation. Thank you to you
for joining us today.
The Honorable Michael Leavitt, founder and chair of the
Leavitt Partners, former Secretary of HHS, and former Governor
of Utah. That is really quite extraordinary.
Greg Burel, president and principal consultant of Hamilton
Grace and former Director of the United States Strategic
National Stockpile. Welcome to you.
And, Dr. Luciana Borio, you are now recognized for 5
minutes. And you need to unmute. So we look forward to your
testimony and that of each one of the witnesses. I think we
have really extraordinary witnesses today and you are all going
to get some good, stiff questions from the brilliant members of
this subcommittee.
So welcome. And you can begin.
STATEMENTS OF LUCIANA BORIO, M.D., VICE PRESIDENT, IN-Q-TEL;
JULIE MORITA, M.D., EXECUTIVE VICE PRESIDENT, ROBERT WOOD
JOHNSON FOUNDATION; MICHAEL O. LEAVITT, FOUNDER AND CHAIR,
LEAVITT PARTNERS; AND GREG BUREL, PRESIDENT AND PRINCIPAL
CONSULTANT, HAMILTON GRACE
STATEMENT OF LUCIANA BORIO, M.D.
Dr. Borio. Thank you. And good morning, Chairman Pallone,
Ranking Member McMorris Rodgers, Chairman Eshoo, and Ranking
Member Guthrie, as well as members of the subcommittee. It is
my great pleasure to join you today.
As you know, I work at In-Q-Tel, a nonprofit technology
investment firm that serves U.S. national security. And before
that, I served across four different administrations and most
recently as a member of the Biden-Harris transition team in its
COVID-19 Advisory Board. I am appearing before you in my
personal capacity.
The situation is dire, and I fear that our worst days could
be ahead, given the variants that emerged recently in the U.K.,
South Africa, and Brazil, and have spread globally. The South
African strain is exceptionally concerning since it invades at
least partially the antibody-based therapies and diminishes the
protective effect of at least some vaccines.
In my testimony today, I would like to share a few thoughts
about the past, present, and future.
I do not wish to dwell too much on the past, other than to
say that the Nation learned the consequences of departing from
the science-driven response, however imperfect, historically
taken during public health emergencies. At the same time, we
must recognize that many of the shortcomings of this response
are due to factors that preceded the most recent
administration, and repairing it will require reckoning with
early missteps, a failure of imagination, and a significant
complacency that has plagued us for years.
Here are seven priorities for the present:
First, given the variants, CDC must immediately expand its
genomic surveillance system in collaboration with public
health, private, and academic labs. I am glad to see early
steps in this direction.
Second, vaccines. We are quite fortunate. We have two safe
and effective vaccines developed in record time, with
additional ones on the horizon. This incredible success would
not have been possible without decades of investments in U.S.
biomedical research, the people of Operation Warp Speed, and
the FDA's Office of Vaccines under the leadership of Drs.
Marion Gruber and Phil Krause. They guided the rapid
development of these innovative vaccines without compromising
the highest scientific standards, and ensuring transparency.
This is what makes American scientific enterprise so powerful
and so hard to replicate elsewhere. Sadly, the chaotic rollout
of the vaccines has frustrated millions of Americans. The new
administration has taken steps to fix the situation, and you
should see more improvements soon.
Third, the virus variants. The threat will not be resolved
with travel restrictions. We must take urgent measures to
reduce the spread of this virus to lessen the opportunities for
the virus to further mutate and become even more dangerous. The
virus continues to burn through our country, while many people
continue to gather indoors and in large groups and refuse to
wear masks or social distance. Small businesses across our
country that are lucky enough to have survived thus far simply
cannot afford another lockdown. If we care about our jobs, we
must mask up and change our behavior urgently.
Fourth, the supply chain. I am encouraged to see vaccine
manufacturers taking steps to develop new candidates that may
be needed to effectively protect against new variants, but the
supply chain for making and distributing vaccinations remains
extremely fragile. The Federal Government is using the Defense
Production Act to prioritize the allocation of limited critical
materials. DPA helps, but it is not a final solution. HHS must
urgently expand the industrial base for critical supplies to
ensure the U.S. has sufficient supplies for this and future
pandemics.
Fifth, we do need better therapies. The quest for cures has
been hampered by the lack of a national capability for
conducting simple and pragmatic randomized clinical trials. In
departure from prior practice and under intense political
pressure, the FDA issued a series of EUAs for products that had
not been properly evaluated. Patient care needs to be driven
not by hope, but by science.
Sixth, diagnostic tests. As the Federal Government worked
to increase testing ability, it never developed a strategy to
help guide clinical and public health practice. To maximize the
impact of testing, I urge the CDC to develop guidance for
testing in a variety of settings: travel, workplace, and
educational settings, for example.
And seventh, the U.S. still lacks an interoperable data
infrastructure for public health. This should be one of the
principal areas of retention if we are to build a 2lst century
public health system.
As for the future, biological threats are not going away.
As we continue to battle this pandemic, we must also build a
system that can meet future threats, one that integrates the
private sector in cutting-edge technology, that values the
critical role of public health in our collective well-being,
health, and economic security, and realizes that good
governance is necessary to bring capabilities to fruition.
A better day will soon come upon us if we let science and
the American innovation lead the way.
Thank you.
[The prepared statement of Dr. Borio follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. Thank you, Dr. Borio.
I now would like to recognize Dr. Julie Morita. You are
recognized for your 5 minutes of testimony. And please remember
to unmute.
STATEMENT OF JULIE MORITA, M.D.
Dr. Morita. Chairman Pallone, Ranking Member McMorris
Rodgers, Chairman Eshoo, Ranking Member Guthrie, and members of
the subcommittee, thank you for this opportunity to testify. My
name is Julie Morita, and I am the executive vice president of
the Robert Wood Johnson Foundation, the Nation's largest health
philanthropy, and I served on the COVID-19 transition advisory
board in my personal capacity. Previously, I served as
commissioner and chief medical officer of the Chicago
Department of Public Health, an epidemic intelligence service
officer at the Centers for Disease Control and Prevention, and
a member of the CDC's Advisory Committee on Immunization
Practices.
Our foundation believes that everyone deserves a fair and
just opportunity to live the healthiest life possible. The
pandemic, with more than 26 million Americans infected and
440,000 lives lost, illustrates the critical nature of our
mission.
Vaccines offer real hope to eventually end the pandemic,
but we must improve distribution by adhering to three
fundamental principles: equity, accessibility, and
coordination.
We must begin with equity. People and communities of color
are disproportionately impacted by COVID-19. These populations
historically and currently face discrimination,
marginalization, and neglect. As a result, they are more likely
to be denied basic necessities, like a living wage, health
insurance, and paid leave.
The CDC recommends that frontline and essential workers,
predominantly people of color, be among those prioritized for
vaccination due to high exposure risk. But today, the country
is consumed with total allotments and weekly averages instead
of whether shots are getting in the right arms.
We must course correct quickly. Our foundation believes an
equitable response to the pandemic starts with collecting and
reporting all COVID-19-related data by race, ethnicity, and
other socioeconomic factors. Yet most States do not publish
vaccine data that includes race and ethnicity. Among States
that do, the share of vaccinations among Black people lags
behind the share of cases and deaths.
We can no longer accept the systemic racism that drives
these disparities. Congress and the administration should
encourage and enable all States to vaccinate priority
populations first and to report vaccine by race, ethnicity,
occupation, and neighborhood.
Second, we must increase accessibility. Vaccines are only
as effective as people's ability to obtain them and willingness
to take them.
Across our Nation, those with means and privilege are
increasingly getting vaccinated before those with highest
exposure risks. Necessities that some may take for granted--an
internet connection to make an appointment online, a car to
drive to a large-scale vaccination site, the time that it takes
to navigate complex systems--are unaffordable for millions.
A fairer approach simplifies appointment systems and brings
vaccines directly to priority populations. In Chicago, during
the H1N1 pandemic, we partnered with pharmacies and federally
qualified community health centers that provided care to the
uninsured in neighborhoods with less access to healthcare
providers. More than 700 locations in Chicago ultimately
received more than 1 million H1N1 vaccines during a critical
12-week stretch.
We also established meaningful connections with trusted
community partners to address vaccine hesitancy, which remains
an issue today. More than one-quarter of Americans report they
will not or likely will not get a COVID vaccine. Notably,
hesitancy rises to 1 in 3 among rural residents, Black adults,
and essential workers.
Community groups, faith organizations, and other
neighborhood pillars of trust play a pivotal role in helping
people make appointments and understanding and addressing their
concerns. Our foundation is providing grant support to State
and territorial health officials and community organizations to
address vaccine hesitancy. As we await additional doses,
funding and supporting critical and local efforts will help us
move to vaccine confidence and equitable distribution.
Third, the incredible complexity and urgency of this
vaccine rollout requires coordination and illustrates the
unique role of the Federal Government.
I am proud of how Chicago handled H1N1, but we didn't do it
alone. CDC's clear guidance, additional funding, and technical
assistance were invaluable. Without that support, our vaccine
rollout would not have been as successful.
I am encouraged that the current administration,
particularly Dr. Rochelle Walensky, the new CDC Director, is
committed to improving coordination at the Federal level. Open
lines of communication, increased transparency, such as more
specific, accurate, and timely estimates of State allotments of
vaccine, and ramping up our public health workforce, will all
help State and local health officials perform their heroic
work.
In conclusion, the Robert Wood Johnson Foundation is
invested in creating a more equitable Nation during this
pandemic and beyond. In the short term, America's ability to
weather this crisis will require wearing masks, social
distancing, washing hands, and additional support from Congress
to help those hit hardest. Vaccines will eventually lead us to
this pandemic's end, but saving the greatest number of lives
will require a recommitment from all of us to equity,
accessibility, and coordination in vaccine distribution in all
facets of our response.
Thank you. I look forward to your questions.
[The prepared statement of Dr. Morita follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. Thank you, Dr. Morita.
Next, I would like to recognize Governor Michael Leavitt.
You are recognized for your 5 minutes, and we thank you for
your willingness to be a witness today. Welcome to our
subcommittee. And please unmute. We want to hear every word you
have to say.
STATEMENT OF MICHAEL LEAVITT
Mr. Leavitt. Well, thank you to all of the committee.
This hearing is about looking ahead. The summation of the
submitted testimony that I provided can be expressed in a
simple phrase: ``Scout the next valley.'' Explorers and others
that navigated new territories always sent scouts ahead to help
them anticipate the problems. In a pandemic, surprises are just
an inherent condition, but we should not be surprised by the
fact that, in every phase of this pandemic, there are new
challenges.
So today I would like to talk a bit not about the next
pandemic, I think we need to focus now on what we should be
doing next in this pandemic. What should we be prepared for 3
to 6 months from now? What problems will we likely face 6 to 9
months from now?
My submitted testimony lists 11 categories that we need to
be planning today for predictable near-term problems. In the 5
minutes I am allocated today, I would like to focus on just
one: the need to develop an open source vendor-agnostic digital
vaccination and testing credential.
Here is the problem: Of course, we have vaccines and we
celebrate that. We are moving with increasing haste to
distribute them, and it is happening at an increasing velocity.
There is great anticipation this is going to bring down
transmission rates and the disease prevalence will fall. But
vaccines are, of course, voluntary. Many people are still
reluctant. There are still risks even after vaccination.
Inevitably, to open up the economy and to get back to what
we consider to be normal, we are going to need to have many
parts of our economy adopt a strategy of requiring some form of
proof of vaccination as an entrance requirement. Now, dozens of
efforts are underway right now by large companies and small
enterprises that are building the killer app that would allow
people to authenticate their status as a person who has been
vaccinated. All of them assume that there is a trusted source
of truth on who has been vaccinated, and who has not.
Today, my message is that it does not exist. Let me repeat
that: It does not exist. Unless action is taken very quickly,
this is going to be a mess. This is a valley we need to scout
now, or it is going to present substantial delay in the
fulfillment of the need and the promise of vaccines.
Now, we have made this mistake before. While I was
Secretary of Health, I was dealing with electronic medical
records, the fact that there were 200 different standards, and
we couldn't connect up and talk--the computers could not talk
to each other. We have seen it in banking. I remember the day
when you would walk into an airport and there would be nine ATM
machines, and you had to take your card and match up which one
would fit into that system. We can't make that mistake again.
Consumers need an easy means of voluntarily demonstrating their
vaccination status.
Now, to be clear, I am not arguing here about mandatory
vaccination. I am saying that consumers are going to need
access to their own vaccination records. Yes, they have a card,
and they will find that useful. But they are going to need
access to their records digitally and on paper. Let's be
candid: Paper records are simply not going to be adequate.
Every State has an immunization information system, and
that is good, but every vaccination is not being reported, and
they need to be.
More importantly, every State should be participating in
the CDC/APHL IZ Gateway. Let me explain. HHS developed a
technology called the IZ Gateway, which allows State
jurisdictions to share vaccination information. This enables
individuals and provides access to vaccination information from
any jurisdiction in the country. Here is the problem:
Unfortunately, only about half the jurisdictions--there are 64
in total, but about half of them are participating in the IZ
Gateway. Without that data, such a system of being able to get
our economy going based on the existence of validated, trusted
records of who is vaccinated will not exist.
If the committee wants a way to scout the next valley, you
should include in the next stimulus bill a requirement for
States that give Federal vaccine to participate in the IZ
Gateway and to ensure that every vaccine that is administered
gets reported to the States through their IIS system and allows
consumers the ability to access their own vaccination records.
In my remaining time, I will just list a couple of the
other areas that have been--that I will add emphasis to. Others
have mentioned them, that is, the increased worry of supply
chains on syringes and vials and drug ingredients, and so
forth.
Madam Chairman, I think my time is up. I will stop. I look
forward to the questions.
[The prepared statement of Mr. Leavitt follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. Thank you, Governor, very much. And we will
follow up on the last point that you made with our questions.
Next, I would like to recognize Mr. Greg Burel for 5
minutes for his opening statement. And thank you again for
being with us today.
STATEMENT OF GREG BUREL
Mr. Burel. Thank you.
Chairman Pallone, Ranking Member McMorris Rodgers,
Chairwoman Eshoo, and Ranking Member Guthrie, members of the
committee, thank you for the opportunity to testify today.
It was my privilege to serve as Director of the Strategic
National Stockpile for almost 13 years until my retirement in
January of 2020. I am now president of Hamilton Grace and am an
elected fellow of the National Academy of Public
Administration.
COVID-19 has exposed the fragility of our Nation's medical
supply chain. It brought to the fore the vital need to
consistently and properly resource our preparedness for health
security threats. The most glaring supply chain problem was the
inability to provide PPE due to political and geographic
vulnerabilities. We must channel what we have learned into
better policies to prevent this from ever happening again. We
must simultaneously address today's response by preparing to
meet future health security needs.
To address the fragile supply chain, we must invest in
sustained domestic critical healthcare manufacturing. Without
regular investment post-COVID-19, domestic manufacturing will
wane again as the crisis abates and demand recedes while
competition from low-cost foreign sources undercuts new
domestic manufacturers. Continued domestic manufacturing is a
national security imperative.
We find ourselves trying to successfully vaccinate our
whole population. Rapid, mass delivery of medicine will always
present challenges, but advanced preparedness investment,
planning, and use of operating distribution systems will better
facilitate the process. A successful government-led response
must engage the whole commercial healthcare supply chain.
We must pivot from our long history of inconsistent,
inadequate preparedness funding to long-term mandatory
sustainable preparedness. How we drive those policy changes
today will define our success in the future. We have witnessed
the devastating effects of a lack of preparedness on our
Nation's health. To respond now and lay the groundwork for
future needs, I offer the following recommendations:
First, we must rely on our healthcare system to bring an
end to this crisis. We must engage all commercial healthcare
distributors and manufacturers. Vaccines are not readily and
easily available at expected dispensing sites. Part of this is
due to the shortage, but another part is due to the lack of
distribution partnering engagement. A sole distributor cannot
reach the full breadth of dispensing capability. This is
especially a problem for those unable to spend hours online
searching for available vaccines and navigating failing
websites to register. It is particularly vexing for those
without technology resources or abilities. This affects the
most vulnerable of our citizens.
Second, we must clearly assign responsibilities to the
appropriate entities. The SNS has long been the lead to
acquire, manage, and deliver countermeasures to secure the
Nation's public health in emergency. But SNS appears somehow to
have been sidelined somewhat during this response. Other
Federal departments have been assigned responsibilities SNS can
lead effectively. As a result, success in buying and delivering
the right products has been, at times, inconsistent. Engaging
SNS expertise can make sure we get the right thing to the right
place at the right time.
SNS needs significant increased appropriations if it is to
be our bulwark against failing supplies of vital medical
material in crises. Making such appropriations mandatory rather
than discretionary would help achieve better preparedness.
Third, we know as a crisis abates, so does the urgency for
sustaining their preparedness. We cannot continue to claim we
are ready, only to act shocked when we find ourselves
unprepared because we couldn't invest to meet the need. We must
invest in purchasing domestic capacity or otherwise providing
incentives for manufacturers to sustain domestic production and
create greater material stocks. We must support and resource
regulatory structures friendly to domestic manufacturing while
always respecting the science that assures safe and effective
products. These actions, along with using the existing
distribution infrastructure, will help create flexibility in an
otherwise lean supply chain that can cushion surging needs.
As the current crisis subsides, we must incentivize those
manufacturers who now boldly enter a domestic market to
continue consistent production. They must be incentivized to
improve capability, plants, and machinery to achieve better
quality and higher output. Establishment of an aggressive
government investment platform driven by clear needs for
critical products will allow us to use and develop and maintain
this domestic base.
Finally, we must improve planning at all levels. At one
time, SNS supported State, local, Tribal, and territorial
officials with dedicated consultants. A return to linking the
medical logistics professionals in SNS directly with these
public health officials will assure strong preparedness
planning.
Our path forward must incorporate elements of all of these
considerations. We must unyieldingly fund health preparedness
in the United States.
I look forward to your questions, and I always remain
available to assist our Nation in these endeavors.
[The prepared statement of Mr. Burel follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. Thank you very much, Mr. Burel.
We now are going to move to Members' questions, and I
recognize myself for 5 minutes for questions.
First, to--and, please, to the witnesses, know that each
Member only has 5 minutes to ask the questions, get the
answers. So let's all try to be as--you know, conserve time so
that we can optimize it.
To Dr. Borio, the American Rescue Plan provides the
resources needed to vaccinate the 300 million Americans by the
end of this summer. How do the new mutant viruses affect the
timeline, if they do, for this planned vaccine rollout? And
what do we need to be doing today to be ready for that tomorrow
and the days following?
Dr. Borio. So, you know, in that short time, nothing really
changes. The response remains, which is to decrease
transmission of the virus through public health measures,
intervention, and, importantly, vaccinations. So it is urgent
that we get vaccine rolled out. Every dose that comes out of
the manufacturing line should make it into somebody's arm as
soon as possible.
Ms. Eshoo. Good.
Dr. Borio. In the midterm, we do need to begin to be
prepared in case we do need to manufacture on large scale the
new candidates if there is a significant erosion in protection
and revaccinate the population. We do not know right now if
that will be necessary. We hope that it may not be.
And also, I would just add that we do believe that these
vaccines will need to be boosted periodically, whether it is
the original vaccines, modified vaccines. So we do need to
build the industrial base and capacity, just like we do for flu
vaccines. That is the current thinking.
Ms. Eshoo. Thank you very much.
To Dr. Morita, thank you again for joining us today. In
just the first few weeks of vaccinations, Black Americans are
receiving them at dramatically lower rates than White
Americans. How do the increased resources from the new
administration's plan help bring the vaccine to underserved
communities? You spoke to this, to the issue and the problem
and the inequities relative to the rates, so can you be
instructive to us in terms of what needs to change and how
those increased resources are going to change the rates that--
the really shameful rates in our country?
