[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]


                    BOOSTER SHOT: ENHANCING PUBLIC HEALTH 
                        THROUGH VACCINE LEGISLATION

=======================================================================

                            VIRTUAL HEARING

                               BEFORE THE

                         SUBCOMMITTEE ON HEALTH

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 15, 2021

                               __________

                           Serial No. 117-38
                           
[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
51-211 PDF                          WASHINGTON: 2023         
                        
                        
                        
                        
                        
                        
                    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, Vice     MICHAEL C. BURGESS, Texas
    Chair                            H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont                 GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon                BILLY LONG, Missouri
TONY CARDENAS, California            LARRY BUCSHON, Indiana
RAUL RUIZ, California                MARKWAYNE MULLIN, Oklahoma
DEBBIE DINGELL, Michigan             RICHARD HUDSON, North Carolina
ANN M. KUSTER, New Hampshire         EARL L. ``BUDDY'' CARTER, Georgia
ROBIN L. KELLY, Illinois             NEAL P. DUNN, Florida
NANETTE DIAZ BARRAGAN, California    JOHN R. CURTIS, Utah
LISA BLUNT ROCHESTER, Delaware       DAN CRENSHAW, Texas
ANGIE CRAIG, Minnesota               JOHN JOYCE, Pennsylvania
KIM SCHRIER, Washington              CATHY McMORRIS RODGERS, Washington 
LORI TRAHAN, Massachusetts               (ex officio)
LIZZIE FLETCHER, Texas
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...........................................     5
Hon. Frank Pallone, Jr., a Representative in Congress from the 
  State of New Jersey, opening statement.........................     7
    Prepared statement...........................................     8
Hon. Cathy McMorris Rodgers, a Representative in Congress from 
  the State of Washington, opening statement.....................     9
    Prepared statement...........................................    11
Hon. Michael C. Burgess, a Representative in Congress from the 
  State of Texas, prepared statement.............................   102

                               Witnesses

Lijen ``LJ'' Tan, Ph.D., Chief Strategy Officer, Immunization 
  Action Coalition...............................................    13
    Prepared statement...........................................    16
    Answers to submitted questions...............................   138
Yvonne Maldonado, M.D., Chair, Committee on Infectious Diseases, 
  American Academy of Pediatrics, and Professor of Pediatrics and 
  of Epidemiology and Public Health, Stanford University Center 
  for Academic Medicine..........................................    23
    Prepared statement...........................................    25
    Answers to submitted questions...............................   145
Rebecca Coyle, Executive Director, American Immunization Registry 
  Association....................................................    30
    Prepared statement...........................................    32
    Additional material submitted for the record \1\
    Answers to submitted questions...............................   150
Phyllis Arthur, Vice President, Infectious Diseases and 
  Diagnostic Policy, Biotechnology Innovation Organizaton........    38
    Prepared statement...........................................    40
    Questions submitted for the record \2\.......................   152

                           Submitted Material

H.R. 550, The Immunization Infrastructure Modernization Act\3\
H.R. 951, The Maternal Vaccinations Act\3\
H.R. 979, The Vaccine Fairness Act\3\
H.R. 1452, To Direct the Secretary of Health and Human Services 
  to Publish the Formula the Secretary Uses to Determine the 
  Allocation of COVID-19 Vaccines, and for Other Purposes\3\
H.R. 1550, The Promoting Resources to Expand Vaccination, 
  Education and New Treatments for HPV Cancers Act of 2021\3\
H.R. 1978, The Protecting Seniors Through Immunization Act of 
  2021\3\

----------

\1\ The information has been retained in committee files and is 
available at https://docs.house.gov/meetings/IF/IF14/20210615/112768/
HHRG-117-IF14-Wstate-CoyleR-20210615-SD001.pdf.
\2\ Ms. Arthur did not answer submitted questions for the record by the 
time of publication.
\3\ The legislation has been retained in committee files and is 
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=112768.
H.R. 2170, The Helping Adults Protect Immunity Act\3\
H.R. 2347, The Strengthening the Vaccines for Children Act of 
  2021\3\
H.R. 3013, The COVID Vaccine Transportation Access Act\3\
H.R. 3655, The Vaccine Injury Compensation Modernization Act\3\
H.R. 3742, The Vaccine Information for Nursing Facility Operators 
  Act\3\
H.R. 3743, The Supporting the Foundation for the National 
  Institutes of Health and the Reagan-Udall Foundation for the 
  Food and Drug Administration Act\3\
Statement of Stacey D. Stewart, President and Chief Executive 
  Officer, March of Dimes, June 15, 2021, submitted by Ms. Eshoo.   104
Letter of June 11, 2021, from Gary L. LeRoy, Board Chair, 
  American Academy of Family Physicians, to Ms. Eshoo and Mr. 
  Guthrie, submitted by Ms. Eshoo................................   109
Letter of June 15, 2021, from Matthew Eyles, President and Chief 
  Executive Officer, AHIP, to Ms. Eshoo and Mr. Guthrie, 
  submitted by Ms. Eshoo.........................................   111
Letter of June 14, 2021, from Mary R. Grealy, President, 
  Healthcare Leadership Council, to Ms. Eshoo and Mr. Guthrie, 
  submitted by Ms. Eshoo.........................................   115
Letter of June 11, 2021, from Renee J. Gentry, Director, Vaccine 
  Injury Litigation Clinic, George Washington University Law 
  School, to Ms. Eshoo and Mr. Guthrie, submitted by Ms. Eshoo...   117
Statement of the National Community Pharmacists Association 
  (NCPA), June 15, 2021, submitted by Ms. Eshoo..................   119
Letter of June 14, 2021, from Dan Klein, President and Chief 
  Executive Officer, Patient Access Network Foundation, to Mr. 
  Pallone, et al., submitted by Ms. Eshoo........................   123
Letter of March 17, 2021, from Mr. Crenshaw to Gene Dodaro, 
  Comptroller General, Government Accountability Office, 
  submitted by Mr. Crenshaw......................................   125
Letter of February 24, 2021, from Rep. Sheila Jackson, et al., to 
  Rochelle P. Walensky, Director, Centers for Disease Control and 
  Prevention, submitted by Mr. Crenshaw..........................   127
Article of January 29, 2021, ```Nobody is getting enough': Why 
  Texas ranks near the bottom for COVID-19 vaccines per capita,'' 
  by Jordan Rubio and Alejandro Serrano, Houston Chronicle, 
  submitted by Mr. Crenshaw......................................   131

----------

\3\ The legislation has been retained in committee files and is 
available at https://docs.house.gov/Committee/Calendar/
ByEvent.aspx?EventID=112768.

 
   BOOSTER SHOT: ENHANCING PUBLIC HEALTH THROUGH VACCINE LEGISLATION

                              ----------                              


                         TUESDAY, JUNE 15, 2021

                  House of Representatives,
                            Subcommittee on Health,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:30 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, Long, Bucshon, Mullin, Hudson, Carter, Dunn, Curtis, 
Crenshaw, Joyce, and Rodgers (ex officio).
    Also present: Representative Schakowsky.
    Staff present: Jacquelyn Bolen, Health Counsel; Jeffrey C. 
Carroll, Staff Director; Waverly Gordon, General Counsel; 
Tiffany Guarascio, Deputy Staff Director; Perry Hamilton, 
Clerk; Stephen Holland, Health Counsel; Mackenzie Kuhl, Digital 
Assistant; Una Lee, Chief Health Counsel; Aisling McDonough, 
Policy Coordinator; Meghan Mullon, Policy Analyst; Kaitlyn 
Peel, Digital Director; Tim Robinson, Chief Counsel; Chloe 
Rodriguez, Clerk; Kylea Rogers, Staff Assistant; Kimberlee 
Trzeciak, Chief Health Advisor; Rick Van Buren, Health Counsel; 
C.J. Young, Deputy Communications Director; Alec Aramanda, 
Minority Professional Staff Member, Health; Sarah Burke, 
Minority Deputy Staff Director; Theresa Gambo, Minority 
Financial and Office Administrator; Seth Gold, Minority 
Professional Staff Member, Health; Grace Graham, Minority Chief 
Counsel, Health; Nate Hodson, Minority Staff Director; Peter 
Kielty, Minority General Counsel; Emily King, Minority Member 
Services Director; Bijan Koohmaraie, Minority Chief Counsel, 
Oversight and Investigations Chief Counsel; Clare Paoletta, 
Minority Policy Analyst, Health; Kristin Seum, Minority 
Counsel, Health; Kristen Shatynski, Minority Professional Staff 
Member, Health; and Olivia Shields, Minority Communications 
Director.
    Ms. Eshoo. The Subcommittee on Health will now come to 
order.
    And due to COVID-19, today's hearing is being held 
remotely. 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, and Members and witnesses, you will 
need to unmute your microphone each time you wish to speak. So 
please try to remember that.
    Documents for the record should be sent to Meghan Mullon at 
the email address we have provided to your staff. 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

    Good morning, colleagues, and good morning, witnesses. 
Vaccines are a powerful testament to scientific genius. As 
President Biden said about the COVID-19 vaccine, ``Every shot 
is giving a dose of hope.''
    We have seen the power of the safe, effective, and free 
COVID-19 vaccines. As they become widely available, fewer 
COVID-19 hospitalizations and deaths are being reported each 
day than at any point since the pandemic began. COVID-19 
vaccines aren't unique in their lifesaving ability. According 
to the CDC, routine childhood vaccinations have prevented more 
than 21 million hospitalizations and over 700,000 deaths among 
children born in the last 20 years.
    But a vaccine that remains in its vial is zero percent 
effective. That is why the Vaccines for Children program is one 
of the most important public health achievements in our 
Nation's history. The Vaccines for Children program provides 
free and easy access to vaccines to children in low-income 
families. And thanks to the program, most children are no 
longer vulnerable to measles or whooping cough.
    But this continued success is not guaranteed. The shelter-
at-home orders caused childhood vaccinations to plunge last 
year. According to the CDC, clinicians ordered 11\1/2\ million 
fewer vaccine doses for children, compared to the previous 
year. Gaps in vaccine rates could lead to deadly outbreaks 
among our Nation's children.
    Fortunately, Dr. Schrier, our subcommittee's resident 
pediatrician, has introduced the bipartisan Strengthening 
Vaccines for Children Act. The bill expands the Vaccines for 
Children program to cover more children and clinicians at more 
locations and reduce the financial and administrative barriers 
to boost vaccine rates. The bill provides vaccine counseling 
for parents, which is important to address misinformation as 
well as making clear to parents that vaccines are free for 
children even if they are uninsured or on Medicaid.
    Representative Sewell's Maternal Vaccination Act helps make 
sure that newborns and pregnant mothers are protected from the 
flu and whooping cough. By receiving the Tdap and flu vaccines 
while pregnant, mothers avoid serious--potentially serious 
hospitalizations, while also providing the mother's gift of 
antibodies to their newborns.
    While the benefits of maternal vaccinations are clear, our 
healthcare system does a poor job of helping pregnant women 
receive important vaccines. A CDC prepandemic survey found that 
only 35 percent of mothers receive both the Tdap and flu 
vaccine during pregnancy.
    Vaccines are important as people age. Seniors should 
receive vaccines to prevent the flu, pneumonia, shingles, 
tetanus, and whooping cough. Representative Kuster's bipartisan 
Protecting Seniors Through Immunization Act ensures that all 
Medicare Part D-covered vaccines are free to beneficiaries.
    Our hearing today will cover 12 bills, most of them 
bipartisan. The aim is to ensure that every American, no matter 
their age, race, or income, are empowered to receive the dose 
of hope from vaccine protection. Our communities can be 
completely free of vaccine-preventable diseases, including 
COVID-19, so I look forward to hearing from our superb 
witnesses today how the critical bills before us will help 
achieve this important goal.
    [The prepared statement of Ms. Eshoo follows:]

                Prepared Statement of Hon. Anna G. Eshoo

    Vaccines are a powerful testament to scientific genius. As 
President Biden said about the COVID-19 vaccine, ``every shot 
is giving a dose of hope.''
    We've seen the power of the safe, effective, and free 
COVID-19 vaccines. As they've become widely available, fewer 
COVID-19 hospitalizations and deaths are being reported each 
day than at any point since the pandemic began.
    COVID-19 vaccines aren't unique in their lifesaving 
ability. According to the CDC, routine childhood vaccinations 
have prevented more than 21 million hospitalizations and over 
700,000 deaths among children born in the last 20 years.
    But a vaccine that remains in its vial is 0% effective. 
That's why the Vaccines for Children Program is one of the most 
important public health achievements in our Nation's history. 
The Vaccines for Children Program provides free and easy access 
to vaccines to children in low-income families. Thanks to the 
Program, most children are no longer vulnerable to measles or 
whooping cough.
    But this continued success is not guaranteed. The shelter-
at-home orders caused childhood vaccinations to plunge last 
year. According to the CDC, clinicians ordered 11.5 million 
fewer vaccine doses for children compared to the previous year. 
Gaps in vaccine rates could lead to deadly outbreaks among our 
Nation's children.
    Fortunately, Dr. Schrier, our subcommittee's resident 
pediatrician, has introduced the bipartisan Strengthening the 
Vaccines for Children Act. The bill expands the Vaccines for 
Children Program to cover more children and clinicians at more 
locations and reduces financial or administrative barriers to 
boost vaccination rates. The bill provides vaccine counseling 
for parents which is important to address misinformation, as 
well as make clear to parents that vaccines are free for 
children, even if they're uninsured or on Medicaid.
    Representative Sewell's Maternal Vaccination Act helps make 
sure that newborns and pregnant mothers are protected from the 
flu and whooping cough. By receiving the ``Tdap'' and flu 
vaccines while pregnant, mothers avoid potentially serious 
hospitalizations while also providing the ``mother's gift'' of 
antibodies to their newborns.
    While the benefits of maternal vaccinations are clear, our 
healthcare system does a poor job of helping pregnant women 
receive important vaccines. A CDC pre-pandemic survey found 
that only 35% of mothers receive both the Tdap and flu vaccine 
during pregnancy.
    Vaccines are important as people age. Seniors should 
receive vaccines to prevent the flu, pneumonia, shingles, 
tetanus, and whooping cough. Representative Kuster's bipartisan 
Protecting Seniors through Immunization Act ensures that all 
Medicare Part D-covered vaccines are free to beneficiaries.
    Our hearing today will cover 12 bills, most of them 
bipartisan, that aim to ensure that every American, no matter 
their age, race, or income, are empowered to receive the ``dose 
of hope'' from vaccine protection.
    Our communities can be completely free of vaccine-
preventable diseases, including COVID-19. I look forward to 
hearing from our superb witnesses how the critical bills before 
us will help achieve this important goal.

    Ms. Eshoo. The Chair now recognizes with pleasure Mr. 
Guthrie, the ranking member of our Subcommittee on Health, for 
5 minutes for his opening statement.

 OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN 
           CONGRESS FROM THE COMMONWEALTH OF KENTUCKY

    Mr. Guthrie. Thank you. Thank you, Madam Chair, Chair 
Eshoo, for holding this important hearing on vaccines.
    Vaccines are the exact reason we can and should be in 
person today in the hearing room. We are asking Americans to 
come back to work. Members of Congress should also be back at 
work in the hearing room. I am forward to--looking forward to 
the committee meeting together in person very soon.
    Without Operation Warp Speed, we would not have three safe 
and effective vaccines that are currently being administered to 
Americans. Congress and President Trump came together to help 
unleash private-sector innovation to make this possible. 
Without medical innovation, we would be nowhere close to where 
we are currently with COVID-19 vaccination numbers. Roughly 52 
percent of Americans have received at least 1 dose, and about 
43 percent of Americans are fully vaccinated.
    We have advanced and improved our COVID-19 vaccine 
distribution strategies, and continue to do so. Congress has 
appropriated nearly $4 trillion in response to the COVID-19 
pandemic. Most recently, Congress provided 1.9 trillion through 
the American Rescue Plan, with only 9 percent of the funding 
going directly to fighting COVID-19. Of the 9 percent of COVID-
19 relief, 7\1/2\ billion was appropriated for vaccine 
planning, distribution, monitoring, and tracking; 1 billion for 
vaccine confidence activities; and 6.05 billion for COVID 
vaccine supply chain; and 7.6 billion for community health 
centers for activities, including COVID-19 vaccine distribution 
and administration, testing, and community outreach.
    This bill became law 4 months ago. Have these funds been 
distributed? How are these funds currently being used?
    As a former Republican leader of Oversight and 
Investigation Subcommittee, I believe that oversight is a very 
important aspect of our response. I have supported much-needed 
relief for American families, workers, and small businesses, 
but we must ensure it is being used effectively and wisely. 
Specifically, I am concerned that a number of these bills are 
duplicative of current efforts already underway to address the 
COVID-19 pandemic.
    Let me be clear. I support efforts to give every American 
the opportunity to be vaccinated, and any other vaccine-
preventable disease where a vaccination is recommended. But at 
this point we need to fully evaluate the current situation: Why 
are Americans not getting vaccinated?
    We need to tailor meaningful solutions to these problems. 
Cost may be part of the problem, but there are likely other 
issues that negatively affect vaccination rates.
    For example, we are considering today H.R. 979, the Vaccine 
Fairness Act, which would require weekly reporting of 
vaccines--vaccine distribution. I agree with my colleagues that 
this information is helpful, but this is currently already 
being done by HHS, and each member of the committee receives 
its vaccine information weekly.
    Additionally, today, we are examining H.R. 3013, the COVID 
Vaccine Transportation Access Act. This bill would provide 
grants for transporting--transportation to receive vaccines. I 
certainly agree that transportation should not be a limiting 
factor for an individual, but currently there are already 
several resources available for these services, including Uber 
and Lyft, who stepped up to provide transportation. Congress 
also authorized nonemergency transportation for Medicaid 
individuals in the December bipartisan COVID-19 relief package. 
Lastly, many areas offer a phone number that an individual can 
text and make a vaccination appointment, and they can also help 
you coordinate a ride.
    We do currently have gaps in our vaccine system, and I look 
forward to discussing H.R. 3742, the Vaccine Information for 
Nursing Facility Operators Act, or Vaccine INFO Act, which 
would require nursing homes to provide educational information 
on the value of getting all of the appropriate ACIP-recommended 
vaccines for healthcare workers to their staff in a similar 
manner to how they provide educational information on certain 
vaccines for their residents.
    I also look forward to discussing H.R. 1452. This bill 
would require HHS to publish the formula used to distribute 
that allocation of COVID-19 vaccines. This bill would allow 
States, local governments, and certain entities to better 
prepare for vaccine distribution.
    And lastly, I encourage all to get vaccinated. Vaccines 
save lives and help prevent many diseases. The Democrat bill 
H.R. 3 would disincentivize further development of vaccines and 
hinder development of lifesaving drugs. During a global 
pandemic they want to advance policies that would lead to fewer 
cures and treatment. This is very backwards to me, and I hope 
my colleagues fully evaluate how damaging a slow vaccine 
development could have been for COVID-19.
    Many around the world, particularly the European Union, did 
exactly what H.R. 3 was trying to get us to do in the United 
States. These behaviors have resulted in the EU being way 
behind the U.S. in distributing COVID-19 vaccines to their 
citizens. We must continue to be a leader of medical innovation 
and encourage the development of new treatments and cures in 
our great country.
    And 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 
on vaccines.
    Vaccines are the exact reason we can and should be in 
person today in the hearing room. We are asking Americans to 
come back to work. Members of Congress should also be back at 
work. I look forward to the committee meeting together in 
person very soon. Without Operation Warp Speed, we would not 
have three safe and effective vaccines that are currently being 
administered to Americans. Congress and President Trump came 
together to help unleash private sector innovation to make this 
possible. Without medical innovation, we would be nowhere close 
to where we are currently with COVID-19 vaccination numbers. 
Roughly 52% of Americans have received at least one dose, and 
about 43% of Americans are fully vaccinated.
    We have advanced and improved our COVID-19 vaccine 
distribution strategies and continue to do so. Congress has 
appropriated nearly $4 trillion in response to the COVID-19 
pandemic. Most recently, Congress provided $1.9 trillion 
through the American Rescue Plan. I strongly disagreed with 
this legislation because it was mostly used as a trojan horse 
for progressive polices and only 9% of the funding went 
directly to fighting COVID-19. Of the 9% for COVID-19 relief, 
$7.5 billion was appropriated for vaccine planning, 
distribution, monitoring, and tracking; $1 billion for vaccine 
confidence activities; $6.05 billion for COVID vaccine supply 
chain; and $7.6 billion for community health centers for 
activities including COVID-19 vaccine distribution and 
administration, testing, and community outreach and education. 
This bill became law four months ago. Have these funds been 
distributed? How are these funds currently being used? As the 
former Republican Leader of the Oversight and Investigations 
Subcommittee, I believe that oversight is a very important 
aspect of our response. I have supported much-needed relief for 
American families, workers, and small businesses, but we must 
ensure it is being used effectively and wisely.
    Specifically, I am concerned that a number of these bills 
are duplicative of current efforts already underway to address 
the COVID-19 pandemic. Let me be clear, I support efforts to 
give every American the opportunity to be vaccinated for COVID-
19 and any other vaccine preventable disease where vaccination 
is recommended. But at this point, we need to fully evaluate 
the current situation--why are Americans not getting 
vaccinated? We need to tailor meaningful solutions to these 
problems. Cost may be a part of the problem, but there are 
likely other issues that are negatively affecting vaccination 
rates.
    For example, we are considering today is H.R. 979, the 
``Vaccine Fairness Act,'' which would require weekly reporting 
of vaccine distribution. I agree with my colleagues that this 
is helpful information, but this is currently already being 
done by HHS and each Member office receives this vaccine 
information weekly.
    Additionally, today we are examining H.R. 3013, the ``COVID 
Vaccine Transportation Access Act''. This bill would provide 
grants for transportation to receive vaccines. I certainly 
agree that transportation should not be a limiting factor for 
an individual, but currently there are already several 
resources available for these services, including Uber and Lyft 
who stepped up to provide transportation. Congress also 
authorized non-emergency transportation for Medicaid 
individuals in the December bipartisan COVID-19 relief package. 
Lastly, many areas offer a phone number that an individual can 
text and to make a vaccination appointment and they will also 
help you coordinate a ride.
    We do currently still have gaps in our vaccine system, and 
I look forward to discussing H.R. 3742, the ``Vaccine 
Information for Nursing Facility Operators Act'' or the 
``Vaccine INFO Act,'' which would require nursing homes to 
provide educational information on the value of getting all of 
the appropriate ACIP-recommended vaccines for healthcare 
workers to their staff in a similar manner to how they already 
provide educational information on certain vaccines for their 
residents. I also look forward to discussing H.R. 1452. This 
bill would require HHS to publish the formula used to 
distribute the allocation of COVID-19 vaccines. This bill will 
allow States, local governments, and certain entities to better 
prepare for vaccine distribution.
    Lastly, I encourage all to get vaccinated for COVID-19. 
Vaccines saves lives and help protect against many diseases. 
The Democrat bill, H.R. 3 would disincentivize further 
development of vaccines and hinder development of lifesaving 
drugs. During a global pandemic, they want to advance polices 
that would lead to fewer cures and treatments. This is very 
backwards to me. I hope my colleagues fully evaluate how 
damaging a slowed vaccine development could have been for 
COVID-19. Many around the world, particularly the European 
Union, did exactly what the Democrats are trying to get us to 
do in the United States. These behaviors have resulted in the 
EU being way behind the U.S. in distributing COVID-19 vaccines 
to their citizens. We must continue to be a leader in medical 
innovation and encourage the development of new treatments and 
cures in our great country.

    Ms. Eshoo. Thank you, Mr. Guthrie.
    The gentleman yields back. The Chair now is pleased to 
recognize the chairman of the full committee for 5 minutes for 
his opening statement.
    Mr. Pallone.

OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE 
            IN CONGRESS FROM THE STATE OF NEW JERSEY

    Mr. Pallone. Thank you, Chairwoman Eshoo, for having this 
very important hearing.
    The COVID-19 pandemic has drawn the world's attention to 
the value of vaccines, and the rapid development of COVID-19 
vaccines was a direct result of decades of progress in the 
immunization landscape and laser focus on science and safety 
and historic investment by the Federal Government and the 
courage of clinical trial participants.
    While the development of these remarkable vaccines marked a 
huge step forward, this terrible pandemic has also made clear 
that we must do more to reduce incidence of all vaccine-
preventable disease. And this includes taking action to raise 
awareness of the value of vaccines, improving vaccine-related 
public health infrastructure, and reduced barriers to access 
for these life-saving preventative tools. And this is, 
obviously, your focus today, Madam Chair.
    One of the areas where we can most improve is on adult 
vaccination rates. As our witnesses will mention in their 
testimony today, while the vaccination rates for childhood 
vaccines is generally considered high, vaccination rates for 
adults are lower across the board. These low vaccine rates 
increase the burden of vaccine-preventable disease in the 
United States. Each year there are over 3,000 cases of 
hepatitis B, 40,000 cases of pneumococcal disease, and about 1 
million cases of shingles. Vaccination rates in the recommended 
adult population for each of these diseases are all below 30 
percent. Moreover, only 48 percent of adults in the U.S. 
received a flu shot during the 2019-2020 flu season.
    So clearly, we need to explore ways to increase these 
rates, and one place to look is the approach we are taking with 
children. After all, over 90 percent of American kindergartners 
receive the majority of their recommended vaccines for 
hepatitis, chickenpox, polio, tetanus, and measles, among 
others. And those are strong results, but we must remain 
vigilant.
    Last week the Centers for Disease Control and Prevention 
reported a decline in childhood vaccination rates during the 
early days of the COVID-19 pandemic, which could pose a serious 
public health threat.
    And we also know that there are significant disparities in 
vaccination rates by age, gender, race, ethnicity, and economic 
status. Black and Hispanic adults have lower vaccination rates 
than White adults for every recommended vaccine from the 
Advisory Committee on Immunization, and only 40 percent of 
pregnant women received the 2 vaccines recommended during 
pregnancy to protect the mother and unborn child. Moreover, 
only 23 percent of Black pregnant women and 25 percent of 
Hispanic pregnant women received the recommended shots.
    So coverage of vaccines by private and public health 
insurance plays a significant role in vaccine access. And lack 
of health coverage correlates with significantly lower 
vaccination rates.
    The comprehensive collection of bills we are considering 
today would make significant enhancements to vaccine coverage 
for adults and children in Medicare, Medicaid, and the CHIP 
program. This includes H.R. 1978, the Protecting Seniors 
Through Immunization Act, which was introduced by 
Representatives Kuster and Bucshon. This legislation would 
ensure that Medicare beneficiaries are not charged out-of-
pocket costs when receiving a vaccine through Part D.
    And H.R. 2170, the Helping Adults Protect Immunity Act, 
introduced by Representative Soto, would require all State 
Medicaid programs to cover ACIP-recommended vaccines for adults 
and prohibit cost sharing.
    And then there is H.R. 2347, the Strengthening the Vaccines 
for Children Act, introduced by Representatives Schrier, Joyce, 
Butterfield, and McKinley, and that would enhance vaccines for 
children. This program provides vaccines to low-income children 
by extending eligibility and boosting incentives for providers 
to participate in the program.
    H.R. 951, another bill, the Maternal Vaccination Act, 
introduced by Representative Sewell, would create a public 
awareness campaign for maternal vaccinations, with a focus on 
communities with historically low vaccination rates. This bill 
is an important continuation of our work to address the 
maternal mortality and morbidity crisis in America.
    And finally, I wanted to mention, Madam Chair, H.R. 550, 
the Immunization Infrastructure Modernization Act, also 
introduced by Representatives Kuster and Bucshon. This bill 
would provide funding for significant improvements to 
immunization information systems. These systems are critical 
tools for providers in public health systems but must be 
brought into the 21st century information age.
    Increasing immunizations in the U.S. will promote longer, 
healthier lives, while saving billions of dollars in healthcare 
costs. And as we climb out of the pandemic, our focus cannot be 
returned to the status quo. Our mandate is to build a stronger 
and more equitable public health system, and today's hearing, 
Madam Chair, and these bills, is an important step.
    So again, I thank you, and I yield back. Thank you.
    [The prepared statement of the Mr. Pallone follows:]

             Prepared Statement of Hon. Frank Pallone, Jr.

