[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:]
    
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    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:]
    
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    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.
---------------------------------------------------------------------------
    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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