Dr. Morita. So you are right. In addition to the
disproportionate impact on our communities of color in terms of
disease, who is dying, who is hospitalized, what we are seeing
is that there are lower rates of vaccination administration in
our communities of color as well.
Things that can be done to improve that situation would be
to really make sure that the sites that are vaccinating are
located in the communities themselves, that the appointment
processes are simplified so that people can use the telephone,
they aren't just internet dependent, that there are community
workers that are going into communities and actually helping
people to register, whether it is online or by phone.
So what we have seen are the processes are challenging for
people to actually access the vaccine. I, myself, am trying to
get my 91-year-old dad an appointment and struggling through
use of the internet. These processes themselves have to be
simplified, and additional resources will help. Hire staff to
actually do the community work. Simplify the stand-up phone so
that people can actually make phone calls instead of just going
online----
Ms. Eshoo. I just want to get one more question in, so we
can follow up with more questions with you, and all Members can
do that.
To Mr. Burel, on our Nation's national stockpile, it ran
dry. And, as someone that worked with former Congresswoman
Susan Brooks on preparedness and the stockpile, it was
absolutely maddening to all of us what we experienced. When you
were selecting contracts for the stockpile, did you weigh the
country of origin versus the cost?
See, I think we should have an American stockpile. This
business of being dependent on other countries--some of them
who don't wish us well--I think was a national embarrassment.
So what can you share quickly with us about this?
Mr. Burel. Thank you for the question, Chairwoman Eshoo.
We followed all the appropriate procurement regulations in
making our purchases.
Ms. Eshoo. What were they? Did we have Buy American only?
Or was it first come, first served? Was it China? Others? I
mean, it is----
Mr. Burel. Sure. I appreciate the question.
Ms. Eshoo. Both sides of the aisle care about this.
Mr. Burel. Yes, ma'am, I understand.
What we did is we procured products under Buy American,
where that is appropriate, and that is most products. Where
there were products that were not manufactured in the United
States, we purchased those from a U.S. vendor.
Ms. Eshoo. What is not manufactured in the United States
relative to PPE?
Mr. Burel. So much of the PPE we find is manufactured
overseas, particularly N95 masks.
Ms. Eshoo. That is not true. We have a major American
manufacturer for that.
I think I need to stop because I have gone over my time,
but we are going to follow up with you with more questions.
Mr. Burel. Thank you.
Ms. Eshoo. Thank you, sir.
So the Chair now recognizes our new ranking member, Mr.
Guthrie, for his 5 minutes of questions.
Mr. Guthrie. Thank you very much. Thank you, Madam Chair, I
appreciate it.
And this is to all the panelists. So my question is--and I
am not going to get back into why it was delayed--but we had
two vaccines approved mid-December. Then we had $4.5 billion
approved December the 27th for States to distribute the
vaccines. Some States have been successful, some States
haven't.
So looking forward, we are looking at, perhaps, doing it
different ways. Do you think now that the States have had the
money for a month that they are going to improve, or do you
think we really need to restructure how we are distributing
these vaccines currently? So we have some States successful,
some aren't. The money came late. They now have it. Are we
seeing improvements enough, or do we need to overhaul how we
are getting these vaccines distributed and in arms of people,
which we all want?
So I can start with--I can see Dr. Morita in my screen
first, so I will just call on you, if that is OK.
Dr. Morita. Thank you so much for your question. I really
appreciate it.
So the challenges that we have experienced with the
distribution are because of a lack of initial resources to
support States and locals. As much money that went into
Operation Warp Speed, which was an incredible process and
incredible results with two vaccine being developed and
manufactured so quickly, additional resources in equal amounts
were needed to go to States and locals so that they could
actually ramp up their systems. But they are playing catchup at
this point. What we heard consistently during the transition
period was that they didn't have enough resources to hire
staff, to open up clinics, to actually do community work to
improve understanding of the vaccine, to drive demand, enhance
the electronic----
Ms. Eshoo. Excuse me. Dr. Morita, can you either maybe get
closer to your microphone, speak a little louder? We don't want
to miss a word you are saying.
Dr. Morita. Sure.
Ms. Eshoo. And whatever time I have taken to say that you
won't lose.
Dr. Morita. Additional resources are necessary, so although
things are improving, and I am thrilled to see how much the
rate of administration is actually improving, additional
resources are necessary so we can actually do this as quickly
as possible.
What Dr. Borio mentioned in terms of the variants really
gives us urgency in terms of the need to vaccinate as quickly
as possible. And we can do it equitably if additional resources
are made available so they can get in the community, help
people sign up for the vaccines. Make sure those who need the
vaccine the most are really able to access it as well.
Mr. Guthrie. OK. Thanks.
And to get to all of my questions, I am probably just going
to jump next, but it is sort of the same thing for Governor
Leavitt to touch on that, but also you mentioned in your
testimony about Medicaid and how the--the competition with
Medicaid and public health spending.
So as a former Governor, I mean, the money has now moved
forward. I know they need additional resources. But could you
kind of address my question, please, for Medicaid and public
health spending issues as well?
Mr. Leavitt. Well, we have allowed public health to go to
seed over the last 25 or 30 years in this country. There are
probably a lot of things that have contributed to that, but one
of course has been the tension that States are under to deal
with both Medicaid and public health. We can pursue that.
Could I just comment briefly on----
Mr. Guthrie. Yes.
Mr. Leavitt [continuing]. The previous question?
I had the privilege of serving as HHS Secretary when we
rolled out Medicare part D to 45 million people. That is not a
challenge of doing vaccines to 300 million, but I learned
something, I think, important, and that is we are going to get
better at this. The first month, I am sure there are always
going to be issues. The second month will be better. The third
month will be better. If we were trying to give everyone in
America a hamburger, we can get that done in 30 days because we
have the infrastructure. Everyone knows how to do it, and
people could go through the drive through and we would be
finished. But the reality is we are standing up something
entirely new, and we will get better at it. And it is a good
thing, because we are going to likely be doing this for some
time, well beyond this year.
Mr. Guthrie. Thank you.
And, Dr. Borio, just to kind of nuance that question, if
you want to address that, you can. But I also have Kentucky
BioProcessing in my district, and they are coming up with a new
generation vaccine. They are telling me they are having trouble
finding clinical trials because, as more people get vaccinated,
there are not going to be the test populations, particularly
placebo groups that they need. So could you talk about what HHS
and BARDA must do to help development of the next generation
vaccines?
Dr. Borio. That is a really great point, because once you
have a product that is authorized broadly and broadly
available, it makes it more challenging for new products to
come in and evaluate them with the same type of standards that
we would have accepted for the first trial. So we do the
randomized control trials. You may have heard in the news, for
example, that a company, Novavax, are now doing studies in the
U.S. Some of the older patients in that study are dropping out
of the study to be able to get the authorized vaccines. So that
is not an issue that is, you know, just to this company.
I know the FDA is working really hard to then develop, you
know, more of the pathway forward for these companies. How can
we show scientifically and that these products are indeed safe
and effective if they are--you know, how to demonstrate that.
And it may be that it will require a different type of trial
than the original ones. And I know they are working hard at
that.
It is possible that, you know, we be able to rely on immune
markers to be able to establish the efficacy of these vaccines.
I don't have the answers today, but hopefully soon.
Mr. Guthrie. Well, thank you very much. I see my time has
expired. And sorry, Mr. Burel, but my time has expired.
I will yield back.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize the chairman of the full
committee, Mr. Pallone, for his 5 minutes of questions.
Mr. Pallone. Thank you. Thank you, Chairwoman Eshoo.
I just wanted to comment, I heard when our Ranking Member
Rodgers in her opening statement mentioned how we have too much
reliance on China and other countries and we needed to do more
domestically, including manufacturing. I just want to say I
totally agree with you on that, and that is certainly something
that we need to continue to look at: you know, too much
reliance on other countries, particularly China, for supplies,
ingredients and that. And also that we need to prepare for
future epidemics or pandemics. One of the things that was
always done in our committee every year, including under Greg
Walden and Mr. Upton when they were chairs, was an annual flu
hearing. So we would always, like, prepare for the future, and
that continues to need to be done.
But I, of course--with Mrs. Rodgers, I don't agree about
her analysis of the Trump administration. I don't want to dwell
on the past, but I think it is important to understand the
message the Trump administration left behind. And one of the
areas of concerns that we heard from States yesterday at the
hearing was the lack of communications, lack of national
preparations, guidance, and resources when it came time to roll
out the vaccination program. And States were given a vaccine
supply under Trump, but very few resources to carry out
distribution.
Now, I know that, Dr. Morita, you talked about this, so I
don't went to dwell on it, but give me a little more analysis,
if you can quickly, about the lack of resources. And
particularly, I don't know if you have seen or want to comment
on Biden's American Rescue Plan, which we have put into
legislation form, we are going to start the process today. How
can we benefit from additional resources moving forward if we
are going to meet President Biden's goal of vaccinating these
300 million people by summer or fall? I am only going to give
you 30 seconds or a minute because I have to move on to
testing.
Dr. Morita. Sure thing. Thank you so much for your
question.
In my past experience, whether it was H1N1, Zika, or Ebola,
the best responses were those that were really coordinated at
the Federal level, because the Federal agencies work so closely
with State and local health officials. That kind of
coordination is reflected in the American Rescue Plan, and we
heard about it during the transition period as well as the
planning was being developed. There is a strong commitment for
there to be this coordination so that supplies are arriving
appropriately, places that are doing well or recognized places
that are struggling get the support and resources they actually
need.
So this level of coordination that CDC and other Federal
agencies can do is really, really critical. That and this clear
and consistent communication regarding the science. So the
science-based recommendations and guidance usually flow from
CDC to State and locals were incredibly valuable. And that kind
of issue, those guidances are already starting to flow, and the
communication is much more consistent and regular. So we are
really seeing signs that this can be a more coordinated and
robust response moving forward. So those approaches are clear
in the American Rescue Plan, but also in the strategy that was
released the day after inauguration.
Mr. Pallone. Well, thank you.
Now let met get to Dr. Borio. I want to emphasize the
importance of our vigilance in testing and contact tracing in
doing other mitigation activities. I don't think that vaccines
alone are going to be enough to protect people as we continue
to have outbreaks. So, Dr. Borio, as you noted in your
testimony, the Federal Government never developed a
comprehensive national testing strategy, despite the fact that
we know one of the keys to controlling outbreaks relies on
access to reliable diagnostic tests. And, of course, I was
critical of the lack of a national strategy under President
Trump.
So can you talk about the importance of national
coordination in a testing strategy and the importance of
providing resources to carry out mitigation such as contact
tracing? Do you think--you know, tell us about additional
national investments to increase testing. And if you want to
comment on Biden's American Rescue Plan in that regard, I would
appreciate it as well. You have only got 45 seconds.
Dr. Borio. So, yes, just like a clinician, you know, has
usually a menu of options to care for patients and which tests
to use, public health practitioners also need the menu of
options to be able to optimize the use of these finite supplies
of testing. It is not an infinite supply, and there are
strategies that are more effective than others. And we need
Federal guidance for that.
With respect to contact tracing, it is very critical. We
cannot do it without technology, I will say that. And to be
able to have, you know, people--it is important, it is a
critical aspect, but we are also going to have to need
technology to be able to do it with a speed of which a pandemic
requires. We need Federal coordination for that to develop the
standard, the privacy standards, and to evaluate the
effectiveness of these technologies that are just emerging.
Other countries have deployed it. We need do it too.
Mr. Pallone. Thank you so much.
And I yield back, Madam Chair. Thank you.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize the ranking member of the
full committee, Congresswoman Cathy McMorris Rodgers.
Mrs. Rodgers. Thank you, Madam Chair. It is great to be
with you.
And, Mr. Pallone, chairman of the committee, I just want
you to know that the Republicans stand ready to go to work, to
identify the gaps, and to work together to continue to address
the needs around the pandemic. And we really appreciate the
chance to talk with our witnesses today. Thank you all for
taking the time to be with us.
I wanted just to start by asking each one of you: At the
start of this pandemic, did any of you anticipate that we would
have a safe and effective COVID-19 vaccine to distribute and
administer only 10 months later? And if you would just answer
yes or no, maybe beginning with Dr. Borio.
Dr. Borio. Well, I'm an optimist, and I did. I did have
deep hope. I wasn't 100 percent sure, but I have great
confidence in, you know, the type of science that underpins the
current technologies and also in our ability to be able to move
fast, given the tools that we have today at our disposal. And
thanks to the FDA for helping with that.
Mrs. Rodgers. Thank you.
Dr. Morita. So I too was not certain, was hopeful, and have
been so appreciative of the work that Congress had for
supporting Operation Warp Speed, because the amount of resource
and attention that was provided guaranteed that this effort was
actually going to be successful. So it is the amount of
resource and attention that will be supported.
Mrs. Rodgers. Very good.
Mr. Leavitt. I will just say, based on past history and
what I know about historic process, there was not a lot of
reason to be optimistic. It was truly a remarkable feat.
Mrs. Rodgers. Thank you.
Mr. Burel. I was hopeful as well, but I was not convinced.
I do think we have made a lot of progress in being able to do
these sort of things in public health emergencies. We need to
continue to invest to be able to do this in the future.
Mrs. Rodgers. Yes.
Has vaccine distribution of this magnitude and complexity
ever been attempted in the United States before? And, again, I
would just like to ask each one of you to answer yes or no.
Dr. Borio. Not even close.
Mrs. Rodgers. OK. Thanks.
Dr. Morita. This is the largest I have seen in my lifetime.
Mrs. Rodgers. Great.
Mr. Leavitt. I think it is clear it is unparalleled.
Mr. Burel. No, we have never done anything at this level
before.
Mrs. Rodgers. Great.
Governor Leavitt, given your experience serving in
government and your tremendous service both at the State and
the Federal level, I just wanted you to speak, and I know you
did some in your opening testimony, but a little bit more about
the appropriate role of the Federal Government when it comes to
vaccines. If you would just talk a little bit more about that.
And what flexibilities you believe need to be preserved to the
State or local authorities to best respond to the unique needs
facing their individual constituencies.
Mr. Leavitt. Well, I will start by saying there is a role
for both, and both need to do their job and work together to
make this work. The point that has not been made that needs to
be: Both of the vaccines that we have in the market today are
based on new technologies that were actually developed under
Federal procurement and/or other Federal investment beginning
in 2006, 2007, and 2008, when we were dealing with the H5N1 and
Congress responded by appropriating at nearly $8 billion.
The point here is, if you want to have this kind of result,
it doesn't just happen in 11 months. It requires perpetual
investment and perpetual vigilance to be ready.
Mrs. Rodgers. Thank you. Good point.
To Dr. Borio, you mentioned in your testimony the
complexities of the vaccine supply chain and how the disruption
of any critical component will disrupt the availability and the
administration of the vaccines. I just wanted to ask you, are
there any immediate additional actions that you believe that we
need to be taking right now to ensure a stable supply chain for
COVID vaccines?
Dr. Borio. Thank you. I really do believe that Operation
Warp Speed has done everything to maximize the process, to
optimize it, and to basically rely as much as they could have
already on DPA, the Defense Production Act.
I think to be able to--the next step really is about
expanding the industrial base, domestic base, to manufacture
some of the critical supplies here. We are talking about
filters and columns and syringes and needles and bags that are
required for the biomanufacturing. We are talking about filling
finish lines to be able to bottle the vaccines. Every little
single component, no matter how small it seems, can really
bring the whole process to a halt if we don't have access to
it.
Mrs. Rodgers. Very good. Well, I ran out of time. Again,
thanks all. I will save my questions for later.
Ms. Eshoo. We thank the ranking member.
And just to remind everyone that we leave the record open
so that questions can be submitted to our witnesses. And I will
do another reminder of that at the end of the hearing.
It is a pleasure now to recognize the gentleman from North
Carolina, Mr. Butterfield, for his 5 minutes of questions.
Mr. Butterfield. Thank you, Madam Chair. Good morning, good
afternoon to all of you. And thank you, Madam Chair, for you
leadership, and thank you for the direction in which you are
taking this subcommittee.
And let me just say in the outset to our new ranking
member, Mr. Guthrie, I look forward, sir, to working with you
as we worked together in previous Congresses. I look forward to
not only working with you, but also to all of you on the other
side of the aisle.
Let me just take a moment to thank the witnesses. I have
listened very carefully to your testimonies. Your testimony is
very much appreciated today. And thank you for all the work
that you do in the space in which you operate.
But I am going to concentrate my three questions, if I have
enough time, on Dr. Morita.
Dr. Morita, thank you for your willingness to give the
Nation the benefit of your expertise.
Since the very beginning, it has been clear that, while
COVID-19 affects us all, it does not affect us all equally. And
I think some of the witnesses made reference to that in their
testimonies. African-American and Latino, Asian, Native
Americans, all of these individuals are more likely than White
Americans to be infected. That is a fact. More likely to be
hospitalized. More likely to die from COVID. This reality is
why health equity must be at the center of any plan for
distributing the vaccines. Unfortunately, the trends from the
first several weeks are headed in the wrong direction.
The previous administration failed our country in so many
ways. And the chairman of the full committee is right: We are
not going to dwell unnecessarily on the past, but the previous
administration did fail, including not putting forth a clear
plan for vaccine distribution. Because of this failure, we now
have a lack of reporting and incomplete data.
According to the CDC, we only have race and ethnicity data
for about half of those receiving the vaccines. And where do we
have data, only 5.4 percent of individuals getting the vaccines
are African-American, 11 percent are Latino, 6 percent are
Asian, 2 percent Native American, despite the fact that these
groups bear a higher share of the COVID burden and often
serving on the front lines of our healthcare workforce. And we
have got to fix this now. I think we can all agree on that.
Dr. Morita, with such limited data, the situation might be
worse than we know. How can we improve data collection and
vaccine distribution?
Dr. Morita. Thank you for your question. The equity issue
is critical. In order to respond appropriately, we need to
really improve the data systems that are being used currently.
And there need to be additional resources made to make the
systems better but also to support the manpower necessary to
enter the information. It takes time to enter additional fields
like race, ethnicity, gender, geography, occupation. And so it
is manpower and it is also data systems.
What can be done? While we already acknowledge that there
are some discrepancies in terms of who is getting vaccines,
improve the systems by making it more accessible to people. So
making sure the sites are located in geographies where people
can easily access them without cars if they don't have them.
Make sure they can make appointments by telephone, to make sure
that there are community workers going into the communities to
actually help people register and make appointments. All these
kinds of things are necessary to make sure that we are reaching
the people who are most likely to die and be hospitalized
because of COVID, and those things often require additional
resources.
Mr. Butterfield. Let me share this with you, if I can:
Ninety percent of Americans live within 5 miles of a community
pharmacy. Retail pharmacies are accessible. They are
convenient. They are based on recent modeling. They have the
capacity to administer 100 million vaccine doses in 30 days.
From your experience as the chief medical officer in
Chicago, what more can be done to utilize retail community
pharmacies?
Dr. Morita. Retail community pharmacies played a major role
in our response during H1N1. They do have reach into
communities. And so, just yesterday, the Biden administration
announced that they will be making more vaccine available
through pharmacies throughout the Nation, particularly focusing
on communities of color. They are one mechanism for getting
vaccine to these communities.
Federally qualified health centers or community health
centers and rural health centers are also places that are
located in these communities and have trust within the
communities to actually help address some of the concerns that
people have about the safety or the efficacy of the vaccines.
So a full-court press really needs to happen right now with
healthcare providers, health centers, pharmacies, mass
vaccination clinics, all those things need to be happening
right now so we can get these vaccines out quickly and
equitably.
Mr. Butterfield. Thank you very much, Dr. Morita.