    The COVID-19 pandemic has drawn the world's attention to 
the value of vaccines. The rapid development of COVID-19 
vaccines was a direct result of decades of progress in the 
immunization landscape, laser-focus on science and safety, 
historic investment by the Federal Government, and the courage 
of clinical trial participants.
    While the development of these remarkable vaccines marked a 
huge step forward, this terrible pandemic has also made clear 
that we must do more to reduce incidence of all vaccine-
preventable diseases. This includes taking action to raise 
awareness of the value of vaccines, improve vaccine-related 
public health infrastructure, and reduce barriers to access for 
these lifesaving preventive tools. That is our focus today.
    One of the areas where we can most improve is on adult 
vaccination rates. As our witnesses will mention in their 
testimony today, while the vaccination rates for childhood 
vaccines is generally considered high, vaccination rates for 
adults are lower across the board.
    These low vaccine rates increase the burden of vaccine-
preventable disease in the United States. Each year, there are 
over 3,000 cases of hepatitis B, 40,000 cases of pneumococcal 
disease, and about one million cases of shingles. Vaccination 
rates in the recommended adult population for each of those 
diseases are all below 30 percent. Moreover, only 48 percent of 
adults in the United States received a flu shot during the 
2019-2020 flu season.
    Clearly, we need to explore ways to increase these rates 
and one place to look is the approach we are taking with 
children. After all, over 90 percent of American kindergartners 
receive the majority of their recommended vaccines for 
hepatitis, chickenpox, polio, tetanus, and measles, among 
others. Those are strong results but we must remain vigilant. 
Last week, the Centers for Disease Control and Prevention (CDC) 
reported a decline in childhood vaccination rates during the 
early days of the COVID-19 pandemic, which could pose a serious 
public health threat.
    We also know that there are significant disparities in 
vaccination rates by age, gender, race, ethnicity, and economic 
status. Black and Hispanic adults have lower vaccination rates 
than white adults for every recommended vaccine from the 
Advisory Committee on Immunization (ACIP). Only 40 percent of 
pregnant women receive the two vaccines recommended during 
pregnancy to protect the mother and unborn child. Moreover, 
only 23 percent of Black pregnant women and 25 percent of 
Hispanic pregnant women receive the recommended shots.
    Coverage of vaccines by private and public health insurance 
plays a significant role in vaccine access, and lack of health 
coverage correlates with significantly lower vaccination rates.
    The comprehensive collection of bills we are considering 
today would make significant enhancements to vaccine coverage 
for adults and children in Medicare, Medicaid, and the 
Children's Health Insurance Program (CHIP).
    This includes H.R. 1978, the Protecting Seniors Through 
Immunization Act, which was introduced by Representatives 
Kuster and Bucshon. This legislation would ensure that Medicare 
beneficiaries are not charged out-of-pocket costs when 
receiving a vaccine through Part D. And H.R. 2170, the Helping 
Adults Protect Immunity Act, introduced by Representative Soto, 
would require all State Medicaid programs to cover ACIP 
recommended vaccines for adults and prohibit cost-sharing.
    H.R. 2347, the Strengthening the Vaccines for Children Act, 
introduced by Representatives Schrier, Joyce, Butterfield, and 
McKinley, would enhance the Vaccines for Children Program. This 
program provides vaccines to low-income children, by extending 
eligibility and boosting incentives for providers to 
participate in the program.
    H.R. 951, the Maternal Vaccinations Act, introduced by 
Representative Sewell, would create a public awareness campaign 
for maternal vaccinations with a focus on communities with 
historically low vaccination rates. This bill is an important 
continuation of our work to address the maternal mortality and 
morbidity crisis in America.
    And finally, I want to mention H.R. 550, the Immunization 
Infrastructure Modernization Act, also introduced by 
Representatives Kuster and Bucshon. This legislation would 
provide funding for significant improvements to immunization 
information systems. These systems are critical tools for 
providers and public health systems but must be brought into 
the 21st century information age.
    Increasing immunizations in the United States will promote 
longer, healthier lives while saving billions of dollars in 
healthcare costs. As we climb out of this pandemic, our focus 
cannot be a return to the status quo. Our mandate is to build a 
stronger and more equitable public health system, and today's 
hearing on these bills is an important step.
    Thank you, I yield back.

    Ms. Eshoo. Thank you, Mr. Pallone.
    The gentleman yields back. The Chair is now pleased to 
recognize Representative Cathy McMorris Rodgers, the ranking 
member of our full committee, for 5 minutes for her opening 
statement.

      OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A 
    REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON

    Mrs. Rodgers. Thank you, Madam Chair and Republican Leader 
Guthrie.
    Vaccines are a bright spot in the fight to enable Americans 
to live long, healthy lives. COVID-19 is the latest chapter in 
that story. It is also a bright spot to be in the committee 
room today with my colleagues.
    We know that vaccines save lives. Thanks to vaccines, four 
preventable diseases have been completely eliminated from the 
Americas today. Between 2011 and 2020, immunization programs in 
low-income countries are estimated to have saved more than 23 
million lives.
    And now, thanks to the Trump administration and Operation 
Warp Speed, we have three authorized vaccines in record time to 
crush COVID-19. It is because of the private sector leveraging 
investment and regulatory flexibility provided by Congress and 
the Trump administration to unleash innovation.
    Think about it. Today, just over a year since the pandemic 
began, we are holding a hearing about getting a vaccine to 
every person who wants one. At the start of the pandemic, 
experts were estimated at--estimating it would take much 
longer. This record speed is a remarkable story of American 
innovation.
    Since December, when the first COVID-19 vaccine was 
authorized, COVID-19 deaths have plummeted, countless lives 
have been saved, and, as more adults are getting vaccinated, 
cases are decreasing all across the country. Operation Warp 
Speed has brought us back from the brink, back to work, back to 
school, attending weddings, visiting grandparents, planning 
vacations without fear of an unknown virus.
    Congress took unprecedented additional steps to make sure 
every American could get a vaccine for COVID-19 for free. But, 
as we have seen, there's additional barriers to vaccination. I 
am pleased that we are examining existing programs that aim to 
improve access to all vaccines, to make sure that those who 
want vaccines can get them, and, in the case of childhood 
vaccines, parents have the best information to make decisions 
for their family.
    The State and Federal governments worked together to 
implement two programs to make sure those who cannot afford 
recommended vaccines have access. The Section 317 vaccine 
program has been around for more than 50 years and authorizes 
the Federal purchase of vaccines for children, adolescents, and 
adults.
    Additionally, the Vaccines for Children, VFC, program was 
established in 1993. The VFC provides vaccines at no cost to 
children who are Medicaid-eligible, uninsured, under-insured, 
and American Indian or Alaska Natives. With the creation of the 
Vaccines for Children program, the Section 317 vaccine program 
focuses on uninsured adults and under-insured children not 
eligible for VFC. These programs allow the CDC to purchase 
vaccines directly from the manufacturer and then provide the 
vaccines to States.
    As we have learned from the pandemic, State and local 
public health agencies are best situated to tailor programs for 
their communities. I am glad that we are looking at these 
programs today, and I hope that any COVID-19 vaccines approved 
by the FDA will soon be distributed through these channels.
    To win the future, America must lead in the development and 
the discovery of safe and effective vaccines. I want to make 
sure that, as we debate access to vaccines, we are not 
disincentivizing the investment and the risk necessary to study 
and bring vaccines to market. Unlike drugs for when you are 
sick, vaccines are given to healthy children and adults. Large 
studies are necessary to ensure safety and build trust, given 
the breadth of the population often taking the vaccine. The 
risk benefit profile is different than, say, a cancer drug, 
where side effects may be more acceptable, given the risk of 
the disease.
    More vaccines are desperately needed for diseases we know 
about, like HIV and flu. Just this month, promising reports 
released about a universal flu vaccine and potential novel ways 
to vaccinate against HIV.
    We also need to be ready for the next unknown virus, as 
COVID-19 was unknown to us in 2018. The Federal Government 
needs to continue investing in research and prioritizing 
vaccine development while also making sure that incentives 
exist for private industry to do the same.
    Making sure that patients have access to vaccines once they 
are developed and approved is one important way to promote and 
unleash innovation, and I look forward to hearing what more we 
can do. I yield back, Madam Chair.
    [The prepared statement of Mrs. McMorris Rodgers follows:]

           Prepared Statement of Hon. Cathy McMorris Rodgers

    Thank you, Chair Eshoo and Republican Leader Guthrie.
    Vaccines are a bright spot in the fight to enable Americans 
to live long, healthy lives.
    The return to normalcy after COVID-19 is just one chapter 
of that story.
    Examples of Vaccines & Impact on Public Health
    We know that vaccines save lives.
    Thanks to vaccines, four preventable disease are completely 
eliminated from the Americas today.
    Between 2011 and 2020, immunization programs in low-income 
countries are estimated to have saved more than 23 million 
lives.
    And now, thanks to the Trump administration and Operation 
Warp Speed, we have three authorized vaccines in record time to 
crush COVID-19.
    It's because the private sector leveraged investment and 
regulatory flexibility provided by Congress and the Trump 
administration to unleash innovation.
    Think about it.... Today--just over a year since the 
pandemic began--we are holding a hearing about getting a 
vaccine to every person who wants one.
    At the start of the pandemic, experts were estimating that 
we may just be getting the first vaccines at this point.
    This record speed is a remarkable story of American 
innovation.
    Since December when the first COVID-19 vaccine was 
authorized, COVID-19 deaths have plummeted...
    ... And, as more adults get vaccinated, cases are 
decreasing all over the country.
    Operation Warp Speed has brought us back from the brink--
back to work, back to school, attending weddings, visiting 
grandparents, planning vacations--without fear of an unknown 
virus.
    Congress took unprecedented additional steps to make sure 
every American could get a vaccine for COVID-19 for free.
    But we have seen that there are additional barriers to 
vaccination.
    As we return to normalcy, I am glad we are examining 
existing programs that aim to improve access to all vaccines to 
make sure that those who want vaccines, can get them, and in 
the case of childhood vaccines, parents have the best 
information to make decisions for their family.
    Existing Programs to Incentivize Vaccine Innovation & 
Access
    The State and Federal governments work together to 
implement two programs to make sure those who cannot afford 
recommended vaccines have access.
    The ``Section 317'' vaccine program has been around for 
more than 50 years, and authorizes the Federal purchase of 
vaccines for children, adolescents, and adults.
    Additionally, the Vaccines for Children (VFC) program was 
established in 1993.
    The VFC provides vaccines at no cost to children who are 
Medicaid eligible, uninsured, underinsured, and American Indian 
or Alaskan natives.
    With the creation of the Vaccines for Children program, the 
``Section 317'' vaccine program focuses on uninsured adults and 
underinsured children not eligible for VFC.
    These programs allow the CDC to purchase vaccines directly 
from the manufacturer, and then provide the vaccines to States.
    As we've learned from the pandemic, State and local public 
health agencies are best situated to tailor programs best for 
their communities.
    I am glad we're looking at these programs today and hope 
that any COVID-19 vaccines approved by the FDA will soon be 
distributed through these traditional channels.
    Innovation & Healthy Future Through Vaccines
    To win the future, America must lead in the development and 
discovery of safe and effective vaccines.
    I want to make sure that as we debate access to vaccines, 
we are not disincentivizing the investment and risk necessary 
to study and bring vaccines to market.
    Unlike drugs for when you are sick, vaccines are given to 
healthy children and adults.
    Large studies are necessary to ensure safety and build 
trust.... given the breadth of the population often taking a 
vaccine.
    The risk-benefit profile is different than say, a cancer 
drug, where side effects may be more acceptable given the risk 
of the disease.
    More vaccines are desperately needed.
    .. for diseases we know about, like HIV and flu.
    Just this month, promising reports were released about a 
universal flu vaccine and potential novel ways to vaccinate 
against HIV.
    We also need to be ready for the next unknown virus, as 
COVID-19 was unknown to us in 2018.
    The Federal Government needs to continue investing in 
research and prioritizing vaccine development, while also 
making sure that incentives exist for private industry to do 
the same.
    Making sure that patients have access to vaccines once they 
are developed and approved is one important way to promote and 
unleash innovation, and I look forward to hearing what more we 
can do.

    Ms. Eshoo. The gentlewoman yields back. I thank her for her 
statement.
    Pursuant to committee rules, all Members' written opening 
statements will be made part of the record.
    I now would like to introduce our four witnesses that are 
with us today.
    We are very grateful to each one of you. It is an honor to 
have you as a witness at our subcommittee.
    First, Dr. Lijen ``LJ'' Tan. He is the chief strategy 
officer of the Immunization Action Coalition.
    So good morning to you, Dr. Tan, and welcome.
    Next, Dr. Yvonne Maldonado. She is a professor of 
pediatrics and epidemiology and public health at Stanford 
University's Center for Academic Medicine, Pediatric Infectious 
Diseases. Dr. Maldonado is my constituent, and I am very proud 
of that. And I am so pleased that our subcommittee is going to 
benefit from her expertise today.
    Importantly, colleagues, Dr. Maldonado is leading the trial 
of the Pfizer drug for children under the age of 12 at Lucile 
Packard Children's Hospital.
    So welcome to you, Dr. Maldonado. We are thrilled you are 
with us.
    Rebecca Coyle, she is the executive director of the 
American Immunization Registry Association.
    We are so pleased and honored to have you with us.
    And Phyllis Arthur, she is the vice president, infectious 
diseases and diagnostic policy, at the Biotechnology Innovation 
Organization.
    Welcome to you, Ms. Arthur. We are pleased to have you with 
us.
    So, Dr. Tan, we will start with you. You have 5 minutes for 
your testimony, and be sure to unmute.

STATEMENTS OF LIJEN ``LJ'' TAN, Ph.D., CHIEF STRATEGY OFFICER, 
 IMMUNIZATION ACTION COALITION; YVONNE MALDONADO, M.D., CHAIR, 
     COMMITTEE ON INFECTIOUS DISEASES, AMERICAN ACADEMY OF 
PEDIATRICS, AND PROFESSOR OF PEDIATRICS AND OF EPIDEMIOLOGY AND 
    PUBLIC HEALTH, STANFORD UNIVERSITY CENTER FOR ACADEMIC 
     MEDICINE; REBECCA COYLE, EXECUTIVE DIRECTOR, AMERICAN 
  IMMUNIZATION REGISTRY ASSOCIATION; AND PHYLLIS ARTHUR, VICE 
     PRESIDENT, INFECTIOUS DISEASES AND DIAGNOSTIC POLICY, 
             BIOTECHNOLOGY INNOVATION ORGANIZATION

                 STATEMENT OF LIJEN ``LJ'' TAN

    Dr. Tan. Thank you very much, Chairman Eshoo, Ranking 
Member Guthrie, members of the committee for allowing me to 
testify today. I am LJ Tan. I am the chief strategy officer for 
the Immunization Action Coalition. And I also cochair and 
cofounded the National Adult and Influenza Immunization Summit. 
I also serve on the board and steering committee of the Adult 
Vaccine Access Coalition.
    As you have heard, the enormous benefits that we have 
received as a result of our successful pediatric immunization 
program, in terms of deaths and diseases averted and healthcare 
costs saved, is clear. Policies that facilitate access to 
immunizations play an important part in that success. For 
example, the Federal Vaccines for Children program covers 
uninsured and underinsured children so that income status is 
not a barrier to receiving that lifesaving vaccine. However, 
our adult immunization coverage rates remain dramatically low.
    Before the onset of this pandemic, adult rates across all 
vaccines recommended by the A-C-I-P, or ACIP, would be low, 
federally set targets. These low coverage rates result in 
significant mortality, morbidity, and cost to the U.S. 
healthcare system. It is estimated that more than 50,000 adults 
die annually from a vaccine-preventable disease. Hundreds of 
thousands suffer consequences from these diseases, including 
hospitalizations, time lost from work and family, and reduction 
in their personal quality of life.
    Adults aged 50 and over are particularly susceptible to 
many vaccine-preventable diseases and account for a 
disproportionate number of the deaths and illnesses associated 
with them. And if that is not enough, data indicates that, for 
adults over 50 years of age, 4 major vaccine-preventable 
diseases accounted for about $26.5 billion in annual healthcare 
costs.
    And as we all deal with the COVID-19 pandemic, adult 
immunization coverage rates have gotten even worse. You heard 
about the decline in pediatric rates. Adult rates have also 
declined drastically. And while pediatric coverage rates are 
now improving, adult rates have not been recovering at the same 
pace.
    So, despite all this evidence to the benefits of immunizing 
adults, particularly older adults, why are immunization 
coverage rates so low?
    Access to vaccines and vaccination is the biggest barrier 
to improving adult immunization coverage rates. Adult care 
tends to be acute-based. So you go in to see a physician when 
you are not feeling well, and well care visits are challenging 
to adhere to in that busy adult life. As such, patients are 
often not aware of the vaccines that they need as adults. When 
you combine this lack of awareness and education with the 
access challenges facing adult patients, physical and 
logistical, many adults end up forgoing their recommended 
vaccines.
    Many older adults live on fixed incomes, and studies 
indicate that additional cost to get vaccinated will delay or 
even prevent them from getting vaccinated.
    We must improve our public health infrastructure, and 
particularly our immunization infrastructure, to be able to 
ensure that any adult in the United States is able to receive a 
vaccine that is recommended for them.
    As we emerge from this pandemic, we need to maintain the 
investments made as a result of COVID-19 and recognize that the 
time to invest in our capacity to vaccinate all our adults is 
now. The ability to deliver vaccines into this population will 
predict our ability to respond effectively when the next 
pandemic rears its ugly head. Annual readiness translates into 
pandemic preparedness.
    What can we do to develop the immunization infrastructure 
that will support not only better health but, as I suggest, 
also prepare us for the next pandemic to come?
    We must ensure that our most vulnerable adults, our older 
adults and adults with chronic health conditions, can be 
vaccinated without barriers. In doing so, we are not only 
preparing the infrastructure, we are also making immunization 
of adults a societal norm, a preventive health intervention 
that we value.
    The Protecting Seniors Through Immunization Act ensures all 
vaccines under Medicare are available to beneficiaries with no 
cost sharing or deductibles as part of your budget proposal to 
Congress. This bill brings parity to out-of-pocket costs 
between Medicare Part B and Medicare Part D plans. The bill 
also strengthens vaccine confidence by providing education on 
and increasing equitable access to recommended vaccines for 
Medicare beneficiaries.
    We cannot ignore those who are more vulnerable to vaccine-
preventable diseases as a result of their socioeconomic status. 
For low-income individuals, any financial barrier may impede 
people showing up to get vaccinated. We must fix current 
disparities in coverage and payment in the Medicaid program by 
providing a baseline of consistent and reliable Medicaid 
coverage for patients across the country.
    The Helping Adults Protect Immunity Act seeks to ensure 
that all Medicaid enrollees have access to this important 
preventive health service, and do not face financial burdens to 
become vaccinated with recommended vaccines.
    A fully vaccinated public is an investment in our future 
well-being and economic success of our Nation. We can make a 
difference in terms of morbidity, mortality, and quality of 
life for our population and in terms of cost to our healthcare 
system. Our annual readiness will translate into pandemic 
preparedness.
    Thank you for your time and your commitment to vaccines. I 
am happy to answer any questions.
    [The prepared statement of Dr. Tan follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]  
    
    Ms. Eshoo. Thank you, Dr. Tan, for your excellent 
testimony.
    Next, Dr. Maldonado, welcome again, and thank you, and you 
have 5 minutes to deliver your remarks to our committee.
    [Pause.]
    Ms. Eshoo. You need to unmute.
    Dr. Maldonado. Yes, I think I should. I should have known 
that already, sorry. OK, here we go.
    Ms. Eshoo. Here you are. Welcome.

                 STATEMENT OF YVONNE MALDONADO

    Dr. Maldonado. Thank you so much.
    Chairman Eshoo, Ranking Member Guthrie, and members of the 
committee, thank you for the opportunity to testify today 
before you. It is an honor to talk about the importance of 
vaccines for children. My name is Dr. Yvonne Maldonado, and I 
am testifying today on behalf of the American Academy of 
Pediatrics, AAP, a nonprofit professional membership 
organization of 67,000 pediatricians dedicated to the health 
and well-being of children.
    I am an infectious disease pediatrician and serve as the 
chair of the AAP's Committee on Infectious Disease. I am also a 
professor of pediatrics, epidemiology, and population health, 
chief of the Division of Pediatric Infectious Diseases at 
Stanford University School of Medicine, where I also practice 
at the Lucile Packard Children's Hospital. I currently lead 
several COVID-19 treatment and prevention programs.
    The past year and a half has been extremely challenging for 
adults and children alike, as we have lived through the COVID-
19 pandemic. While the vast majority of deaths and severe 
illness from COVID-19 have occurred in adults, children have 
experienced severe harmful impacts of the pandemic. Nearly 4 
million children have been infected with the virus, over 16,000 
have been hospitalized, and more than 315 have died, with more 
than two-thirds of those being Black and Latinx children.
    The pandemic has also led to make limited social 
interactions with peers and relatives and curtailed access to 
other activities that help children develop social, emotional 
well-being and maintain good mental health. This is why we are 
so grateful that we finally have a COVID-19 vaccine for 
adolescents aged 12 and up. We strongly encourage parents to 
get the vaccine for themselves and for their eligible children. 
Vaccinating children and families against COVID-19 will save 
lives and help them return to a more normal life.
    Pediatricians believe in strengthening child immunization 
rates as a major path to advancing child health. That is why we 
must vigorously support the Vaccines for Children program, the 
backbone of the childhood vaccine delivery system in the United 
States, which provides immunizations at no cost to children who 
are enrolled in Medicaid, are uninsured or underinsured, or who 
are Native American or Native Alaskan. Since its inception in 
1993, the VFC program, which provides half of all vaccines to 
American children, has increased vaccination rates and reduced 
the risk of preventable infections across all races, 
ethnicities, and income groups and reduced racial and ethnic 
disparities.
    Unfortunately, over the last 15 months we have seen a 
staggering decrease in routine childhood immunizations. Recent 
CDC data shows that overall VFC provider orders for nonflu 
vaccines are down by more than 11.5 million doses, compared to 
the previous year. When children miss recommended vaccinations, 
they leave themselves, other children, and adults in their 
communities more vulnerable to outbreaks of preventable 
diseases like measles and whooping cough, particularly in 
school settings.
    While the VFC program has been a tremendous success, 
current financial and administrative barriers make it difficult 
for clinicians to participate. The COVID-19 pandemic has only 
exacerbated these challenges, as dramatic decreases in revenue 
from fewer patient visits, compounded with higher overhead 
costs, has financially stressed many practices.
    As such, the American Academy of Pediatrics strongly 
supports the strengthening of the Vaccines for Children Program 
Act of 2021, and we thank Representative Schrier, a fellow 
pediatrician, and Representatives Joyce, Butterfield, and 
McKinley for introducing this strong, bipartisan piece of 
legislation. This bill provides incentive payments for 
participating providers to stay in the program and entices new 
providers to join. It also addresses providers' financial 
burden by increasing Medicaid payment for vaccine 
administration to match Medicare payment rates for 2 years.
    The legislation also extends VFC eligibility to children 
enrolled in the Children's Health Insurance Program and enables 
underinsured children to receive VFC vaccines in their medical 
home, as opposed to having to go to another clinic to receive 
care.
    Additionally, the legislation would finally allow VFC 
payments for administration of multiple component vaccines, 
vaccines that protect against more than one disease. In short, 
the Vaccines for Children program is the heart of the childhood 
vaccine delivery system, and we need to do all we can to 
support it.
    In addition, it is imperative that we bolster immunization 
information systems, IIS. The Immunization Infrastructure 
Modernization Act would provide critical resources for IIS 
modernization and has the ability to capture and share 
immunization data, thus improving our ability to keep children 
up to date on their vaccines.
    Thank you so much for the opportunity to testify today. We 
appreciate the subcommittee calling attention to the importance 
of vaccines this morning, and we look forward to working with 
you to ensure that all Americans have access to routine 
vaccinations, including the COVID-19 vaccines.
    [The prepared statement of Dr. Maldonado follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]  
    
    Ms. Eshoo. Thank you, Dr. Maldonado. And you delivered your 
testimony not using all of your time, which is always noted by 
Members, so thank you very much.
    Next, Ms. Coyle, you are recognized for 5 minutes. And 
again, all of our thanks for being willing to be a witness 
before our subcommittee today. You have 5 minutes, so make sure 
you unmute. We want to hear every word.
    [Pause.]
    Ms. Eshoo. We can't hear you.
    [Pause.]
    Ms. Eshoo. We can't hear you.
    Ms. Coyle. Yes.
    Ms. Eshoo. There you are.
    Ms. Coyle. Great.
    Ms. Eshoo. I hope you heard me welcome you. And thank you 
again for being a witness today. You have 5 minutes for your 
testimony.

