Booster Shot: Enhancing Public Health Through Vaccine Legislation — House Hearing
Summary
Transcript of the virtual hearing "Booster Shot: Enhancing Public Health Through Vaccine Legislation" before the Subcommittee on Health of the Committee on Energy and Commerce on June 15, 2021, Serial No. 117-38. Opening statements are listed for Anna G. Eshoo, Brett Guthrie, Frank Pallone, Jr. and Cathy McMorris Rodgers. Witnesses included Yvonne Maldonado of the American Academy of Pediatrics, Rebecca Coyle of the American Immunization Registry Association and Phyllis Arthur, along with a witness from the Immunization Action Coalition. The bills before the subcommittee include H.R. 550, the Immunization Infrastructure Modernization Act, and H.R. 1978, the Protecting Seniors Through Immunization Act of 2021. The record notes that Ms. Arthur did not answer submitted questions for the record by the time of publication.
Summary drafted by a model from the document's text below and checked by script against that text before publication. It is a navigation aid, not a reading of what the document proves. Where AI is used
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“Booster Shot: Enhancing Public Health Through Vaccine Legislation — House Hearing.”
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[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.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[Ms. Arthur did not answer submitted questions for the
record by the time of publication.]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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