And I yield back the 5 seconds that I have, Madam Chair.
Ms. Eshoo. We thank the gentleman. And thank you for your
continuing focus on this issue. I don't really know whether our
public health departments across the country are even equipped
to gather the information that is needed in a very efficient
and effective way, and I think that we need to do a little
deeper dive on that.
The Chair now recognizes the former chairman of the full
committee, someone that is always--he is really, I think, one
of the most popular guys on the committee. Everyone loves Fred
Upton.
So, Fred, you have 5 minutes for your questions.
Mr. Upton. Well, thank you for your generous words. I am
delighted to participate in this most important hearing.
I just have to say we all have to work so hard together. I
mean, we are just hearing all these frustrating stories, not
only from our constituents, but you see the news at night and
the long lines of people in folding chairs in other places all
around the country just waiting. The serious concerns about
folks of color not having access. I mean, all these things just
tear at our heartstrings, and we need to work together to do
the very best that we can to improve the infrastructure.
Ms. Eshoo. Excuse me, can you speak up? I don't know if it
is my computer or what.
Mr. Upton. Is that OK? Is that better?
Ms. Eshoo. A little bit.
Mr. Upton. All right.
The question that I have, I guess, for Greg Burel, what are
your thoughts on the steps that we need to make sure that
domestic manufacturing is, in fact, doing the right job being
prepared as we look at the Defense Production Act? Where are we
actually short in providing PPE for our communities that really
need it? Is it masks, is it gowns, is it gloves, is it testing
supplies? What products can you identify that we really need to
step up, particularly as we have looked at the private sector,
at least in my district, a whole number of different entities
are producing that, which is a really good thing, but where do
we need to go from here?
Mr. Burel. Thank you, sir. I think that we are short in
almost every area of PPE, both in the medical field and for the
public who might want access to those kind of, say, N95 masks.
I think what we have got to do is find a way to invest
better in onshoring or nearshoring some of that work. Most of
that is not manufactured in the United States anymore. And
there are a lot of manufacturers that want to get into this
business and stay in this business, not just to respond to a
DPA. So I think that we need to continue to invest. We need to
encourage those manufacturers after this event ends to increase
their capability, to make better quality products, to make
products faster.
Mr. Upton. Thank you.
Governor Leavitt, as you well know, our committee and most
of the Members here, you will remember that we worked in such a
bipartisan way to get 21st Century Cures done, which really led
to Operation Warp Speed so that we could actually get a vaccine
approved within the 10 months. For me, it was obviously very
personal, not only with the legislation that Diana DeGette and
I worked on together, every member of the this committee, but
even more so in my own district. Pfizer's largest production
facility is in Portage, Michigan, and it was so exhilarating to
see the trucks roll out on that December Sunday morning to
distribute with UPS and with FedEx all around the country. But
now we are hearing obviously troubling reports, at least in
Michigan, a number of counties having to cancel or reschedule
second doses of that Pfizer or Moderna vaccine because they are
getting differing amounts than what were expected from the
State.
FDA's data indicates that the second dose needs to be given
about 21 days after the first one; in the case of Pfizer about
28 days, in the case of those two companies in order to have
the proper efficacy. So timing is critical. What steps do we
need to take within the supply chain to ensure that the second
doses are not foregone, especially in light of the recent
decision not to reserve them, knowing that there is a line at
virtually every entity of people ready to roll up their sleeve
and get vaccinated?
Mr. Leavitt. Well, Mr. Upton, let's remember first of all
supply. We have to have a steady supply. Second, could I say
coordination and communication between every level of
government. This is a coordination and collaboration exercise.
And finally, may I say that we have to be persistent in
improving continually our process. And that will include our
data systems.
I recently had the privilege of getting my first vaccine. I
was scheduled for an appointment to go back for my second. I
thought that was a very important step. I know when I am going,
and assuming that the supply is there, I will get it. I think
we will get better at this as we go, and we need to. This needs
to be an iteratively improved process with lots of
communication between Federal, State, and local governments.
Mr. Upton. The last thing, and I wonder if you can--knowing
that my time is quickly expiring, can you provide us a list of
the States that are complying with the IZ, the form that you
talked about in your testimony? It is so easy--you know, I have
seen the little cards that people have. Obviously, it is so
easy to counterfeit or whatever. I mean, we need a standard
form. Whether getting on an airplane or going to a stadium, you
would think that there ought to be some device that you can
show on your iPhone or some program showing that you were
vaccinated, to assure the folks around you and to your family
members and others that, in fact, you have had that
vaccination.
Mr. Leavitt. Thank you for highlighting that. Yes, we can.
I will submit it to you and for the record.
Mr. Upton. Great.
And with that, my time has expired. Thank you, Madam Chair.
Ms. Eshoo. Thank you, Mr. Upton.
It is a pleasure to recognize the gentlewoman from
California, my friend, everyone's friend, Ms. Matsui.
Are you unmuted?
Ms. Matsui. I am unmuted now.
Ms. Eshoo. There you are. Five minutes. Thank you.
Ms. Matsui. Thank you very much, Madam Chair, for really
calling this important hearing.
And I want to thank all the witnesses. We are learning a
lot with you and from you, so it is very important. Yet the sad
thing is we are about to hit 450,000 COVID-19 deaths in this
country. And nearly 300,000 Americans over the age of 65 have
died from the virus. And that we probably can estimate, by the
time we look back on this pandemic, some 250,000 older adults
will have died from COVID-19 while living in a nursing home,
assisted-living facility, or a group home.
You know, these are people who have died and will continue
to die until we improve our response to managing the pandemic
for vulnerable older adults and the frontline staff who care
for them. And that is really why, as cochair of the House
Democratic Caucus Task Force on Aging and Families along with
Jan Schakowsky, I have called on the Biden administration to
involve a geriatrician or expert in aging services on the
COVID-19 response team. An aging expert, someone with a deep
understanding of a long-term care system, will help ensure that
moving forward we are really addressing the unique needs of
older Americans as we take critical steps to get the virus
under control and safely and equitably distribute vaccines,
therapies, PPE, and tests.
Now, while the Trump administration left the delivery of
most vaccines to the States, officials at Operation Warp Speed
pursued a Federal public/private partnership with chain
pharmacies to supply and administer vaccines to long-term care
residents and staff. Now, the former HHS Secretary Azar said in
mid-December that we could have every nursing home patient
vaccinated in the United States by Christmas. The only State
that met this mark was West Virginia, which opted out of the
Federal program and instead used local pharmacies to administer
vaccines.
Now, like many aspects of the vaccine rollout, leveraging
the existing network of chain pharmacies like CVS really has
worked in some places but not in others.
While I am encouraged by the centralized leadership being
taken at the Federal level, it seems like the one-size-fits-all
approach to vaccinating long-term care residents may cause
further delays.
Now, Dr. Borio, in your view, what are some of the
challenges with one-size-fits-all distribution and that
leadership model? And what needs to be done to make the
vaccination process more efficient?
Dr. Borio. You know, I think you really--first of all, I
would like to acknowledge that the pharmacy programs have done
a tremendous job in preparing for one of the most challenging
vaccination components of this challenging program. And, you
know, this is not an easy task.
I think that nobody was prepared, for example, for the
amount of hesitancy associated with vaccinating the workers in
those facilities. The receptivity to the vaccine has been
extraordinarily low, given the high-risk population that they
serve. There were also issues with informed consent, and I
think that they really wanted to make sure that patients, for
example, were--that the vaccinees or their families were
comfortable. There is still an investigation of vaccine
authorized by the FDA. Investigation is important to make sure
that people are comfortable receiving those vaccines.
So these are things that--I mean, you know, the other
member said, you know, we are always going to have a lot of
challenges when we launch a new program, and we have picked the
most challenging component of this program as the step one of
this.
But to answer your question directly, I think it is true,
there needs to be a coordination and communication, as
Secretary Leavitt says, because there is no such thing as one
size fits all. You do need to be able to have Federal
leadership and standards, but also tailor it to the needs of
the community at the local level.
Ms. Matsui. Absolutely. When you brought up vaccine
hesitancy, you know, there is no question that staff are a
primary source of transmitting the virus in long-term care
facilities. Now I am deeply concerned about the large
percentage of long-term care workers nationwide who are
declining to take the COVID-19 vaccine.
Dr. Morita, what needs to be done to better support higher
uptake of the vaccine by staff members of nursing homes and
assisted-living facilities and group homes? And I think I only
gave you 25 seconds.
Dr. Morita. I will speak fast. Thank you so much for your
question.
Vaccine hesitancy needs to be addressed across the board,
and the way that we do that is really--it is not easy work. It
is hard work. It means talking with those who are actually
hesitant, understanding what their concerns are, what
information do they need, who do they want to hear from to have
their questions addressed, because it is not one size fits all
for that either. And so really getting into these communities
and understanding what are their concerns, and that requires
resources.
There are many States and locals who are actually doing
that kind of work right now, but they need the dollars to pay
the community workers, the trusted voices to engage with the
people to address their concerns so that demand increases.
Ms. Matsui. OK. We have run out of time, and I appreciate
it.
And I yield back. And I have got further questions I will
submit. Thank you.
Ms. Eshoo. The gentlewoman yields back.
The Chair now recognizes the gentleman from Texas, Mr.
Burgess, for his 5 minutes of questions.
Mr. Burgess. Thank you.
Secretary Leavitt, it is so good to see you in our
committee again. You know, in this committee a year ago, we
received a number of briefings from the top people in public
health, and one of the things that, of course, people have
brought up this morning, it still stands out in my mind, was
Dr. Fauci telling us that, under the best of circumstances, if
absolutely nothing goes wrong, that it would take 18 months to
deliver a vaccine. And he also emphasized that it almost never
goes perfectly. But here we are now a year later with not one
but two highly effective vaccines, perhaps two more waiting in
the wings to rapidly come forward, and really we should
celebrate [inaudible] former Chairman Upton that [inaudible]
watching my local news show about the trucks leaving. Fred, I
thought it was from Kalamazoo. Maybe I was mistaken. But just
the emotional response to seeing those trucks leaving the
factory with the vaccines on board, I wasn't prepared to be as
affected as I was, but the enormous sense of relief and joy at
having those vaccines now on the road to get into the arms of
people who would now be protected from this terrible virus. It
really was a significant moment.
And, you know, I think some credit does go to the previous
administration. They made it a priority. The 18 months was
perfectly reasonable in January, February of 2020. Now we know
that that timeline can be significantly condensed.
And, Secretary Leavitt, I also--your reference of your
earlier work, and you are right, another thing short of
stunning to get the rollout of part D done in the timeframe
that you did. And I would remind members of the committee, that
was on top of a public health emergency when Hurricane Katrina
came ashore Labor Day weekend in 2005. And, in fact, I remember
questioning you and Administrator McClellan at the time if it
was even possible to go through the rollout of part D while
this public health emergency was tearing across the country.
And you assured me that it was, and I certainly became a big
fan of your administrative capabilities at that time because,
clearly, you were correct.
And one of the things I also remember from back then, 2005,
I think the Defense Appropriations Bill where you got money for
Sanofi to begin manufacturing vaccine in this country.
Apparently, vaccines were no longer manufactured in this
country, but in the advent of the bird flu, you thought it was
important and got those dollars in that appropriations bill to
start that. And the reason that is significant, I mentioned
yesterday in our hearing, Sanofi is one of those companies that
was in development of its own vaccine. Things didn't go perhaps
as they wanted, but they are now partnering with a rival, with
Pfizer, to manufacture more vaccine, more of the Pfizer vaccine
that has gotten through the FDA approval and shown to be so
effective.
So that really brings up the point, one of things that is
hindering our getting vaccine into people is the amount of
vaccine that is available. So this type of partnering between
private companies seems something that could be enormously
effective. So I just wondered, Secretary Leavitt, if you had
any thoughts on that.
Mr. Leavitt. You properly point out the fact that there has
been investment in the vaccine infrastructure for some time
now. And may I say that is a very important component. I would
point to three other things that have added to this.
One is that we did enter into partnerships, as you have
said, and that kind of collaboration is essential in this kind
of emergency. The second thing I will mention is that we
planted many seeds, knowing that not everything would turn out.
And lastly, I will point out that the Federal Government did
accept a lot of risk here. That kind of risk could not have
been taken by the private sector or any State. Only the Federal
Government could do that. And because there was a relentless
concentration on delivering those four and many other
ingredients, this has been a great success, one that we will
have to perpetuate, because I have a feeling that, over the
course of not just this year but probably 2 or 3 years, COVID
is going to be with us. We are going to see variants. We are
going to have to respond with different vaccines. And we have
got to get better at this.
Mr. Burgess. Certainly, again, thank you for your long
service to our country. And I have a number of other questions.
I will submit those for the record.
And I will yield back my time.
Ms. Eshoo. It is a pleasure to recognize the gentlewoman
from Florida, Ms. Castor, for your 5 minutes of questions.
Unmute.
Ms. Castor. There we are. Thank you, Chairwoman Eshoo and
Chairman Pallone, for calling this very important hearing. And
congratulations to my good friend Brett Guthrie for serving as
ranking member. I look forward to our continued work together.
And thanks to the witnesses for your excellent testimony.
It is clear that we must act with urgency on vaccines, on
the next generation of diagnostic tests and more, because we
have got to get kids back into school safely and folks back to
work. And Americans just want to live their lives again.
So my takeaway from the witnesses and your great testimony
is you believe Congress must act with urgency and with greater
specificity in support for our partners all across the country.
I think that means that we must ramp up the equitable vaccine
distribution. And thank goodness President Biden now has a
robust plan in the American Rescue Plan. And then we have got
to improve our public health infrastructure. It needs
modernization, especially accurate and timely reporting of
data. That transparent information allows our scientists and
community leaders, everyone, to make the right decisions and
ensure we are acting in an equitable way.
This has been a real problem. I mean, just in my home State
of Florida, it has been very difficult at times to get
transparent information simply on mortality rates, on what is
happening in our skilled nursing centers, what is happening
with testing.
So, Dr. Morita, you have a very unique perspective on this
as the former chief medical officer in Chicago and your work at
CDC. In your testimony, you say that an equitable response to
the pandemic starts with collecting and reporting all COVID-19-
related data by race, ethnicity, and socioeconomic factors. Yet
most States don't do this, and especially with vaccine data,
they are not publishing and collecting the data that way. How
can we improve our reporting and make sure that States are
following through with what they need to do?
Dr. Morita. Thank you for the question. The Robert Wood
Johnson Foundation issued some health equity principles early
in the pandemic because we recognized that there were
disproportionate impacts on communities of color. And the top
recommendation that we have is really to have data [inaudible]
by race, by age, by ethnicities, by socioeconomic factors,
geography, all those things. That work, though, requires
dedicated resources and higher education. And so the problem
that we have had with past response is that the same people
that were doing testing, contact tracing, arranging the--
investigating the outbreaks, were also asked to ramp up the
vaccination systems. And some of the systems weren't equipped.
They actually lacked this kind of information. So there are
resources needed to support enhancement of our systems and also
manpower to actually collect that information and then analyze
the information, because it is not enough just to have the
information. There have to be people to actually analyze the
data, to generate reports, develop the systems to reporting
consistently.
So all these things are critical. They need to be
prioritized so that actually the work that is being done can be
guided by what we find. When we see there are populations or
communities that are underserved, we can actually get the
resources to them, meet their needs, provide the services
needed so they can actually have access to the vaccines just as
much as everybody else.
Ms. Castor. And, Dr. Borio, you have made similar
recommendations. And, Governor Leavitt, I heard you loud and
clear as well on your specific recommendations.
I introduced the Ensuring Transparent Honest Information on
COVID Act, or the ETHIC Act, last Congress with Reps Underwood
and Haaland. We are going to be updating that and introducing
it soon to make sure that we are providing that specific
direction to States in the next emergency aid package.
And, Dr. Borio, it is hard to believe that here we are a
year later, and we do not have a true national testing
strategy. I would have thought by now that our diagnostic
testing capacity with public and private labs would be state of
the art, but the prior administration just did not prioritize
this. What else needs to happen in the next emergency aid
package to ensure that we have the most robust diagnostic
testing system?
Dr. Borio. So, as I recommended in my written testimony, I
would like to see the CDC working alongside sister agencies--
the FDA, HHS and others--to be able to provide much more clear
guidance for testing in the different types of settings.
What are the options, for example, for an employer? What
are the options for workplace? What are the options for
travelers? What are the options for higher education? Right
now, there are so many different types of strategies being
deployed in a very ad hoc manner. We don't have that much data
about, you know, which strategy is the most efficient. And,
again, the supply of testing is just not something that can
grow infinitely. We have a finite supply, we need to be able to
optimize what we have through a really public-health-oriented
guidance.
Ms. Eshoo. The gentlewoman's time has expired.
The Chair now recognizes the gentleman from Virginia, Mr.
Griffith, for your 5 minutes of questions.
Mr. Griffith. Thank you very much, Madam Chair. And I am
going to----
Ms. Eshoo. Good to see you. Speak up.
Mr. Griffith. OK. I will try to speak up a little bit. I
have this mask on. There you go.
I am going to tag team with your questions earlier, Madam
Chair, and, Mr. Burel, if you will help me out here. I agree
with Ms. Eshoo that, you know, there were some suppliers in the
country for PPE and that we need to have more domestic
production. That being said, I need help and the committee
needs help. We need to figure out, assuming that we can't bring
all the production necessary for the United States back to the
United States, what percentage--and you may not have an answer
today, but I want us to work on this going forward--what
percentage of our Nation's needs when it comes to, whether it
be PPE or, as Dr. Borio mentioned, filters dealing with the
manufacturing of vaccinations, et cetera, what percentage of
that needs to be in the United States?
And then, as a sidebar to that, we were having the
discussion here that, you know, we had that problem when Puerto
Rico got hit by the storms, and what percentage of that then
needs to be split up so that we are not being hit by various
storms? I mean, different parts of the country have different
issues, but it would seem to me we need to make sure that we
have a diversity of geographic locations. But I do think on
these important matters we need to have production in the
United States.
Knowing that we probably could have done better before,
what can we do better going forward? And what percentage is
necessary to be on our home territory, whether it be one of our
territories, like Puerto Rico or Micronesia, or wherever it is,
where we can get our hands on it when we need it?
Mr. Burel. Sir, I appreciate the question. I am going to
have to come back to you with some thoughts on percentages or
possibly other measures we might consider about what should be
manufactured here. But I think it is absolutely vital. We have
made efforts to invest in the vaccine infrastructure, as
Governor Leavitt discussed. I think we have got to make
investments at the Federal level in the PPE infrastructure,
because regardless of what pandemic event hits us again in the
future--and I am sure there will be another--we have got to be
better prepared. So we need to encourage people to enter the
PPE market that are not currently in it. We need to encourage
those that currently manufacture PPE to do that. And I agree
with your discussion of, for example, the small saline bags
that were manufactured only in Puerto Rico. We cannot limit
ourselves to a single manufacturer or a single location
geographically. We must have diversity.
Mr. Griffith. Well, I appreciate that.
And let me say that, in relationship to the PPE
infrastructure, earlier this year we had a hearing where we had
some of those people in. In fact, it must have been pretty
early because I think we were live here in the room. And they
said, if the Federal Government would just issue contracts to
purchase it, we don't necessarily need to buy the equipment.
But if we said we were going to buy a certain amount of PPE,
they felt like they could ramp up much easier. And in my
district, several folks came forward. I know one is going to
continue long term, I don't know if the others are, to make
masks and to make other PPE, and they are ready to go. But if
the market were to suddenly drop out, we would be back in the
same boat we were in before. So I think that that is important.
Do you agree with that, Mr. Burel?