                   STATEMENT OF REBECCA COYLE

    Ms. Coyle. Thank you, Chairwoman Eshoo, Ranking Member 
Guthrie, and members of the committee. I appreciate the 
opportunity to be part of the hearing today to talk about 
immunization information systems, also known as immunization 
registries.
    My name is Rebecca Coyle. I serve as the executive director 
of the American Immunization Registry Association, known as 
AIRA. AIRA members include IIS and immunization program staff 
working in State and local health departments and organizations 
such as IIS implementers, nonprofits, and others interested in 
IIS.
    IIS are confidential, population-based computerized 
databases that record all immunization doses administered by 
participating vaccination providers to persons residing within 
a State or jurisdiction. IIS exists in all States, Territories, 
and several large cities and counties. Nationally, 96 percent 
of children, 82 percent of adolescents, and 60 percent of 
adults have immunization records and an IIS as of 2019. IIS are 
primarily funded through Federal investments using cooperative 
agreement funds from CDC's immunization program using section 
317 funds. IIS support the administration of the Vaccines for 
Children program, with a majority of VFC vaccines being ordered 
by providers using an IIS.
    However, there is no overarching Federal policy that 
requires VFC providers to record these doses in an IIS. And 
there is no equivalent vaccination program for adults. Many 
jurisdictions have implemented reporting requirements, but 
policies vary by jurisdiction. States have similar but 
different laws and policies for a variety of functions, 
including data exchange, vaccine reporting, access, and sharing 
data with another IIS. And it is these variations that are most 
often criticized, because not all States function the same.
    IIS are part of the immunization program infrastructure and 
are powerful tools for managing immunization records and 
supporting healthier communities. IIS are used to consolidate 
vaccination data from multiple providers into one record. They 
are used for vaccine ordering and managing inventory, which 
minimizes waste and saves money.
    IIS has been used in nearly all vaccine-preventable disease 
outbreaks in the past decade, the 2009 H1N1 pandemic, and the 
current COVID-19 pandemic.
    Of the utmost concern is the privacy and security of all 
system data. Standards set by CDC state that all IIS must have 
a written policy that clearly defines expectations, such as the 
type of information contained and how the data will be used and 
who has access to that information. IIS are expected to mirror 
industry standards for system security.
    COVID-19 vaccine efforts have highlighted multiple areas 
where investments in IIS are critical. Without an investment, 
IIS will continue to face failing and capacity issues. The 
ability to process and manage the volume of data that has been 
generated from COVID-19 vaccination events highlights the need 
for systems to move to cloud-based hosting, with scaling and 
surge capacity capabilities.
    To put it simply, most jurisdictions were operating the 
highway, but with the pandemic traffic there was a need to 
expand to an eight-lane freeway.
    Additional efforts are also needed to identify and expand 
bidirectional data exchange. Bidirectional means sending 
information to an IIS and also receiving a vaccine history and 
forecast in return. There is a need to onboard small providers 
that are often located in rural areas, as well as the many 
unique and varied entities administering vaccinations to 
adults. It is critical to have a workforce that can support and 
perform system management functions and leverage new 
technologies to increase efficiencies. Many of our current 
workforce are leaving for better-paying jobs.
    The present pandemic is the first time near-real-time 
vaccination data has been shared with CDC to provide a 
comprehensive surveillance at the Federal level. These data are 
primarily coming from IIS. Special policies were instituted to 
allow for this sharing of data. However, these policies do not 
extend to other vaccines, and this limits our Nation's public 
health agencies' ability to monitor outbreaks and routine 
vaccine administration from a national perspective. A national 
policy framework is needed to align reporting and consent 
requirements, authorized use, and data access.
    Congress has an opportunity to improve, enhance, and expand 
the ability of IIS to securely exchange real-time immunization 
data while safely protecting personal information. The 
Immunization Infrastructure Modernization Act, H.R. 550, 
introduced by Representatives Kuster and Bucshon, will help 
provide the needed national framework for IIS operations. 
Providing resources and supporting policies to modernize IIS 
will allow better management of routine immunization efforts 
and enhance public health's ability to respond to pandemics and 
outbreaks of other vaccine-preventable diseases.
    Thank you for this opportunity to share the information 
with you today, and I look forward to your questions.
    [The prepared statement of Ms. Coyle follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]  
    
    Ms. Eshoo. Thank you, Ms. Coyle, for your testimony. The 
Chair is pleased to recognize Phyllis Arthur.
    Welcome to the subcommittee. Please unmute. We are happy to 
have you with us, and you have 5 minutes.
    Ms. Arthur. Thank you.

                  STATEMENT OF PHYLLIS ARTHUR

    Ms. Arthur. Good morning, Chairwoman Eshoo, Ranking Member 
Guthrie, and members of the committee. I am Phyllis Arthur, 
vice president of infectious diseases and diagnostics policy at 
the Biotechnology Innovation Organization. Thank you for the 
opportunity to speak on the vaccine legislation being 
considered today.
    Our association includes companies that are committed to 
bringing vaccines to people of all ages. Vaccine manufacturers 
conduct research to the highest regulatory standards to ensure 
safety, efficacy, and manufacturing quality. And they are a 
vital--they are vital to national and global public health.
    Vaccines are the cornerstone of public health, reducing or 
eliminating many infectious diseases. The CDC projects that 
pediatric vaccines given between 1994 and 2018 will actually 
prevent over 400 million illnesses, 27 million 
hospitalizations, and over 936,000 deaths, while saving over 
$1.9 trillion in societal costs, including 406 billion in 
direct healthcare costs.
    The pandemic taught us several lessons.
    First, public health infrastructure is vital in peacetime 
and during a pandemic. We saw a dangerous drop in pediatric, 
adolescent, and adult routine immunizations this past year. 
Reinvigorating public health through catchup vaccination is 
crucial to avoid future outbreaks from vaccine-preventable 
diseases. The Immunization Infrastructure Modernization Act 
seeks to modernize our immunization registries, helping States 
manage public data on routine immunizations while enhancing our 
response to outbreaks and future pandemics.
    Second, BIO, like others, partnered with many organizations 
to educate the public on the COVID-19 vaccines. Education must 
expand to other vaccines, and outreach to at-risk populations 
using trusted messengers can increase immunization rates. 
Congress should pass H.R. 951, H.R. 1550, and H.R. 3742 for 
these goals.
    Lastly, we realize the different barriers to access, 
especially for people of color, seniors, and those in rural 
areas. Many faced financial and logistical impediments. 
Congress acted early to ensure COVID-19 vaccines were covered 
and accessible. Please do the same for the full complement of 
CDC-recommended vaccines for adults by passing the Protecting 
Seniors Through Immunization Act and the HAPI Act. These bills 
will reduce financial barriers by addressing cost sharing in 
Medicare and Medicaid.
    Cost sharing for vaccines is senseless because of their 
immense benefits. Vaccines not only prevent a person from 
getting sick, they prevent others as well, and thus they 
generate a high societal benefit.
    Infectious diseases exacerbate underlying conditions, 
leading to long-term negative outcomes. COVID-19 made this 
clear. Under Medicare Part D, seniors pay significant 
copayments on vaccine. Not all Medicaid programs fully cover 
ACIP-recommended vaccines, and many have copayments that 
discourage uptake. The Protecting Seniors and the HAPI Act will 
encourage parity by covering vaccines at no cost sharing, just 
as they are in Medicare Part B and private insurance. Removing 
this barrier provides direct financial and health benefits, 
improving access and equity for those adults who will benefit 
the most from vaccination.
    Patient safety is also critical. Vaccines are one of the 
safest medical interventions, and serious injuries are 
exceptionally rare. The U.S. has one of the most comprehensive 
compensation programs, the National Vaccine Injury Compensation 
Program, or VICP. This no-fault compensation makes compensation 
quicker, cheaper, and easier for those injured by vaccines. The 
Vaccine Injury Compensation Modernization Act would update and 
strengthen the program by providing more adequate compensation 
while extending protection to adult vaccinees.
    BIO is excited to see bipartisan legislation focused on 
vaccines, and we should continue the tremendous collaboration 
that carried us through this pandemic. These policies are--can 
dramatically impact the uptake and access to vaccines, leading 
to a healthier population, a robust economy, and new innovation 
in vaccines and preventive monoclonal antibodies that tackle 
unmet medical needs.
    Increased investment by vaccine developers of all sizes 
could lead to new immunization options and healthcare savings 
in the United States and around the world.
    Thank you for the opportunity to testify today.
    [The prepared statement of Ms. Arthur follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]  
    
    Ms. Eshoo. Thank you very much. We will now move to 
Members' questions, and I--the Chair recognizes herself for 5 
minutes first to Dr. Maldonado, and then a question to Dr. Tan 
and a question to Phyllis Arthur.
    To Dr. Maldonado: Vaccine hesitancy and misinformation, I 
think, have become a new culture war, with news media and with 
some politicians who are hyperfocused on highlighting the 
latest rumors. It is just so damaging, in my view. In looking 
at CDC data, it--I think it becomes clear that insurance status 
and income play a major role in keeping people, especially 
children, from getting vaccines.
    So tell us what you think the barriers are that your 
pediatric patients face in getting their vaccinations, and what 
should be done to--for children, to make it easier for children 
to get vaccinations.
    And then I am just going to state my questions off the top, 
so each one allow time for the other.
    To Dr. Tan: What do you think the barriers are that 
Congress should address to help more adults get their vaccines?
    And to Ms. Arthur: Prior to COVID-19, vaccine research was 
really underfunded, because vaccines are less profitable than 
other innovative treatments. So can you tell us if you think 
COVID-19 and the success of mRNA vaccines have changed this?
    And what is needed to make sure the United States of 
America has the strongest pipeline for new and effective 
vaccines?
    So, Dr. Maldonado, back to you.
    Dr. Maldonado. Thank you for this important question. And 
so I think there are two major components to our failure to 
vaccinate all of our children.
    This is a remarkable opportunity for us to save lives, to 
make lives healthier.
    I have been in practice for over 30 years myself, and I 
have seen diseases completely disappear from my practice across 
the street here, at this children's hospital, where I saw, on a 
weekly basis, children die from diseases that I no longer see. 
And that is because--entirely because of vaccination.
    And so what we are seeing are two different things. One is 
the rise of vaccine hesitancy. I won't say it is new. It has 
been around since Benjamin Franklin's days and before. What is 
new is social media, and the--a rapid spread of misinformation.
    I think we need to do a better job of making sure that 
people hear proper messaging from trusted leaders, that they 
can feel comfortable hearing the proper news, the right 
information about vaccines, and making sure that they know that 
vaccines are safe and effective, and that here in the United 
States we have the safest vaccine development delivery systems 
in the world.
    The second issue that I think is important for children is 
health and income disparities that really reduce the access for 
children to get vaccinated. They have to travel frequently to 
different locations where they can get access to vaccines, for 
example, through VFC sites that are allowed to give them 
vaccines.
    We are hearing, for example, even before the pandemic, 
about practices that don't--can't afford to give vaccines 
because of the poor reimbursement rates for the cost that it 
takes them in small practices to give vaccines. They are 
writing prescriptions to children to go to publicly funded 
clinics where they can get the vaccines, losing their medical 
home and losing that trusted source of other routine childhood 
care.
    So those are the two major areas. One is really getting 
good, safe, proper information out to all venues, public and 
private venues, as well as to making it easier for our 
providers, public and private providers, to give vaccines to 
all children, regardless of their income status.
    Ms. Eshoo. Thank you very much.
    Dr. Tan?
    Dr. Tan. Oh, thank you, Chairwoman Eshoo. I am going to be 
brief. I think, with adults, it is about convenience and access 
again.
    You know, adults have to get access to vaccines through 
multiple venues. You know, I am not--you know, with pediatrics 
you have got a pediatrician, a family physician. With adults 
you are talking all over, right? Employers, grocery stores, you 
know, outpatient settings, and so on and so forth.
    So I think, you know, firstly, we need to make sure that 
access is available. And then that means incentivizing 
providers to make themselves providers for adult vaccines.
    And then secondly, when we then bring our patients in, the 
patients have to go in and recognize that they are going to be 
paid--that they don't have something that is going to get in 
their way, like financial barriers. When someone goes in and 
says, ``I am ready to get my vaccine,'' and then they find out, 
oh, you have got a $160 copay, they are going to back away from 
that, for adults, especially.
    So I think those are the two big things I can think about 
right now.
    Ms. Eshoo. Thank you.
    Ms. Arthur, I don't have time for you to answer, but I will 
submit my question to you in writing. Thank you.
    The Chair is now pleased to recognize the chairman of the 
full committee, Mr. Pallone, for his 5 minutes of questions.
    Mr. Pallone. Thank you, Madam Chair. I just wanted to thank 
all the witnesses for their testimony. And as I mentioned in my 
opening statement, we are taking a comprehensive look at how to 
improve vaccine infrastructure awareness and access in our 
country. But I wanted to start out with Ms. Coyle.
    In your testimony you mentioned that 96 percent of children 
and 82 percent of adolescents have records in Immunization 
Information Systems in the U.S., but only 60 percent of adults 
have immunization records in these same systems. So could you 
explain why there is such a significant dropoff among adults, 
and how can we improve these systems so healthcare providers 
have ready access to immunization data for the adult patients?
    [Pause.]
    Mr. Pallone. Were you guys able to hear me?
    Ms. Eshoo. We can hear you, Mr. Chairman, but we can't hear 
the witness.
    You need to unmute.
    Mr. Pallone. Ms. Coyle?
    Ms. Eshoo. I don't know what happened to her. Why don't you 
move to your next question, Frank. We will see what we can do--
--
    Mr. Pallone. OK, well, let me just--Dr. Maldonado, I wanted 
to ask you, as--you know, as a physician, can you explain how 
increasing vaccinations among pregnant women can also protect 
their infants?
    Dr. Maldonado. Yes. Maternal immunization is a critical new 
area that has really long been overlooked. And we are really 
proud and happy to see that more and more maternal 
immunizations are being administered, for example, for 
influenza, for--and for whooping cough, and now for COVID-19.
    We know that, when mothers get vaccinated, especially 
during pregnancy, it does increase the safety of the infant 
through passively acquired maternal antibodies that are 
transferred to their infant. For example, for pertussis, that 
has been absolutely shown to be the case.
    And we also know that it keeps the mother safe from 
infectious diseases herself during a vulnerable period, and 
also helps to cocoon the child, protecting the child from 
infections because she--this young infant will be very close to 
their mother.
    So we do applaud these efforts to encourage maternal 
immunization.
    Mr. Pallone. And then, Doctor, it is also critical that we 
ensure all children get their recommended vaccinations. Are you 
aware of any data which shows how improving vaccination rates 
among pregnant women will affect the likelihood that the child 
receives recommended vaccines on time?
    Dr. Maldonado. Yes, there are some data that have been 
published over the years showing that women and families who 
get vaccinated sooner are more likely to engage in vaccinating 
their children at a young age. It is important to engage them 
early on, because children need their first well child visits 
at 2 weeks of age, sometimes sooner, and that first 
vaccinations are given at 2 months. So engaging families before 
the birth of the baby has been shown to increase well child 
visits and immunizations of their subsequent family--children 
and family members.
    Mr. Pallone. Well, thank you, Doctor.
    And finally, I wanted to mention the importance of having 
vaccines covered without cost sharing, because, under the 
Affordable Care Act, individuals in commercial health insurance 
plans cannot be charged out-of-pocket costs for vaccines they 
received in network. However, in Medicare Part D and Medicaid, 
some beneficiaries may be required to pay a copay to receive a 
recommended vaccine.
    So, Dr. Tan, can you explain how having a copay, including 
at a level that some might consider a low dollar amount, can 
negatively affect vaccination rates in the Medicare and 
Medicaid programs, if you will?
    Dr. Tan. Well, thank you for that question. Absolutely.
    I think one of the things that we found out, especially 
people from lower socioeconomic status and older adults who are 
on fixed income, is that when you tackle all the logistical 
barriers and get them to a point of vaccination, when they show 
up and they find out all of a sudden that they have to pay a 
copay, there is a--there is already data that shows that they 
do what we call abandoning the prescription. They basically 
turn around and walk away without getting that lifesaving 
vaccine.
    And it is a surprise to them, if you are going in thinking 
the vaccine is free because you are hearing from your child, 
for example, right, that--who is under a commercial private 
plan, that, ``Hey, I got my flu vaccine for free, Mom. You need 
to go get in and get vaccinated,'' and they go in and, you 
know--or for shingles, for example, and then they find out, you 
know, I can't get vaccinated without a copay, they are going to 
be very surprised and walk away. And that is a major challenge.
    I think it is important also to recognize that providers 
are important reasons why adults get vaccinated. And a lot of 
providers have uncertainty with the Part D copays, especially 
as to what is going to be there for their patients, and as a 
result they hesitate to recommend vaccines as strongly, because 
they don't want to succumb their patients to a copay.
    Thank you very much.
    Mr. Pallone. Thank you.
    Thank you, Madam Chairwoman.
    Ms. Eshoo. The gentleman yields back, and now anyone that 
understands Latin, mea culpa, mea culpa, mea maxima culpa. I 
made a mistake. Mr. Guthrie, our ranking member, was to be 
next, and I blew it.
    So all of my apologies to you, Mr. Guthrie. You have 5 
minutes for your questions.
    Mr. Guthrie. Thanks, Madam Chair. I knew it was an 
oversight. And if we were sitting next to each other, we could 
have elbowed each other and said, ``Hey, it is time to''--so, 
hopefully, we will be back together soon.
    So, thanks to Operation Warp Speed and the successful 
development and deployment of 3 safe and effective COVID-19 
vaccines, millions of American adults, adolescents, and 
recently children age 12 years old and older are being 
vaccinated every day. These vaccinations are key to combating 
the COVID-19 pandemic.
    Yet we still have many not getting vaccinated. CMS released 
data last week breaking down vaccination rates among staff in 
nursing homes by State. States range from 78 percent vaccinated 
to 39.9 percent vaccinated. I was alarmed to see Kentucky only 
had 44 percent of staff vaccinated.
    And we talked about logistics in getting people all the 
various vaccines. When you consider vaccines are free and 
retail pharmacies went to nursing homes and offered staff and 
residents vaccination through their partnership with the 
Federal Government, the challenge for Americans to obtain a 
COVID-19 vaccine isn't about affordability or an individual's 
health insurance coverage. Instead of tossing more money of the 
billions of dollars we have already allocated for vaccine 
distribution, testing, and pandemic mitigation programs, among 
others--need to evaluate how we get more individuals 
vaccinated.
    So, Ms. Coyle, the nationwide average for vaccinated 
nursing home staff is only 60 percent. I would hope these 
individuals can see the value of vaccines, considering they 
work with the most vulnerable population. How can Congress 
better leverage Immunization Information Systems to address 
vaccination gaps and reach more people?
    [Pause.]
    Mr. Guthrie. Ms. Coyle?
    Ms. Eshoo. I think IT is working with her, Mr. Guthrie.
    Mr. Guthrie. OK, well, let me switch to my next question, 
then----
    Ms. Eshoo. But we have lost her, and that is unfortunate. 
But why don't you go on with your----
    Mr. Guthrie. OK----
    Ms. Eshoo [continuing]. Questions, and perhaps we will get 
her back.
    Mr. Guthrie. OK, good.
    So, Ms. Arthur, maybe you might want to speak to that, but 
my real question that I had for you was, can you please speak 
to vaccine innovation that is on the horizon?
    And I know there are many interested in the flu/COVID 
vaccine shot. Do you see this possible in coming years, where 
there will be universal flu along with the COVID shot?
    And then how would any policy, such as maybe H.R. 3, affect 
that innovation?
    Ms. Arthur. Thank you very much, Congressman, for the 
question. So definitely, we are excited by the pipeline of 
vaccines that could be coming in the future. You have mentioned 
companies that are working on combining COVID with influenza, 
given the potential seasonality, companies that are working on 
universal flu vaccines so we may not have to get a vaccine for 
flu every single year. And of course, the technologies used for 
the COVID vaccines could be used for multiple unmet medical 
needs in the future.
    I think--I am an expert in vaccines and not so much in 
reimbursement, but I do think it is extremely important to note 
that we always worry about policies that disincentivize private 
and public-sector investment in new technologies and new 
medicines. And so there are some concerns that some policies 
put forward could actually make companies think of investing 
not so much in infectious diseases. It is extremely important 
for us to have incentives for industry to continue to invest in 
solving these unmet medical need problems.
    H.R. 3 could actually have companies decide that they don't 
want to invest in things that are as complicated and, as I 
think Chairwoman Eshoo said, not as much a return on investment 
as vaccines. And this could mean that we don't have some of the 
novel vaccines that are in the pipeline or actually leverage 
this technology for new unmet medical needs in the future.
    Thank you for the question.
    Mr. Guthrie. OK, thank you. And my remaining question is 
for Ms. Coyle, so I will submit those for the record.
    So thank you, and I will yield back.
    Ms. Eshoo. The gentleman yields back.
    And again, my apologies to you.
    The Chair is pleased to recognize the ranking member of the 
full committee, Mrs. McMorris Rodgers.
    Mrs. Rodgers. Thank you, Madam Chair, and thank you to all 
our witnesses for joining us today.
    I wanted to start with a question for Ms. Arthur and ask 
what we, as Members of Congress, can do to make sure that 
America remains the leader when it comes to vaccine innovation 
and if there's any ways that we can improve the regulatory 
process.
    Ms. Arthur. So thank you so much for the question. In 
actuality, a lot of the great things that happened during COVID 
were--happened because of the collaboration of sponsors, 
Operation Warp Speed, and the regulatory agencies. They really 
worked very hard to work with sponsors of drugs to shorten the 
timelines for doing some of the key things we needed to do for 
research for the vaccines, the treatments, and the diagnostics, 
while still maintaining that high-caliber standard of efficacy, 
safety, and manufacturing quality.
    And so many of those things actually could remain. And I 
think, as we work through the next steps of pandemic 
preparedness, we should be thinking about incorporating some of 
those regulatory advantages: decentralized clinical trials, use 
of telehealth in our trials, master protocols for therapeutics. 
These kinds of activities could help us go faster the next time 
but also could help us shorten development.
    A second part of your question that is very important is 
actually that we need to continue to support these great 
platforms we developed in the United States and make sure the 
incentives are there to really get the full maximum benefit out 
of the investment we made. There is quite a bit of great 
technology we have developed in partnership with the U.S. 
Government and with industry, and we need to make sure we 
maintain that in the United States and actually offer it from 
the U.S. to the world. It is an American strength, to say the 
least.
    Mrs. Rodgers. Thank you. As a followup, would you speak to 
the challenges that manufacturers face when they are 
researching and developing innovative vaccines to treat either 
existing or emerging infectious diseases?
    Ms. Arthur. Absolutely. Companies actually approach their 
vaccine programs from a global perspective. And so they want to 
make sure that they have thought about how they are going to 
manufacture for the world, what is their strategy for where 
they place their manufacturing sites, how are they going to 
make sure they have the broadest clinical trials, how are they 
going to make sure that they have all the data needed for 
regulators, both in the United States, in Europe, and around 
the world?
    We work a great deal with those countries, those companies 
and organizations that serve low- and middle-income countries. 
So how do we make sure we are working with big--WHO and others? 
It is a global strategy that companies need to undertake, and 
they make sure that they are investing in the safety worldwide, 
the manufacturing scale-up worldwide, and that they are able to 
bring that product to as many people as possible through their 
partnerships with other organizations, other manufacturers, and 
nongovernmental organizations.
    It is quite a complicated process, because you are 
vaccinating healthy people everywhere that you go.
    Mrs. Rodgers. Right. Are there any innovative technologies 
in the pipeline that you are especially excited about? And 
would you just take a minute to describe the potential that 
they have to transform healthcare in the United States as well 
as around the world?
    Ms. Arthur. Absolutely. So very excited about what we might 
accomplish with the platforms being used for COVID. I think we 
are going to see these platforms become the springboard for a 
lot more innovation, in terms of conquering some diseases we 
had not been able to conquer scientifically in the past. So you 
are going to go for cytomegalovirus, better flu vaccines, 
malaria, and other diseases that travel or endemic in--here and 
in other places.
    And then I think you are going to see innovations around 
new platforms that might oral, you are going to see innovations 
in using monoclonal antibodies as preventions for diseases. 
This is another opportunity to actually leverage new technology 
we developed during the pandemic, and use it to actually more 
quickly get immunity and protection for more people, and could 
be a very good strategy, coupled with regular vaccination. So 
there is quite a bit of exciting vaccine and immunization 
technology on the horizon.
    Mrs. Rodgers. That is great. Well, thanks for being with us 
today. I really appreciate hearing your insights.
    I will yield back, Madam Chair.
    Ms. Eshoo. The gentlewoman yields back.
    I just want to add something, and that is that vaccines are 
not profitable, for the most part. It was the Federal 
Government that put the billions and billions of dollars into 
this, and we have seen the success. And now that--those 
successes, I believe--and I think everyone on the subcommittee 
would like to see built upon. So--but it was the Federal 
Government's investment that guaranteed that to the companies, 
guaranteed a market.
    So where do we go? All right.
    Now the next on deck is the bridegroom, the gentleman from 
North Carolina, with all of our congratulations to you, Mr. 
Butterfield. We are thrilled. And it was a beautiful wedding. I 
couldn't wait to tune in, and we are all thrilled for you. So 
you have 5 minutes for your questions.
    Mr. Butterfield. Thank you. Thank you very much, Madam 
Chair. Thank you for your friendship, and thank you for joining 
Sylvia and I on our very special day. The day was May 31st, and 
it was one of the best days of my life. Thank you so very much, 
and thank you for convening this very important hearing.
    And thank you to the witnesses for your testimony today. 
All of you are experts, by any definition.
    Let me just, before I get started, let me join my 
Republican friends in hoping that we can very soon resume in-
person hearings. There is no substitute for an in-person 
hearing when it is possible. My Election Subcommittee that I 
chair will be experimenting with in-person hearings very soon.
    But, you know, it would be very, very helpful if all 
Members would publicly disclose whether they have been 
vaccinated. That is the fly in the ointment, if you will. We 
need to know who has and has not been vaccinated.
    I saw on television this morning that eight States--eight 
States--are reporting that infections are actually rising.
    But, having said that, first question to our witnesses--
witness, Dr. Maldonado--I cannot pronounce it properly, please 
excuse me.
    But, Doctor, routine childhood immunizations are important 
tools to keep children safe and healthy. We heard during 
today's testimony that the pediatric vaccines given through the 
Vaccines for Children program will prevent over 400 million 
illnesses, over 900,000 deaths. The benefit is absolutely 
clear. That is why I am proud to colead H.R. 2347, the 
Strengthening the Vaccines for Children Act of 2021, along with 
my colleagues Dr. Schrier, Dr. Joyce, and Mr. McKinley. This 
bill will make improvements to the program to ensure that 
physicians can afford to participate in the program and 
children can continue to have access to lifesaving 
vaccinations.
    And so, Doctor, in your testimony you said that the 
program, the VFC program, has increased vaccination rates 
across all ethnicities and has reduced racial health 
disparities among children--are down by more than 11.5 million 
doses, compared to last year.
    What can we expect to see regarding vaccination rates among 
different racial groups? Help us with this.
    Dr. Maldonado. Yes, it is a major concern. What we have 
seen since the pandemic began is a reduction, overall, of 27 
percent of--among visits to pediatricians for well child care. 
And a lot of that was, understandably, due to fear of going 
out. Part of it was lock-down. Part of it was practices that 
couldn't handle dealing with multiple sick visits plus well 
child visits.
    So what we have been doing at the American Academy of 
Pediatrics is providing resources. I serve on a number of 
guidance committees for masking, for distancing, for return to 
school. We were one of the first to advocate for returning to 
school last June, in a safe manner, providing guidance to 
pediatricians to make sure that they understood how to bring 
children back, not only to school but to their practices. And 
we are pushing that information out to all of our 67,000 
members as well as to federally qualified health centers and 
others around the country so that they can actually encourage 
children to come back.
    We are trying to get children to be visited in whatever 
their medical home is, and we believe in the value of their 
medical home. It is what gets the children through their 
formative years. So----
    Mr. Butterfield. Our children--you work with children every 
day, and, you know, children are precious. Can you explain why 
it is so important that we catch children up on the vaccines 
that they have missed during the pandemic, and how contagious 
are diseases like measles and mumps, compared to COVID?
    Dr. Maldonado. Measles is almost 10 times more infectious 
than COVID-19. It has a very different mechanism of 
transmission. Very few diseases are as infectious as measles, 
chickenpox, and tuberculosis. And we, fortunately, have 
suppressed most of those infections. But we run the risk, if we 
don't get our children back up to par on vaccinations for those 
diseases, to having measles outbreaks again in the U.S., mumps 
outbreaks, which can lead to--that can lead to sterility, for 
sure, and other----
    Mr. Butterfield. My last question, I am going to ask you to 
give it to me in writing, if you will. Insufficient payment 
rates for vaccine administration have contributed to a decrease 
in participation in the VFC program. This decrease has 
coincided with an increase in Medicaid enrollment.
    How will the incentives in H.R. 2347 work to ensure that 
physicians continue to participate in the program and children 
are able to access the vaccines that they need?
    I would ask that you give me that response in writing.
    Thank you, Madam Chair. I yield back.
    Ms. Eshoo. The gentleman yields back.
    Actually, Mr. Upton is next, but he is not immediately 
available.
    So we will go to Dr. Burgess of Texas for your 5 minutes of 
questions.
    Mr. Burgess. I thank the Chair, and I thank the witnesses 
for being here this morning. This is an important topic.
    Madam Chair, I do have an opening statement that I will 
submit, ask that it be made part of the record.
    Dr. Maldonado, you have a difficult task, with the advent 
of the--now vaccinating the pediatric population for the 
coronavirus, and I think you have written some about this. 
There are some concerns about perhaps some side effects that 
have emerged, and let me just hasten to say I wasn't entirely 
convinced that the pause on the J&J vaccine was the correct 
response.
    [The prepared statement of Mr. Burgess appears at the 
conclusion of the hearing.]
    I understood how it was important that the FDA and the CDC 
show that they were serious about evaluating any potential 
complications, but we have seen just the data since the J&J 
pause, the actual vaccine rate nationally, seems to have 
declined. And whether that is just because we reached that 
point where so many people had already been vaccinated that now 
it is just getting harder--the last mile of the vaccination 
line is the hardest one to reach.
    But now also, in the pediatric literature, there is 
surfacing the question about some potential for some side 
effects. And let me just stipulate this is a difficult problem. 
With a therapeutic, someone who is sick and they need help and 
you administer a therapeutic, and you accept a certain risk of 
side effects. With a vaccine, though, it is entirely different. 
You are giving it to a person who is not ill. And then, of 
course, any side effects or any untoward effects will be 
magnified.
    But could you speak a little bit to that? I know the CDC 
convened an emergency meeting. Can you give us any update as to 
where things are with the vaccine for the younger-age 
population?
    Dr. Maldonado. Yes. So, very briefly, there are vaccines 
that were--we are vaccinating today and the rest of this week 
with some of the vaccine trials in the children in 5 to 11, and 
we will proceed with children under 5, as well, soon.
    So the--as I mentioned in my initial opening statements--
and thank you for the question--we know that COVID-19 is 
critically important to prevent in children. We know that it is 
not as serious as it appears to be in adults, but currently it 
is still the 10th highest cause of death in children in the 
United States. And that is because children are not supposed to 
die. So when you see 300 to 600 children die, with 16,000 
hospitalizations, it is a serious disease in children. It is 
2\1/2\ to 3 times more likely to kill children than the flu.
    And so we do recognize that vaccines need to have the 
highest standards for safety. And at this point, the CDC will 
give us more data this Friday at an ACIP meeting. And the FDA 
convened a 7-hour meeting last week around the safety of the 
vaccines in children.
    So in summary, there is a concern that there might be a 
link to cardiac inflammation. But so far, that link, if it 
exists, is extremely rare. And the children that have been 
followed so far have recovered from that illness. So we will 
find out more on Friday. And we have been clear at the American 
Academy to make those data as transparent as possible to all 
pediatricians and all families, to make sure they can calculate 
the risks and the benefits that they think are involved in 
getting their children vaccinated against COVID-19. Thank you 
for that----
    Mr. Burgess. Yes, well, to be sure, it is something that 
is--I mean, it is hard to get everything right, but this is one 
that just simply doesn't allow any margin for error.
    Ms. Arthur--Dr. Arthur, if I may ask you just a brief 
question on some of the issues surrounding the pause in the 
patents that the administration has proposed. How do you see 
that as impacting investment in new and innovative vaccines?
    Ms. Arthur. Thank you very much, Dr. Burgess, for the 
question.
    In actuality, we at BIO are very concerned about this 
particular policy around intellectual property. We think that--
we definitely share the same goal as the administration, in the 
sense of getting more vaccines to more people worldwide. This 
is everyone's mission, everyone's mission. And companies are 
extremely committed to this. They are ramping up production 
right now worldwide. And we are on track to, through the 250 
partnerships that companies have engaged in worldwide, deliver 
about 11 billion doses--that is with a B, billion doses--this 
year, and many of those going through COVAX and also to the 
African Union and PAHO.
    So we think that, in essence, this particular policy is not 
the answer to the question. Intellectual property is not what 
is blocking us from getting more doses to more people 
worldwide. We are very concerned this could disincentivize 
pandemic response in the future.
    Mr. Burgess. Right, and the public-private partnerships 
have been so critical. And it is not three vaccines. We always 
forget about AstraZeneca, and now Novavax has come on the 
scene, not to mention the Soviets and the Chinese--I mean, the 
Russian and Chinese vaccines that were also produced. So it 
really is phenomenal, with a year's time, to see this many 
agents.
    But I thank you for your testimony today. I have other 
questions. I will follow up with questions for the record.
    And thank you, and I yield back.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize the gentlewoman from California, Ms. Matsui.
    You have 5 minutes for your questions, it is great to see 
you.
    Ms. Matsui. It is great to see you, too, and thank you very 
much, Madam Chair, for having this very, very important 
hearing. And I want to thank the witnesses for being here 
today. You know, this question is for Dr. Tan.
    Our healthcare workers have been true heroes during the 
pandemic. However, I have been troubled by the fact that a 
large number of nursing home staff have not been vaccinated 
against COVID-19 despite the devastating impact the virus has 
had on seniors living in nursing homes and long-term care 
facilities. And a lot of these healthcare workers have seen the 
consequences if--when the vaccine was not available.
    In March the Centers for Disease Control and Prevention 
reported that over 80 percent of nursing home residents had 
received at least 1 dose of the vaccine, but only half of the 
facility had even been partially vaccinated. And Dr. Tan, just 
briefly discuss the reasons behind this trend, because I have 
other questions for you.
    Dr. Tan. Thank you for the opportunity. Absolutely. I 
think, you know, we have done some work in nursing homes, and a 
lot of it has to do with outreach and education of the nursing 
homes--nursing aides. The predominant number of unvaccinated 
folks resides in that nursing aide population. And we need to 
help them understand why is it that, not just do we want to 
vaccinate the patient, we also need to vaccinate them to cocoon 
the patient, so that they don't spread infection to that one 
patient that might not have taken the vaccine well.
    I think sometimes they feel, ``Oh, my patient is 
vaccinated, therefore I can decline.'' And part of that 
declination comes from a hesitancy that results from 
misinformation that they might have heard from friends, family 
about the potential or alleged side effects of a vaccine.
    Ms. Matsui. Well, this immunization of the healthcare 
workforce is important. Do we see similar trends in other 
vaccine-preventable diseases, such as flu and pneumonia?
    Dr. Tan. Yes, absolutely. So we have done a study, 
actually, in nursing homes, and a lot of the challenges of 
influenza vaccination of nursing aides is actually turnover. 
And that also partly turns--plays into this idea of education 
and outreach, as well. Nursing homes turn--aides turn over very 
rapidly.
    And so, with influenza, for example, having to make sure 
that they get vaccinated when they first start the flu season. 
By the time the season is in full swing, many of those nursing 
aides have already turned over and moved on to other 
facilities. And so--basically, make--tracking is really, really 
difficult. So there are logistic problems with that.
    Ms. Matsui. OK, certainly the legislation we are discussing 
today, the Vaccine Information for Nursing Facility Operators, 
would really require healthcare workers are educated on the 
benefits of ACIP-recommended vaccines.
    Dr. Tan. Yes, absolutely----
    Ms. Matsui. Thank you, Dr. Tan. And I have a question--is 
Dr. Coyle here?
    I can see you now, I can see you on the screen now, great. 
I wanted to ask you, following up on your testimony, that you 
mentioned that 96 percent of children and 82 percent of 
adolescents had records in Immunization Information Systems. 
But only 60 percent of adults have an immunization record in 
these systems.
    Can you explain why there is such a significant dropoff 
among adults? And how can we improve these systems so 
healthcare providers can have ready access to these 
immunization records for their adult patients?
    Ms. Coyle. That is a very great question, and thank you for 
that.
    I think it is important to note that the history of IIS 
really started with the pediatric population. And so these 
systems are really designed to get kids in, because they were 
the ones receiving the bulk of the immunizations. As the 
platforms have been built out for an adolescent vaccine 
platform and now more vaccines are administered to adults, we 
are just slowly seeing that growth within those populations.
    I should also note that those statistics that I gave you, 
that is all pre-COVID. So we don't actually know what it is 
going to look like, you know, post-COVID. But my assumption is 
those adult captures are going to be significantly higher.
    Ms. Matsui. OK, well, I really believe it is something we 
have to do, because I know, when you are growing up and you 
are--you know, you get a vaccine all the time, and your parents 
keep track of that so closely. But once it is an adult, we just 
kind of get our shots whenever we feel we need them.
    I also want--so thank you for touching on the importance of 
interoperability in your testimony. Can you expand on how--use 
financial incentives to play a role in helping to establish 
provider interfaces with IIS?
    Ms. Coyle. Certainly. Thank you for the question. So, back 
when interoperability was first being established between 
electronic health records systems, which are the systems that 
are employed by a lot of physicians and healthcare systems, the 
idea of connecting to a registry was sort of that Holy Grail. 
Like, this is a great idea, let's do this. But it was really 
difficult to try and get providers to invest the time and 
energy and resources to make that connection.
    Meaningful use did a lot to really enhance those 
connections, and we saw a tremendous number of systems being 
able to connect. So pre-COVID we had about 117,000 live 
connections with systems and IIS. So it is a very broad network 
that has really been leveraged during this pandemic.
    Ms. Matsui. Well, thank you very much. And we certainly 
have a responsibility here to help our public health 
surveillance systems modernize. And I appreciate the committee 
prioritizing this work.
    Thank you, and I yield back.
    Ms. Eshoo. The gentlewoman yields back. It is a pleasure to 
recognize the gentleman from Michigan, the former chairman of 
the full Committee of Energy and Commerce.
    Mr. Upton, you have 5 minutes for your questions.
    Mr. Upton. Well, thank you, Madam Chair. Sorry, I am in and 
out. We have got a lot of different activities, but obviously 
this is a very important hearing, and I am very pleased, 
actually, to see legislation that I am leading with 
Representative Doggett on the list. The Vaccine Injury 
Compensation Modernization Act is on the list of bills that we 
are discussing today.
    This bill provides updates for the Vaccine Injury 
Compensation Program, which, frankly, hasn't been substantially 
updated since its creation in the 1980s. It provides much-
needed modernization to address case backlogs, inappropriately 
low damages involving vaccine market. Obviously, it is time--we 
experienced this last year. I look forward to the committee 
moving the bill to the House floor soon.
    I guess my first question for--is for Ms. Arthur. The 21st 
Century Cures Act, which every one of us voted for, was 
introduced by DeGette and myself. We really wanted to solve 
healthcare problems and expedite the approval of drugs and 
licensing--we do, in fact, have a better understanding of 
reforms that still need to be embraced--patients need.
    We understand better today than what we did back in 2019 
the importance of vaccines to prevent illnesses from diseases. 
And we know that some segments of our patient population is--
difficult, the majority of patients do not. That is why 
Representative DeGette and myself will be putting out our 
latest discussion draft in the next few days. It is going to 
help support vaccine access and coverage--improve coverage for 
new cures, modernize our healthcare programs, and improve 
development and better medicine.
    As we have witnessed recently, vaccines are preventative 
measures and also medical responses. Global health [audio 
malfunction].
    So as we consider reform to our healthcare system, I am 
interested in the ways to improve vaccine access. Part of that 
puzzle is, how do we encourage manufacturers to develop the 
drugs and vaccines needed to prevent the next global pandemic?
    What recommendations might you suggest as we tackle the 
issue of improving vaccine access and use in the future?
    Ms. Arthur. Thank you so much, Mr. Upton. And, actually, 
thank you so much for the work that you and Congresswoman 
DeGette did on Cures. Many of the provisions there helped to 
stimulate vaccine investment. And so it is extremely important, 
and we look forward to working with everyone on Cures 2.0 when 
that happens.
    So I think that access is extremely important to all of us 
in the vaccine community. The best success of vaccines is when 
everyone gets them. It is a very unique medical intervention, 
in the sense that my getting vaccinated protects you and me, 
and that is what makes them such a special part of the medical 
and public health infrastructure.
    So I think that what we would like to do is, therefore, 
support the legislation, any of the legislation that are being 
discussed today, because they are meant to remove some of those 
barriers like financial barriers, access barriers that keep 
people from getting the vaccines when they are standing there 
in front of a learned intermediary, a healthcare professional 
who is telling them about the value.
    I think, in addition, we need to do education and 
springboard from what we have learned from COVID all the 
education we have done in the last year about vaccines, using 
the trusted messengers that have been out there, talking about 
COVID in our communities, and have them explain to people why 
they need to get the other vaccines that are already 
recommended for their health.
    Doing these things actually makes the vaccine space an 
extremely important area of investment for vaccine companies. 
These things go hand in glove. So we support access, because we 
want everyone to be able to get the vaccines that are 
recommended for them by the process. And that brings more 
vaccines to people, as they understand the value.
    Mr. Upton. Ms. Coyle--and I will be quick in my question--
so Michigan, we rank 23rd out of 50 in terms of the percentage 
of the eligible population getting vaccinated. I represent 6 
counties, and there are a number of counties in my district 
that are under 40 percent vaccinated. These numbers are 
surprising from a State that--you know, the several of the 
devastating waves of deaths and hospitalizations, we were 
number 1 for a number of weeks. Vaccine hesitancy remains a 
huge part of the problem.
    Can you talk about how this vaccine injury compensation 
program can be used as a tool to help us to get to a better 
percentage?
    Ms. Coyle. So I think the question was directed at me. 
However, I am not going to be your best witness to talk about 
the Vaccine Injury Compensation Act.
    Ms. Arthur. But I can just say to your point, Congressman, 
that I think having a vaccine injury compensation program that 
is robust, that is clear to patients, that actually quickly 
takes them through the injury compensation process, is 
extremely important to reinforcing our very strong safety 
system in the United States. And it is a part of how we help 
people understand that, although injuries are rare from 
vaccines, there is a system in place to make sure they are 
compensated should something arise.
    Mr. Upton. Thank you. I yield back. Thank you, Madam Chair.
    Ms. Eshoo. Yes, the gentleman's time has expired.
    It is a pleasure to recognize the gentlewoman from Florida, 
Ms. Castor, for your 5 minutes of questions.
    Ms. Castor. Well, thank you, Madam Chair, and thank you to 
our expert panel for being with us today. I am so appreciative 
that you have included my bipartisan bill with Congresswoman 
Schrier, the Prevent HPV Cancers Act.
    Colleagues, if the NIH's Dr. Francis Collins called a press 
conference today to announce that a cure for cancer had been 
found after the years of funding research, it would be cause 
for celebration. Well, you know, since 2006, there has been a 
safe and effective vaccine that prevents cancer. It is pretty 
remarkable. It has saved lives. The human papillomavirus causes 
six types of cancer, including cervical cancer and head and 
neck cancer.
    And by the way, the rates of head and neck cancer in men 
over the past two decades have increased fivefold. So we have 
special work to do there. And, unlike cervical cancer, there is 
no test for head and neck cancer.
    The--what has been very concerning is, with all of these 
vaccinations, is during COVID we have had a very dramatic 
dropoff. And before the pandemic the HPV vaccination rates were 
lower than most other childhood vaccines, especially for 
adolescents in rural areas, and in boys.
    But now, with the COVID effect, the childhood vaccination 
rates, especially for HPV, are way down. HPV doses fell by 
almost 64 percent for kids ages 9 to 12 and 71 percent for 
young people 13 to 17, compared to the last 2 years. So last 
year alone, more than 1 million doses were missed.
    Our bill takes four necessary steps to raise awareness 
about HPV cancers and the vaccine that can help prevent them. 
It creates a national public awareness campaign at CDC, it 
increases help to the NCI to expand and coordinate research, it 
gives States additional resources and an additional focus on 
early detection. This is about saving lives.
    So for Dr. Maldonado and Dr. Tan--first, maybe, for Dr. 
Maldonado: AAP has been doing great work over the years on your 
efforts to increase HPV vaccination rates. How do you think 
the--a targeted new effort would benefit families across the 
country?
    Dr. Maldonado. Well, I can tell you the first thing that we 
have been pushing very strongly to do at the AAP is to 
reinforce to families that the vaccine can be given at 9 years 
of age. The current ACIP recommendation is 11 to 12, with as 
young as 9.
    We think--and there are data now that support--that giving 
vaccines at 9 years of age, before children enter adolescence, 
actually--it strengthens the immunization rates, because the 
children are easier to access at that age. So that is a simple 
thing that can be done. It is already approved at that age 
group. And if we could just reinforce getting them vaccinated 
younger, it is easier for them to come back for their second 
dose.
    And the AAP has been putting--it supports the bill, 
overall. There are some issues around the NIH provisions. We 
tend to favor more broad, nonrestricted research opportunities 
for NIH to distribute the funds how they see fit.
    But in addition, we actually have put together resources, 
HPV tool kits for families and for providers. And I do think 
that the biggest challenge is getting those adolescents back. 
So moving the vaccination back to the age where it is already 
approved at 9 years would improve, right off the bat, 
immunization rates.
    Ms. Castor. Dr. Tan?
    Dr. Tan. Yes, I think I am just going to follow up and say 
that we shouldn't forget also the older adolescents that have, 
obviously, had a huge decline in immunization coverage rates 
for HPV vaccine, and they aren't recovering as fast as the 