Mr. Burel. Sir, I do agree with that. I think that, once we
create more market, more manufacturing capability for these
things in the United States, we have got to continue to support
that market or the bottom will drop out again and we will have
wasted investment. So my concern here is that we have a
diversity of suppliers, we bring other people into the
pipeline.
And one thing I would encourage your thoughts about are, it
is difficult to hold this PPE because it is large. It occupies
a lot of space. Maybe we need to hold bridge stocks and then
have capability to turn directly, immediately to domestic
manufacturers to bring in rapid surge directly to where the
government would direct or directly to fill behind government
needs.
Mr. Griffith. And, Dr. Borio, I want to get one more
question to Mr. Burel, but if you could think about it and we
might ask you to answer that question after this hearing,
because my time is almost up.
Mr. Burel, you specifically mentioned in your testimony the
need to engage all commercial healthcare distributors and
manufacturers. You reference the single vaccine distributor.
Are you aware of other situations in which additional parties
stand ready to partner with Federal, State and local
governments?
Mr. Burel. Sir, I believe that most parties involved in the
typical day-to-day healthcare supply chain are very much
prepared to partner with the Federal Government. We have a
system that operates every day. And, if we make ourselves take
advantage of all aspects of that everyday operating planning
and distribution system, I think we will have a better,
stronger result going forward. As we see vaccines increase----
Mr. Griffith. I have to cut you off, because I do want to
say one last thing and my time is just out.
Dr. Borio, you always are so good to give us testimony in
this committee, and I always appreciate it. So I apologize I
didn't get to you live today, but I would love to see some of
your thoughts after this meeting is over. Thank you so much.
And, Madam Chair, I yield back.
Ms. Eshoo. I thank the gentleman. And I just want to say I
look forward to working with you on the supply chain. In my
book, it should be all American. This business of maybe we
should do this and then be dependent on so-and-so, I just--
excuse the expression, I just don't buy that.
Mr. Griffith. We certainly need to have a big percentage of
it here.
Ms. Eshoo. Exactly, exactly. We guaranteed a market for the
pharmaceutical companies to buy vaccines. So, if we can do
that, we can certainly promise a market for American
manufacturers of American products to be used by the American
people in their hour of need. So thank you very much.
I now recognize the gentleman from Vermont, Mr. Welch, for
his 5 minutes of questions.
Mr. Welch. Thank you, Madam Chair. And I agree with all
your comments. And, Mr. Guthrie, congratulations to you as
well. I really look forward to working together to get some
things done here.
You know, the last administration, I think, could be
credited with doing a good job in public/private partnerships
to create the vaccines. The challenge, however, is how do you
get them injected into the arms of all Americans? And there
really wasn't a plan.
Vermont is doing pretty well, but it is very rural and
there are lots of folks who are homebound. And in the original
package, the Federal Government passed legislation to work with
our pharmacies. And we have got like 40,000 pharmacies that are
well situated to provide help to rural Americans.
And the question I wanted to ask Mr. Burel and Dr. Morita
is, how could we make that plan work better? The two things
that our Department of Health director has said is there has to
be predictability on the delivery of the vaccine. And, number
two, there has to be better Federal and State coordination.
Mr. Burel, do you have any comments about that?
Mr. Burel. Thank you for the opportunity, sir. I believe
that we can rely on our everyday outlets for healthcare
delivery that our American citizens are accustomed to seeing.
But I think one of the important things is we must engage the
entire supply chain, all distributors who are accustomed to
dealing with specific clientele across the country who are
specifically ready to deliver to their normal clients. I think
that we need to, as vaccine supplies increase, make sure that
all the distribution capability we have in healthcare in the
U.S. is engaged with assuring products are available at all of
the outlets that people expect them to be.
Mr. Welch. Well, Dr. Borio, maybe you could follow up on
that. And just, you know, this is operational now. We are not
talking just general and abstract. This is like the really hard
work of systems that are repetitive, reliable, and sustainable.
Dr. Morita?
Dr. Morita. Thank you for your question. I completely agree
with your health director in that having a predictable
awareness or knowledge of how much vaccine the health directors
can actually anticipate on a regular basis really helps to do
the kind of planning and operational work that you are talking
about. That was part of the challenge with some of the
cancellations that people were experiencing early on, is
because the health directors weren't actually hearing about the
supply of vaccines, except for a couple of days before the
vaccine actually arrived.
So what we are hearing now is the health directors are
actually getting 3 weeks' notice. So they actually can predict
and plan how to schedule their clinics, how to hire people,
where to locate their clinics, how much vaccine can they give
to their healthcare providers. So this predictability is really
critical.
The other thing is this level of coordination, because, as
Mr. Burel mentioned, we have a strong infrastructure for
delivering healthcare services, vaccines included. But there
really does need to be a coordination to understand where does
one system work and where does one system not work, because it
is not a one size fits all. And so having this Federal
coordination which CDC is overseeing what is working, where is
it working well, how do you share those best practices among
various jurisdictions is really, really critical to having a
successful ramped up system that optimizes all the different
ways of delivery of vaccines.
Mr. Welch. Thank you very much.
Madam Chair, I yield back. I appreciate the time of the
panel.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize a great Greek American from
Florida, Mr. Bilirakis.
Mr. Bilirakis. Thank you very much.
Ms. Eshoo. How are you feeling, Gus?
Mr. Bilirakis. I am doing good. I appreciate it.
Ms. Eshoo. Do you feel better?
Mr. Bilirakis. I am feeling much better. Thank you.
Ms. Eshoo. Good.
Mr. Bilirakis. Thank you for the letter too. I appreciate
it very much.
It is great to serve on this committee again in this term.
It is a wonderful committee. And I want to congratulate my good
friend Brett Guthrie as well for being the ranking member.
I have a couple of questions. The first is for Mr. Burel. I
want to follow up on Mr. Griffith's question. Were States and
localities properly set up to order and receive shipments from
the Strategic National Stockpile? If not, how did that impact
the effectiveness of the response for those particular States?
Mr. Burel. Sir, I think one of the things that we need to
make sure of going forward is that the Strategic National
Stockpile has direct communication with State public health
officials. We used to have a strong connection to those so we
all understood what to expect from each other. That kind of got
lost somewhere a few years back as priorities changed, money
moved away from the Public Health Emergency Preparedness
Cooperative Agreements.
We talked to them in the past around flu about allocations
per capita, but some of those conversations I think have been
broken and we need to reenter those between the SNS and those
States so everybody really understands each other well.
Mr. Bilirakis. Absolutely.
Governor Leavitt, I have a question. Tell me a little bit
about the availability of therapeutics. You know, I am all for
the vaccines, don't get me wrong, but tell me the availability
of therapeutics. Where are the challenges that we are facing in
administering therapeutics?
Mr. Leavitt. Yes, we have failed to make the robust
progress on therapeutics that we have on vaccines. And I think
we can learn from that and realize that it requires perpetual
investment, that we have got to enter into the same kind of
partnerships, and we have got to plant a lot of seeds to make
this happen. And as COVID elongates--and I think it is going
to; we will I hope go back toward normal, but we are all going
to be managing this for a long time--we need more tools. Even
vaccines are not such that it guarantees our success. So those
would be my suggestions.
Mr. Bilirakis. Thank you, Governor.
Mr. Burel, today's leading manufacturing supply chains
often operate just in time instead of the just in case to
reduce costs and maximize efficiency. However, this is a dual
edge that can present challenges, obviously, in the midst of a
pandemic response. As we saw with personal protective
equipment, how can supply chains balance resiliency with value
moving forward? Again, this is for Mr. Burel.
Mr. Burel. Sure. I like your words of ``just in case.'' And
I think that what we can do is, one, we can build stock in the
Strategic National Stockpile. We can build stock at State and
local levels with Federal assistance to do that. We can
encourage manufacturers and distributors to hold some flexible
stock for that really bad day that we just went through that we
hoped we never would. I think that there are ways to
incentivize that, and I would love to think about that and come
back to you with further answers.
Mr. Bilirakis. Please do. I would appreciate that very
much.
Again for Governor Leavitt, as policymakers consult the
data to direct response efforts, where should the goal post be
erected--talking about the--you know, we have the Super Bowl
coming up. Go Bucs. In other words, where should the bulk of
our attention and the resources be directed as States reopen?
Is it about total confirmed cases, hospitalizations, or deaths?
And, again, this is for Governor Leavitt.
Mr. Leavitt. Look, it is a combination of those things,
every one of them. Everyone has their own metric they like to
watch. But the reality is we have got to take a holistic view
of this. But I would like to underscore the point that Julie
Morita and others have made today, and that is the need for
data systems, because we won't get the data if we don't begin
to invest in the system.
And might I add, this has been a challenge. And I might
suggest also a priority for multiple administrations, and that
part of the dilemma isn't that they have not been asking, it is
that they haven't been funded. And so I think we need all of
those metrics available in readily assessable ways in an
integrated, open source fashion that give us the tools we need.
Mr. Bilirakis. Very good.
Thank you, Madam Chair, I appreciate it very much. Take
care. And, again, go Bucs, everyone. Kathy agrees with me on
that one.
Ms. Eshoo. Well, we are all relieved that you are feeling
100 percent better.
Mr. Bilirakis. Thank you.
Ms. Eshoo. And, Governor Leavitt, I couldn't agree with you
more about funding of the public health agencies. They are not
in good shape across the country. Some of them have systems. I
mean, there are all kinds of levels, and I think the grades
that we would attach to them, many of them are not where they
should be in the second decade of the 21st century. So I think
that is a point that Members need to--that we all need to take
seriously, because we are not going to get beyond this lack of
reporting of the kind of data that we need unless we have
agencies that have the systems that are necessary to collect
them. So thank you.
I now call on the gentleman from Oregon, a wonderful member
of our subcommittee, Mr. Schrader, for your 5 minutes of
questions. You need to unmute.
Mr. Schrader. All right. It takes a while.
I agree with you on the public health piece, Madam Chair,
100 percent. It is time for us to start to incentivize public
health at the State and local level, certain--we should have
some base funding that we put out there and then, frankly, use
the database collection as an incentive to have local
governments and States report good data on vaccines and other
critical and public health pieces of information, and they get
more money. I mean, that is the way the system should work.
I will add my voice a little bit to the whole PPE
situation. I am not sure I think it all has to be made in
America to start with, but we have to have at least a base
level made in America to make it worthwhile for American
manufactures to be online and have that capacity.
And to Congressman Griffith's point, I think we need to put
a panel together, a board, if you will, of manufacturers,
public health officials, and other certified smart folks, to
come up with what is a plan for ongoing manufacturing in this
country. We have had testimony that it is mostly just a lack of
having the ability to keep manufacturing going. So we should
invest in that, I think.
And I am curious, Mr. Burel, you know, very specifically,
what can we do to encourage, in this capitalist system of ours,
the manufacturers to set up and continue to manufacture? I
assume it has to do with churning over the stockpiles at a
certain rate that it makes sense for manufacturers, making sure
there is a percentage that providers of their gear, of their
PPE gear that has to be coming from America. What specific
recommendations would you have for us going forward?
Mr. Burel. So I think there are several things. I would
like to come back with you for a longer list, but a couple of
things immediately come to mind.
The first is we know there are people who want to enter
this market. There are people who have already taken risks to
enter this market. We need to support them, whether that be
through some sort of subsidy program, possibly investing in a
joint venture of certain lines with them, guarantees of certain
sales into the Federal Government, so that they can continue to
manufacture, but not only manufacture, improve their ability to
manufacture.
What we have found is the use of machinery made to do this
are made offshore as well. So we need to invest in how to make
our own machines.
I would like to come back with you with a more fulsome
list, if that would be possible.
Mr. Schrader. That is great. That is very, very helpful and
totally on point.
Dr. Borio----
Mr. Leavitt. Mr. Schrader, would you be open to me
commenting on this?
Mr. Schrader. Please.
Mr. Leavitt. This points, I think, to a very important
principle, and it is that there are certain expenditures that
are just a cost of doing business for a country to be safe, and
we make those expenditures in the area of defense every year.
But we now find that there are enemies that are substantially
more debilitating than anything we face as far as hostile
opponents. And we need to invest not just in PPE and vaccines,
but in readiness every year as a matter of national security.
Mr. Schrader. I would totally agree. And as the chair and
the committee knows, active ingredients are largely
manufactured in China and India for pharmaceuticals, and we
need to bring some of that back as another discussion.
Dr. Borio, what about treatment? I mean, there are a lot of
different treatment options hawked out there, some more
realistic and successful than others. I think a lot of folks
are facing difficulties accessing treatment and knowing what
treatments are peer-reviewed and actually going to be
successful.
What can we do to make sure that folks are getting the
right information regarding effective treatments?
Dr. Borio. Thank you for the question. It is indeed the
wild west out there.
I have to say that in 2014, the U.S., the U.S. Government,
led the way in the conduct of very rigorous clinical trials
that were very effective and very fast in West Africa during
the outbreak, when the rest of the world did not think it was
possible. We did the same thing in 2017 in the Democratic
Republic of the Congo in the middle of conflict. We actually
did clinical studies of vaccines and therapeutics. And here in
the U.S., we had a proliferation of trials being conducted that
did not meet standards, that did not have any hope for giving
us really interpretable data that we need to be able to inform
patient care.
We do need to establish a national infrastructure that can
be used in peacetime for studying infectious diseases, but also
that can rapidly be able to evaluate products quickly, but in a
scientifically valid manner, similar to what the U.K. has done
with recovery. And it is not too late to start. We need to do
this today, because there are so many promising therapies out
there, and we just do not want to waste more time in tiny
little studies that are not going to help us get information we
need to confidently use these products and ramp up supplies and
really go the extra mile to make sure that that we can deliver
them. We need data to make decisions in those investments.
Mr. Schrader. Very good. Thank you so much.
And I yield back, Madam Chair.
Ms. Eshoo. I thank the gentleman.
It is a pleasure to recognize the gentleman from Indiana,
Dr. Bucshon, for his 5 minutes of questions.
Mr. Bucshon. Thank you, Madam Chairwoman.
And, Dr. Morita, I just want to touch on something. In your
testimony, you talked about the equitable distribution of
vaccines, and I represent a rural America area, which is 98
percent White. But we have a lot of the same challenges in my
rural counties that we do in inner cities, which, in certain
areas of the cities, are mostly African-American.
It is a complicated process to register a vaccine, and what
I want to talk about is, do you have data to back up the
premise that currently there are people out there in our States
that are purposely not distributing vaccines equitably to
communities of color? Because if that is true, I was a
physician with--that is an appalling and unacceptable
situation. Or is it because of the difficulty that I have in
rural America, in actually accessing the vaccines that have
been distributed? I know that is a distinction, but it is very
important that we understand that.
Can you comment on that?
Dr. Morita. Thank you, Dr. Bucshon.
That is a critical distinction to make. I did not mean to
suggest that there are people that are withholding actively the
vaccine from communities of color. My concern is----
Mr. Bucshon. Yes, I didn't think that you meant that, but I
wanted to clarify that because, as a physician, it would just
be an appalling and shocking thing if people were doing that.
Dr. Morita. What you described, though, in terms of the
challenges of rural communities in terms of accessing the
vaccine, are still the same in some of our inner cities,
challenges they have in terms of making appointments, making it
on time to the places as well. So it is really--the challenges
are very similar, so the systems in both rural communities as
well as in urban areas really need to be overcome.
Mr. Bucshon. Yes, and we need to do better, no doubt about
that. Thank you for that.
And, Dr. Borio, in your testimony, you speak at length on
testing and warning that we are still not meeting the capacity
and rapid response that we need in order to limit the spread of
COVID-19 most effectively. I know some of this has been touched
upon, but increasing our testing capacity is something I have
been working on since the onset of the pandemic. When I heard
from my constituents, they are unable to access the test, and
even then--even when they are symptomatic--and then once they
were able to find a test, they had to wait 7 to 12 days. And
let me tell you, in certain areas that has not changed.
And while our testing has come leaps and bounds since
March, we still are not where we need to be. Turnaround times
have improved for some, but in rural parts of the country,
which I represent, I continue to hear from my constituents that
the turnaround times are long. And, in fact, nearly 20 percent
of U.S. counties lack a single testing site that administers
for COVID-19.
And as of last fall, nearly 40 percent of our public health
labs still lacked access to a single high throughput testing
platform.
If we can increase our capacity and have more rapid test
results, it will continue--if we can't do that, it will
continue to make it difficult for us to limit the spread. That
is why today, my colleague and I, Diana DeGette, will be
reintroducing the Access for Test Act, which would aid our
public health labs in acquiring high throughput platforms and
hospitals and doctors and pharmacists in also acquiring these
tests. I think we have already touched on our lack of funding
for public health.
Dr. Borio, could you speak more again to the need our
country still has for greater testing capacity and more rapid
results, and how arming our public health labs with more rapid
high throughput testing platforms and supplying our doctors and
hospitals with more point-of-care tests might achieve that
goal, and better prepare us for the days ahead with variants
now making their way across our borders?
Dr. Borio. Sure. So, you know, clearly, testing is critical
for us to be able to know what are we dealing with and to
provide the appropriate patient care and public health
interventions.
But let me go and make a link that may not be so evident.
You know, we have these monoclonal antibodies that have been
authorized by the FDA based on very limited data. Initially
they were designed, or hoped that they would be very effective
in treating patients who were sick with COVID. It turns out
they don't work very well then. We have to give them very
early.
Now, if patients cannot access testing when they are sick,
the delay in the results, they will miss the opportunity to be
able to access the therapeutics that need to begin very early
on. So you see how really difficult it is to break this into
very discrete systems, because it is really about the patient,
and the patient needs all of this to work----
Mr. Bucshon. Yes.
Dr. Borio [continuing]. They can have some good outcomes.
Mr. Bucshon. Yes. I mean, long turnaround times just are
not acceptable. I mean, you need to be able to get a result the
same day, especially, like you said, if you have early
symptoms, and it takes you out of the window of getting these
therapeutics, these antibody therapeutics, if you can't get
your test results for 4 or 5 days, and then you get really
sick, and then you are out of the window where maybe you could
have been helped and prevented hospitalization.
So thanks for that answer. And, Madam Chairwoman, my time
has expired. I yield back.
Ms. Eshoo. Thank you, Doctor.
I would just add that there is $50 billion in this plan of
the administration that will be coming before us, $50 billion,
with a B, and $3 billion relative to the therapeutics that you
were just asking about, which are really so important, because
time has gone by, but we have not really developed what needs
to be developed there. So I just wanted to add that to--add
that layer of money on the issues that we are talking about.
It is a pleasure to recognize a good friend, a wonderful
member of our subcommittee, the gentleman from California, Mr.
Cardenas, for his 5 minutes of questions.
Mr. Cardenas. Thank you very much, Madam Chair Eshoo. And
also, I am looking forward to working with you, Mr. Ranking
Member Guthrie, and all the members of the committee.
Four hundred thousand lives have been taken by COVID-19 in
America. Tens of millions of Americans have been affected. I
personally believe it didn't have to come to this. The numbers
are too high. We are the greatest country on the planet, and
when it comes to research, when it comes to development, when
it comes to being able to step up when the country or the world
is faced with, whether it be a pandemic or something that
threatens the lives of human beings across the planet.
One of the things that I would like to report, put on the
record, is President Biden met with some of us this morning,
and this morning he, once again, reassured us that, as the
President, he is committed to provide every resource that our
country can provide to save American lives and to reignite our
economy.
And one of our presenters today, I quote, said ``a trusted
source of truth,'' that is what people are looking for. And I
believe, in this current Biden administration, we are going to
get that.
I also want to point out that vaccinations need to be
recorded and reported, as some of our witnesses have mentioned,
and also when it comes to details as to who is getting the
vaccination and some of the background information, because
everybody knows, especially if you are a scientist, if you
believe in science and you believe in progress, information is
critical, and accurate information is important. And, again, I
believe that we are going to have more of that going forward.