pediatric population. So we want to make sure that, as part of 
this education, we help bring them back in, as well, for their 
catchup, so that they can complete the HPV vaccination series.
    And then also to remind us, speaking for the adult 
population, again, you know, there is a shared clinical 
decision-making recommendation from ACIP regarding HPV 
vaccination for women--sorry, for adults 19 through the age of 
45. So 26 through the age of 45. My apologies. So I just don't 
want to leave them out, as well.
    Ms. Castor. And--but thank you very much.
    Ms. Coyle, I am sorry I don't have time for your input, but 
thank you so much. You have been very helpful as we did broad 
outreach in building the provisions in this bill. So I will ask 
you to respond for the record.
    Thank you so much. I yield back.
    Ms. Eshoo. The gentlewoman yields back.
    I hope the witnesses will tell us--feel very comfortable in 
telling us what you think we are missing.
    I mean, we have 12 bills. Half of them are bipartisan. And 
I am listening very hard to each one of you and trying to 
figure out if--what you are pointing out, if we have actually 
covered the bases. If we haven't, please say so, because we 
need your expertise.
    Now to the gentleman--and he is a gentleman--from Virginia, 
Mr. Griffith, for your 5 minutes of questions.
    Mr. Griffith. Thank you very much. You are very kind, Madam 
Chair.
    Ms. Arthur, it is my understanding that vaccine developers 
have received emergency use authorization, but when they 
receive that they are not free to communicate information about 
their vaccine, because the vaccine doesn't have an FDA-approved 
label. Is that true?
    Ms. Arthur. So, yes. Under an EUA, companies that have that 
authorization cannot directly talk to healthcare providers.
    Mr. Griffith. And so what--you mentioned healthcare 
providers. What entities are prohibited from receiving 
information about vaccines that do not have the FDA-approved 
labeling, in addition to healthcare providers that you just 
mentioned?
    Ms. Arthur. So, by and large, companies focus their direct 
energies on information to healthcare providers: pharmacists, 
nurses, doctors. So that is the primary audience they would 
probably want--they would mostly share information with, and 
those providers would share information with the general 
public.
    Mr. Griffith. And so----
    Ms. Arthur. Companies also do talk to insurance companies 
and State health departments, as well.
    Mr. Griffith. I know it has gotten a lot of attention, but 
how might these entities use that information about vaccines?
    And if we see a problem developing in the future that 
maybe--not shuts the whole country down, do you think it would 
be helpful if companies were able to share that information 
with----
    Ms. Arthur. I do.
    Mr. Griffith [continuing]. Healthcare providers?
    Ms. Arthur. I think that it is extremely important, because 
companies should have a way to--with the approval of the FDA, 
and with the shared messaging, following the guidelines of 
their authorization--to be able to actually speak to healthcare 
providers so that healthcare providers have the latest possible 
data.
    Healthcare providers are extremely busy, and they can't 
necessarily keep up with all the information that is happening 
every day. We are all trying to do that. So certainly, as we go 
into this next phase of the pandemic, where we are going to 
have updates on--by age, we are going to have updates on the 
performance of the vaccine for variants, healthcare providers 
probably have quite a number of questions they are getting from 
their patients and from mothers and fathers. And this would 
certainly help them more quickly answer those questions, if 
they could have a systematic interaction with the companies on 
the approved information.
    Mr. Griffith. Well, and as a parent of children who are in 
that 13 to 16 age bracket, I might want to know, OK, ask my 
healthcare providers, ``Which vaccine do you think is better 
for my child, with his background''--they are both boys--``with 
his background?''
    And so, in answer to the question that the chairwoman 
asked, ``What are we missing?,'' I have recently introduced a 
bill, H.R. 3705, that would allow vaccine sponsors who have 
received an EUA to communicate information about the vaccine to 
certain entities without fear of violating the law. And, based 
on what you have said, I think you would think that something 
along those lines would be helpful for the--both the producers 
of the vaccines, the developers, but also for the healthcare 
providers and then those of us who rely on our healthcare 
providers to give us the information. Am I reading that 
correctly?
    Ms. Arthur. Yes, sir. You are.
    Mr. Griffith. All right. I appreciate that. I am going to 
switch over. Thank you so much for your testimony. I am going 
to switch over to Dr. Maldonado, briefly.
    And I am changing gears on you just a little bit, but in 
talking with Mr. Butterfield, you mentioned tuberculosis. I 
have been looking at phage therapy, and I don't know--because 
that is a bacterial infection, I don't know, do we have a 
vaccine, or is there a vaccine in the works for tuberculosis?
    Dr. Maldonado. Oh, we have been working on vaccines for 
tuberculosis for 30-plus years. There are some recent updates. 
There has been a vaccine in the last 5 years that seems to do a 
reasonable job. That is, it is about 30 percent effective. But 
we really haven't advanced as well.
    Tuberculosis is a very complicated disease. It is a 
bacterial infection, and we don't really understand very well 
how it grows. And so I--we are urging additional resources to 
understand, first of all, how the bacteria itself causes latent 
or silent infection, because that is the key. It somehow 
manages to slow down and then pop up at unexpected times. And 
that has been very difficult for vaccination.
    But there are a number of breakthroughs that we hope will 
be coming through with innovative new technologies at this 
point. But certainly one in three people in the world is 
infected, and clearly a very important target for research. 
Thank you for bringing that up.
    Mr. Griffith. Yes, absolutely. And as we deal with it, it 
is something I have been interested in, because I read a 
marvelous book on--I think it was--but on phage therapy, which 
deals with bacterial infections, not TB particularly, but 
bacterial infections that are now resistant or immune to our 
current antibodies, and I think that is something this 
committee and the O&I Committee should look at.
    I yield back, Madam Chair, thank you.
    Ms. Eshoo. The gentleman yields back. The Chair is pleased 
to recognize the gentleman from Maryland, Mr. Sarbanes, a name 
that is revered in the State of Maryland. You are recognized 
for 5 minutes for your questions.
    Mr. Sarbanes. No more so than the name Eshoo is revered in 
the State of California, Madam Chair.
    In any event, thank you for holding a hearing today. It is 
very, very important.
    During this pandemic, we have all witnessed the power of 
timely, effective healthcare, and particularly the power of 
vaccinations. As we continue to come out of the pandemic, we 
must make sure that we are building on the lessons that we 
learn and investing in reforms, from healthcare workforce 
reforms to increased investment and preparedness that can help 
bolster the healthcare infrastructure and make sure that 
healthcare is available and accessible to everybody in our 
communities.
    On access to healthcare, particularly preventive 
healthcare, it is especially important for our children. That 
is why I am a very strong supporter of school-based health 
centers. SBHCs provide high-quality, comprehensive healthcare 
services to primarily low-income children and adolescents 
across the Nation.
    During the COVID-19 pandemic, many SBHCs have been using 
telehealth to provide key healthcare services to their student 
populations. As children return to school, these school-based 
health centers will play a critical role, along with many other 
providers, in making sure that children can access the 
important health and mental health services that they need.
    One of those key services, of course, is vaccinations. Last 
fall, data from the Centers for Medicare and Medicaid Services 
showed that rates of vaccinations, primary and preventive 
healthcare, had declined for children in Medicaid and CHIP 
during the pandemic. In other words, across the board. Today's 
hearing is so important so we can examine the ways that 
Congress can act to make vaccinations and other key services 
even more affordable and accessible.
    Dr. Maldonado, I would like to ask you a few questions on 
this. Your expertise as a pediatrician is critical to our 
discussion. Pediatricians, obviously, are a very trusted voice 
for parents when explaining the importance, safety, and 
effectiveness of vaccines and play a central role in getting 
children vaccinated.
    The Vaccines for Children program, which you have talked 
about, is perhaps the most critical tool we can use to bring 
childhood vaccinations back on track, especially for very 
vulnerable communities. In your testimony you discussed some of 
the financial and administrative barriers to improving the 
vaccine delivery system for children. I would like to elaborate 
on this and discuss how the legislation we are considering will 
enhance the pediatric workforce and vaccine landscape.
    Compared to other physician specialties, what challenges do 
pediatricians face in recruiting a sustainable workforce to 
meet the needs of children in communities throughout the 
country?
    Dr. Maldonado. Well, thank you very much for that question.
    Pediatricians, if you look at the compensation scale--and I 
know we all think that physicians are highly paid individuals--
but pediatric providers are at the very low end of compensation 
among physicians. They frequently serve underinsured and 
uninsured populations, and frequently the vaccine components of 
their practice, which is a major component in addition to other 
well-care services, is highly undercompensated, and has been 
for a long time. And that is why we were really excited to see 
that the VFC bill proposal would actually help to provide some 
parity.
    So what happens with pediatricians is they have to give 
multiple component vaccines, and that is good for children 
because they can get multiple vaccinations in one shot. But 
they spend a lot of time explaining, rightly so, vaccines to 
children and to their families. And they are not compensated 
for that time that they spend in the office. So this bill would 
actually help provide some parity to pediatricians who are 
spending that amount of time building that trusted 
relationship, so that they could get some compensation for the 
time that they are spending.
    They would also be able to provide resources to provide 
separate refrigerators, which are required for different types 
of vaccines versus public and private-funded vaccines, and also 
to incentivize some providers to accept VFC patients, which 
some don't do because of the reductions in their ability to be 
compensated for their time.
    So, again, while we don't like to think about compensation 
as a primary driver, it does--and especially in these times--
keep our practitioners afloat, especially in areas that are 
rural and lower-income areas where patients don't have the 
wherewithal to provide have insurance.
    Mr. Sarbanes. Excellent. Thank you very much for that 
testimony. I want to thank Congresswoman Schrier and others who 
have helped put forward important legislation in this space.
    With that, I yield back, Madam Chair,
    Ms. Eshoo. The gentleman yields back. We thank him for his 
questions.
    It is a pleasure to recognize the other Greek from--this 
time from Florida, Mr. Sarbanes from Maryland--Mr. Bilirakis.
    You have 5 minutes for your questions. Great to see you.
    Mr. Bilirakis. Good seeing you too.
    Ms. Eshoo. What are you doing, growing a goatee? My 
goodness.
    Mr. Bilirakis. Yes, yes, yes.
    Ms. Eshoo. We will call you ``Professor'' pretty soon.
    Mr. Bilirakis. I am experimenting with this. We will see 
what happens.
    But anyway, some people seem to like it. My wife seems to 
like it, which is more important----
    Ms. Eshoo. Well, that is what counts the most.
    Mr. Bilirakis. Yes, exactly, exactly.
    OK, here we go. Dr. Tan, how easily can infections spread 
in nursing home facilities?
    And are vaccines effective at lowering transmission rates 
in these settings?
    I know that you could--if you could answer that question 
quickly, and I have got some followups here.
    Dr. Tan. Oh, absolutely. It is like a spark into dry hay. 
It goes really, really fast. You have got people who are 
vulnerable because of some compromised immune responses, and 
then you have got family members coming in and out. So 
absolutely, it can spread very, very quickly.
    Mr. Bilirakis. OK. Why has there been COVID vaccine 
hesitation among healthcare workers? It seems ironic, no?
    Dr. Tan. Yes, I think it has----
    Mr. Bilirakis. I know you mentioned this, but if you could 
elaborate a little bit, please.
    Dr. Tan. Yes, absolutely. I think you have to kind of 
figure out the healthcare worker, and who the healthcare worker 
is getting information from. I think you will find that surveys 
have recently said that there are--physicians, pharmacies have 
actually been showing an increased acceptance and, actually, 
vaccination rate.
    I think we still have challenges with healthcare workers, 
such as nursing aides, who work predominantly in nursing homes 
because of education. And I think--and also because of the fact 
that these healthcare workers are extremely high stressed, and 
they are also looking to continue to move on in their careers. 
There is a lot of turnover.
    And so I think, as a result of that, I think we need to 
continue to emphasize the education and outreach to healthcare 
workers in nursing homes--nurses, nursing aides--because they 
don't always have access to the most important information. And 
sometimes the antivaccine messages may predominate in some of 
their social circles. So I think we need to be very, very aware 
of what they are hearing, what they are listening to, and 
providing education is, indeed, one of the most important ways 
we can move them along, with regards to, obviously, accepting a 
COVID-19 vaccine and getting those rates up among the nursing 
aides and nurses.
    Mr. Bilirakis. Thank you very much. The nursing home 
facilities with higher reported rates of vaccination in 
residents, staff have lower rates--in other words, if they are 
vaccinated, and I know that not everyone has access to a 
vaccine--are there lower rates of infection?
    Dr. Tan. Yes, absolutely. So not only just----
    Mr. Bilirakis. We have stats?
    Dr. Tan. Yes, we do have data on that, not just in terms of 
what we see with COVID-19, where the effect of vaccination of 
both the patients and the staff has been tremendous in reducing 
mortality, we also have data with regards to the more 
traditional adult vaccines, like influenza, and how vaccinating 
staff as well as the patients have reduced infections in those 
facilities, as well.
    Mr. Bilirakis. Now, what about other--in other words, other 
diseases, as far as educating staff, what have you, with regard 
to other vaccines?
    I mean, one silver lining is that we have learned so much 
during the pandemic. But shouldn't we go further with other 
vaccines?
    Dr. Tan. That is a great point, sir. I think absolutely. I 
think what COVID-19 vaccination education has shown us is that 
we have got a public that is hungry for information about 
vaccines. And the great news is that now, when I speak to the 
public, I don't have to go into those details about why 
vaccines are important anymore.
    And so I think this is a rising tide that can lift all 
boats. We can make sure parents, patients, adults, younger 
adults, adults with chronic conditions all understand the 
importance of vaccination and getting a vaccine. And I think 
this is so critical. This is what COVID-19 has shown us. And I 
think we need to build upon that and make sure that now, when 
these adults and these other patients show up to get 
vaccinated, they don't get turned away because of a financial 
or logistical barrier.
    So thank you very much for that question.
    Mr. Bilirakis. Well, my pleasure. And I would like to 
recommend--I have said this before to the committee, Madam 
Chair--I had a telephone town hall meeting, and plan to do some 
in-person meetings, as well, with my constituents. And we 
invited experts to come in and answer questions with regard to 
the vaccine. I think it is so very important to get the word 
out there.
    Thank you very much, Madam Chairman, and I will yield back 
the 45 seconds. Thank you.
    Ms. Eshoo. I thank the gentleman. And I do telephone town 
hall meetings every week into the communities in my district, 
and Dr. Maldonado is the trusted voice to my constituents.
    And so I join the gentleman in making that recommendation 
to all of our colleagues. It really makes a difference to our 
constituents, to have doctors come home with us. And boy, am I 
grateful, deeply grateful, and get terrific feedback from them.
    OK. Now to the gentleman from Vermont, Mr. Welch.
    Mr. Welch. Thank you very much.
    Ms. Eshoo. There you are.
    Mr. Welch. Thank you very much. I want to thank the 
witnesses.
    You know, we are really excited in Vermont. As you may 
know, we hit the 80 percent vaccine rate yesterday. And 
Governor Scott, our Republican Governor who has done an 
incredibly good job, incredible job, was able to announce the 
reopening. So there is a view in Vermont that vaccines work, 
and a lot of excitement. And we are a rural State.
    And one of the areas I wanted to ask is, how do we address 
this difference in vaccination uptake in rural versus urban 
areas?
    The CDC found in rural counties about 39 percent versus 46 
percent. And Dr. Tan, knowing of the rural access differences, 
are there things we can do better to reach rural communities?
    Dr. Tan. Yes, absolutely, and I think, with rural 
communities, I think there are some lessons that we are 
learning from COVID-19.
    I think, certainly, we need to be finding individuals in 
those communities that can be--that can serve as 
representatives for vaccination in general, you know, folks 
that are trusted leaders in that--in those communities that the 
rural community listens to. They can be church leaders, they 
can even be farmers. I mean, there's initiatives going on right 
now with rural outreach to the farming community, using farmers 
that have sought out and got COVID-19 vaccines, to communicate 
why they did so.
    Mr. Welch. OK, one other question. You know, this vaccine, 
the COVID vaccine, was free. And by all accounts, it made a 
huge difference. It eliminated the barrier altogether. Does it 
make sense, from a public health standpoint, to have vaccines 
be free?
    Dr. Tan. In my personal opinion, absolutely. I think we 
need to make sure that access to all these lifesaving vaccines 
across the lifespan happens with no cost to the patient.
    Mr. Welch. Thank you.
    And Dr. Maldonado, I am a big supporter of the work of my 
colleagues, Congresswoman Schrier, Butterfield, McKinley, and 
Joyce on their Strengthening Vaccines for Children Act. That is 
one of the bills before us. It would increase provider payments 
for beneficiary counseling and education.
    Can you just comment on the role of hesitancy and how that 
comes into play, and how my colleagues' bill may be helpful in 
addressing that and increasing vaccination rates?
    Dr. Maldonado. Yes, so I have been involved with the 
National Vaccine Advisory Committee for two different 
appointments. And over that period of time, we have spent some 
time with the National Vaccine Plan and assessing how well we 
are doing as--at a national level in vaccine hesitancy and 
vaccine confidence. And I do think that messaging to 
individuals is important.
    The vast majority of people are not antivaxxers, they are 
vaccine questioners. They want information. In this day and 
age, with social media and access to the Internet, people have 
a lot of information that they cannot always digest properly on 
their own. And I do think that the role of the trusted 
provider, the trusted local leader, whatever that person might 
be or whatever their profession is, is going to be critical to 
providing information to people, helping them answer their 
questions, because most people, as I mentioned, are just 
questioning.
    We also know that there is a now-new group that we have 
called vaccine apathy. So these are people who don't see the 
value because they don't see the disease in front of them. We, 
as providers, see the diseases, but most people don't generally 
see that on a daily basis. And getting that apathetic viewpoint 
away and making it clear that this can affect them and their 
family members is another critical way to communicate.
    So a lot of this comes down to communication, getting those 
VFC providers back on track so that they can actually provide 
the important information that our academic societies provide 
to them is going to be important. And making sure that that 
happens across the board is important.
    Let me give you an example. In the 1980s we had a big 
measles outbreak in the United States. And at the end of the 
day, when people thought it was due to a failure of the 
vaccine, it was actually because of a failure to vaccinate. And 
the failure to vaccinate occurred in urban inner-city 
populations that had just been overlooked, because they didn't 
have access. With the strengthening of that process, access 
to--in their urban inner-city areas, we have essentially 
eliminated measles in this country, so far.
    But we need to keep vigilant, because these diseases are 
not gone yet, and they can come back at a moment's notice. So 
really, keeping our providers access to vaccine and messaging 
out is really important. Thank you so much for that question.
    Mr. Welch. Thank you very much, and I yield back.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize the gentleman from Missouri, Mr. Long. And I would 
add that, if there were to be an auction of vaccines, there 
would be one person in this country that would make sure it was 
the most successful auction.
    So we now recognize you for your 5 minutes of questions.
    Mr. Long. Thank you, Madam Chair.
    And Dr. Tan, I would like to start out by talking about the 
situation that happened to a Member of Congress and his wife 
during the COVID epidemic. And I don't know how many cases like 
this went on, but when our medical system was completely 
upended, routine things were delayed or whatever. But 
unfortunately, Representative Andy Barr's wife, Carol, who was 
39 years old at the time, went to her doctor. And on her chart 
the doctor wrote, ``Echo when virus subsides.'' That is 
echocardiogram. Unfortunately, she subsided before the virus 
did, leaving Andy with two beautiful young daughters to raise. 
So there was a lot of things like that that went on during this 
epidemic that are not reported, I don't think counted in the 
totals.
    But, as I mentioned, COVID-19 upended a lot of routine care 
with lockdowns and with the strain it placed on our overall 
healthcare system. What have we seen in terms of utilization of 
recommended vaccines for adults over the course of the last 
year? And how did that compare to the year 2019?
    Dr. Tan. Thank you, sir, for that question, and my 
condolences to the Representative. I am so sorry to hear that. 
And, indeed, that is--those are stories that we are hearing, 
and they do count to that toll.
    I have to say the last year has seen similar dramatic 
impact, as we have heard, not just on pediatric but also on 
adolescent and adult vaccination coverage rates. We have got 
numbers like 85 percent reduction in coverage rates for one 
particular adult vaccine. We have had a tremendous reduction in 
terms of vaccines that have been going out to adults. And a lot 
of it has to do with the fact that, you know, a lot of the 
preventive care visits that a lot of our older adults used to 
go to declined dramatically, as well, during this past year, as 
you have mentioned.
    So yes, we are, unfortunately, really in the pit here with 
adult immunization coverage rates. We are trying to dig back 
out of it. We are not doing as well as the pediatric population 
right now. And that is because of wonderful people like Dr. 
Maldonado working really hard to get them vaccinated.
    The adult population is more challenging. It is broader, it 
is more diverse. And we need to therefore make sure that, when 
you can get them out of the pit, they don't find reasons to not 
get vaccinated. So thank you for that question, sir.
    Mr. Long. Excuse me. We are getting back to routine 
healthcare services, but there are still issues with older 
Americans getting vaccines recommended by the CDC, whether it 
is for measles or for shingles or whatever the case may be. 
What is the biggest impediment for vaccine utilization for 
older adults?
    Is it cost or lack of adequate information about 
recommended vaccine, and how does H.R. 1978, the Protecting 
Seniors Through Immunization Act, address both of those 
concerns?
    Dr. Tan. Thanks for the question. All of the above. I took 
the easy way out on that one.
    But, specifically with the Protecting Seniors Act, I think 
one of the things that--you know, if you think about how adults 
over 65 get--pay for their vaccines, they go either through the 
Medicare Part B or the Medicare Part D plans. And some of those 
vaccines, you know, flu, pneumococcal, and hepatitis B are in 
Part B, and there is no cost sharing.
    In the Part D plans, unfortunately, that is where some of 
the more recent vaccines for adults have gone, and we do have a 
lot of research and development that you have heard about that 
will introduce better and newer adult vaccines into the market. 
They will all, at this time, currently, will go into Medicare 
Part D, where unfortunately there is a copay for those Medicare 
Part D beneficiaries.
    When those beneficiaries go in, they are not aware as to 
what that level of copay may be, and that number may actually 
give them sticker shock. You know, they are looking at others 
getting vaccines for free, like if their kids are on private 
plans, and they go into their pharmacy to get, let's say, their 
shingles and they find out that there is a $150 copay, for 
example. It gives them sticker shock. They turn away, and say, 
``You know, I can't afford that right now because I am on fixed 
income.''
    So absolutely, sir, I think we need to think about how this 
Act will actually even that playing field between copays, 
between B, which has none, and D, which has a varying and 
confusing array of copays, and make them all the same, which is 
no copay to the patient.
    Mr. Long. OK, let's talk about the longer-term financial 
cost. Vaccines, of course, have an up-front cost, as you 
mentioned, but what are the longer-term financial costs that 
vaccine-preventable conditions have on the system, particularly 
for older adults?
    Dr. Tan. So, as you know, I think, to talk about costs, we 
are talking about the cost of caring for an adult who perhaps 
develops shingles and perhaps postherpetic neuralgia. All those 
costs are extremely expensive to the healthcare systems, not to 
mention just the cost of hospitalizations for flu and 
pneumococcal disease.
    The other cost I think we need to remember is there is a 
quality-of-life cost to the older adults. Now, when I talk to 
older adults, most of the time they are not talking to me about 
fear of death or hospitalizations--a fear of death, sorry. They 
are talking to me about whether their quality of life will 
suffer. So I think we need to just also remind ourselves that 
it is not just actual dollars, which are immense, but also this 
cost of quality of life.
    Mr. Long. OK, I have run over my time and, Madam Chair, 
thank you again, and I do yield back.
    Dr. Tan. Thank you, sir.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize the gentleman from Oregon, Mr. Schrader, for 5 
minutes of questions.
    Mr. Schrader. Oh, thank you very much, Madam Chair, great 
hearing, great panel today.
    As a veterinarian, I have relied on vaccinations my entire 
career to prevent a lot of the serious diseases that 
incapacitate or kill some of my clients' patients. And frankly, 
it is a much lower-cost way to prevent the higher-cost, more 
invasive chemical, you know, treatments and stuff that go on. 
So it is hard for me to believe people will not vaccinate 
either themselves and certainly their children.
    And to that point, I guess, Dr. Maldonado, I--we have 
talked a lot about this. I may have missed a specific point, 
but what is the actual cost for, you know, some of these 
childhood vaccinations? I know it all varies. The seniors' ones 
are a little more expensive, potentially. But what is the 
actual cost to the pediatrician?
    And then what is the commercial--if there is such a thing 
as the average commercial reimbursement, and what is the 
reimbursement for Medicaid and what is the reimbursement for 
Medicare?
    Dr. Maldonado. You know, those are great questions. And, as 
you said, it is a complicated formula. The cost will vary, 
depending on the product and depending on whether you are a 
public or private recipient, and I won't be able to provide you 
the specific numbers, unfortunately, but we can certainly get 
those numbers to you and provide them for the record. Yes.
    Mr. Schrader. Yes, and I would appreciate if anyone on the 
panel has some examples. I just wanted everyone to hear. I 
mean, the cost of vaccines in--for most of them, or for many of 
them, are actually not that high. And the problem that the 
physician has is, as you have alluded to, and Dr. Tan, and 
others, that, you know, it is just the cost of administration. 
I mean, you have got to store the stuff. That is a cost. You 
have got to have the refrigeration, in some cases. That is a 
cost. You have got to train your staff. The staff person gets 
paid----
    Dr. Maldonado. Yes.
    Mr. Schrader [continuing]. They spend the time. So the cost 
of administration is really what we should be trying to 
reimburse our physicians and physician assistants and nurses 
for at the end of the day. I think that oftentimes gets lost. 
But I would really love to get some examples in front of the 
committee, so they can see the great disparity that is out 
there.
    Could you talk a little bit about the difference between 
Medicaid and Medicare reimbursement?
    Dr. Maldonado. Yes, absolutely. So the Medicaid 
reimbursement will vary from State to State. As you know, each 
State provides its own limits.
    And as you had mentioned before, while I can't give you the 
specific numbers, they actually pale in comparison, say, to the 
cost of major invasive procedures that insurance frequently 
will cover, or other--Medicare or other providers will cover. 
Immunizations are not expensive on the grand scale, but 
pediatricians and in particular family practitioners, who may 
only provide vaccines to a portion of their population, may 
find them prohibitive because, while they aren't quite as 
highly cost-driven, there are--they are, many times, 
unreimbursable, and they may wind up taking a big hit overall 
because the volume, especially for pediatricians, of 
immunizations is such a large component of their practice.
    And so, when you are taking a--actually a loss, which many 
of them do on these amounts over time, it really does affect 
their bottom line and their ability to take new patient and--
and patients.
    And so, yes, so the Medicaid is really all over the map, 
truly, literally and figuratively. Every State has its own 
reimbursements, and----
    Mr. Schrader. Dramatically below Medicare----
    Dr. Maldonado. And it is absolutely below Medicare. So, in 
many cases, actually bringing providers' reimbursement up to 
the Medicare rate, even for a short period of time, would bring 
them back up to parity, especially during this time when, 
again, we have seen the visits really plummet for most of our 
providers. And they are really, really on the precipice, 
especially in those rural and smaller population areas, just 
having a hard time keeping their doors open, as well.
    Mr. Schrader. Very well said, very well said. I totally 
agree.
    Dr. Tan, you talked a little bit also about the problem of 
getting seniors vaccinated. It would seem like a no-brainer, 
again, to me, because that age, you know, some of us don't 
respond as well to a lot of the more invasive procedures or 
newer drugs that have other side effects. It seems like a no-
brainer to get your vaccination.
    What are some of the things we could do to encourage the 
seniors--you have talked a little, others have talked a little 
about this--but encourage seniors to get the vaccinations?
    And what is the best way, easiest access way, for seniors 
to get the vaccinations, in your opinion?
    Dr. Tan. So I think we have to deal with, firstly, the 
logistical challenges some seniors face. There are mobility 
issues, for example. And I think transport issues remain a 
challenge for a lot of seniors getting to vaccines. So I think, 
by increasing more access points, bringing pharmacies, bringing 
in community centers where seniors can actually get to easily, 
is a great way to start. And then taking away that financial 
barrier when they get there, so they don't get sticker shock.
    But then thirdly, I think very quickly, I think we need to 
be reminding the seniors that vaccines do more than just 
prevent infection. They protect them from getting hospitalized 
and, in many cases, quality of life. I sometimes say to seniors 
that I talk to, you know, ``If you don't get the flu 
vaccinations, you may walk into a hospital with influenza, but 
chances are you might actually walk out with a walker 4 weeks 
later because of influenza.''
    Mr. Schrader. Very good, very good. Thank you all very much 
for your testimony.
    And I yield back, Madam Chair.
    Ms. Eshoo. I thank the gentleman, and he yields back. It is 
a pleasure to recognize one of the terrific doctors that we are 
so fortunate to have on our subcommittee, the gentleman from 
Indiana.
    Dr. Bucshon, you have 5 minutes for your questions.
    Mr. Bucshon. Thank you, Madam Chairwoman. I very much 
appreciate that.
    I would like to thank Chair Pallone, Ranking Member 
McMorris Rodgers for holding this important hearing and 
including two bipartisan bills, H.R. 1978 and H.R. 550, that I 
authored with Representative Kuster. These bills aim to 
prioritize preventive healthcare through vaccines and modernize 
our Nation's vaccine infrastructure, respectively.
    It is a great frustration of mine that Congress oftentimes 
doesn't properly incentivize and want to pay for preventive 
care, simply because of its budget impact over a 10-year budget 
window, completely neglecting the fact that keeping patients 
healthy by preventing disease and sickness actually saves the 
system much more in avoided hospitalizations, doctor visits, et 
cetera. It leads to a better quality-of-life outcome over time 
and keeps people active in society and contributory, which is 
why I believe that H.R. 1978 is such an important bill.
    Dr. Tan, we have been over some of this territory, but I 
want to talk about this bill a little bit. Do commercial 
insurance plans cover vaccines under their medical benefit, 
their pharmacy benefit, or both?
    Dr. Tan. Yes, so thank you for that question, sir. 
Commercial, private plans cover vaccines under both pharmacy 
benefits as well as under medical benefits. And in fact that is 
the reason why, you know, someone who is under a commercial 
private plan can go in and get a vaccine and, essentially, 
there is no copay to that person.
    Mr. Bucshon. Right. And I think you have already went over 
this, but it is different than Medicare under Part B and D, and 
you--can you summarize that again, just--because I think this 
is a really important point.
    Dr. Tan. Yes, absolutely. So, for Medicare Part B, there 
are three vaccines--flu, pneumococcal, and hepatitis B 
vaccines--that are covered with no copay for the patient.
    Unfortunately, because of the Medicare Modernization Act, a 
lot of new adult vaccines now go under the Medicare Part D 
plan. And in the Medicare Part D plan, those plans are subject 
to copay to the patients. And, as you know, that copay will 
vary depending on individual patients and on the carrier plans, 
of which there are thousands in the United States, which adds a 
lot of confusion, a lot of variability to the patient.
    Mr. Bucshon. And that is why our H.R. 1978 extends Medicare 
Part B cost sharing policy to Medicare Part D plan coverage of 
vaccines which are recommended for adults by the Advisory 
Committee on Immunization Practices. The bill removes the 
application of the beneficiaries deductible coinsurance initial 
coverage limit and annual out-of-pocket threshold for ACIP-
recommended vaccines. And it also requires the Medicare new 
handbook to include relevant vaccine coverage and cost sharing 
information. I do believe this bill will increase the 
utilization of vaccines in the adult population.
    Ms. Coyle, another subject: The COVID-19 pandemic has 
revealed some important deficiencies that Representative Kuster 
and I have introduced legislation to help address. Immunization 
Information Systems serve as a vital link between public health 
officials, community providers, and individuals, not only in 
cases of disease outbreaks or emergencies but also during 
routine vaccination efforts.
    Can you talk a little bit about how these systems have been 
traditionally used by healthcare providers, how the provider 
use of these systems changed during the pandemic, and what 
lessons we should take away from this experience to improve 
immunization data exchange efforts?
    Ms. Coyle. Thank you for your question, and thank you for 
your leadership in this area. We really appreciate that 
attention.
    So, in terms of how providers have typically accessed this 
system, particularly within our pediatric and family practice 
and larger medical systems, they are connected to Immunization 
Information Systems using electronic data exchange. That has 
been the traditional way. We have certainly seen a lot of 
different settings where vaccines have been administered, such 
as baseball stadiums, parking lots, you name it. And so those 
types of settings may or may not yield a system with which to 
connect. And so there is often some data entry that has to 
happen on the back end of that.
    Reporting is critical. There is certainly a required 
timeframe for reporting, and that has been very different this 
time around. While we always want fast information, it is 
important to make sure that we also have accurate information.
    So, where this--what we have also seen is just that volume 
with--the number of vaccines that are flowing on any given day, 
you know, are significantly more than what we have ever seen 
before. And what that has really called to light is a need to 
really modernize and beef up a lot of our systems. Without 
that, the ability to actually query an immunization registry 
for a provider history--or sorry, patient history--is limited. 
And in some cases that has had to be turned off, just so that 
the IIS could receive vaccines, let alone not--they just don't 
have the bandwidth to push that information back out.
    So we have seen some real gaps over the last several 
months.
    Mr. Bucshon. Thank you very much for that input, and that 
is why I think H.R. 550 is so important.
    With that, Madam Chairwoman, I yield back. Thank you very 
much.
    Ms. Eshoo. The gentleman yields back, and we all thank you 
for your good work.
    And I would just add to that that I believe that it was our 
former colleague, Donna Shalala, and former Secretary of HHS, 
that was the original sponsor of the bill. And now you have 
taken it up with Ms. Kuster, and we are grateful to you for it. 
It is important work.
    The Chair now recognizes the gentleman from California, Mr. 
Cardenas, for his 5 minutes of questions.
    Mr. Cardenas. Thank you, Madam Chairwoman and Ranking 
Member, for having this very important committee hearing to 
discuss these very excellent bills that--we hope to have all of 
them move forward as soon as possible, addressing issues of 
vaccination of seniors, children, and everybody in between.
    But equally important, I think, it is wonderful to see so 
many experts coming before us, Members of Congress, to educate 
us and also the American people who are watching this public 
hearing, as it should be. Deliberating and discussing the 
policies that affect everyday life of Americans and beyond is 
important for us to continue to do that in full view of the 
public. Thank God for modern technology.
    We are getting through this COVID-19 pandemic. Things are 
improving, but we are not out of the woods yet. And what this 
pandemic has proven is that there are wide inequities that 
persist. They persisted before this pandemic, and this pandemic 
exacerbated the truth of these inequities.
    For example, Hispanic populations continue to contract this 
COVID-19 virus at the highest rates of any other race, while 
having some of the lowest rates of vaccine uptake. According to 
recent polling conducted by the Kaiser Family Foundation, 
Hispanic adults are about twice as likely as White adults to 
say that they want to get the COVID-19 vaccine, yet have 
expressed facing more barriers to accessing the vaccine than 
their White counterparts.
    Barriers to access include but are not limited to concern 
regarding missing work, trust in their provider, and travel to 
vaccination sites. That is why Representative Barragan's bill, 
H.R. 3013, the COVID-19 Transportation Access Act--I am pleased 
to see that she has introduced it, and I am glad to cosponsor 
that bill, as well, along with many of my colleagues.
    With that said, our efforts cannot stop there. We need to 
make sure that people are aware of the resources that we are 
working to provide for them.
    Research has also shown that, despite the vaccine being 
available free of cost thanks to the leadership of our 
committee and others, 59 percent of Hispanic adults have 
reported concerns about having to pay out-of-pocket costs to 
get the vaccine.
    Similarly, despite all U.S. adults being eligible for the 
vaccine no matter their citizenship status, 42 percent of 
Hispanic adults are not sure whether they are currently 
eligible to get a vaccine where they live. So awareness is a 
big, big issue to make sure that what--the good work that we 
do, the good things that we fund actually--that people can 
actually have the confidence and ability to realize that we are 
there for them and that we are providing these resources for 
them.
    And discussing vaccine efforts more broadly and as we 
continue to work to better our public health systems, let us 
learn from the successes and failures of the COVID-19 
vaccination efforts to ensure that every person has equitable 
access to information, resources, and vaccinations.
    Further, equity should be intertwined in every conversation 
we have, and we should commit to finally understanding and 
meeting the needs of the populations we have historically 
failed to consider and serve, as well as some others.
    From the perspective of our witnesses, what are some--and 
you are teaching us some of the largest lessons learned 
throughout the COVID-19 pandemic, and how we can use those 
lessons to build better, more equitable legislation to guide 
future vaccination programs.
    So my question to you, Ms. Maldonado: Is there anything you 
would like to share with us that we can express from the--what 
we have learned from this COVID-19 pandemic when it comes to 
disparities?
    Dr. Maldonado. Yes, thank you for that important statement. 
I actually set up one of the first outpatient outdoor tent 
treatment centers in the country, here at Stanford. We did it, 
actually, in the football field parking lot of the university 
when everything was shut down last March. And I helped run that 
site and continue to help run the site.
    And what we saw were Latino families coming in in large 
numbers, carloads of families who were infected, people who 
were afraid to come in, because they knew that, if they were 
sick, they would have to stop going to work. People who had no 
resources for food, we were trying to help provide them with 
resources to get delivered food and--through food--to food 
banks and other places.
    The disparities here in California, as you probably know, 
were just incredible. We were completely unprepared for the 
disparities that we saw in these communities. And I actually 
witnessed a couple that came in with their two children. They 
were--the children were not sick, the parents were sick. They 
were both urged to be hospitalized, but there was nobody to 
take care of their--the children. So they had to decide which 
one was sicker to be hospitalized here, at our hospital. The 
other one went home to take care of the kids.
    This is just one story, but it is absolutely representative 
of what is happening across our entire country, with all of our 
racial, ethnic, and lower socioeconomic populations facing the 
biggest brunt of this disease now. Initially, obviously, it was 
the older population, but now, with that high vaccination rate 
in the old people [audio malfunction] in our racial, ethnic, 
and lower socioeconomic minorities. Thank you for those 
questions.
    Mr. Cardenas. Thank you. It is unfortunate to hear stories 
like that happening in America. Let's do what we can to make 
sure that we end that.
    So thank you, Madam Chair. I am sorry I went over my time. 
I yield back.
    Ms. Eshoo. The gentleman yields back. The Chair now 
recognizes the gentleman from Oklahoma, Mr. Mullin.
    And we hope that your son is feeling just better and better 
and better.
    Mr. Mullin. Thank you, Madam Chair. I--Bakersfield right 
now, and I--he is doing much better. So----
    Ms. Eshoo. Great.
    Mr. Mullin. Thank you for asking.
    Ms. Eshoo. Thank you.
    Mr. Mullin. This month he has been testing, and everything 
is looking good. So I appreciate your concern.
    Sorry about the bad connection. I have very bad reception, 
even though I am in Bakersfield. We need a rural development 
out here, too, I guess, not just in my district.
    But I got a couple of questions, and I--Madam Chair, I 
appreciate so much you holding this meeting and this hearing, 
because it is important to all of us. Unfortunately, sometimes 
it does become political, and my questions may not seem to be 
much different, but we want to make sure that we are being 
transparent with the American people.
    Ms. Phyllis Arthur, Russia and China both have 
preapproved--vaccines utilize mRNA technology?
    Ms. Arthur. The vaccines that have been authorized in China 
do not use the mRNA technology at this time, although they do, 
it appears, have an mRNA vaccine in development in China. Not 
sure where the technology comes from.
    Mr. Mullin. What about Russia? Are we familiar with that?
    Ms. Arthur. Russia does not have an mRNA vaccine in 
development in their labs and companies.
    Mr. Mullin. Well, the reason I ask is these countries are 
both a significant threat to our democracy. I mean, obviously--
an advisory over the years. And do you think that it is wise 
for the Biden administration to hand over a novel vaccine 
technology to these adversaries?
    Ms. Arthur. I think it is extremely important to maintain 
the great biotechnology industry innovations that we have 
developed over decades within the private sector and in 
partnership with the U.S. Government, regardless of the 
administration.
    And so, knowing that we have actually had decades of 
research and development in all of the different platforms that 
led to the COVID vaccines, I think it is very important that we 
put forward policies that allow us to maximize that in the 
United States and also partner, as we should, with countries 
that guarantee that the great work that we have done in U.S. 
companies, in partnership with others, is protected and allowed 
to bring other innovations forward.
    Mr. Mullin. Right. Under the Trump administration--
Operation Warp Speed produced three COVID vaccines in under a 
year, which was unheard of. In any issue we have ran into 
throughout the country, we have never seen the development of--
the partnership between--the private-public partnership come 
together like we did during Operation Warp Speed. What can we 
learn from the success of Operation Warp Speed?
    Ms. Arthur. So thank you very much for that question. 
Operation Warp Speed was definitely a success in terms of the 
public-private partnership it represented. It leveraged the 
skills and management of the U.S. Government and the expertise 
and skills and decades of experience of industry in developing 
safe and effective vaccines.
    One of the hardest parts about going so quickly was 
figuring out what things could be done in collapsed time and 
what things had to be done in the regular amount of time we use 
for development, because we wanted to make sure the American 
people--actually, people all over the world--could feel like 
they were getting vaccines that were researched in a safe way, 
that they could see themselves in the data, and that we were 
manufacturing to proper quality.
    And it is--I think Operation Warp Speed is an example of 
the kind of public-private partnership that brings forward 
success, especially during an emergency. It is extremely 
important to learn how we thought about the collapsing of 
timelines. How we approach the manufacturing scale-up was 
another success. I think, more importantly, Operation Warp 
Speed really leveraged all the investments government and 
industry had been making all this time in platforms, which 
allowed us to go quickly.
    So galvanizing the FDA, NIH, and other agencies and 
industry really allowed for that success. And it was that 
coordination and that reliance on expertise that allowed that 
to happen.
    Mr. Mullin. Thank you. Thank you so much. I hope that the 
Biden administration rethinks this before they start handing 
over the intellectual property, because, you know, American 
people, we invested a lot in this. And we are not just talking 
about the investment of the tax dollars, but it is also part of 
our national security. So we need to make sure we put those 
first before we start handing out this intellectual property, 
especially to our adversaries.
    And with that, I will yield back. Thank you so much.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize the gentlewoman from Michigan, Mrs. Dingell. And we 
are so glad that you are feeling much better, Debbie.
    Mrs. Dingell. Thank you, Madam Chair. It is good to be 
feeling better. I really want to thank you----
    Ms. Eshoo. Some person needs to unmute--to mute in their 
offices, because there is a background conversation, and the 
gentlewoman from Michigan is recognized for her 5 minutes. 
Thank you.
    Mrs. Dingell. Thank you, Madam Chair--thanks, Madam Chair 
and Ranking Member Guthrie, for convening this very important 
bipartisan hearing to discuss improving public health through 
vaccination.
    You know, it is--but I think we need to, you know, continue 
to look at the broader picture. As we have seen in the current 
pandemic, vaccines, if properly deployed, are one of the most 
single effective public health interventions we had to address 
COVID-19, but as well as influenza and other vaccine-
preventable diseases like measles, chickenpox, et cetera.
    However, too often the cost in our fragmented healthcare 
infrastructure serves as a barrier to immunization. We have got 
to ensure people get vaccines when recommended throughout their 
lifetime, not just when they are kids but also throughout 
adolescence. But most vaccines are given to protect our very 
young. In our older populations, the fact of the matter is that 
we have got to ensure--fall through the gaps in the in-between, 
and there are a lot of vaccinations we need to be keeping up 
with throughout our lifetime.
    So I have a question for each of you, and I will go one by 
one.
    Dr. Maldonado, can you talk more about the importance of 
immunizations as part of healthy aging?
    As a pediatrician, how can we set kids and adolescents up 
to get recommended vaccines as they move throughout their----
    Dr. Maldonado. Yes, I think this issue--thank you so much, 
Representative Dingell, for this question.
    We do think something called life course is a really 
important issue. And that is, as a pediatrician, as 
pediatricians, we focus on prevention. It is--fundamental to 
how we work with children is how do we prevent diseases that 
will affect people 20 or 30 or 40 years or more in their life 
course. And we are doing more and more research in this area.
    What is it that we do for the pregnant woman, for the young 
infant, and the child, and the adolescent that will affect 
their lives, and even their children's lives? And so this is an 
area that we are starting to study in more detail, as we have 
more access to genomics and precision health and precision 
medicine.
    But, from the immediate perspective, well child care, 
preventive care, anticipatory guidance, that is all really 
fundamental to every single pediatric provider. That is why the 
Vaccines for Children and other bills are important to really 
bring families in. This is what really brings the families in, 
knowing that they need these vaccines.
    But what comes along with that is the ability to provide 
all the other platform information that families need around--
all the guidance that families would need to raise their 
children properly, give them proper food, proper nutrition, and 
track all of the milestones that they need to develop as young 
children.
    And as adolescents, the same thing is important. We need to 
start talking to them about issues that children may--that age 
group may not talk to their parents about, and they will trust 
their provider to discuss. And these are things that I 
personally have seen over the years, as well. So these are 
things that will help us move our--into the adult age group.
    And as you have heard from my colleagues, adult 
immunizations are important, as well, making people aware that 
it is not just the vaccine but everything that comes along with 
it.
    Mrs. Dingell. Thank you, Doctor. I am going to--I had a 
couple, and I am probably not going to have time, so Dr. Tan, 
do you have recommendations on how to help spread this 
important message in order to help more older adults, 
especially those with chronic conditions, understand the role 
of immunization in healthy aging?
    Dr. Tan. Well, thank you for the question, Representative 
Dingell, and I want to point out that the Seniors Act is going 
to also talk about education for the adults, and I think that 
is extremely important.
    I think we need to think about helping them understand what 
the access to--what vaccines they are--they need to have, and 
then also finding ways to get them access and removing those 
potential financial barriers to that vaccine.
    I want to pick up also a little bit on something you said 
about the chronic diseases that might sometimes impact adults 
that are perhaps between the ages of 50 to 64 years of age. We 
sometimes forget that they are also vulnerable. So they are 
outside the Medicare population, but they are also vulnerable 
to severe consequences from vaccine-preventable diseases. So I 
think helping to reach out to them, as well, is probably as 
important, to make sure that, if you have got a chronic 
illness, you are recommended for immunizations and you should 
be seeking those out.
    Mrs. Dingell. And I am really not going to have enough time 
to ask another question, Madam Chair, but I would also--and we 
were talking a little about it, the other question, getting 
accurate--I was--accurate information to people is really 
important. I had Guillain-Barre from a swine flu shot, but I 
still know--I am not an antivaxxer--how important we need to 
educate ourselves and get information. I was scared to death of 
the COVID vaccine. But here I am, alive and well, and in a 
normal life. So working with people really--OK, maybe--Anna, 
but I survived the COVID vaccine, and I yield back my time.
    Ms. Eshoo. The gentlewoman yields back. And as I said at 
the top of the meeting, we want to get--hear the rest of the 
bounce in your voice returned. So please take good care of 
yourself.
    The Chair is so pleased to recognize our colleague from 
North Carolina, Mr. Hudson, for your 5 minutes of questions.
    Mr. Hudson. Thank you, Chairwoman Eshoo and Ranking Member 
Guthrie, for holding this hearing. And thank you to our 
witnesses for your time and testimony today.
    As a proud cosponsor of H.R. 1978, the Protecting Seniors 
Through Immunization Act, and the lead on H.R. 3743 supporting 
the Foundation for NIH and the Reagan-Udall Foundation for the 
FDA, I am particularly happy to be here discussing these 
important issues.
    I would also like to thank Chairwoman Eshoo for her 
leadership and her partnership in introducing H.R. 3743 
together. This bill builds on our work together in the last 
Congress, and I am pleased to say the bill has already passed 
the Senate Health Committee last month under the leadership of 
our old friend, Senator Lujan, as well as Senator Collins.
    This bill seeks to build upon the immense success we have 
had over the past year with public-private partnerships for 
medical breakthroughs.
    Both the NIH and FDA have nonprofit, independent 
organizations established by Congress to help carry out each 
agency's mission. These organizations create and manage 
relationships between public and private institutions, 
administering research programs, supporting education and 
training, and providing support to patients. Together, the 
Foundation for NIH and the Reagan-Udall Foundation have been 
incredibly successful over the years and are strong stewards of 
promoting innovation.
    In fact, the FNIH was a crucial supporter of creating 
ACTIV, the partnership in April 2020 in response to the COVID-
19 pandemic. ACTIV brought together agencies, academia, 
philanthropic organizations, and [audio malfunction] promising 
COVID-19 vaccines and treatments. As a result, six COVID-19 
treatments are now well underway.
    We also saw the success of Operation Warp Speed, another 
public-private partnership that, in my opinion, and because it 
really--not receive the credit it deserves. Putting politics 
aside, though, Operation Warp Speed, through that program, we 
were able to develop, manufacture, and distribute vaccines in 
record time.
    One critical way we can build on this success is to 
continue to support our public institutions and encourage them 
to further partner with private entities. I am honored to work 
with Chairwoman Eshoo on this bill that would increase the 
level of funding that NIH and FDA transfer to their foundations 
to do just that. This bill will continue to build on the 
success of ACTIV and Operation Warp Speed and other public-
private partnerships to develop novel vaccines, diagnostics, 
and therapeutics at even faster rates in the future.
    Turning to Ms. Arthur, thank you for your testimony so far 
today. I have two questions I will ask, and then I will let you 
use the rest of the time to answer.
    The first question is, I mentioned ACTIV, with the support 
of FNIH, has been extremely successful. Can you explain how my 
bill, H.R. 3743, might further enhance these partnerships and 
bring more innovative vaccines to the American people?
    And then my second question, in response to the COVID-19 
pandemic, key sectors of the pharmaceutical industry acted as 
partners with the U.S. Government to mobilize and unleash 
innovation. However, recent news about the Biden 
administration's support for waiving IP patents for COVID-19 
vaccines is extremely alarming to me. I believe doing so would 
jeopardize industry incentives for innovation, undercut 
America's leadership in the life sciences, and endanger over 4 
million pharmaceutical jobs. Could you speak about how industry 
might respond if the U.S. Government suddenly undercut the 
decades of research and billions of dollars invested in R&D 
innovation and how this might impact our future response to 
pandemics or public health emergencies?
    And I will mute and let you answer, thank you.
    Ms. Arthur. Thank you.
    First, I just want to add something to the great discussion 
on what we can do to have more people get vaccinated. Dr. Tan 
mentioned that we want to make this a social norm. And so I 
think it is important to continue to build on the great 
investments we made in trusted messengers for very--for many 
communities. A lot of African-American, Latinx, Native American 
organizations rose up and educated on COVID. We can't lose all 
the investment in what they built, in talking to their 
constituents, and I hope we make sure that we think of that as 
a gap and we do something about that, moving forward.
    For ACTIV, Congressman, I think ACTIV was an excellent way 
to spearhead research across many different therapeutics and 
vaccines. And it actually could be a model, moving forward, for 
pandemic preparedness response so that we have a more organized 
way to approach the R&D we need to do in a pandemic, when we 
have millions of patients and many products coming forward. And 
I think that it was an example of what could be done across 
many stakeholders, including industry.
    Lastly, I think we have talked about the waiver. Industry 
is definitely concerned that, if the waiver moves forward, not 
only would it jeopardize the way we are managing a very 
constrained supply chain globally, because we would have to 
have all these different manufacturers around the world who 
might want to start manufacturing the product but aren't 
necessarily ready to do so, it could actually, more 
importantly, jeopardize the way industry thinks about their 
investments in both the commercial sector and then, as 
congresswoman Eshoo mentioned, in the way they think about 
pandemic response.
    Companies brought 950 products to bear on COVID-19 across 
the world. They brought every technology they had and they 
stopped working on what they were working on before to turn 
their attentions to COVID, regardless of whether they were 
going to get funded by the U.S. Government. We want to make 
sure that we guarantee companies continue to do that every time 
we need to respond to an unknown pathogen or known pathogen. 
And one of the cornerstones for industry in doing that is 
knowing that there's intellectual property protections.
    Mr. Hudson. Thank you, and I yield back, Madam Chair.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize the gentlewoman from New Hampshire, Ms. Kuster, for 
your 5 minutes of questions.
    Ms. Kuster. Thank you so much, Chairwoman Eshoo, and thank 
you for holding this important hearing to discuss efforts to 
improve public health through specific and targeted vaccine 
initiatives. And I particularly appreciate the inclusion of two 
bipartisan pieces of legislation that I have authored this 
Congress.
    Before I dive into questions, I want to take a moment and 
encourage all Americans to consult with your doctor and get 
vaccinated against COVID-19. We have recently passed the grim 
milestone of 600,000 Americans who have died from this terrible 
pandemic. And while we have over 43 percent of our adult 
population fully vaccinated, Americans are still ending up in 
the ICU and succumbing to this disease because they have not 
yet been vaccinated.
    We have come too far to allow this virus to move us 
backwards. So please roll up your sleeves and do your part to 
crush this awful virus.
    As we continue to make progress toward ending the pandemic, 
it is critical that we not lose sight of the lessons we have 
learned. And one lesson we have learned is that our system for 
adult immunization needs serious improvement, and we need to 
expand access.
    While the COVID-19 vaccine is free of cost regardless of 
your insurance status, for other routinely recommended vaccines 
Medicare beneficiaries may still be required to pay a copay or 
coinsurance out of pocket. And that is why I have partnered 
with my colleague and friend, Representative Dr. Larry Bucshon, 
on introducing the Protecting Seniors Through Immunization Act, 
which provides Medicare beneficiaries with Part D coverage the 
same access to vaccines that individuals under the age of 65 
currently enjoy. Medicare beneficiaries should not be forced to 
choose between getting a provider-recommended vaccine or other 
medicines to manage chronic or acute medical issues.
    So I have a question for Dr. Tan.
    Could you speak to the importance of initiatives that 
prioritize high-value care for seniors and expand access to 
routine vaccination for seniors?
    And in your opinion, would the Protecting Seniors Through 
Immunization Act help improve access to recommended vaccines 
under Medicare?
    Dr. Tan. Oh, yes, thank you very much, and thank you to you 
and also to Representative Bucshon for introducing this bill. 
Thank you.
    Yes, absolutely. I think part of the bill also talks about 
the fact that there is an education component and an outreach 
component. And I think that is really, really vital to not just 
help seniors understand that they can get access to these vital 
vaccines, hopefully, at no copay but also to help providers 
understand that, as well.
    Sometimes provider hesitation to recommend vaccines is 
because they don't want to put a burden of a payment on their 
patients, especially those who are on fixed incomes. And so, by 
taking that concern away, we can also strengthen that provider 
recommendation, ``I recommend you get the vaccine because it 
doesn't cost you anything,'' and they can say that with 
confidence. So I think that is extremely important. And [audio 
malfunction] playing field, right, as you have said. We need to 
make sure that my grandparents--well, actually, my parents--can 
get a vaccine the same way I can get one through commercial 
health plans. So that is an important, important part of the 
bill, as well. So thank you very much for that question.
    Ms. Kuster. Thank you. I also want to highlight--excuse 
me--I also want to highlight my bipartisan bill, also with Dr. 
Bucshon, that would provide critical funding to bolster our 
immunization infrastructure around the country and bring it 
into the 21st century. The Immunization Infrastructure 
Modernization Act would boost funding to improve information 
technology, data collection, and interoperability between IIS 
systems.
    This is a question for Rebecca Coyle: Through your work and 
experience working with IIS systems, what has hindered States 
and local health departments from bringing their systems into 
the 21st century?
    Ms. Coyle. Thank you for that question, and I really 
appreciate your leadership in this area. I think the question 
you ask is great. You know, what has hindered us from moving 
forward?
    And quite frankly, it boils down to prioritization. There 
are a number of different things that public health is faced 
with trying to navigate.
    And then the other piece is funding. There has not been any 
sort of dedicated resources for immunization information 
systems. They are part of the much larger immunization program 
funding, which then relies upon the State or jurisdiction to 
dictate where their priorities rest and making those 
modernization efforts.
    I think, as a result of that, we have seen a variety of 
different systems across the U.S. Some are more highly 
functioning than others, and I think our goal here is to really 
try and improve that flow and the operation to the same level.
    Ms. Kuster. Great. Perfect timing. My time is up, and with 
that I yield back.
    Ms. Eshoo. The gentlewoman yields back. It is a pleasure to 
recognize another one of our outstanding doctors on our 
subcommittee, and we are so fortunate to have them.
    Dr. Dunn of Florida, you are recognized for your 5 minutes 
of questions.
    Mr. Dunn. Thank you very much, Madam Chair, for your kind 
words, and Ranking Member Guthrie, for hosting this hearing 
today.
    You know, the United States has a wonderful story to tell 
when it comes to the development of the vaccines. It is my hope 
that the success of this public-private partnership that 
brought us these vaccines can be leveraged to continue 
innovating and move towards eradicating vaccine-preventable 
diseases in the U.S. and beyond.
    For any vaccination, we know that immunity may fade over 
time. The most appropriate way to ensure that a vaccine has 
produced a strong immune response is to test for persistent 
immunity in both a qualitative and quantitative sense. Testing 
for immunity can be an important tool in determining when, 
after any vaccination, a booster shot may be needed, or to 
determine if someone was previously infected with a specific 
virus and already has significant immunity.
    Some viruses principally evoke a B cell immune response, 
such as hepatitis B and A. This we measure with antibody 
titers. In other viral diseases, the principal immune response 
is mediated by T cells. We call this humoral immunity, and it 
is best measured by testing for activated T cells, not 
antibodies, which are fleeting after vaccination or infection 
with SARS-CoV-2.
    Coronavirus is such a virus. Testing for antibodies is of 
little use in detecting or quantifying immune status. T cells 
are available--T cell tests are available, although not nearly 
as widely or cheaply yet. But our experience in Singapore, 
SARS-Cov-1 showed, essentially, 100 percent immunity to this 
disease in survivors fully 17 to 18 years later. This was 
measured by testing for activated T cells to SARS-CoV-1. 
Interestingly, these same patients demonstrated a similar level 
of immunity to SARS-CoV-2.
    This underscores the obvious conclusions that we need to 
have readily available T cell immunity testing so that we can 
definitively determine who has immunity and who does not. 
Someone may have had the vaccine but failed to mount a 
significant immune response, as some 5 percent of vaccine 
recipients do. Or they may have unknowingly had a subclinical 
infection and still demonstrate clinical immunity, significant 
clinical immunity, thereby not needing the vaccination.
    Indeed, there may be a small but real risk that vaccination 
in these patients, especially the younger ones, may excite a 
cytokine storm response that renders them seriously ill.
    So on that subject, Dr. Maldonado, do you have anything to 
add regarding the importance of being able to test for humoral 
immunity, T cell immunity, compared to antibody testing when it 
comes to COVID-19?
    Dr. Maldonado. Yes. Clearly--thank you so much for that 
comment, Representative Dunn.
    So we have a Human Systems Immunology Center here at 
Stanford, and there are centers all around the country and 
within, actually, the industry, as well, that are conducting, 
actively, very cutting-edge work around measurement of T and B 
cell immunity. So clearly, humoral and cell-mediated immune 
markers are critical for understanding not only how this virus 
is producing the effects that it does, but also the----
    Mr. Dunn. But also the vaccines. I am going to reclaim my 
time, because we are running out, and I have other questions 
for you.
    Are other members of your specialty pediatricians routinely 
using T cell testing?
    Dr. Maldonado. So we are----
    Mr. Dunn. In this country.
    Dr. Maldonado. So we are doing T cell testing here at 
Stanford, absolutely. We are working with NIH and FDA and 
others to do studies. I have a----
    Mr. Dunn. But outside academic centers, I think it is not 
as widely available, am I correct?
    Dr. Maldonado. There are some T cell assays, but we don't 
have a good understanding of how they are going to work. So, 
yes, absolutely, we need to understand them better so they 
could be potentially commercially used.
    And then the question will be, of course, whether we should 
use them--use these to identify booster----
    Mr. Dunn. OK, I am going to move on, but I appreciate that. 
And I am--by the way, I will be submitting questions in writing 
after this.
    As the industry seeks to--this is to Ms. Arthur--as the 
industry seeks to determine the specifics of when COVID-19 
booster shots might be necessary, if--or if they are necessary, 
do you know if vaccine manufacturers are evaluating T cell 
immunity data to drive decision making?
    Ms. Arthur. So I am not sure. I think that companies are 
working with the FDA to look at different markers, and so they 
are trying to look at----
    Mr. Dunn. So I am going to--again, I am going to interrupt, 
because we are--but I would urge your companies to look at the 
Singapore data. They have a lot of experience with this and 
SAR-CoV-1. It was very good data. I look forward to learning 
more about this testing in the future and how we are using it 
clinically and in research. And I would submit the data on 
human immunity would be extremely valuable to doctors treating 
patients on a daily basis and to our vaccine makers. And, as I 
say, I will be submitting questions.
    And thank you very much, Madam Chair and Ranking Member 
Guthrie. I yield back.
    Ms. Arthur. Dr. Dunn, I would love to have that question in 
writing so we can respond to you.
    Mr. Dunn. You will. You will, I promise.
    Ms. Arthur. Thank you.
    Ms. Eshoo. The gentleman yields back. It is a pleasure to 
recognize the gentlewoman from Illinois, Ms. Kelly, for your 5 
minutes of questions.
    Ms. Kelly. Thank you, Chairwoman Eshoo and Ranking Member 
Guthrie, for your leadership, and for holding this hearing to 
discuss improving vaccination rates, especially in populations 
that are at higher risk for vaccine-preventable diseases.
    According to the CDC, pregnant people, and recently--
pregnant people have a higher risk for severe illness from 
COVID-19 compared to nonpregnant people. A recent study 
published in JAMA found that people with COVID-19 diagnosis 
have an increased risk of maternal morbidity and mortality and 
that newborns of people with a COVID-19 diagnosis had a higher 
risk of morbidity. We must, must ensure that COVID-19 
vaccinations make it to the arms of the people who need it 
most.
    Unfortunately, vaccination rates tend to be low on pregnant 
people overall. In 2019, only 40 percent of pregnant women 
received recommended vaccines. The rates were even lower for 
Black and Latinx women, with 23 percent and 25.4 percent, 
respectively, getting vaccinated, compared to 46 percent of 
White women.
    This is personal to me. My daughter just had a baby, so I 
have a grandbaby, another one, as of 2 days ago, and she hasn't 
been vaccinated yet.
    So Dr. Tan, why aren't all pregnant women getting access to 
potentially lifesaving vaccines?
    And what actions are needed to ensure that maternal 
populations and providers who care for them are able to make 
preventive health measures such as that?
    Dr. Tan. Thank you very much for that very important 
question.
    I think, when I was in the National Vaccine Advisory 
Committee, we actually issued a report on maternal 
immunization, looking at some of the barriers. And I think it 
is important to recognize that one of the major reasons why a 
pregnant person gets vaccinated is a healthcare provider 
recommendation. And so it is because of that recognition that a 
lot of work was done to bring on board OB/GYNs to become 
immunizers, to provide recommendations for immunizations and 
give the vaccines. I think that has been a testimony to ACOG on 
their efforts on that.
    But I think, that being said, I think we have now hit a 
point where we went from 15 percent to about 50 percent, for 
example, for flu, and we are not getting much higher. And I 
think that reflects, actually, some traction with regards to 
what other providers can we engage to provide access to 
vaccines for pregnant women.
    And I think one of the challenges that we have is that it 
does cost providers a lot of money to start vaccinating. You 
know, the family physicians have been vaccinating for forever. 
Pediatricians have done this very well for a long time. But 
when we start expanding to providers of healthcare to pregnant 
women, internists, we need to figure out ways to incentivize 
them to absorb--to take on these costs, to start up, to 
vaccinate people. And I think that is one of the most important 
things that we can do, with regards to the provider component.
    And the maternal immunization bill that is in front of us, 
actually, is really, really important, because it starts that 
conversation between the patient and the provider by providing 
education and outreach on why maternal immunizations are 
important.
    I am going to just wrap by saying, you know, there's a lot 
of new vaccines coming up for maternal immunizations, and it 
would be a shame if we did not move this forward to a point 
where we get to see the benefits of those new vaccines. Thank 
you so much.
    Ms. Kelly. Well, I very much support H.R. 951, the Maternal 
Vaccinations Act. I think it is really important.
    Dr. Maldonado, some women are reluctant about these 
vaccines for safety concerns. As a physician, can you speak to 
the safety and importance of maternal vaccinations, 
specifically the inclusion of pregnant people in vaccine 
research?
    Dr. Maldonado. Yes, absolutely. Thank you so much for this 
important question.
    As we know, these vaccines are recommended by the CDC now 
for use in pregnant women. The ACOG, American College of 
Obstetrics and Gynecology, also recommend the safety of these 
vaccines for pregnant women--persons. The issue is that there 
has been some misinformation on social media that has been 
circulating much faster than others--than people was--were 
expected, that there is--around the inability of--the ability 
of the vaccine to potentially cause infertility. That is 
absolutely baseless. It is based on nonscience, and it has 
frightened a number of individuals into not getting vaccinated, 
for fear of fertility issues.
    But in addition, it has also frightened pregnant people 
into not considering getting the vaccine. So I do think that, 
again, coming back to this issue of providing more support, as 
LJ mentioned, we published this paper, white paper, many years 
ago on maternal immunization efforts. And there are some, 
still, very good recommendations there on how to educate our 
OB/GYN providers, our private practice providers, our 
communities around the safety of these vaccines, because we do 
have an extremely safe surveillance system. The FDA, CDC, and 
others do track vaccines very carefully and cautiously. And we 
have the highest confidence in vaccination of pregnant people.
    Ms. Kelly. And I know I am out of town--time, but I just 
want to say passing the Helping Adults Protect Immunity Act is 
critical to ensuring access to vaccines.
    And I thank Representative Soto for his leadership here, 
in--continue pushing my bill, the MOMMA's Act, which would 
mandate Medicaid programs to expand postpartum coverage from 60 
days to 1. Together, these changes will ensure that both 
pregnant people and new moms can receive the vaccinations 
they--receive.
    Thank you, and I yield back.
    Ms. Eshoo. I thank the gentlewoman for her terrific work.
    It is a pleasure to recognize Mr. Curtis from Utah for your 
5 minutes of questions.
    Mr. Curtis. Thank you.
    Ms. Eshoo. And thank you for your patience.
    Mr. Curtis. Thank you, Madam Chair. A special thanks to 
Representative Kelly. Congratulations on that new little 
grandbaby. As a grandfather of 11, I can really relate to your 
joy.
    I can also relate to some of the concerns expressed. I have 
heard this from my own daughters, who are--some expecting, and 
some--I have six kids, by the way, and it has been real 
frustrating to me, as their father, somebody who is a strong 
advocate of getting a vaccination, to watch them struggle with 
this personal decision. And we just have to do a much better 
job of getting information out there, and I am struggling in my 
own family to do that.
    I have been a strong proponent for getting vaccinations. I 
had an early vaccination myself, and yet I represent a district 
[audio malfunction] are reluctant to get a vaccination. And I 
feel compelled just to speak for them, just to some degree, to 
say that it is still a personal choice and something that 
cannot be forced upon them. As a matter of fact, I think the 
more we talk about it in these terms, the more resistant they 
are to doing it. It reminds me a little bit of somebody who is 
diabetic or susceptible to diabetes who wants to sit on the 
couch and watch TV, no matter how much we talk and tell them to 
go out and exercise. They don't.
    I am a little frustrated when I hear things like we can't 
hold our committee meetings until we know who is vaccinated and 
who is not. Nobody has exactly explained that science to me, of 
why we need to know that. And I realize there's many cases that 
are quite personal, where we don't know that.
    I would like to switch gears just a little bit to 
vaccinations in general and ask Dr. Maldonado, how many annual 
immunizations are recommended for children, and at what ages 
are children recommended to receive these immunizations?
    And then, a follow-up to that is, is there an age bracket 
in which we see these drop, the immunization rates drop? And, 
if so, what can we do to close that gap?
    Dr. Maldonado. Yes, thank you. There are over 27 different 
types of diseases that are prevented by immunizations, not all 
of them recommended for every single child. So it really 
depends on whether children have underlying risk factors or 
not.
    But the vaccinations generally start by around 2 months of 
age in this country, and they can continue all the way through 
adulthood, as we know, for HPV, for example, and pneumococcal 
diseases. But the age groups are generally concentrated in the 
first 5 years of age. And then they tend to have an adolescent 
platform, where there are vaccines recommended in the 11-to-12-
year-old age group and above, and then there are some vaccines 
that are recommended for young adults, and then, again, 
pregnant people, and then finally for seniors.
    So there is a whole, very nicely put-together schedule that 
the American Academy of Pediatrics harmonizes with ACIP. It is 
available on the CDC website, and it includes regular 
vaccinations, vaccinations for catchup, and for different ages.
    Mr. Curtis. Thank you.
    Ms. Arthur, there has been a lot of discussion at today's 
hearing about President Biden's administration proposal to hand 
over the COVID-19 vaccine intellectual property. I think you 
have been pretty clear about how you feel about that. And I 
might say that I think those are legitimate fears.
    But let me kind of change that question just a little bit 
and say we all agree that we want to get vaccinations out to 
the world. What can we be doing, without losing an intellectual 
property?
    In many ways, I think we have seen a great display with 
that, with President Biden's recent commitment to put a half a 
billion out there. But what would you advise us, as Members of 
Congress, that we can do, short of giving away that 
intellectual property, to get vaccinations out to the world?
    Ms. Arthur. Thank you so much for that question, 
Congressman. I think that is actually exactly where we would 
like to focus the policy energies around COVID for the world, 
is actually thinking about those very important things we can 
do right now to get more vaccines produced.
    We have put out our BIO Share program, and we have 
encouraged anything the Government could do to help reduce 
export controls around the world that limit the free movement, 
particularly of the key raw materials we need to manufacture 
more vaccines, not just here but in other countries that are 
also serving their nations and other nations.
    Secondly, the donations that are organized are really, 
really important.
    And third, we need to actually use, as the President said, 
our arsenal of power in the United States and all the 
manufacturing capacity that we built over the last year to 
actually export doses to countries so that companies can honor 
the commitments they have made to COVAX and to other nations to 
bring more doses as quickly as possible to people.
    Mr. Curtis. Thank you. It appears to me that that is 
actually a much quicker way to get vaccinations out to the 
world, rather than letting people redevelop so many things that 
you have already done.
    Ms. Arthur. These are things that could happen today and 
are happening right now.
    Mr. Curtis. Thank you. I am out of time.
    Madam Chairman, I yield. Thank you.
    Ms. Eshoo. The gentleman yields back. The gentlewoman from 
Delaware, a small State but with big representation.
    Ms. Lisa Rochester, you are--Blunt Rochester, you are 
recognized for 5 minutes.
    Ms. Blunt Rochester. Thank you so much, Madam Chairwoman, 
for the recognition, also of the recognition of our small, 
wondrous State and for calling this important hearing today. I 
would also like to thank the witnesses for being here.
    President Biden declared June a month of action in order to 
help the country reach the target goal of 70 percent of adults 
immunized against COVID-19 by the Fourth of July holiday. While 
the United States has vaccinated more people than anywhere else 
in the world, we are still working on connecting vaccines to 
individuals at that last mile, especially among racial and 
ethnic minorities.
    Due to investments from the American Rescue Plan and 
leadership from the Biden administration, we have seen 
healthcare providers, community-based organizations, civil 
rights and religious leaders come together around targeted 
COVID-19 vaccination campaigns.
    And, in my State, Beebe Healthcare and local partners have 
repurposed a bus normally used as a mobile library with vaccine 
workstations to literally meet people where they are. And, 
while we have made progress, the data shows we still have much 
work to do. According to the Kaiser Family Foundation, Black 
and Hispanic individuals have received smaller shares of 
vaccinations compared to their shares of cases and compared to 
their share of total population in most States.
    Dr. Tan, can you talk about how these outreach activities 
have helped reach these critical populations, and what more can 
be done?
    Dr. Tan. Well, thank you so much for that question. I think 
it is--I think COVID-19 woke us all up to the discrepancies 
that we see in our access to care. And I think these 
initiatives that came out of that have been very successful.
    I think one of the big pictures it has shown us is that 
with rural, with low socioeconomic, with ethnic and disparate 
populations, we need to figure ways to bring the vaccine to the 
community. And that starts, also, with bringing people in the 
community to the vaccine, in the sense that--you know, bringing 
leadership that can speak to the benefits of getting 
vaccinated.
    In the African-American population there has been previous 
work that has demonstrated success where, when you engage a 
respected pastor to talk about vaccination, vaccination being 
offered in his or her church, that increases immunization 
coverage rates. And I think these programs that you talked 
about that started with COVID-19 are achieving that success.
    What I would urge is that we continue to use these 
techniques, that--these interventions that we have learned to 
do this with all the adult vaccines, going forward, and to 
build on that, so we don't lose that momentum.
    Ms. Blunt Rochester. Well----
    Dr. Tan. Thank you so much for that question.
    Ms. Blunt Rochester. Well, you actually read my mind, 
because my next question was, how can this increased 
coordination be utilized to help with catchup activities for 
routine immunizations, as well?
    Dr. Tan. So that is a great followup. Thank you for that. I 
would like to speak a little bit longer to that, absolutely. 
And I think this is the other thing that we are also beginning 
to figure out with COVID-19, is that--this exquisite 
collaboration between State public health, county public 
health, and the communities that they serve are really required 
in order to bring these programs to fruition.
    And on that note, I think it is important to recognize that 
a lot of the work that we are doing, you know, needs to be 
sustained with improvements in our public health 
infrastructure. And I think that is the big picture that we 
also want to not forget, that, in order to continue and sustain 
these improvements, we need to fund public health 
infrastructure the way it has not been funded before. Thank you 
again.
    Ms. Blunt Rochester. Yes. You testified that coverage is 
key for getting people vaccinated. What does the data tell us 
about how health coverage affects vaccination rates among 
racial and ethnic minorities?
    Dr. Tan. Yes, a one-word answer. The more someone has to 
pay out of pocket for a vaccine, the more likely they are going 
to refuse or not even show up for that vaccine. So we need to 
make sure that patients have no copay, so that they will get 
the vaccines that will potentially save their lives.
    Ms. Blunt Rochester. I really want to thank you, Madam 
Chairwoman, for this hearing. This, as we know, is 
consequential to not only our physical and mental recovery but 
also to our economic recovery. And this is such an important 
moment for us.
    And I am glad also, Dr. Tan, that you mentioned rural 
communities. I represent the entire State of Delaware. We are 
small, so we only have one congressperson. And so I am--we are 
representing urban, suburban, and rural communities. And so us 
being creative and innovative and finding these different ways 
in multiple entry points is going to be very important, not 
just for today but also, as you mentioned, for the future of 
our healthcare and our health infrastructure. So thank you so 
much.
    And I yield back the balance of my time.
    Ms. Eshoo. The gentlewoman yields back.
    I think you are the only Senator in the House of 
Representatives, so we love you.
    It is a pleasure to recognize the gentleman--oh, I am 
sorry, another one of our great doctors on the subcommittee, 
Dr. Joyce from the State of Pennsylvania.
    You are recognized for 5 minutes.
    Mr. Joyce. Thank you for the kind words. And thank you, 
Chair Eshoo and Ranking Member Guthrie, for convening this 
hearing. And thanks to the witnesses for appearing today on 
such an important topic.
    The COVID-19 pandemic has caused disruptions in almost 
every aspect of Americans' daily lives over the last 15 months. 
And thanks to President Trump's Operation Warp Speed, we have 
seen multiple vaccines authorized for use in record time and a 
return to normal life. Children have been greatly affected by 
the pandemic, as we have seen school closings, loss of 