Also, I would like to point out that it is not enough, in
my opinion, to just make sure that we got a vaccination to the
market and available in record time. That is a feat, and it is
phenomenal, and I am sure everybody applauds that. But I think
about it when I grew up in a family where my mother and father
had 11 children, and my mother used to serve 13 of us every
single day. She didn't just put the food on the stove and leave
it there and say, ``Come get it and find your own plate or find
your own utensils and figure out how you are going to put it in
your mouths.''
No, no. She went the whole way. She went ahead and served
it. She went ahead and provided everything that we needed to
make sure that we got that nourishment every single day for
decades.
And yet, at the same time, I personally am disappointed
that the greatest Federal Government on the planet just decided
to focus on a few things, and really allowed everybody to be to
their own devices without the critical support that our Federal
Government has proven that we are amazing at.
So with that, I would like to ask Dr. Morita, do you think
there is a risk in the United States investing too little today
in going forward, or should we invest as much as the science
requires us to?
Dr. Morita. Thank you for sharing your story with us.
This is the biggest public health emergency we have
experienced in our lifetimes. And the resources that are needed
to respond to this public health emergency are large. And so,
as much money that went into creating and supporting
development and manufacturing a vaccine, also there needs to be
a similar amount of resource and support given to assure the
delivery of the vaccine into all Americans throughout the
United States. And we recognize that some of the systems that
are in place aren't meant----
[Audio malfunction.]
Mr. Cardenas. I am sorry, I think you cut off a bit.
I would also like to ask Dr. Borio the same question, but I
would also like to insert that my father stayed married to my
mother for 48 years. So that partnership, it wasn't just my
mother. It was also somebody going to work every single day, 6
days a week, for decades to make sure that that partnership
could provide that food on the table.
Dr. Borio, a similar question to you as far as--let me get
a little bit more specific. If we don't include good and robust
appropriate funding for State and local governments and our
local providers, would we be able to address this pandemic
properly if we don't include that component in the next tranche
of support legislation?
Dr. Borio. Clearly, funding it underpins a lot of the
activities. So I can't say that we can respond adequately
without the resources. As Governor Leavitt just mentioned, you
know, there is a cost of doing business to be able to keep our
citizens safe and--but, I think I would go beyond that, which
is there is a need at this point to provide more direct
technical assistance as well because of the chronic
underfunding that has existed over the years.
So each locality has different needs. Some funding is all
they need. Others will require a lot more of a hands-on
approach to be able to get us to the other side of this crisis.
Mr. Cardenas. And when we don't do that, the people who
suffer the most are the people who had lacked before the
pandemic hit. So thank you very much. My time has expired, and
I yield back.
Thank you, Madam Chair.
Ms. Eshoo. Thank you, Mr. Cardenas.
I would say God bless your mother. Imagine the work that
woman did.
You didn't mention who cleaned up. Maybe--hopefully most of
the kids did after all the work she did.
Mr. Cardenas. Yes. Yes, we all had chores. Thank you very
much, Madam Chairwoman.
Ms. Eshoo. God love her. God bless the mothers.
It is a pleasure to recognize the gentleman from North
Carolina, Mr. Hudson, for your 5 minutes of questions.
Mr. Hudson. Thank you, Madam Chair. Thank you for holding
this very important hearing. I also want to congratulate my
colleague, Mr. Guthrie, on taking over as ranking member here
in this first hearing. I look forward to working with both of
you as we move forward.
It is no secret Washington is sharply divided, but this
committee must focus on the areas where we can work together.
Today, I have seen a lot of finger pointing, so I must remind
my colleagues that finger pointing and assigning blame gets us
nowhere. We need to focus on solutions.
From what I hear back home, our immediate priorities must
be increasing our manufacturing capacity for vaccines and
creating better systems of coordination for vaccine
distribution.
If we had held this hearing a year ago and an expert
witness told us we would not have one but two vaccines and over
20 million Americans vaccinated at this time, they would have
been laughed out of the room. Thanks to President Donald
Trump's Operation Warp Speed, we have two vaccines approved,
hundreds of millions of doses manufactured, and more promising
candidates in the pipeline.
In fact, despite all of the partisan sniping today,
President Biden inherited from President Trump a million
vaccines per day. President Biden came into office saying he
had a better plan to end the COVID-19 pandemic and promising
better vaccine distribution. I am pleased this has been a
priority for the President, but we are eagerly waiting to see
what he will do differently than the Trump plan. I am eager to
work with President Biden to get vaccines in the arms of my
constituents.
And there is much room for improvement. We need every
entity, from the Federal Government to the States down to the
individual facilities that are administering these tests,
talking to each other and coordinating vaccine supply. As an
example, my Governor told me he finds out how many vaccines he
is going to get less than a week before. I learned this morning
that a new system is being stood up to allow 3-week windows in
the coming doses, which is good but I fear may not be good
enough.
Another example is a facility in my district declined to
receive the vaccine they were offered this week, while another
facility in the same large suburban county has a 7,000-person
waiting list for the vaccine. This same county did not receive
any doses of vaccine for the 2 weeks prior. There is simply not
enough coordination to this effort yet, but I have faith we can
get there.
Governor Leavitt, given your extraordinary experience as a
Governor and Secretary of Health and Human Services, how do you
recommend increasing coordination among the many entities
responsible for vaccine distribution: the facilities, the
counties, the States, and the Federal Government?
Mr. Leavitt. Mr. Hudson, earlier I spoke of my experience
rolling out Medicare part D, where we had a much lesser
challenge, but it was 45 million people in a very short time.
In the weeks prior to that, I spent a lot of time as Secretary
going from community to community, drawing them together,
Federal, State, local, civil society, and other aspects,
churches, schools, and saying to them, ``We have to
collaboratively work together to make this happen.'' And that
is what it is going to take to make this happen, collaborative
action among all levels. And if we do, we can do better, and
over time we will get better.
Mr. Hudson. I am sorry I muted myself, but I think you are
exactly right, Mr. Secretary.
And I would just say, Madam Chair, I think this committee
could look at ways that we can promote better coordination in
the communities like that. We, as individual Members of
Congress, could play a role in this. In my State, I have got a
Democratic Governor, I am a Republican Member of Congress, but
we have worked very closely together. You know, we have had
issues, but we have tried to resolve them together, not in the
media. You know, I think that is the model.
I think that is what we as a committee ought to be looking
at, is how we can help with this coordination problem, because
there are people out there who desperately want this vaccine,
and there is plenty--I wouldn't say plenty, but there is a lot
of vaccine out there. We need to make sure it is getting to the
right places.
So I appreciate the testimony from you, Mr. Secretary. And,
Madam Chair, I hope this will be a good starting point for us
to work together on this.
With that, I will yield back to you.
Ms. Eshoo. I very much appreciate the comments of the
gentleman, and let's put our heads together about how best to
do that. Sometimes--my grandmother used to say the most
uncommon of the senses is common sense. So I think that we can
make some real headway together. And I sincerely appreciate
what you said.
It is a pleasure now to recognize the doctor from
California, Dr. Ruiz, for 5 minutes for your questions.
How are you feeling, number one?
Mr. Ruiz. I am feeling much better. Thank you for asking. I
am----
Ms. Eshoo. But you are not all better yet? You still have a
ways?
Mr. Ruiz. Not all better. I am still at home. I still have
some of those long lingering symptoms, but I am much better.
Ms. Eshoo. Well, get all better fast. We need you.
Mr. Ruiz. Thank you, thank you. Thank you, Madam Chair.
Ms. Eshoo. Get your shots. Listen to your elder.
You are recognized.
Mr. Ruiz. Thank you, Madam Chair. Thank you for holding
this very important hearing.
Large vaccination centers serve an important purpose, and
they are good for getting large numbers of people vaccinated in
a short period of time. And sites like that work for someone
who has a computer to sign up for an appointment, a car to get
there, and a job with flexibility that allows them to wait
hours to receive the vaccine.
But those are not useful for everyone, like high-risk farm
workers and other essential workers who are working for and
also high risk of getting infected from COVID.
I know this from personal experience as a physician. Very
early on in this pandemic, I have been coordinating and
organizing testing outreach for the homeless as well as farm
workers, in trailer parks, churches, school areas, and so, I
have had a really up close and personal interaction and have
heard their stories, their concerns, their difficulties.
And many don't have internet to make an appointment. They
don't have hours to spend on a phone trying to reserve their
slot. They don't have transportation to get to the vaccination
site, let alone spending hours waiting to receive the vaccine.
And they don't have information in their own language to help
them navigate the system.
So what we are doing now is just not working, and it is
disproportionately harming underserved populations and
communities of color.
A recent Kaiser Family Foundation analysis found that, in
Mississippi, Black people account for 15 percent of the
vaccinations while accounting for 42 percent of the deaths. In
Nebraska, 4 percent of vaccinations are to Hispanic
individuals, even though they make up 23 percent of the cases.
So this is not only a moral failure, this is prolonging the
pandemic.
We need a science-based public health approach that serves
the hard-to-reach communities, and we can't simply rely on our
broken healthcare system that has produced the disparities in
infections and deaths due to COVID to begin with to address
equity. This means making better use of local physician offices
and FQHCs. By and large, physician offices, outside of large
group practices, have been left out of the effort to vaccinate
patients that have heightened challenges, particularly in
communities of color where vaccine hesitancy remains high.
People trust their doctor, and they must play a critical role
in addressing issues of access and hesitancy. According to a
recent Harris Poll, the majority of Americans would prefer to
get their shot in their family's doctor's office, and less than
a quarter Americans want to be vaccinated at special sites
built to administer the vaccine.
Activating primary care and vaccination efforts will open
up thousands of access points providing broader reach and
better accessibility. And FQHCs, the sites that are there to
serve the very communities we are trying to reach, have been
massively underutilized during this vaccination process. And
they are ready. They just don't have the vaccines and resources
to activate their plans.
We need to provide our FQHCs with vaccines and the
resources to administer them both in their clinics and out in
the community. We need to provide funding for mobile clinics.
We need to provide funding for promotoras and the community
health workers, or for providers to take vaccines directly to
the people, like this past Monday where I joined a
collaborative of growers, nonprofits, and public health
officials to literally go into the fields to talk to the farm
workers about the safety and efficacy of the vaccine, and then
inoculate them on the spot. If we don't give them the resources
to carry out a vaccination plan, it won't work, and we are
seeing that play out now.
The Trump administration told States and counties to
develop their own distribution plans but left them no resources
to do it. States, county, and travel budgets are already
strapped from this pandemic. They need more resources if we
expect them to do this right.
So I urge this committee as we move forward in this
reconciliation process to make this a priority.
Dr. Morita, let's talk about FQHCs as a source of access
point for vaccinating our hard-to-reach areas, rather--and how
could FQHCs play an important role? And do you foresee any
barriers for them that we need to address?
Dr. Morita. Thank you so much, Congressman.
The federally qualified health centers played a major role
in Chicago's H1N1 response because they are so well connected
to our hard-to-reach communities. They are used to providing
the social services, as well as they are the trusted messengers
in sources of information for those communities. I think that
can play a critical role as we are trying to develop a more
equitable distribution system.
Mr. Ruiz. What were the barriers that you had to address
with FQHCs, so we can learn from those?
Dr. Morita. The barriers were really resources and adequate
staffing, adequate vaccine, adequate--just compensation for the
work that was actually being done. So, in order for those FQHCs
to be able to provide the services, they really need the
resources and support to get the work done. They are fully
capable of doing it. They just need resources to ramp up the
services they actually provide.
Mr. Ruiz. Thank you very much.
Ms. Eshoo. Does the gentleman yield back?
Mr. Ruiz. Yes.
Mr. Leavitt. Madam Chair, this is Mike Leavitt. Would you
allow me 20 seconds to say and echo the community health center
comment?
Ms. Eshoo. I would be glad to with the, I think,
graciousness of the Members. Go ahead, Governor.
Mr. Leavitt. As a former Secretary of Health, and, I might
add, Governor, I experienced directly and firsthand the
importance of community health centers, and it is evident to me
that they have to be a part of being able to solve the equity
issues here. And I could break into song longer, but you have
been gracious to allow what I have.
Thank you.
Ms. Eshoo. Governor, on that, there is full support--first
of all, full understanding and full support from both sides of
the aisle in community health centers, and Congress has
increased funding for community health centers, I think really
quite exponentially, so they are--you are absolutely right, we
agree with you. But we want you to know where we all are and
that, as they say, it is preaching to the choir because, thank
God, all of the Members have a deep appreciation of them.
It is now a pleasure to recognize Mr. Dunn from Florida,
and it is great to have you on our committee.
Mr. Dunn. Thank you very much, Chairwoman Eshoo. It is an
honor to join you on this committee, and I certainly look
forward to the many hard tasks that we have ahead of us.
I appreciate the opportunity today to discuss ideas
relating to ramping up vaccine distribution testing and
ensuring America has a robust medical response to this and to
future pandemics.
As we pass one year from the date that the Trump
administration declared a public health emergency, I would like
to extend my sincere condolences to those who have lost loved
ones to the virus. I also extend my thanks to all of the
healthcare heroes who have risked everything to help us all
through this emergency.
As COVID-19 began to spread in America last year, the Trump
administration got to work implementing timely travel
restrictions, launching the active partnership and Operation
Warp Speed initiative to enhance agency coordination and, more
importantly, to bring private industry ideas and capabilities
to the Federal response. The pace at which Pfizer and Moderna,
J&J and others, who have developed their vaccines, is truly
unprecedented, and I commend the administration's actions for
the fastest vaccine development in history.
As States ramp up their vaccine distribution capabilities,
they must also continue to employ robust diagnostics, and,
importantly, we have to continue to evaluate available
therapeutics, that is to say treatments, for COVID-19. We also
have to turn the lessons we have learned into action when it
comes to supply chain challenges, all the way from production
to distribution.
Dr. Borio, we are hearing about the different variants of
COVID-19 and the challenges that they may present us with. Do
you agree that the efforts to identify new and existing
therapeutics are an important piece of our arsenal to combat
COVID and epidemics in general?
Dr. Borio. I do. Dr. Dunn, I mentioned in my----
Mr. Dunn. You did.
Mr. Borio. Yes, I think it is a very critical component. I
mean, I think we know that vaccines--in public health measures,
vaccines are the most important tools to deal with pandemics,
the contagious disease we are facing today, but we also need
treatments to be able to take care of patients who are ill.
Mr. Dunn. So I like the vaccines for the specific, but I
was thinking here more broad, about the broad-spectrum
therapeutics, which should enjoy activity against many of the
mutations as well as the original virus that we are combating.
If you will forgive me, I am going to move on simply because
the time is so short.
Governor Leavitt, in your testimony, you stress the
importance of preparing what lies ahead, especially as it
relates to ensuring the manufacture of vaccines and other
epidemic-specific products can be sustained.
In December in a supplemental appropriations bill, Congress
authorized $500 billion for domestic manufacturing
capabilities. How, briefly, would you spend that money?
Mr. Leavitt. Briefly, that is a hard question to answer.
Mr. Dunn. Five hundred billion dollars, just blow through
it like that, right?
Mr. Leavitt. Well, I think we need to acknowledge what got
us here in such a short time. We planted multiple seeds. We
need to keep doing that.
The second is that we entered into partnerships. This was
not just about the government, it was about the government and
private sector, and we brought people in the private sector
together. We need to continue to do it in this setting in the
supply chain matters. And we invested in new technologies along
the way, and I commented at various times through this hearing
about the need for that to be an ongoing process, not simply
when we are in the midst of a pandemic or another public health
emergency.
Mr. Dunn. I could not agree with you more.
I had--was party to doing that when I worked in the Army
with USAMRIID, the Institute of Infectious Diseases, so I am on
your side on that. You are going to get more--or hear more from
me about this after today.
And, Mr. Burel, you are too. I am going to be reaching out
to you on some ideas of what we should be spending that $500
billion on. I have my own ideas. I want to hear yours.
In the short time left, Governor Leavitt, you also
recommended communication--you know what, I am going to skip to
my last question, because I care about that more. What advice
do you offer the Federal Government to facilitate the use of
future and currently available therapies for COVID-19? For
example, monoclonal antibodies, you know, they are available.
They are out there. They are approved. There are many providers
who would have the--do have the ability and willingness to set
up outpatient infusion sites. What can we do to get this out to
the people and other therapies?
Mr. Leavitt. Well, it happened with vaccines because we put
the emphasis on it, because we put the dollars behind it, and
because we operated in parallel--we operated rather in parallel
on certain parts of the process as opposed to requiring it at
every case that it be sequential. That same formula will work
in producing and enhancing our supply there.
Mr. Dunn. Our time has expired. I do think that we could
use monoclonal antibodies more, in more cases effectively.
And thank you very much, Madam Chair. Certainly a pleasure
to join your committee.
I yield back.
Ms. Eshoo. It is wonderful to have you with us, Mr. Dunn. I
agree with you on the concern that you raised, and I think it
is worth repeating again that in this recovery act that there
is--as the Governor said, we put money behind the development
of vaccines. There is $3 billion to develop exactly what you
reference.
So thank you, and welcome again to the committee.
Pleasure to recognize the gentlewoman from Michigan, Mrs.
Dingell.
Mrs. Dingell. Thank you, Madam Chair, and to Ranking Member
Guthrie, it is great to be here for the first hearing of this
year to talk about a subject that means so much to all of us
and our constituents.
And I think, before I dig into what I really want to talk
about, I want to associate myself with many of the comments of
my colleagues. But what Dr. Ruiz was saying, I have spent the
last--last Thursday night I had a town hall that, if anybody
could believe, it was worse than the John Dingell one on
affordable care, with people desperate that can't get answers.
They feel like they are being deliberately discriminated
against. They don't know where to call.
And, you know, we don't have--we have a national strategy--
we are trying to get one, to give it to the States. The States
are giving it to State and local governments, and there is
simply not enough vaccine right now. And there is not a central
number to call, and people are--if you call the hospital, the
hospital says, ``Well, they are now giving it to the public
health departments more,'' and the public health department is
sending you someplace else. I was on phone calls with public
health departments and hospitals not being on the same page
yesterday.
And, quite frankly, members of the African-American
community, communities of color, are feeling very isolated.
So I want to talk about that today. This--you talked about
today defining the public health challenges, that we ensure
equitable vaccine access for disadvantaged communities
addressing vaccine hesitancy and clearly communicating
availability for all Americans. And I think we have got to be
realistic about what that really means, because we can't get
them all in everybody's arms right now.
Dr. Morita, in your testimony you highlight the need for an
equitable response to the COVID-19 pandemic as one of the
fundamental principles required to improve distribution. I
agree, couldn't agree more.
Yesterday, Dr. Khaldun, who is our chief medical executive
in the State of Michigan and has been working this really hard,
reiterated that my home State's commitment before--she said it
before the committee--is that no disparity exists in
vaccination rates across racial and ethnic groups or by social
vulnerability index. However, despite these extensive efforts,
we continue to face challenges in Michigan and across the
country with meeting this commitment.
What additional steps should States be taking to address
the racial disparities in vaccination rates? Michigan is
partnering with local health departments and school-based
health centers. Should we be looking at leveraging additional
nontraditional spaces? Is there other outreach that you are
seeing that is effective here? We talk about community health
centers, but they are not being given the vaccine to even be a
place for it to be used. I would welcome your wisdom.
Dr. Morita. Thank you for your questions.
The accessibility of the vaccine is dependent on having the
vaccine broadly available in multiple locations. When the
vaccine supply is limited, it is really hard to do that, and so
there has to be a closer hold on the vaccine. As supply
improves, more and more locations will actually be able to get
it.