activities, and limiting of routine social interactions, which 
have drastic impacts on learning, on mental health, and on the 
social development of our children. With the authorization of 
the COVID-19 vaccine for children 12 and up, all of these 
activities must resume in full.
    Now I would like to take--turn to another matter of 
vaccines in children, and the troubling drop that we saw last 
year in routine childhood vaccinations, particularly early in 
the pandemic. These were especially prevalent in the DTaP and 
the MMR vaccine rates, which prevent several highly 
communicable [audio malfunction].
    My question first is for Dr. Maldonado.
    Thank you for your testimony earlier, when you laid out 
some of these issues, and for highlighting the Strengthening 
the Vaccines for Children Program Act of 2021, which was 
introduced by my fellow physician, Representative Kim Schrier, 
myself, and our colleagues, Representative Butterfield and 
McKinley.
    In particular, I did want to focus on an issue that impacts 
doctors participating in the Vaccine for Children program.
    Dr. Maldonado, can you please discuss how the current 
program reimburses physicians for vaccines that protect against 
these multiple communicable diseases, and how this poses 
challenges?
    Dr. Maldonado. Yes, thank you so much, Representative 
Joyce, for that question.
    So currently, the--it really depends on at what level the 
provider works. So, for example, if they are in a large 
practice or a large health system, they are largely protected 
from the day-to-day work, but they still have quite a bit of 
paperwork to do. It only gets exacerbated if you are in a 
smaller practice, or in a rural area where you might be the 
only provider for many, many miles, for a large geographic 
region.
    What happens is these requirements are really broken down 
between Federal and State requirements, because there are 
separate payment stream fund flows--funds flow for payments. So 
you may have private-insured patients, you may have State-
funded patients, you may have Federal-funded patients. And the 
ability to streamline these processes would really take a big 
bite out of the time that providers have to spend after seeing 
their patients in completing all of the paperwork, hiring back 
office individuals to just do that work, which keeps them from 
seeing more patients and providing the care that they need.
    So the administrative and bureaucratic issues that--
streamlining VFC and CHIP, for example, really would go a long 
way to reducing the financial burden, the administrative 
burden. It would increase the ability of pediatricians and 
other providers, such as family practitioners, as well, to see 
patients face to face rather than to spend time doing a lot of 
the paperwork that is necessary to get this reimbursement.
    Mr. Joyce. Thank you for bringing that into the discussion. 
The area that I represent in south-central and southwestern 
Pennsylvania you described, there are many small practices in 
rural areas, and these individual pediatricians and family 
practice physicians are obligated to take care of these 
children and provide them with the necessary vaccinations.
    Finally, do you believe that the bill, Strengthening the 
Vaccines for Children Program Act of 2021, will alleviate the 
concerns that you just laid out?
    Dr. Maldonado. I do believe that this will make a--take a--
take us a long way into addressing issues that we have been 
bringing up for many years now around the alignment of funds 
flow into practices, especially those that were already 
impacted even before the pandemic, and which has been 
exacerbated by current fiscal constraints that the pandemic has 
imposed on practices around the country.
    So this would have an immediate, immediate impact on the 
ability of practices to really gear up and get back into the 
business of taking care of children and keeping them safe and 
healthy.
    And then the long-term impacts would be important in 
keeping--in enticing more providers, as I mentioned, to come 
into VFC and be allowed to participate in providing more care 
for children, giving them those medical homes that they really 
need.
    Mr. Joyce. Thank you so much for your answer.
    Chair Eshoo, thank you. I see my time has expired, but this 
is such an important issue, I definitely appreciate your 
indulgences in allowing us to continue this conversation. Thank 
you.
    Ms. Eshoo. We appreciate you on the subcommittee, Doctor. 
So--and thank you for yielding back.
    It is a pleasure to recognize a great new member of our 
subcommittee, the gentlewoman from Minnesota, Ms. Craig, for 
your 5 minutes of questions.
    Ms. Craig. Thank you so much, Madam Chairwoman, for holding 
this important hearing today. And thank you to our panelists, 
who have stuck in there for the majority of the day today.
    With over 309 million doses administered within the United 
States, we have made historic progress in developing and 
delivering vaccines. Earlier this year I was proud to vote for 
the American Rescue Plan, which provided $7.5 billion to CDC 
for vaccine distribution and administration.
    However, as we all know and we heard today, those 
persistent gaps persist. In Minnesota, the statewide 
vaccination rate among Black, indigenous, and Hispanic 
Minnesotans is around 50 percent, compared to 62 percent among 
White residents. In rural areas, the vaccination rate among 
Black, indigenous, and Hispanic individuals is even lower. The 
most recent racial and ethnic data from CDC includes 57 percent 
of people who have received at least 1 dose of the vaccine. 
While the national data indicates a narrowing in those 
disparities in vaccination rates among Hispanic, Black, and 
Asian communities, we still do not have State-level data.
    Earlier this year, I introduced H.R. 979, the Vaccine 
Fairness Act, which would direct HHS to provide regular updates 
on their efforts to ensure the COVID-19 vaccine reaches the 
groups most at risk. It would require HHS to report 
disaggregated data vaccine distribution data by age, race, 
ethnicity, and ZIP Code. I want to thank the committee for 
including H.R. 979 in today's legislative hearing and allowing 
me to raise awareness about vaccine equity in Minnesota.
    With that in mind, I wanted to ask you, Ms. Coyle, about 
the critical role immunization information systems play in how 
we respond to outbreaks like COVID-19. We also know how 
difficult it is to address racial, ethnic, and geographic 
barriers to care without robust and accurate data. Can you 
expand on the ways that outdated Immunization Information 
Systems inhibit States' ability to collect demographic data, 
and respond appropriately?
    Ms. Coyle. Sure, and thank you for your question. So I 
think, you know, in terms of equity, it is very important to 
understand how all of that is calculated.
    One of the significant challenges that we faced going into 
this pandemic is really the emphasis on trying to capture some 
of that race and ethnicity data. Some of that data hasn't 
typically flown into an IIS before through data exchange, for a 
variety of reasons: one, perhaps the clinic is not actually 
collecting that information; two, perhaps the system doesn't 
actually submit that information. Or I think even more 
troubling is that our actual systems--and this includes EHRs--
don't actually capture the broad depth of which we need to 
capture for race and ethnicity data. It is very limited in 
nature to about seven fields, whereas we know race and 
ethnicity is very--more complex than that.
    So the ways that we have been able to see this, I think, 
sort of morph, and the attention placed on all of this, we saw 
all of our States, all of our jurisdictions be able to capture 
that information and be able to save that information with the 
patient. Right now we are at a little over 50 percent of all of 
the COVID-related data containing race or ethnicity 
information. But we recognize that there is still a long ways 
to go, and it is a shared responsibility between those 
capturing the information, the medical clinics, and then, also, 
for the systems to maintain that information.
    Ms. Craig. Ms. Coyle, just as a followup, if we were able 
to capture that data more accurately, what are the ways that we 
can leverage that data to improve vaccine equity?
    How would we put that into practice?
    Ms. Coyle. Certainly. Well, with access to data it 
certainly can highlight some of the areas that may need 
additional focus. We know that sometimes, with certain 
populations, they need an outreach that is conducive to their 
cultural or--ways of thinking. And it is one of those things 
where, the more data you have at your hands, the more specific 
you can be in your response.
    And I think that is truly the best tool for these IIS, is 
that you have that complete knowledge and that complete look, 
then being able to leverage that to target your interventions.
    Ms. Craig. Thank you very much, and thank you again to all 
of our panelists here today.
    And Chairwoman Eshoo, with that, I will yield back.
    Ms. Eshoo. The gentlewoman yields back, yielding back some 
extra time, we thank you for that.
    Now the--it is a pleasure to recognize the gentleman from 
Texas, Mr. Crenshaw, and we are so happy that you are with us, 
and hope that you are feeling really well.
    [Pause.]
    Ms. Eshoo. You need to unmute.
    [Pause.]
    Mr. Crenshaw. Working now.
    Ms. Eshoo. There you are.
    Mr. Crenshaw. Yes. I was unmuted, but the settings weren't 
correct. I had to utilize my millennial background to--with 
troubleshooting.
    Ms. Eshoo. I hope you are feeling really well. It is great 
to see you.
    Mr. Crenshaw. Well, thank you. Thank you, Madam Chairwoman, 
and I do. I feel--I am, basically, back to my sense of normal, 
which is a complicated normal, but I am basically back. So I 
really appreciate all the prayers and well wishes.
    And thank you to our witnesses for being here today, 
discussing the important issue of the vaccinations and the 
amazing efforts by American industry to create, manufacture, 
and distribute vaccines at a record pace.
    I want to just briefly discuss one of my bills here today. 
I was disappointed it was not included in the budget 
reconciliation. I know a lot of my colleagues on both sides of 
the aisle have the same concern on the topic of vaccine 
allocation and transparency.
    Every American who wants a vaccine can get a vaccine. We 
are fortunate to have an excess supply to share with the world. 
It really is an amazing thing to be an American. But I want to 
remind us of where we were in February. And by us, I 
particularly mean Texans. The Houston Chronicle ran a story 
with the headline ``Nobody is Getting Enough: Why Texas Ranks 
Near the Bottom for COVID-19 Vaccines Per Capita.'' Again, of 
course, that is comparing to other Americans and other States, 
not the world.
    I would like to submit that article for the record.
    This wasn't an aberration. It was captured in a moment in 
time on January 14th. The CDC was reporting that total 
allocations to Texas were 7,602 doses for 100,000 individuals. 
On that day to the national allocation to the States was 9,339 
per 100,000 individuals. Fast forward to March 12th, where 
reporting shows that Texas was allocated 37,000 per 100,000 
individuals, compared to the national average of just under 
42,000 doses per 100,000 individuals.
    So the administration set out to allocate the most basic 
metric out there with population, but even a population-based 
formula will still have variances, and that is why my bill 
would require HHS to make their methodology public. I would 
love to see this committee continue a robust debate on how to 
prepare for pandemics. And I do think this bill will ensure 
that allocation transparency should be standard practice in the 
future.
    In addition, I am submitting for the record my letter to 
the GAO, asking them to investigate allocations, as well as a 
bipartisan Texas delegation letter to the CDC on this issue, as 
well.
    Thank you, Madam Chair. I will yield back the remainder of 
my time.
    Ms. Eshoo. The gentlemen yields back. It is a pleasure to 
recognize our resident pediatrician, whose name has been 
mentioned many times today by our witnesses.
    Dr. Schrier from the State of Washington, you have 5 
minutes for your questions, and thank you for your great work.
    Ms. Schrier. Thank you, Madam Chair, and thank you for 
those kind words. Thank you to all the witnesses who came to 
speak today.
    Yes, as both a pediatrician and a mom, I have been 
carefully watching the development and approval process for 
COVID vaccines in children, and also worrying about the drop in 
routine childhood immunizations during this pandemic. And this 
has been most dramatic in the tweens and the teens, many of 
whom are now missing the shots that protect them from 
pertussis, which is highly contagious, and HPV. So a big thank 
you, first to my colleagues, and to you, Dr. Maldonado, for 
your support of the Strengthening the Vaccines for Children 
Program Act.
    We just saw updated data from the CDC that, although 
immunization rates are improving, they still haven't sped up 
sufficiently to achieve catchup coverage. And since more than 
half of childhood vaccines are given through the VFC program, 
shoring up this already efficient program is critical, as we 
have all heard, to making sure all children get caught up on 
their shots.
    Also, given the drop in middle and high school vaccination 
rates, again, where it is most pronounced, I was really happy 
to see the CDC recommend that tweens and teens can get their 
COVID-19 shots together with their routine immunizations. It is 
absolutely the most expedient way of catching them up and 
getting it all done at their next doctor's visit.
    Dr. Maldonado, I trained at Packard Children's, and it was 
exciting that you are studying COVID vaccines in younger 
children there. And I have been following the discussion 
about--and even Dr. Burgess talked about this--kind of how you 
weigh the risks and benefits of the COVID vaccines in younger 
kids, particularly as community spread of the disease, 
hopefully, continues to drop.
    With current rates of disease, my assessment is that the 
risk of the disease, whether it is the acute or the multisystem 
inflammatory syndrome or long COVID, far outweigh the remote 
risk of mild myocarditis that might be associated with the 
second dose of an mRNA vaccine. That calculation could change, 
though, if vaccinations--if circulating levels of disease 
continue to drop. And so I was wondering if you could just talk 
about that balance and how you view that.
    Dr. Maldonado. Well, absolutely. And thank you, 
Representative Schrier, for all of the work you have done. And 
we recall your work here at Packard, of course.
    So I have been involved with the vaccine efforts from the 
beginning. And we have been part of the ACIP and FDA meetings 
from the very beginning of the pandemic, as well, and we have 
been following the data. And I think the issue is, as you 
mentioned, always a risk/benefit calculation. My sense is, as I 
mentioned earlier, that COVID is going to be--continue to be a 
major risk for children, even more than the vaccine could be, 
given how safe and effective these vaccines have been, given, 
as you have heard, that millions and millions of doses have 
been given with minimal safety signals. And in children we have 
seen the signal of potential for myocarditis.
    At this time it looks like, at the at the moment--and we 
will see an update from the ACIP on Friday--it looks like it is 
a signal of about 16 cases per million doses of vaccine given. 
So if, in fact, it is associated--and we don't know that yet, 
but if it is, the risk is extremely low. Not to undermine that 
at all, but when you consider how many children have been 
hospitalized and died from COVID itself and if you consider 
what may be happening with the Delta variant and the fact that 
the Delta variant has now been shown to actually increase the 
risk of hospitalization for people--in adults, obviously--we 
don't know the impact in unvaccinated children, because we 
won't have vaccines for kids under 5 for at least the end--
through the end of the fall, maybe even the winter.
    I do think that the risk/benefit needs to be looked at very 
carefully. I would have full confidence in the FDA and the CDC 
in helping us calculate those risks, but continue to think that 
those will be low, and we did write a commentary on----
    Ms. Schrier. Dr. Maldonado----
    Dr. Maldonado [continuing]. Just a couple weeks ago.
    Ms. Schrier [continuing]. I have just quick, yes-or-no 
questions for you, because, doctor to doctor, I have been 
seeing a lot of rumors about vaccines, and I wondered if you 
could help me dispel some myths.
    One, do mRNA vaccines change your DNA?
    Dr. Maldonado. Absolutely not.
    Ms. Schrier. Does the mRNA vaccine even enter your nucleus?
    Dr. Maldonado. No.
    Ms. Schrier. Does taking the COVID vaccine make you 
magnetic?
    Dr. Maldonado. No, not that I am aware of, but I would 
heartily say no.
    Ms. Schrier. Will the COVID vaccine insert some sort of a 
microchip into your body?
    Dr. Maldonado. No, no.
    Ms. Schrier. Does the COVID vaccine decrease fertility?
    Dr. Maldonado. No.
    Ms. Schrier. Now, do any of the vaccines we give today have 
long-term effects, other than long-term protection from 
disease?
    Dr. Maldonado. We are not seeing that signal. Of course, we 
don't have long-term data yet, but absolutely no long-term 
effects.
    Ms. Schrier. Great. So I had no hesitation about getting my 
12-year-old vaccinated. We are looking at a really fun summer, 
with sleepovers and summer camp. And thank you for all the work 
that you do.
    Dr. Maldonado. Thank you, as well.
    Ms. Eshoo. Wonderful yes-no series of questions, and thank 
you.
    It is a pleasure to recognize the gentlewoman from 
Massachusetts, Mrs. Trahan, a terrific new member of our 
committee.
    You are recognized for 5 minutes.
    Mrs. Trahan. Well, thank you, Madam Chair, and thank you to 
the witnesses here today.
    It has recently been reported that there is not one 
community in the State of Massachusetts that is in the red 
zone. And that is a huge milestone for the State as we continue 
to build back better. However, even in highly vaccinated States 
like Massachusetts, our job is not done.
    Dr. Ashish Jha, a physician and health policy researcher, 
and dean at Brown University, recently referred to 
Massachusetts as ``a tale of two cities when it comes to 
inoculation rates in the State's more affluent communities 
versus rates in historically underserved communities.'' And 
these disparities present themselves in my district and are 
reflected in States across our country, and are clearly driven 
by education levels, income, and race, and are all related to 
access.
    Lawrence, Massachusetts, is a gateway city in my district, 
where 80 percent of the city's residents are Hispanic or Latino 
descent, and 20 percent of the residents live at or below the 
poverty line. And throughout the pandemic, Lawrence has had to 
get really creative in their vaccination efforts. In March, 
Lawrence General Hospital launched a mobile vaccine program in 
an effort to bring vaccines directly to their residents. And 
this past weekend the city held a vaccine block party, with 
access to walkup vaccines, music, free food, and family 
activities. One hundred and fifteen individuals received their 
first dose at this event.
    But, despite all these efforts, inoculation rates in 
Lawrence are still trailing inoculation rates in other, more 
affluent communities across the State, a telling sign of the--
various cities like Lawrence still face.
    So, Dr. Tan, although Lawrence has taken creative steps in 
vaccine efforts to reach the most people, city officials have 
discussed with me and my team that having the mobile units and 
physical vaccines is one thing, but they still lack the 
appropriate resources for outreach and education and public 
health infrastructure to continuously put on vaccination events 
like the one they held this past weekend. Can you speak to how 
investments in a public health workforce and public health 
infrastructure in gateway cities like Lawrence is essential to 
getting through this pandemic and preventing a future one from 
occurring?
    Dr. Tan. Oh, thank you so much for that question. And 
absolutely I think, in these gateway cities like Lawrence that 
you are talking about, I think it is absolutely essential that 
we have a very strong public health department that is able to 
drive some of these--and sustain is the critical word--some of 
these innovative practices into the community.
    I don't think it is a one-time intervention. I don't think 
you can just drive a mobile van into a community and be done. I 
think it requires multiple efforts. So I think any kind of 
resources that we can give to these local public health 
departments to sustain some of these efforts is critical to 
maintaining this.
    And I build upon what we said earlier, and this idea that, 
once we do this, we are preparing ourselves for future 
immunization efforts and also for future pandemics, heaven 
forbid, should they show up again. So I think, absolutely, that 
is an important thing to think about.
    The public health infrastructure--I think Dr. Anne Schuchat 
in a New York Times piece said recently this was always the 
little engine that could, until COVID happened, then it was the 
little engine that couldn't anymore. I think we need to make 
sure that this little engine is no longer a little engine, but 
a big engine that can deliver all these lifesaving vaccines 
to--across the lifespan to our public. So thank you for the 
question.
    Mrs. Trahan. Oh, and thank you for the response.
    You know, certainly another group I want to make sure is 
adequately covered--and always is with Dr. Schrier on the 
committee--is our children and adolescents. You know, my own 7- 
and 11-year-old daughters are too young to get vaccinated at 
this time. However, we too are counting down the days until 
they are each able to get their COVID-19 vaccines.
    Due to the COVID-19 pandemic, routine vaccination rates, as 
well as pediatric visits, have declined. And, with school 
starting back up in just a few short months, the last thing we 
need coming out of the pandemic is an outbreak of another 
preventable virus. According to CDC, after initially decreasing 
in early 2021, adolescent hospitalization rates for COVID-19 
increased during March and April. So clearly, children are not 
immune to the serious effects of the coronavirus.
    So, Dr. Maldonado, as we get more creative in the way we 
are reaching folks with vaccinations, can you speak to the role 
that pediatricians and family physicians can play in educating 
families, boosting vaccine confidence, and reaching our 
children with vaccines?
    Dr. Maldonado. Well, as you probably know--thank you so 
much for this question, but as you probably know, when polled, 
it turns out that families trust their providers, their 
pediatric providers, almost more than any other person in their 
community. Pediatricians are really bonded together in terms of 
keeping children's health at the forefront.
    The American Academy of Pediatrics provides resources free 
to all providers. They actually provide resources on their 
website to families, toolkits, information, webinars. It is a 
constant supply of information. Pediatricians are extremely 
responsive to what the Academy does for them, and they have 
full confidence in that information.
    And, of course, we work with CDC and FDA and other partners 
to make sure that our information that we get from them is 
accurate and that we give them our concerns, as well.
    So keeping the pediatricians engaged, and keeping them 
enrolled, for example, with VFC and getting them to provide as 
many vaccines to as many children as possible is not only a 
good way to prevent diseases but also, as I mentioned earlier, 
to make sure that they can address other noninfectious issues 
that arise in these troubling times, when children have had--
suffered social, developmental, and mental health issues as a 
result of the pandemic.
    So thank you for that question.
    Mrs. Trahan. Thank you, Doctor.
    I am sorry for going over my time, Madam Chair. I yield 
back.
    Ms. Eshoo. You are welcome. It is a pleasure to recognize 
yet another one of our terrific doctors on our committee, the 
gentleman from California, Dr. Raul Ruiz.
    You are--you have 5 minutes for your questions.
    Mr. Ruiz. Thank you, Madam Chair. I am so proud that 
equitable access to COVID testing and vaccines have been 
highlighted by this committee throughout the duration of this 
pandemic.
    And I must say that this is a very good set of vaccine 
equity bills that we are putting forward. In particular, the 
bills by our very own pediatrician, Representative Schrier, 
Representative Kuster, Representative Barragan, and 
Representative Soto--those bills, in particular--will go a long 
way in reducing healthcare disparities in our Nation.
    When the first vaccines became available, there was concern 
that Black and Hispanic individuals would have greater amounts 
of vaccine hesitancy than White individuals. But that is not 
what I am seeing on the ground. I have gone into the hardest-
hit, hardest-to-reach Hispanic farm worker communities in my 
district to administer the vaccine, and I have heard their 
stories. The problem is not hesitancy, it is access. It is not 
about whether someone wants to get the vaccine, it is whether 
there are barriers preventing them from doing so.
    And I applaud the work of the Biden administration to give 
vaccines to--into the underserved areas of our communities 
through programs like direct distribution to retail pharmacies 
and FQHCs. It has made an enormous impact. And I know, 
firsthand, after organizing retail pharmacy mobile clinics, 
taking vaccines to the people in my district.
    The thing is, many of my constituents do not have a car, 
with limited access to public transportation. So, for many of 
my constituents, even getting to a pharmacy 5 miles away is 
difficult, as many cannot afford to take a lot of time off of 
work to get to a vaccination site.
    So today I want to talk about H.R. 3013, the COVID Vaccine 
Transportation Access Act, which authorizes grants to 
communities to provide transportation to vaccination sites. The 
bill was introduced by congressional Hispanic Caucus member 
Congresswoman Barragan, and I was proud to join her as one of 
the lead sponsors.
    Dr. Maldonado, can you address this issue and talk about 
the importance of removing last-minute barriers like the lack 
of transportation?
    Dr. Maldonado. Thank you, Representative Ruiz, for that 
question.
    I, too, helped organize some of the first testing sites 
here in our Santa Clara County area for our federally qualified 
health centers, as well as setting up vaccination sites and 
testing sites for some of our migrant farm worker camps in the 
area. So I know how important this work was, early on, in 
getting people vaccinated and making them aware of this 
disease. So I do think that it is a really important issue. We 
need to really underscore the importance of getting access to 
our population.
    The other thing that I noted, when I was taking care of 
patients--we have now since shut down our tents, they are 
bringing our patients in to clinics--but initially it was 
impossible to find transportation for sick people to come in, 
because of COVID restrictions. And especially for those who 
didn't have access to their own cars, we almost could not bring 
people in for treatment. It is a critical issue for children, 
as well as for adults, and the issue of equity is critical for 
all of us, not just for those populations, because as long as 
this virus circulates anywhere in our communities, anywhere in 
the world, it will affect each and every one of us.
    So I absolutely agree that bringing equity to this issue is 
so important to keeping the entire world healthy and safe. 
And----
    Mr. Ruiz. Thank you----
    Dr. Maldonado. I can't overscore that--underscore that 
issue. Thank you so much----
    Mr. Ruiz. Thank you. Right now our focus is on the critical 
issue of COVID-19 and vaccinations. But let's look beyond this 
immediate crisis and take some of the lessons we have learned 
from it and apply that to the future for all vaccines. Routine 
vaccinations are also critical for our public health, and these 
same barriers that exist for COVID vaccine access will continue 
to exist after the public health crisis is over.
    Dr. Maldonado, as a pediatrician, can you address the 
importance of access to routine vaccines for children, in 
particular, and how a grant program like this with 
transportation could help reduce those barriers?
    Dr. Maldonado. Absolutely. Transportation is an important 
piece of all of the puzzle pieces that it takes to keep 
children healthy and safe.
    And again, here at Packard Children's, we do have vans. We 
have access to vans that can go and transport children in and 
out, if we need them. But not everybody has that ability----
    Mr. Ruiz. Thank you.
    Dr. Maldonado [schedule]. To schedule a van, and we--it is 
critically important.
    Mr. Ruiz. Thank you. Well, as a student and an advocate for 
health equity to reduce disparities, my--almost my entire life, 
I am so enthusiastically waiting to vote these bills out of 
committee and send them to the House floor to make a lasting 
difference, once and for all.
    Thank you, I yield back,
    Ms. Eshoo. The gentleman yields back.
    Thank you, Dr. Maldonado, for raising the issue of the farm 
workers. Most people don't think, or wouldn't even guess, that 
we have farm workers as part of the Silicon Valley district 
that I represent. And yet they are there, and that they have 
your care is a great, great blessing.
    And speaking of blessings, the gentlewoman from California, 
Ms. Barragan, is recognized for your 5 minutes of questions.
    Ms. Barragan. Thank you, Chair Eshoo, for holding this 
important hearing, and including my bill, the COVID Vaccine 
Transportation Access Act, in the discussion.
    I also want to thank my committee colleagues, 
Representatives Cardenas, Clarke, Ruiz, and Soto, for 
cosponsoring this legislation.
    Our bill will create a grant program in HHS to remove 
transportation barriers in underserved communities, so people 
can not only get to COVID vaccine appointments but also future 
access for--appointments for boosters. This will help reduce 
disparities in access to care.
    Vaccinations are how we will finally defeat this pandemic. 
However, I have heard from many people in my district who want 
to get their COVID shots but don't have an easy way to get to 
the sites. One man told me about having to take three buses and 
travel for hours to get his vaccine. It is common sense: 
Removing barriers that prevent people getting to and from 
vaccine sites will increase the number of people who can get 
vaccinated.
    We have spoken about this a little bit, but Dr. Tan, can 
you discuss the continued need to provide underserved 
communities with help to get to and from vaccination 
appointments?
    Also, do you believe it is important to continue providing 
resources to these communities beyond what Congress has already 
allocated so that people in these communities are able to 
access COVID vaccine boosters--shots, as they become available?
    Dr. Tan. Oh, yes, absolutely. And I think, you know, beyond 
the communities of color that you have discussed and the 
communities of low socioeconomic status, I want to add older 
adults to that list, as well. I think we all know that 
transportation to a COVID-19 vaccination clinic can be 
challenging for those communities that we discussed.
    In particular, I think you want to think about issues that 
face these patients, such as, you know, do they--if you are 
older and vulnerable, do you want to be getting into, let's 
say, you know, Uber or Lyft van with someone who may not 
necessarily be protected?
    And I think finding alternative ways to get COVID-19 
vaccination sites, the patients--to get patients to these 
COVID-19 vaccination sites is incredibly important. So I 
actually agree with you that, if we can provide transportation 
solutions, we will also improve immunization coverage rates.
    Ms. Barragan. Thank you, Doctor. This next question is for 
you, as well.
    A recent report from the CDC released on May 28 found that, 
despite our best efforts, there are growing disparities in 
terms of COVID vaccination rates between communities that are 
affluent and those that are low-income and communities of 
color. Thus, communities that are more likely to be enrolled in 
the Medicaid are not achieving adequate vaccination levels, 
even through Medicaid, even though Medicaid covers the vaccine, 
its administration, and is the only publicly financed health 
insurance that guarantees nonemergency medical transportation 
to the vaccine site.
    Due to these disparities, wouldn't it make sense to 
incentivize States to remove barriers to nonemergency medical 
transportation and affirmatively reach out to Medicaid patients 
to schedule and transport them to a vaccination site by 
enhancing the Federal match rate to 100 percent for 
transportation to the vaccine site, as we have in the American 
Rescue Plan for Medicaid vaccine purchase and administration?
    Dr. Tan. So, yes. I think one of the things that we have 
always talked about is how do we get patients who are of lower 
socioeconomic status into vaccination access points.
    I think one of the challenges we face with that is, 
actually, not necessarily a transportation issue. So I think we 
need to look bigger than just transportation. We need to look 
at this idea that, with lower socioeconomic status families, it 
is also about time and resources. You know, ``Who is going to 
take care of my child if I have to go in and get vaccinated?''
    So I think transportation is, indeed, one very important 
component, but I think it is one component of a bundle of 
challenges that we face with these populations in order to get 
them into vaccination clinics, even if the vaccine is free, 
even if the administration fee is--there is no copay. I think 
we need to think and recognize that there are more broader 
challenges, of which transportation is indeed one of them.
    Ms. Barragan. Thank you very much for that, and for all of 
our panel today. It is important that we continue to work on 
ways to reduce the disparities and removing the barriers, 
including transportation.
    So thank you for having this hearing. And with that, Madam 
Chairwoman, I yield back.
    Ms. Eshoo. The gentlewoman yields back, and we thank her 
for her important work.
    Last but not least, the gentleman from Georgia, the 
pharmacist on the committee.
    You are recognized----
    Mr. Carter. Thank you, Madam Chair. I appreciate the 
opportunity. I appreciate all the panelists. This has been a 
good hearing----
    Ms. Eshoo. You are not in your car.
    Mr. Carter. I am not in my car. I am not, thank goodness.
    First of all, let me say that, you know, the administration 
has supported waiving the World Trade Organization's trade-
related aspects of intellectual property rights. And that is 
very concerning to me. My fear is that the administration lacks 
the understanding of this complex science and goes into 
biopharmaceutical innovation, or the economics, and--encourage 
private investment in new biotech products and vaccines.
    As a practicing pharmacist for over 30 years, I have seen 
what has gone into research and development, and I know how 
important intellectual property is to companies. And this 
really concerns me, that the administration is proposing to 
give the intellectual property of the vaccine to China--China, 
who--we know that this virus originated in China.
    My question to you, Ms. Arthur: Do you agree that a TRIPS 
waiver for COVID vaccines would discourage innovation and 
future investment in new cures and vaccines?
    Ms. Arthur. I do agree that this is not the right solution 
for bringing more doses to more people around the world. It 
would actually hinder the ability for companies to safely 
partner outside of the country with these new technologies. And 
it could also hinder companies' willingness to respond to the 
next pandemic, with all the great innovations that we have been 
working on.
    Mr. Carter. I couldn't agree with you more, Ms. Arthur.
    I mean, you know, the fact that these pharmaceutical 
manufacturers--and I know we talk about the price of 
pharmaceuticals being too high, I get that, and I happen to 
have the belief that it is--that a lot of the problem, most of 
the problem, is with the middlemen, with the PBMs, the pharmacy 
benefit managers, who are bringing no value whatsoever to the 
healthcare system but are responsible for what has been 
estimated to be 47 percent of the cost of medications.
    But in order for these pharmaceutical manufacturers to 
continue to invest in research and development, they need to 
know that their intellectual property is going to be safe. I 
mean, we have had 200 years of a patent system here in America 
that has worked and has led to nothing short of miracles in the 
way of drug development. And certainly what we have witnessed 
here with the vaccine, I think, will go down--and Operation 
Warp Speed will go down as being one of the great medical 
achievements of our generation. And for us to even consider--or 
for this administration, I say, I should say--to consider to 
give the intellectual property away, that is just insane to me.
    Ms. Arthur, what would be a better way for us to be able to 
get that--the vaccines to people who need it?
    I am OK sharing it. I am OK sharing. As long as Americans 
are taken care of first, we have access, then I am OK with 
that. What do you think would be the best way, Ms. Arthur?
    Ms. Arthur. So I think, first, we applaud the 
administration for doing one of the things we absolutely 
suggested, which was starting to donate. You just brought this 
up, Mr. Carter. And I think donating doses has been pivotal, 
particularly as we try to wait for the resolution of the crisis 
in India, which actually hampered some of the production that 
companies counted on to deliver doses to low- and middle-income 
countries. So we have to recognize this is a global system. And 
the more we can have high-income countries support donations of 
their doses to COVAX and other countries, the better off we'll 
be.
    And in the interim, the other thing we can do is absolutely 
get a free flow of goods, get the supplies we need, and 
manufacture doses both here in America and abroad through the 
great partnerships that are already happening in manufacturing. 
There is--over 250 partnerships that industries entered into 
with developing-country manufacturers all over the world to 
deliver doses as quickly as we can. And they are projected to 
make about 11 billion doses this year. That, coupled with the 
great donations promised by the G7 this week, should really 
help to get more doses to more people as soon as we can.
    Mr. Carter. And thank you for mentioning that. The obvious 
solution is to ramp up production here in the United States. 
That is the quickest way we can get it out there. It saves 
American jobs. It makes all the sense in the world to me. So 
thank you for bringing that up.
    Very quickly, Dr. Tan, I wanted to ask you--health savings 
accounts, they include vaccines as a reimbursable expense, and 
commercial insurance plans also cover [audio malfunction].
    Dr. Tan. I am sorry----
    Mr. Carter. [Audio malfunction] how high deductible health 
plans, coupled with health savings accounts, encourage and 
cover vaccines, and how we can apply those lessons to public 
programs like Medicare?
    Dr. Tan. I am so sorry, Representative Carter, I think you 
cut out on me a couple of times, so I didn't catch your whole 
question. I heard something about health spending accounts.
    Mr. Carter. Yes, commercial and private plans that are 
covering vaccines, and in combination with health savings 
accounts, don't you--I just wanted you to speak to how high-
deductible health plans, when they are coupled with health 
savings accounts, and how they can encourage and cover 
vaccines.
    Dr. Tan. I think that is certainly a wonderful option for 
those who have those accounts. I think we are--we also have to 
be aware that, you know, the access to those kind of accounts 
are not available to a lot of adults who are vulnerable to 
vaccine-preventable diseases. And so part of the great--the 
greatness of these two bills that we are looking at, you know, 
the Seniors Act as well as HAPI, is to try to actually remove 
those--the payment that is required there.
    I think, even with health service--HSAs, as well as high-
deductible plans, there is, obviously, that initial copayment. 
And unfortunately, a lot of times what happens then, again, as 
we have discussed many times, you know, even someone who is on 
those plans may not see that as the best investment of their 
copay dollars, if you get what I mean.
    So I think this is about equalizing it across, for all 
adults.
    Mr. Carter. Great. Well, I am over, Madam Chair, thank you 
for your indulgence, and thank all the panel for your testimony 
today, as well.
    Thank you, and I will yield back.
    Ms. Eshoo. The gentlemen yields back.
    I want to pay all the tribute that I possibly can to our 
witnesses today. You have been--you spent early morning, mid-
morning, late morning, early afternoon, now almost mid-
afternoon with us. So you have missed at least a couple of 
meals.
    But you have really advanced and broadened the case, 
relative to vaccines, whether it is for adults, whether it is 
for younger people or children, where are--the shortcomings are 
in our country, how we maintain innovation, but address the 
issues where there are shortcomings. I think this has just been 
a superb hearing, and it was because of you.
    And you gave us wonderful validation of the legislation, 
because today's hearing was a legislative hearing. And so you 
gave us excellent input on the legislation that we are 
considering. So on behalf of every member of the Health 
Subcommittee, I salute you and I thank you for your work. It 
really is your life's work, and our country is better because 
of you. And I couldn't mean that more. You are a blessing to 
our country, a true blessing to our country, so thank you. 
Thank you. Thank you. Thank you.
    And I know that you will respond to the questions that 
Members submit to you in writing. Many of them made reference 
to that. And if you can do so in as timely a manner as 
possible, we will all be better for that.
    So thank you to each one of you. Dr. Tan, Dr. Maldonado--I 
am just bursting with pride, I mean it, because she is my 
constituent. They are all so wonderful. But of course, we 
always have a special sense of pride when someone is testifying 
that we represent. And Ms. Coyle and Ms. Arthur, just A-plus, 
A-triple-plus. Gold stars. I am trying to think of what the 
nuns would always put on my papers if I did well. You deserve 
it all. So thank you to you, really. You moved the needle 
today. You moved the needle today.
    And now I have a unanimous consent request. To my friend, 
our wonderful ranking member, we have 10 documents, Mr. 
Guthrie. And there isn't anything in here that is, I don't 
think, objectionable. And we just hand-wrote some in that Mr. 
Crenshaw gave to us. So if you would like me to read them all 
out, I would be glad to, but----
    Mr. Guthrie. There is no need to read. And I don't--we do 
not object.
    And I just want to echo what you said to our witnesses. And 
the vaccines is certainly an example. Operation Warp Speed was 
Congress working together with the administration, both 
administrations, as we have switched administrations. And so 
when we work together, we do big things. So thank you, and 
thanks for our witnesses for being here.
    Ms. Eshoo. And thank you for being such a wonderful 
partner.
    For the Members that are still on board--maybe they are all 
gone--I want the members of the subcommittee to know that I am 
doing everything I possibly can to take up as many bipartisan 
bills in our subcommittee. Mr. Pallone is probably long gone 
from the hearing, but he can attest to the fact that I, during 
this period of time that we were at home, I would call him 
every single day--with the exception of Saturdays and Sundays, 
I gave him a break--but otherwise I was like gum stuck to his 
shoe to move these things.
    So we are doing everything--I am doing everything I can to 
take up as many bills as possible. Members, I think, deserve 
that kind of consideration of their bills. Certainly, the 
American people deserve the results of these bills, legislation 
that then becomes law, and the words walk right into their 
lives, into their daily lives.
    So thank you to all of the Members for your marvelous 
questions and participation. And again, to the witnesses, 
absolutely superb and outstanding. And on behalf of all of the 
Members, I once again thank you.
    So having--you have--Members, of course, have 10 days to 
submit additional questions for the record. And I have already 
asked the witnesses to respond as promptly as possible when 
they receive them.
    And without anything else here on my desk, I thank the--do 
I have something to hit my desk with here? My cup on the desk, 
how is that?
    The subcommittee will now adjourn, thank you.
    [Whereupon, at 2:23 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]