Currently, what needs to happen, since there is a limited
supply, is that the locations need to be strategic, so they are
equally accessible to all communities. And, in addition to
that, there is effort that is being made to simplify the
registration process for people who don't have access to
internet, who don't have a car, who have to work during the day
and have to access the vaccine later in the night or on
weekends.
So, the systems have to be developed in a way that actually
helps people that are most difficult to reach or most likely to
get sick to access the vaccines themselves.
Simultaneously, what needs to be happening as well is work
needs to be done within communities to understand what their
issues are in terms of concern or hesitancy, because there is
an element of hesitancy that exists. And the way to overcome
that is really to understand from the community what is
happening. What are their questions? What are the concerns? Who
do they want to hear from?
There are activities going on right now to support those
efforts, but they are just ramping up. To use get out the
count, get out the vote in rural America type of approaches,
with community members going into their communities because
they are trusted voices to really reassure the communities
about how to access the vaccine and why they should get the
vaccination.
So it is going to have to be a stepwise approach, because
we don't have sufficient vaccine for everyone to be vaccinated.
But, while we have limited supplies, we also have to
simultaneously make it available to the communities who are at
greatest risk of getting seriously ill and dying.
Mrs. Dingell. And you said it is a real challenge, and
there isn't one--the problem is that no State, no local has one
simple process of figuring out who to call. And I think it
would be useful if we could figure that out nationwide.
I am out of time.
Dr. Borio. If I may add? I was going to add an observation
that may be helpful to keep in mind. Because of the temperature
control requirements of these vaccines, the early vaccines, as
well as the presentation in multidose vials, it does present an
additional hurdle to making them available at all of the sites
that we would have liked, in addition to the supply
constraints, of course. Hopefully this will get better with
other vaccines being authorized that are less stringent.
Mrs. Dingell. You know, I think that is true, but in
Michigan we have had fire departments and community health
centers actually buy the freezer wanting to be able to do it.
They have got--it is the supply right now. But then those that
are able to access the system aren't necessarily some of those
that need it the most. It is a real challenge.
Thank you.
Ms. Eshoo. The gentlewoman yields back.
Mrs. Dingell. I do yield back.
Ms. Eshoo. Thank you, Debbie.
It is a pleasure to welcome Mr. Curtis as a new member to
our committee, and for his debut of asking his questions.
So welcome, and you are recognized.
Mr. Curtis. Thank you, Madam Chair, Ranking Member Guthrie.
Yes, this is my first Energy and Commerce meeting, and I
want you all to know you pass what I call the elevator test,
which is if I were to get stuck in an elevator, I would love to
be with all of you. I am just really pleased to be on the
committee.
I would like to jump in and discuss an issue. At lot of my
colleagues, and rightly so--and, Congresswoman Dingell, I think
you did a really good job of emphasizing some of the inequities
in our minority communities. Julie Morita talked about
inequities in urban neighborhoods.
Governor Leavitt, hello. It is great to have one of my
fellow members from Utah on the panel. As you well know, my
district in Utah and many of the districts in the country
represent vast areas of rural areas. And, if not careful, these
areas too are underserved. They bear the burden of poor medical
care in many cases, long distances, and also have the problem,
I think, of being underserved in this.
What is the right way to think about distributing doses in
rural areas? You brought up community health centers, and they
are helpful, but they are still far and few between in rural
places.
And, Julie Morita, if you would jump in after Governor
Leavitt and maybe share your perspective on this as well.
Mr. Leavitt. Congressman, let me say I resonate strongly
with many of the things that have been said about the need for
us to get vaccines to these areas that are hard to reach, and,
like you, I have become very familiar with the dilemmas that
happen in rural areas. And I think the first thing to remember
is that the infrastructures in urban areas are not available in
rural areas, and so you have to deal with them in unique ways
and customize the approach to each one. Without that, we will
never be successful.
Dr. Morita. So thank you for your question. I would add
into that as well.
The approach that--I understand the challenges associated
with rural communities as well, and mobile units can be used
more regularly [audio malfunction] vaccines that are available
that don't require the ultra-cold storage or freezer, freezer
storage. So I think there is potential for increased access
through mobile-unit type of approaches in the future.
I think it is really, again, as Governor Leavitt mentioned,
really working with the communities to understand what are the
challenges they are actually experiencing so they can inform
the solution-making as well because, from an equity
perspective, whether it is rural, whether it is urban
communities, the communities know their needs best, and hearing
from them and listening to them to understand what the
solutions are will help to inform a more equitable response
overall.
Mr. Curtis. Thank you.
I would love to give the State of Utah a little shout-out
here. We are in the top 5 percent in the United States in our
distribution, and my congratulations to our new Governor and so
many that are doing a great job.
Governor Leavitt, you are unique in that you had experience
on the State level and on the Federal level. There seems to be
a little clash from time to time about who best handles certain
parts of the responsibilities. Some have advocated the Federal
Government should have taken over all distribution.
Can you kind of share, from your perspective, what the
right marriage is here between Federal and State government,
and how can we maximize each of these two subsets?
Mr. Leavitt. As you pointed out, I served as the chief
executive for the State, and I also served as the chief
executive at HHS. And I can tell you from that experience, that
both have unique jobs and both have limitations. One limitation
the Federal Government has is that it does not execute the
capacity--it doesn't have arms and legs to move around
communities. It depends on the States, and it depends on the
local communities. And so, to some, that somehow the Federal
Government will execute on this at the local level simply is
not acknowledging the reality.
On the other hand, there are many things that States could
never do. States could, on their own, never have developed a
vaccine. States need the resources that the Federal Government
can apply at a point like this. States require the kind of
international coordination that this kind of thing takes place.
States cannot provide situational awareness. You have to have
data from 50 States to be able to know what is happening and
what can be done.
There is a role, a critical role, literally, a role that
simply cannot be done without at both the State and the Federal
level. This requires a collaborative attitude as much as it
does any degree of statute or any degree of regulation. It
requires us all to sort of put down--lay down our swords, sit
around the table, and solve a problem.
Mr. Curtis. Thank you, Governor. I regret that I am out of
time.
I yield my time, Madam Chair.
Ms. Eshoo. I thank the gentleman for his questions.
And it is a pleasure to recognize the gentlewoman from New
Hampshire, Ms. Kuster, better known as Annie.
Ms. Kuster. Great. Thank you very much, Chairwoman Eshoo.
And thank you, Governor. I think you said it exactly right,
we need a coordinated approach between the Federal Government
and the States. And I think the title of this hearing, ``Road
to Recovery,'' is exactly intended for that.
Last spring, after dozens of conversations with our public
health officials and business leaders in New Hampshire, my
staff and I wrote a comprehensive outline of steps that
Congress should take to mitigate this pandemic and support our
economic recovery. And we titled that document ``Road Map to
Recovery'' because there is so much work to do. And while many
of these proposals were included in COVID legislation last
year, we have more work ahead of us specifically related to the
vaccine and improving our health data systems.
While some public health departments have access to the
latest and greatest public health infrastructure, others are
literally collecting case reports with pen and paper and can
only transmit data via telephone and fax. In other cases, COVID
vaccination appointments are made and canceled and remade and
canceled again, while older Americans sit at home frustrated
that they are locked out of the website that thinks they
already received the immunization. So I am glad that Congress
has put resources towards modernizing our public health
infrastructure.
I want to ask you, Dr. Borio, you said in your testimony,
``Improved data infrastructure needs to be one of our principal
areas of attention.'' And I couldn't agree more. Can you give
us a sense of what that data infrastructure will look like for
a 2lst century health data system?
Dr. Borio. Sure, and I will be happy to elaborate in
writing for you. But fundamentally, the way I see this is that,
you know, a company like Uber did not disrupt transportation
business by hiring the best drivers. They did so with
technology, to provide a capability at the hands of every
driver. And we need to do this--think about public health data
similarly. We need to have an integrated interoperable and, at
the Federal level, tremendous analytic capability and link
those to actual actions to information to the public.
And I just want to say that hearing Secretary Leavitt speak
today, too, makes me miss his leadership when I was young in my
career at HHS. So thank you for that.
Ms. Kuster. Thank you, thank you. I appreciate that.
I just want to share with the entire committee, Congressman
Bucshon and I have introduced bipartisan legislation to improve
our data infrastructure by expanding the enrollment and
training of vaccine providers, modernizing public health
information technology, and communicating with patients and
providers in real time.
Dr. Morita, can you tell us some of the current challenges
that healthcare providers and public health departments are
having on the ground due to inadequate immunization information
systems? And how can we strengthen these systems?
Dr. Morita. So, as you pointed out, there are huge needs.
What Dr. Borio mentioned was this critical need for
interoperability, and I would say that is a major challenge for
immunization information systems right now, because each of the
50 States have different systems that they are using. They have
all been created separately and distinctly, and so they aren't
necessarily interoperable.
But, in addition to not relating to each other, they don't
necessarily relate to all of the vaccinators within the
jurisdictions. So hospitals, pharmacies, healthcare providers,
mass immunization clinics--there is not one system where all of
the information comes together.
So, as we look forward to the future, having an
interoperable robust system for information to be shared within
a State and then also between States is really, really
essential. What I would say we have seen play out this year has
been a consistent lack of support. It is a boom or bust in
terms of public health infrastructure, and the data
infrastructure is where you see it play out most statistically.
In order for us to really be prepared for the next
pandemic, or even to do better during peacetime, we really need
sustained levels of support so we can actually maintain these
systems in a way that keeps up with the times.
Ms. Kuster. Well, I love your analogy to Uber.
What steps can be taken to give confidence to the American
people that the information shared in these data systems will
be protected and only used to further public health response
efforts? I know in my district, people are very concerned about
privacy of their healthcare data. And can you mention the
precautions and protections that would be in place?
Dr. Morita. So the public health data, when we access
public health data at the health departments in the State or
local levels, or at the Federal level as well, those data are
protected by HIPAA. And so the only way that we can use that
information is to really guide or inform public health
intervention.
So when we see there is a community that is not being
reached or we see a population that isn't getting vaccinated,
we can actually target and direct our resources to them.
When information is shared, it is shared in aggregate so
that individuals can't be identified. And, if there are too few
people that have similar characteristics, that information is
not shared, out of respect for the privacy of these
individuals. So because of HIPAA being in place----
Ms. Kuster. Thank you. I have to apologize. I have run over
my time. I need to yield back, but that was very helpful. Thank
you so much.
And I yield back.
Ms. Eshoo. The gentlewoman yields back.
I do have legislation on privacy relative to these systems,
so we can talk more about that later.
It is a pleasure to welcome to the committee and recognize
Mr. Joyce from the great State of Pennsylvania. We are thrilled
that you are part of the committee. And your debut, 5 minutes.
Mr. Joyce. Well, first of all, thank you, Chair Eshoo and
Ranking Member Guthrie. I am truly honored to be part of the
Health committee on Energy and Commerce, and specifically, I
want to thank the witnesses for appearing today at this
incredibly important time.
President Trump's Operation Warp Speed has been successful
at delivering multiple FDA-authorized COVID-19 vaccines in less
than a year. This truly is an unparalleled achievement.
However, we are now facing new strains originating from the
United Kingdom, Brazil, and South Africa. Now is not the time
to let up on innovation in face of this additional health
challenge.
Many experts believe the coronavirus might continue to be a
public threat into the future. And while these first-generation
vaccines are nothing short of incredible and significant
achievements, I believe that it is imperative that we as a
Nation begin thinking about the United States' approach to how
we fight this virus in the years to come.
It is also critical that we not lose sight of the
development of new therapeutics to treat the virus, in addition
to second-generation vaccines that will speed the public's
access to the latest therapies and the latest therapeutics.
My questions first are for Governor Leavitt. In your
testimony, you said that the role of Federal policymakers in a
pandemic's response is to scout the next valley, anticipating
dangers, developing contingencies, and adopting strategies to
mitigate potential threats.
Given the emergence of more COVID-19 variants that may be
resistant to the limited treatments that we currently have, how
can we in Congress do what you said, plant the multiple seeds?
As the grandson of an Irish immigrant who planted beautiful
gardens, and I know the importance of planting multiple seeds,
how can we best prepare to face these variants?
Mr. Leavitt. First, we acknowledge that this is likely to
be a much longer process than just the time it takes to get
people vaccinated one time throughout the country. It is very
possible that over time we will need to have booster shots or
we may have to have vaccinations, much like we do the annual
flu, that this is going to be mutating, that we have to be
prepared.
And there are supply chain issues. This is an ongoing
issue. And there will be infrastructure issues that need to
become more permanent, not just temporary.
That is what I think we have to be thinking about in terms
of scouting the next valley. We have to anticipate that we need
to get better.
I said earlier in the hearing that, if we were talking
about distributing 330 million hamburgers, we could do that in
our sleep because there is something on every corner that can
disperse a hamburger, and we all know how to get it.
We need to become good at distributing and receiving
vaccines, and over time our capacity to do this will improve.
Mr. Joyce. Governor Leavitt, what can we do now to equip
agencies like BARDA to ensure that we have access to vaccines
that can provide broad immunity so we aren't crippled by a new
mutation in 2 or 4 or 10 years?
Mr. Leavitt. You start with funding them, make certain that
they have the relationships that they need and the money that
is needed to deploy it. You have to connect them with the
regulatory agencies who are going to need to be partners. One
thing I believe this committee could do that would move this,
move our capacity forward, it has been referenced that we have
learned a lot of lessons. We need to harvest those lessons and
incorporate them in the normal process, not just the emergency
process, because this may be an ongoing need.
Mr. Joyce. My next question is for Dr. Borio. In your
testimony, you mentioned vaccine manufacturers who are taking
steps now to develop and test vaccine candidates that may be
needed to protect against existing and emerging variants that
we certainly will face in the future.
How do you recommend Federal officials lead large-scale
vaccine manufacturing efforts and approach these challenges?
Dr. Borio. Sure. So, at this point, as they develop the
candidate, if they were to make a decision to go to full-scale
production for the new candidate, they are taking away from
what is already being produced for the strain that is also
circulating. So the most direct way to answer your question is
that we do have to expand the industrial base for manufacturing
these vaccines so that we can make more than we are making
today, so that we have more flexibility and not make these very
difficult choices.
Mr. Joyce. Thank you very much.
Madam Chair, my time has expired. It is great to be with
you on this road to recovery.
Ms. Eshoo. Thank you, Congressman Joyce, and we are
delighted that you are with us and part of the team. We love
this subcommittee, and for good reason. It is so important, and
Members take the work very seriously and have been highly
productive. So it is an honor for each one of us to be on the
committee and to be together.
With that, the Chair recognizes the gentlewoman from
California, Ms. Barragan, for her 5 minutes of questions.
Ms. Barragan. Thank you, Madam Chair. Thank you to our
speakers, and for this hearing.
Let me start first by responding to one of my colleagues
who asked, what is this administration doing differently than
the last one? We will also remind people that we inherited over
400,000 deaths from this pandemic, partially for inaction that
was taken.
The first thing that was done is the mask mandate. It is
making sure that we are putting science first and making sure
people understand the best thing we have against this virus
right now is wearing a mask, social distancing, and doing those
things that are necessary until people can get a vaccine.
This administration is calling for more dollars from
Congress, which is why it is important that we invest, so that
we can make sure we are getting money to local, State and local
governments to be able to give more of this vaccine. The new
administration has also ordered more vaccines when the prior
administration wouldn't do so and turned it away. So there is a
lot being done now. But our job in this committee is to say
what can we do to help with what is going on right now. And I
want to thank all the conversations we have had about the
inequitable distribution of vaccines.
I represent a district that is almost 90 percent Latino,
African-American, low-income, poor. And we have seen firsthand
the inequities that are happening. We are having some
constituents having to take three buses just to get to a
vaccination site. We just learned the other day that the
pharmacies were no longer going to get vaccines. They were
going to be pulled away and be given to mega PODs, which is
harder for constituents like mine to get to. And so I
appreciate [inaudible] about the creative solutions.
And let me take a moment to say thank you to Governor
Leavitt for your testimony. You had an entire section about
anticipating and addressing the barriers of the social
determinants of health and equity in your testimony and spoke
very specifically about not leaving those behind in low-income
communities, rural communities, and minority communities. And
you talked about the concerns that we have about transportation
and people's situations.
The one common theme I am hearing today is long-term
investment, and so making sure we are investing in things like
social determinants of health and making sure we are addressing
that long term, not just when the pandemic comes out. So it is
something I hope that we will also look into one of my bills on
social determinants of health.
But I want to start the questioning with you, Dr. Morita.
You have spoken about one of the things that needs to be done
is to use federally qualified health centers and community
clinics. When I was a kid, I relied upon them quite a bit. And
so I have heard that, number one, many of them, the majority of
them, are not getting the vaccine. There are shortages on
gloves, shortages on the needles to be used.
Is there anything that you want to either elaborate again
on or tell us as Congress on what we should be focusing on to
making sure that the community health centers are getting what
they need, whether it is staffing or supplies, to be able to
reach target communities and those that are underserved?
Dr. Morita. I reviewed the Biden administration COVID
strategy that was released the day after inauguration. Within
that strategy is a commitment to providing additional resources
to federally qualified health centers, recognizing the
important role that they play in reaching some of our harder-
to-reach communities who have been so devastated by this
pandemic. And so I think that there is what is necessary. The
equities are committed. They want to do this work. What they
need is the resources to actually ramp up and scale up their
ability to deliver the vaccine and to deliver the healthcare
that is necessary.
I appreciate also your point about the social determinants
of health. What the pandemic has done has made a clear
connection between the systemic barriers to people having good
health. So it is access to insurance, access to good pay, a
good-paying job, access to paid leave. All of these factors
contributed to why certain populations actually are at higher
risk for having hospitalizations and dying. And so these
underlying conditions really need to be addressed for the long
term so that we are not in the same state with the next
pandemic.
Ms. Barragan. Thank you.
I think this is a good opportunity to emphasize the need
for us to invest in community health centers and clinics long
term. Oftentimes we are not funding them long term. We are
going year by year. And guess what? We are not giving them the
increases that they need yearly to invest in our community
health centers.
So I want to thank the panelists. There is a lot to cover,
but I am out of time.
And with that, I yield back.
Ms. Eshoo. The gentlewoman yields back.
It is a pleasure to recognize the only pharmacist, I think,
in the entire House of Representatives, Mr. Carter, for his for
5 minutes.
Mr. Carter. Thank you, Madam Chair. I have to correct you,
though, we have another pharmacist now.
Ms. Eshoo. Oh, good.
Mr. Carter. We have two pharmacists in Congress now.
Ms. Eshoo. Well, that is great.
Mr. Carter. My colleagues are giving me----
Ms. Eshoo. [Inaudible] some of the distribution.
Mr. Carter. Yes, yes. But I am the oldest pharmacist in
Congress, if it matters.
Ms. Eshoo. OK.
Mr. Carter. So, nevertheless, I thank all of the panelists
for being here and discussing this extremely important subject,
obviously.
Governor Leavitt, I wanted to start with you and just talk
about the distribution process. It is so vitally important. And
one of the critical aspects is to pharmacies and to
pharmacists, making sure that we are utilizing retail
pharmacists. Whether it be independent or chain pharmacists, it
is extremely important. As has been mentioned during this
hearing, 95 percent of all Americans live within 5 miles of a
pharmacy. Pharmacists are the most accessible healthcare
professional in America. We need to utilize that. And I think
we would all agree with that.
HHS has made some changes to authorize pharmacists to be
able to administer the vaccine. In fact, early on, they, during
this pandemic or during the administration distribution of the
vaccine, the administration of the vaccine, they passed a rule
where the people--that pharmacists could give it to anybody 3
years or older, and that was very important. And just
yesterday, they also passed a rule to say that the vaccines can
be shipped directly to pharmacies, and that is very important
during this pandemic as well.
I wanted to ask you, Governor Leavitt, you have served at
the State level, you have served at the Federal level, as have
I. I have served at both levels as well. And is it your belief
that all pharmacists should be able to administer the COVID-19
vaccine, if it is approved by the FDA, no matter what the State
laws may be, no matter what varying State laws there may be?
Mr. Leavitt. I have referenced a couple of times in this
hearing my experience with Medicare part D, which is another
moment in time when millions of people all at one time were
seeking some type of new Federal or new government service. The
pharmacies were the main--they were the heroes of that whole
effort, because people went to the pharmacy, they knew they
could get good advice, they knew they could find out the
answers, and I became a great supporter of that. And I think
they are a great support in the annual flu. Typically, that is
[inaudible] I get my flu vaccine is at the [inaudible].
Now, I personally would not go so far as to say that the
Federal Government has an interest in being able to override
local decisions that are being made on what is best in every
community. But I think many communities are and will realize
even more how important the [inaudible] to your important
statement is in being able to serve [inaudible] those
communities, particularly the underserved communities.
Mr. Carter. And I would agree with that. And thank you,
Governor, for that point.
One thing that I wanted to point out--and I would be
interested in knowing your opinion on this as well--is that,
during this pandemic, we have both relaxed some rules and
implemented some new rules. And one thing that I hope that we
do at the Federal level is to review this before we just go and
put them all back into place. I mean, there are things that
pharmacists can do that they need to be doing, not just during
this pandemic, but they need to be doing the whole time in
order to improve healthcare services here in the United States.
Governor, another thing that I wanted to ask you----
Mr. Leavitt. I concur with you having pharmacies operating
at the top of their license being able to do all of
[inaudible].
Mr. Carter. Absolutely.
I represent an area that has a high minority population as
well. And it is very important and very concerning to me about
vaccine hesitancy, particularly in the minority community. Just
wondering what your experience is. What works? What doesn't
work? Just some advice, if you would, on how we can improve
that.
Mr. Leavitt. [Inaudible.]
Dr. Morita. I think he is having difficulty. I am glad to
jump in on this question.
Mr. Carter. Yes, please, please do. Thank you very much.
Dr. Morita. Sure. So I think in addition to the challenges
with people accessing the vaccine from our [inaudible] to our
communities are color, there are also challenges of vaccine
hesitancy because of distrust of the vaccine. Because of
mistreatment in the past or discrimination in the past, people
aren't trusting the vaccine itself. So it is really important
for there to be community efforts where there are trusted
messengers from within the community, engaging with the
communities, to understand what their questions are, what their
concerns are, who they want to hear from so we can actually
address the concerns. So, when a vaccine becomes more readily
available, the communities that are at highest risk actually
have more access to it and their concerns are addressed and
they can demand the vaccine to do it.
Mr. Carter. That is so very important. Thank you, Doctor,
for mentioning that. And I for one, as a member of the Doctors
Caucus and as a Congressman, I went through the clinical trials
myself to try to set a good example. And I was fortunate enough
to be able. Of course, it was a double blind study, but I did
get the vaccine. So I want people to know that it is safe and
effective.
Thank you very much, Madam Chair. And I yield back.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize the gentlewoman from
Delaware, Ms. Blunt Rochester, for 5 minutes of questioning.
Great to see you.
Ms. Blunt Rochester. Good to see you too. And thank you so
much, Madam Chairwoman. Congratulations, Ranking Member
Guthrie. And thank you especially to all of the witnesses.
I want to start by associating myself with the comments of
my colleague Ms. Barragan on illuminating the social
determinants of health. It is an area that we have legislation
on as well, and it is vital, especially we have seen it
illuminated during this pandemic.
And as our Nation marks the 1-year anniversary of declaring
the coronavirus outbreak a public health emergency, it is clear
that Congress must move swiftly and boldly with a pandemic
response that protects the health and the economic well-being
of our constituents and solves this public health crisis at
last.
I am preparing to introduce or reintroduce my bill, the
Coverage for COVID-19 Treatment Act, to guarantee access to
COVID-19 treatment with no cost sharing, because no one should
have to worry about how they can afford treatment if they
contract COVID-19.
Like President Biden, however, I want to make sure that
treatment isn't just affordable but that it is widely
accessible and effective. This is especially true for people
dealing with long-term health impacts of COVID-19 or long COVID
syndrome. And I would like to focus my first questions there.
Dr. Borio, in your testimony, you said that we desperately
need better therapies for COVID-19. Why do you think we should
continue to focus on investing in and support for the
development of therapeutics and treatments for COVID-19?
Dr. Borio. The currently available treatments are very
limited. They are limited in benefit, they are limited in on
whom they work, when they work. They are difficult to scale up.
They are intravenous drugs. So we do need treatments that are
more easily administered, more easily scalable to manufacture,
more easily accessible. And also, this is not going to be the
last biological pandemic. COVID is likely going to become
endemic. We need better antivirals to treat COVID going
forward.
Ms. Blunt Rochester. Thank you.
Dr. Borio. [Inaudible] research program--it is already
late. We have to start a research program that comprehensively
tackles it as soon as possible.
Ms. Blunt Rochester. And following up on that, Governor
Leavitt, thank you for your testimony. And you mentioned that
Congress should be aware of the growing cohorts of patients
with long COVID syndrome. What should Congress do to ensure
there is better access to effective therapies to treat people
with long COVID syndrome?
Mr. Leavitt. I will simply under--I will first underscore
the importance of this. This is a significant challenge. This
is one we ought to be looking into the next valley, scouting
the next valley and getting ahead of. And I would point to
three things.
The first is data. We need more data about this. The second
is the need for us to begin to isolate clinical pathways for
those who have it, even to the point that we still can't--we
don't know how to diagnose it. We don't have a name for it. We
don't have billing codes for it. We need to make progress in
the context of clinical care. And lastly, payment. We have to
begin to think about the impact this is going to have on
payment systems.
Ms. Blunt Rochester. Thank you.
And, Dr. Morita, how can Congress help ensure equitable
access to COVID-19 treatments for the growing number of people
with long-term care COVID symptoms, many of whom are
experiencing economic hardship right now?
Dr. Morita. I have to agree with Governor Leavitt. Having
data and understanding who is actually getting treatment, how
is the treatment working, making sure that those things are all
in place so that it is that when treatments are available and
they have been studied, that we actually can make sure that
they are providing the right places.
In addition, though, as trials are being done with
experimental medications, making sure that we have adequate
representation in communities of color in the trials themselves
so they can feel confident that the medications themselves have
been tested in appropriate populations in those that look like
themselves.
Ms. Blunt Rochester. Thank you.
And I am shifting gears. In the early months of the
pandemic, I joined my colleagues Congressman Pocan and Crist to
introduce legislation to harness the full power of the Defense
Production Act. And I know invoking the DPA is a priority for
President Biden.
Dr. Borio, how will using the Defense Production Act
alleviate supply shortages in our country? And I think you also
mentioned that we still remain vulnerable. Can you talk about
vulnerabilities?
Dr. Borio. Sure. Thank you. Look, I am not an expert on
DPA. It is quite a complex set of authorities we have. All I
know is that Operation Warp Speed has leveraged it very heavily
to be able to provide priority allocation to limited resources,
to the vaccine manufacturers under a U.S. contract. It is not a
final solution. You know, it is very important to recognize
that sometimes allocating priorities for filling finished lines
for vaccine manufacturers is critical right now, has bumped
products in those finished lines that were destined to other
patients with some very critical diseases. So it is just not a
final solution.
Ms. Blunt Rochester. I am out of time, but I do want to
thank Mr. Burel as well, and I am looking forward to his
recommendations on supply chain and DPA. We look forward to
that.
Thank you so much. And I yield back.
Ms. Eshoo. The gentlewoman yields back.
It is a pleasure, a real pleasure, to welcome a new member
to our committee, the gentlewoman from Minnesota, Ms. Angie
Craig. So it is just great to have you with us.
I might add, and I don't know how many Members realize
this, but all of our new members on the Democratic side are
women. We have a whole new team. So watch out, gentlemen. Here
we come. We are coming.
Ms. Craig. We are here. We are here.
Ms. Eshoo. We are here.
The gentlewoman is recognized.
Ms. Craig. Thank you so much, Chairwoman Eshoo. And thank
you to our panelists for sharing your expertise with us here
today.
It is really an honor to be here for my first Health
Subcommittee hearing. I ran for Congress to tackle the very
issues under this subcommittee's jurisdiction, particularly
expanding healthcare access and affordability. And I look so
forward to working with all of you.
I represent the State of Minnesota where, tragically, we
have lost more than 6,200 lives to COVID-19. Like the rest of
the country, people are struggling to survive both a global
pandemic and widespread economic uncertainty.
With the new administration in office, we have an
opportunity to provide the American people with the assistance
that they desperately need. I am encouraged by the Biden
administration's efforts to provide States with more
transparency and increase the vaccine supply, both of which
will accelerate the number of shots in arms.
While our vaccine and testing capabilities continue to
trend in the right direction, it is clear the Federal
Government must do more. Our lives and our economies are
depending on it.
My first question is for Dr. Morita. As you noted in your
testimony, an equitable vaccine allocation and distribution
strategy relies on robust data. Last Congress, I introduced the
Vaccine Fairness Act, which directed HHS to provide regular
updates on their efforts to ensure the COVID-19 vaccine reaches
the groups most at risk.
This week, the CDC released demographic data for the
vaccines administered between December 14 and January 14, about
half of the total vaccines administered to date. These data
points support long-held concerns by public health experts
about disproportionately low vaccination rates among Black and
Hispanic Americans. These trends are reflected in Minnesota,
where we are seeing lower vaccination rates in the areas
outside the Twin Cities and among long-term care staff.
I am encouraged by the Biden administration's commitment to
provide real-time data, and I would further encourage the
administration to include racial and ethnic demographics in on
the CDC dashboard.
Dr. Morita, my question is, what impact does Federal data
collection and reporting have on State and city efforts to
implement an equitable vaccine administration program? In other
words, why is it so important that we have centralized and
transparent data?
Dr. Morita. So having disaggregated the data by race, by
ethnicity, by geography, by occupation is fundamental to the
response being coordinated and an equitable response. In order
for us to make sure that we are reaching the people that we
actually need to reach who are at highest risk, we really have
to have the data available.
What the Federal Government can do is really establish the
expectation, require that these fields actually be included.
So, as the programs are rolling out, they actually are
collecting--the vaccinators are actually collecting this
information. I talked with Walgreens at the beginning, prior to
them actually rolling out their pharmacy vaccination effort in
the long-term care facilities. And they said that they were
required by Federal law to collect that information, race and
ethnicity information, as they were vaccinating.
The challenge is that the systems within the States and
local jurisdictions aren't necessarily equipped to handle that
information or haven't been updated in time so that they can
accept the information in a quick and efficient way. So what
has to happen is the standard has to be established and an
expectation for these collections of information, and then
resources to support the systems so the information can be
collected in an efficient way and then used and reported in a
consistent way so there is transparency.
Ms. Craig. Thank you so much.
My next question quickly is for Mr. Burel. While the
Department of Health and Human Services holds the primary
responsibility for responding to and preparing for public
health emergencies, a crisis as large as this requires
assistance from FEMA. In your assessment, what have the
contributions from FEMA had on the availability of medical
supplies? And I only have about 30 seconds left.
Mr. Burel. I apologize, I wasn't prepared to answer that
question. Let me give it some thought and come back to you. I
do think it is important that, when FEMA takes on those roles,
it works with the people who are the subject matter experts in
that space to make sure we get the right thing to the right
place at the right time. And I think sometimes there is a
disconnect there. Having worked both for HHS and FEMA, I know
it is something that we always have to work on to coordinate
better.
Ms. Craig. I appreciate that very much.
And, Madam Chairwoman, I yield back.
Ms. Eshoo. The gentlewoman yields back. And, again, I am so
thrilled that you are on the committee.
And speaking of being thrilled, it is a pleasure to
recognize Dr. Schrier from Washington State, also a new member
of the committee, and our fourth doctor, a pediatrician. So I
know that she is going to bring a great deal to our
deliberations. We will learn from you, and we are really
thrilled to have you as part of our subcommittee. It is already
enhanced. So you are recognized for your first 5 minutes of the
subcommittee.
Ms. Schrier. Well, thank you for that welcome, Madam Chair.
And thank you to our witnesses.
Like all of us, I am incredibly relieved that we have two
highly effective vaccines, and more to come, in less than a
year's time. And I cannot overstate how grateful I am to the
scientists behind these achievements. With that said, as we all
know, it will take months to immunize the country, and the more
this virus spreads, the more mutations we will see.
To successfully reopen our communities and especially our
schools safely, we just need more tools in our toolbox to
contain the virus and prevent its spread. This is really hard
when asymptomatic people spread the disease and much of the
Nation still does not mask or distance.
So surveillance testing helps pick up evolving outbreaks
once a disease is under control. But, right now, rapid at-home
antigen tests done on a regular basis could dramatically slow
the spread.
So, for regular at-home testing to work, the test would
have to be cheap enough for people to use every day or two to
see if they are shedding the virus and then just take
themselves out of circulation. Guess what? Homes tests like
this already exist. So we are really close. But the ones that
are currently available are way too expensive for daily use, at
$25 to $50 per test. Some require a prescription and equipment.
But here is the thing: The components are really cheap.
Produced at scale, they could cost less than $1 each. Did you
know that the $15 pregnancy test in the store wholesales for 70
cents? And this is the same concept. So why aren't they already
in our hands?
Well, there are lots of reasons, but one is that big
companies are buying up those components, and their profit
margin is higher to making 1,000 $30 tests as opposed to 30,000
$1 tests. So another is that the Trump administration didn't
put its weight behind this concept, and meanwhile a year later,
441,000 dead, more than 3,000 dying every day, and daily at-
home testing would have been the curve. So I want to ask about
that.
Dr. Borio, thank you for your service. In January of last
year, you coauthored an excellent article called ``Act Now to
Prevent an American Epidemic,'' and you encouraged government
agencies to work with private partners to achieve robust
testing. And so I want to ask you about antigen tests.
To your knowledge, Dr. Borio, has there been an effort to
establish an independent comparative evaluation of different
antigen tests, like a head-to-head comparison of test accuracy
to find the best ones?
Dr. Borio. No, I am not aware of a head-to-head effort. I
am encouraged that the new administration has established a
pandemic testing board which will look comprehensively across
all issues around testing.
Ms. Schrier. Great. And I understand there is this kind of
test at the Frederick National Lab for serology or antibody
test. And so it sounds like we could do the same thing for
these lateral slow antigen tests.
Dr. Borio. There is no reason why not to do comparative
assessments of the different tests.
Ms. Schrier. Great. And then, if we did this comparing
apples to apples and found the best test, could we procure the
materials at scale to drive down the price for the American
people?
Dr. Borio. That, I do not know.
Ms. Schrier. OK. Because we would need millions every day.
And then, to your knowledge and from your prior experience,
did the Trump administration dive in and take an active role in
the testing, approval, procurement, and manufacturing of these
sorts of tests?
Dr. Borio. So the prior administration did quite a bit to
interfere with FDA's independence in regulating these tests in
public health emergencies. There has been a lot of confusion as
a result of this interference. I think FDA's now poised to be
able to regain its mission to make sure that the American
public has access to tests that work as intended. And they
don't have to be the best test in the world, they just have to
work as intended and do we understand their limitations.
Ms. Schrier. That is exactly right. We could have an
imperfect test, but if you do it every day, if you don't catch
it on Monday, you will catch it on Tuesday and you will stay
home from work or school. Thank you for that answer, and that
explains some of the holdup.
So thank you, Dr. Borio and all of our witnesses. This has
really been a pleasure today. I can't wait to get these tests
into every home in the country and open up our economy and get
our kids back to school safely and kind of layer these layers
of Swiss cheese. You know, we can have masks and distancing and
cleaning and rapid tests and vaccines, and we will get much
farther much sooner.
Thank so much. I yield back.
Ms. Eshoo. Thank you, Dr. Schrier. Wonderful questions,
wonderful points. I agree with you. I think in terms of
testing, that so far we have missed the boat. Because these
tests really should be 79 cents, $1 each. People should be able
to buy a packet for a month or 2 weeks, especially essential
workers. And I think the money in the recovery plan will go a
long ways to making that happen.
We really have to put our pedal to the metal. This is the
United States of America, for heaven's sakes. We can do this,
and it is a source of embarrassment to me that we have these
gaps. But, boy, with this committee pushing, we can close them
and then some.
It is now a pleasure to welcome another new member to our
subcommittee, the gentlewoman from Massachusetts, Mrs. Trahan.
And I know that she has a great deal of biotechnology in her
congressional district and that she will be a voice for issues
coming out of that particular segment of the healthcare
industry.
So welcome, and you are recognized.
Mrs. Trahan. Thank you. Thank you, Chairwoman Eshoo and
Ranking Member Guthrie, as well as to all the witnesses.
I will start by just saying, as Chairman Eshoo, Chairman
Pallone, the Ranking Member Rodgers stated, I too want to
emphasize that, in order to build a system to address future
threats and protect our national security, we must revitalize
America's manufacturing industry. And I won't say much more
about it, except that I welcome my colleagues to join the
bipartisan Pandemic Preparedness Caucus that I started with
Congressman Balderson and Congresswoman Axne.
I will echo the concerns of my colleagues about ensuring
equitable and accelerated access to COVID-19 testing,
treatment, and vaccination. Now, I recently spoke with
healthcare providers at Lawrence General Hospital in Lawrence,
Massachusetts, a majority minority gateway city in my district,
and they shared that the mortality rate for Hispanic patients
rose from below 2 percent pre-COVID to nearly 13 percent--a
massive spike, and one we are seeing predominantly in our
communities of color across the country. Conversely, the
mortality for White Americans climbed just 1 single percent. So
we can't allow inequities like this to persist. Rather, equity
has to be our central concern.
And I too celebrate the miracle of having two highly
effective vaccines. But we must be focused on dramatically
accelerating the distribution while also addressing the fact
that we have fallen behind in testing innovation, as
Congresswoman Schrier mentioned, and capacity building central
to opening our schools and businesses. We have fallen behind on
genomic research, specifically sequencing surveillance that
identifies new variants. And we have fallen behind on
developing treatments that mitigate the most severe symptoms.
So today I just want to zero in on one method to help
reduce mortality for all Americans, and that is developing new
therapies for COVID-19. The development of effective
therapeutic agents can greatly decrease the severity of the
disease while we are vaccinating Americans and preventing
hospitalizations, long-term effects, certainly death.
So, Dr. Borio, you have answered in your testimony and here
today why it is important to continue to invest in developing
COVID therapies but also mentioned that the U.S. response was
hindered by its lack of a clinical trial network that could be
utilized quickly during a pandemic. Can you explain how a
network like this can be established and adapted to different
novel diseases?
Dr. Borio. Thank you. Absolutely. So, you know, just taking
a step back, we had to rely on existing clinical trial networks
that existed for other diseases, for oncology, for et cetera,
and we had to repurpose them. That took a long time.
NIH did some quicker studies. Actually they brought us
remdesivir, for example. But they were limited to certain of
number of sites across the U.S. And we really need to be able
to leverage technology and leverage advances in how we conduct
clinical studies, including around the oversight clinical
studies, to really be able to capture patients where they are.
If you do the math and see how many cases we are seeing
today across America, only a very, very tiny fraction of those
patients are really able to enroll in clinical research. That
allows us to have a learning system where we can learn as we go
through this and be able to modify our practice according to
new knowledge. So we need to be able to, you know, really use
all of our healthcare systems, our networks, hospitals, medical
centers, VA, et cetera, into a clinical research enterprise.
Mrs. Trahan. Great. Thank you for that.