             Prepared Statement of Hon. Michael C. Burgess

    Over this past year, we have witnessed history with the 
development of the COVID-19 vaccine. As we will hear from our 
witnesses today, vaccines are safe and effective tools that 
have been proven to protect Americans from preventable, life-
threatening diseases. However, vaccines are only effective if 
people receive them, which is why I am grateful we are holding 
a hearing today on legislation which addresses barriers to 
vaccine access.
    One of the largest barriers to vaccinations is hesitancy. 
In my nearly three decades of medical practice prior to serving 
in Congress, I witnessed vaccine hesitancy firsthand. I would 
see college students opt not to receive the measles vaccination 
prior to a mission trip and return from Mexico sick with 
measles. The best medicine we have is preventive medicine, and 
vaccines are one of, if not the most powerful preventive tools 
in our toolbox.
    While the bills being discussed today are intended to break 
these barriers, I do question the necessity of some given the 
significant funding included in COVID response packages for 
this very purpose. With that being said, we have learned a 
great deal about vaccinations as we worked to immunize as many 
Americans as possible against COVID-19. Improvements must 
certainly be made to immunization infrastructure, vaccine 
confidence, and education. We have also learned a great deal 
about the importance of innovation, and how it saves lives too. 
That is why bills which increase support for public-private 
partnerships, like H.R. 3743, the Supporting the Foundation for 
the National Institutes of Health and the Reagan-Udall 
Foundation for the Food and Drug Administration Act, introduced 
by Rep. Hudson and Rep. Eshoo, are so important.
    Addressing barriers to immunizations is not a partisan 
issue. We have all witnessed the lives saved by vaccines since 
December. More than just the COVID-19 vaccine, immunizations 
protect not only the health of our own children but the health 
of entire communities. Parents who have babies too young to be 
vaccinated, or people who are too sick to receive vaccines 
count on others for high vaccinations rates.
    Thank you, Madame Chair, for holding this important hearing 
today, and thank you to our witnesses for being here.

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    [Ms. Arthur did not answer submitted questions for the 
record by the time of publication.]
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