You know, vaccine development for COVID-19 leveraged major
biomedical research investments, and it created these public-
private industry partnerships to get a vaccine to market in
record time. What lessons should we take from our early
approaches to testing potential therapeutic agents as well as
the success of vaccine development that would help catalyze
better treatments for COVID-19 as well as other emerging
infectious diseases?
Dr. Borio. I will say that just trust the importance of the
adequately conducted studies, rigorous studies that give us
definitive answers about whether a product works or doesn't, so
we can go all in into making sure that we have sufficient
supplies and ways to administer them.
Vaccines are a great example where we did, you know, the
gold standard in a most efficient way, very thoughtful
approach, and we have definitive data about their safety and
effectiveness. We do not have that same degree of information
from most therapeutics. There are very few exceptions. So we
can't cut corners in therapeutics if we want to really be able
to provide cures that we can send support to our patients.
Mrs. Trahan. Understood. Well, thank you. I appreciate your
answers.
And I will yield back. Thank you, Madam Chair.
Ms. Eshoo. The gentlewoman yields back.
And, boy, today is filled with a lot of pleasures relative
to our subcommittee. Another great new member, the gentlewoman
from Texas, Ms. Fletcher. Welcome to the subcommittee. We are
thrilled that you are part of it. And it is your debut, your
first 5 minutes of questions.
Mrs. Fletcher. Well, thank you so much, Chairwoman Eshoo. I
am just delighted and honored to be here and to serve on this
subcommittee. So I thank you and Ranking Member Guthrie for
holding this vital hearing today. And I am so glad to be able
to do the critical work to combat this public health crisis.
And I thank our witnesses today for their time and their
excellent insight.
My colleagues have touched on many of the critical issues
before us. Focusing on vaccines and vaccination rates are vital
issues in my district in Houston as well. But I want to pick up
on the line of questioning that my colleague, Dr. Schrier, was
asking about just now about testing. Because as we understand
it now, that administering the vaccine will take time and that
those vaccinated may still be carriers of the virus even if
there--you know, the impact of the disease that emerges from it
with COVID-19. So that really brings us back to the need to
having an effective testing strategy.
And, Dr. Borio, in your testimony, you talked about the
need for CDC and FDA to develop still a national testing
strategy. Part of any good strategy is ensuring that you have
adequate supply to follow demand, and we know that if it is
done right, there will be demand for a long time.
We saw last summer, particularly where we had outbreaks in
the South, that there was driving demand, some labs had excess
capacity and others were having long testing delays. So can you
discuss a little bit how we can efficiently get testing
supplies to labs where there is need and how we can do this on
an ongoing basis?
Dr. Borio. So part of making sure that we have sufficient
supply has to do with having the strategy so that we know where
to focus, where to be able to put the dollars behind. And we
don't have that today. So it is not sufficient to say let's,
you know, increase the supply of every possible available test.
We need to know which ones really need the most attention,
which ones might be fine, and what is the balance of rapid
tests and other high throughput tests. We don't have that
information today because we don't have a strategy.
Mrs. Fletcher. OK. Well, and I guess there is sort of a
related strategic issue that I want to touch on with the time I
have left for Dr. Morita and then anyone else who wants to
weigh in, because I think another important aspect of
understanding the supply issues is also ensuring that we have
the adequate public health workforce to conduct the testing and
the contact tracing while we are still vaccinating individuals.
And I was glad to see that the American Rescue Plan includes
resources for testing and a greater public health workforce. I
also understand there was some testimony just yesterday in
another hearing that State and local governments have diverted
some of the resources for testing and contact tracing to
vaccines.
And so what do you think, starting with Dr. Morita, what do
you think can and should be done to ensure that the proper
resources and personnel are allocated to testing and tracing?
Dr. Morita. Your point is well taken. During the transition
period of time, we spoke with a number of State and local
health officials, and what they reported was they were really
struggling in terms of manpower, because it was the same people
that were being asked to do the testing, to do the contact
tracing, to do the outbreak investigations, and to start
planning for the vaccine. This is prior to the vaccine being
available. And so there are just insufficient numbers of staff
that are actually available.
What has to happen is really ramping up and shoring up that
infrastructure with staff right now for the immediate response
but in looking at how to sustain that for the long haul,
because it is really difficult to hire a bunch of staff within
State or local government and to get them mobilized and have
them trained up to actually do the kind of work that is
necessary, rather than having an existing solid network of
workforce that could actually respond when the crisis actually
occurs.
I think I agree with Dr. Borio in terms of there needs to
be a testing strategy. And in order to have a strategy, there
really--it won't all be just public health workforce that is
doing the testing. It can rely on healthcare providers that are
in the community, in health centers and clinics and hospitals
doing some testing as well, just because I don't think that the
workforce necessarily has to do the testing on an ongoing
basis. It can be a coordinated effort with other providers as
well.
Mrs. Fletcher. Terrific. Thank you for that.
Would anyone else like to weigh in with their thoughts on
that question?
Mr. Leavitt. I will simply remind us all that, during the
early part of this pandemic, we were in a big hurry to get
tests, and a lot of tests went on to the market. And a lot of
damage happens when tests are inaccurate on either side. And so
there needs to be a testing strategy. Part of that has to be
accuracy and dependability. And a test is not a test that is
not a test. They are not all the same.
Mrs. Fletcher. Thank you for that. And thank you all again
for your insights today.
I am just out of time, so I will yield back. Thank you,
Chairwoman Eshoo.
Ms. Eshoo. The gentlewoman yields back. Again, welcome to
the committee.
And now I would like to recognize the gentlewoman from
Illinois, Ms. Kelly, a really valued member of the committee.
Where are you, Robin? I don't see you. There you are. You
are recognized.
Ms. Kelly. New glasses. Thank you, Chairwoman Eshoo. And
thank you to all of our witnesses. Thank you for your patience.
And, again, welcome to all of our new members.
As the chair of the Congressional Black Caucus Health Brain
Trust, vaccine equity is very, very important to me, and
testing. I mean, there was a story on CNN about a vaccine that
was supposed to go to a more Latino neighborhood, but the
appointments were taken by Whites coming into the neighborhood
and them not getting their vaccines. And also stories around
hospitals who are coding the way they give their vaccines out
so doctors and nurses and folks like that come first and Black
and Brown folks who are janitors are pushed to the background.
So those stories are very, very concerning.
And the other thing that I am worried about: What happens
with people with disabilities? Like, do you know anything about
what is happening with people who are deaf or people that are
blind? We don't seem to talk about that that much. And I was
just curious, do any of you know anything about that
population?
Dr. Morita. I can jump in on this question. Nice to see
you, Congresswoman.
Ms. Kelly. Nice to see you.
Dr. Morita. In terms of just what is happening with
communities of color and the challenges that are being
experienced, the systems have to be developed. And whether it
is communities of color or it is disabled communities
themselves, the systems have to be developed in a way that
everyone has easy access to them. So it can't just be a one-
size-fits-all, internet-access appointment-making schedule,
because that is just not going to work for everybody. And it
can't just be vaccines offered in hospitals, large hospitals.
And so what really is happening right now is on the ground,
and I have heard this from many jurisdictions, they are making
the plans to broaden out how they actually make the vaccine
available. They focused on hospitals and healthcare systems
because that is who was supposed to get it first, but now as
the groups are broadened, they will be broadening out to the
locations and places. But they also are working on developing
systems to actually have community workers go out into the
communities to help people register for the vaccines, making
the vaccines available in the appropriate sites, working with
federally qualified health centers that actually provide
services to those communities themselves. And also that they
should be building into the systems and are building for people
with disabilities to actually access the systems as well. So it
is a comprehensive type of approach.
And you mentioned it earlier and have been saying it pretty
consistently, that in order to build the systems out and have
the people to actually do this kind of critical work, more
research is really needed to flow to the States and locals who
are on the ground doing this critical work.
Ms. Kelly. I actually just got a phone call from one of my
mayors. In our local supermarket, they are vaccinating 500
people today, and then they will be backs in 3 weeks to
vaccinate 500 more. And this is in a suburban town outside of
Chicago.
Just also out of curiosity, we can just go down the panel,
how do you feel about school opening? It is a big issue in
Chicago, as I am sure that you have heard about. And, you know,
our Catholic schools have been open, but it is a big issue
about public schools. I am just curious how each one of you see
that.
Mr. Leavitt. Well, I will just say, as Governor I learned
that those decisions are not well made at State capitals or
Washington, DC. They are best made by local school communities,
because every school community is different, and it changes
from time to time and it needs to be managed in a very direct,
individualized way.
Ms. Kelly. Thank you.
Dr. Morita. There was a recently published article in JAMA
by the CDC that described schools that have reopened safely and
what assistance needed to be in place to allow them to open
safely. So I think it is really important that these kind of
publications are coming out. There is a lot of natural
experiments that have been happening over the past year where
school systems have been open, and understanding how to open
them safely is really, really important. We all want our kids
to be back in school, because we know learning is optimal in
that school setting. And yet we have to make sure that the
systems are in place, appropriate social distancing,
requirements for mask wearing, or appropriate ventilation.
Those kinds of assistance are critical for State schools to be
open safely.
Ms. Kelly. Ms. Borio?
Dr. Borio. I think the data is really critical, and I think
we begin to see the data. I agree with Governor Leavitt as well
that it is important to make decisions locally. But we do--the
Federal Government has a duty to be able to provide schools
with information and with guidance and with assistance to be
able to reopen safely.
Ms. Kelly. Thank you, Doctor.
Mr. Burel, my last few seconds.
Mr. Burel. Sure. I think that I agree with all of my
colleagues. One of the things that I think we have talked about
here is the need for availability of testing, the need for
availability of personal protective equipment. I think all of
these things would go a long way to creating a safer
environment for schools and businesses to reopen faster.
Ms. Kelly. Thank you.
And thank you, Madam Chair. I yield back.
Ms. Eshoo. The gentlewoman yields back.
It is a pleasure to recognize the gentleman from Maryland,
Mr. Sarbanes. And thank you for your patience.
Mr. Sarbanes. Thank you very much, Madam Chair. Can you
hear me OK?
Ms. Eshoo. Yes. Just speak up a little louder. I don't know
if everyone's systems are as dim as mine, but everyone's voice
seems awfully almost muted to me today. So do speak out.
Mr. Sarbanes. I will try to speak clearly for the benefit
of you, Madam Chair, and other members in the panel.
I want to thank our witnesses today. This has been an
exhaustive and long session, but I think you covered really
important dimensions of the crisis that we are facing,
particularly this vaccine distribution challenge.
Dr. Borio, I am very interested in your thoughts, and
perhaps Governor Leavitt as well, when it comes to workforce
challenges. We already had a public health infrastructure that
lacked the kind of robust workforce component that you would
need in normal times. The pressure that has been placed on our
public health infrastructure and just broadly on our healthcare
system by the pandemic has exposed these workforce shortages
and, of course, has aggravated them in many places, because the
healthcare workers themselves have come down with the pandemic
and they have been knocked out of work, many have lost their
lives and so forth.
Could you speak, beginning with Dr. Borio, to what
strategies you see for deploying in this moment additional
healthcare workers, anyone, for that matter, who would be
viewed as qualified to administer vaccines? Because, as we
tried to deliver the vaccine more creatively, whether that is
having mass vaccination sites or mobile vaccination sites,
reaching out to communities that have less access, et cetera,
we are going to need the people. And that is often the
bottleneck that we face. Along with protective equipment, along
with the availability of the vaccine itself, along with the
cold chain custody and all the rest of it, speak specifically
to the workforce part of this crisis and what we are doing in
the moment to try to ramp up that capacity to handle all of
these things, but in particular you could talk to the vaccine
distribution.
Dr. Borio. So, briefly, I think that we always know about
the four S's: the supply, system, space, and staff. And we
sometimes forget that staff is also a supply chain issue. There
are efforts to now find a way to create more flexibilities with
allowing practitioners to move from State to State as well as
rehire retired healthcare professionals to be able to
participate in the program. Look at other types of health-
related professions to be able to administer, whether it is
EMS, dentists, and pharmacists. I think that there are ways to
be able to do that in the short term. But in the long run, it
is really about expanding public health workforce to be able to
tackle the types of threats that we are going to face, continue
to face in the future.
I don't want to over--also take this moment to just share
that, even in the manufacturing of this vaccine [inaudible] to
staff it, because it is about staff. We think about the back,
the filters, the columns, the space. But staffing with people
that really understand vaccine production has been a challenge
as well. So it is all around the whole response program.
Mr. Sarbanes. Thank you.
Governor Leavitt?
Mr. Leavitt. Yes. I am of the view that, in the long term,
this has to be an all-hands-on-deck exercise. One of the things
that I believe is limiting about a highly centralized
distribution process is that it in many ways is not convenient
for people, and hence, it will be less accessible. However,
what militated against that in the early stages of distribution
is that it takes infrastructure to do it. And I believe one of
the things that will occur as time goes on, as this becomes an
elongated process--that is to say, it has to endure for a long
time--there needs to be mobile units, employer-based units, all
kinds of different mechanisms. But they not only need to know
how to give a shot, they also need to be able to access the
records so that, as we begin to deploy what I spoke of earlier,
which is a vaccine credentialing process, that people can gain
access to their own vaccination records and have them digitally
presentable to people. They need to be part of that system.
Mr. Sarbanes. Thank you very much.
I yield back, Madam Chair.
Ms. Eshoo. The gentleman yields back. And we thank him for
his always excellent questions.
So this concludes all members of the subcommittee that were
with us today in having their time to question. We also extend
a legislative courtesy to members of the full committee that
wish to join us. And we have Mr. O'Halleran, the gentleman from
Arizona, who is waiving on. And I would like to recognize him
for his 5 minutes of questions.
So welcome back, Tom. It is always great to see you.
Mr. O'Halleran. Thank you, Madam Chair. Thank you for the
panel. This has been an excellent presentation.
The first cases of COVID were detected in the United States
a year ago. Early in the pandemic, Congress acted in four
bipartisan bills, which is important for the unity that we need
in America today.
Secretary Leavitt in testimony noted that we will get
better at this. We are a year in, actually more than a year in,
because we need to be working 24 hours a day. And so that year
is really 3 years of work, hopefully.
Mr. Burel noted that we are short on everything. And Dr.
Morita said that, today, we are going to need a full-court
press. We needed a full-court press from the beginning.
Over the summer, in one of the hearings, I asked Dr. Fauci,
would we be ready in the fall and early winter. He said, ``I
hope so.'' Then I asked him again in another meeting, will we
be ready in the fall or winter? In fact, he said that, as we
were getting into the fall, he said again, ``I hope so.''
It is obvious from the testimony today that we are nowhere
where we need to be in relationship to where we should be. From
April until the end of December, Congress was unable to come
together to provide additional support to build out a robust
national testing contact tracing system. And, in fact, almost
every other discussion we have had today.
Despite claims to the contrary, it became overly reliant,
the prior administration, on States to implement their own
testing strategies. That is clear. They are needed, but it has
to be a coordinated process. Test kits, everything else, we are
still in short supply.
I am going to try to cut some of this out because it has
been talked about. But the national strategy has been talked
about time and time and time again, and not just today but the
need for it, and here we are sitting, talking about it still a
year later. Time is of the most importance.
In my district, I have people in my district, similar to
others, mostly rural areas, not being able to get tested. And
when they get the first shot, they can't get to a second shot.
The computer systems are in a situation where they are mostly,
if you are dealing with somebody from the Hispanic community or
some other Tribal communities, which I have a lot of, they have
problems even having a computer, and it is required in many
areas. And I am glad to see that the President has called for
$50 billion to build out a national testing program, which we
have talked about so many times over the course of this last
year.
We have to ask so much from our frontline workers, and we
are still where--I can remember when this first started, they
still don't have where we need to be.
Dr. Borio, I appreciate the honesty and self-reflection in
your testimony. One of your recommendations called for the CDC
to immediately expand its genomic surveillance system. Can you
expand upon how, in conjunction with President Biden's plan to
spend $50 billion in testing, this will help quickly identify
new variants of infectious diseases like COVID-19 and how that
will impact public health recommendations offered by scientists
at the FDA or the CDC, and how it will help in the future?
Dr. Borio. Thank you. I will elaborate in writing for you
afterwards. But, briefly, the fact is that, early on, we knew
this was an RNA virus. They mutate, they always mutate, and we
didn't really have a system to be able to begin to sequence, to
receive viral samples from patients, to locals, to State labs,
to the CDC, or under the sequencing labs, sequence them and
then do a data analysis so we can really track the evolution of
the virus, detect the emergence of variants, and understand
where they were spreading. So we took, you know, the alerts in
the U.K. and South Africa to get us then to begin to scale up
our systems, but it still is very inadequate for what the need
is.
Mr. O'Halleran. Doctor, I have to interrupt you because my
time is almost up. And I would like to ask you, how long has
this system been needed and how long have the professionals
been asking for it?
Dr. Borio. The need precedes this pandemic.
Mr. O'Halleran. Thank you very much.
And I yield. Thank you, Madam Chair.
Ms. Eshoo. The gentleman yields back. And always know how
welcome you are at the subcommittee, Mr. O'Halleran.
Well, that concludes all of the questions for today. I want
to thank our witnesses, Dr. Julie Morita, Dr. Luciana Borio,
Governor Leavitt. It was really wonderful to have you join us.
I think Members--well, Members have learned from each one of
you, and, of course, to Greg Burel as well.
I need to request unanimous consent to enter the following
into the record, which includes documents submitted by both
Democratic and Republican Members. It is a rather long list. I
am going to speed read. And if any of my colleagues want to
interrupt and ask for unanimous consent before I finish reading
it, otherwise bear with me.
A January 31, 2021, Politico article entitled ```It's a
mess': Biden's first 10 days dominated by vaccine mysteries'';
a statement from the Association of American Medical Colleges;
a letter from AARP; a statement from the National Immigration
Law Center; a statement from the Asian & Pacific Islander
American Health Forum; a letter from the American Academy of
Family Physicians; testimony from Dr. Arthur C. Evans, CEO and
executive vice president of the American Psychological
Association; a statement from the American Society for
Microbiology; a statement from Steven C.----
Mrs. Fletcher. Madam Chairwoman?
Ms. Eshoo. Yes.
Mrs. Fletcher. Madam Chairwoman, I rise to request
unanimous consent that all of the items be included in the
record.
Ms. Eshoo. Is there a second to the motion?
Ms. Schrier. I second. I second.
Ms. Eshoo. Wonderful. Thank you, Dr. Kim.
Mr. Guthrie. Madam Chair? Can we just make sure the list--
can we read--I don't want you to have to read. That is fine. Is
there a procedure that we can verify that if we had something
that was left off for some reason that we submitted, gets
admitted?
Ms. Eshoo. Absolutely.
Mr. Guthrie. Just make the motion that if something we
agreed to as admitted can be included in the record? That is
all. I am fine with you not reading them. I just want to make
sure we double-check.
Ms. Eshoo. Absolutely. And as I said, this includes
documents submitted by Democratic and Republican Members.
Mr. Guthrie. OK. All right. Thank you.
Ms. Eshoo. So, if there are any Members that have
something, please submit it and we will gladly add it to the
list.
I hear no objections to the motion. So ordered.1A\1\
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\1\ The information appears at the conclusion of the hearing,
except for five documents that have been retained in committee files
and are available with the other material at https://docs.house.gov/
Committee/Calendar/ByEvent.aspx?EventID=111136.
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And, let's see, it is 3 o'clock, so 4 hours on the dot. And
this has been quite an extensive hearing, but I think every
moment, every comment, every question, and all of the
information gleaned from our witnesses are absolutely essential
to this national effort to crush COVID. So thank you, everyone.
Again, it is really a joy to welcome the new members from
both sides of the aisle.
And I don't think we have any other business before us. So
the Health Subcommittee hearing of today has now ended. Thank
you. Thank you, everyone.
[Whereupon, at 3:00 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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