[House Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
ASSESSING AMERICA'S
VACCINE SAFETY SYSTEMS
PART II
=======================================================================
HEARING
BEFORE THE
SELECT SUBCOMMITTEE ON THE CORONAVIRUS PANDEMIC
OF THE
COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTEENTH CONGRESS
SECOND SESSION
__________
MARCH 21, 2024
__________
Serial No. 118-98
__________
Printed for the use of the Committee on Oversight and Accountability
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available on: govinfo.gov,
oversight.house.gov or
docs.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
55-222 PDF WASHINGTON : 2024
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COMMITTEE ON OVERSIGHT AND ACCOUNTABILITY
JAMES COMER, Kentucky, Chairman
Jim Jordan, Ohio Jamie Raskin, Maryland, Ranking
Mike Turner, Ohio Minority Member
Paul Gosar, Arizona Eleanor Holmes Norton, District of
Virginia Foxx, North Carolina Columbia
Glenn Grothman, Wisconsin Stephen F. Lynch, Massachusetts
Michael Cloud, Texas Gerald E. Connolly, Virginia
Gary Palmer, Alabama Raja Krishnamoorthi, Illinois
Clay Higgins, Louisiana Ro Khanna, California
Pete Sessions, Texas Kweisi Mfume, Maryland
Andy Biggs, Arizona Alexandria Ocasio-Cortez, New York
Nancy Mace, South Carolina Katie Porter, California
Jake LaTurner, Kansas Cori Bush, Missouri
Pat Fallon, Texas Shontel Brown, Ohio
Byron Donalds, Florida Melanie Stansbury, New Mexico
Scott Perry, Pennsylvania Robert Garcia, California
William Timmons, South Carolina Maxwell Frost, Florida
Tim Burchett, Tennessee Summer Lee, Pennsylvania
Marjorie Taylor Greene, Georgia Greg Casar, Texas
Lisa McClain, Michigan Jasmine Crockett, Texas
Lauren Boebert, Colorado Dan Goldman, New York
Russell Fry, South Carolina Jared Moskowitz, Florida
Anna Paulina Luna, Florida Rashida Tlaib, Michigan
Nick Langworthy, New York Ayanna Pressley, Massachusetts
Eric Burlison, Missouri
Mike Waltz, Florida
------
Mark Marin, Staff Director
Mitchell Benzine, Subcommittee Staff Director
Marie Policastro, Clerk
Contact Number: 202-225-5074
Miles Lichtman, Minority Staff Director
Contact Number: 202-225-5051
------
Select Subcommittee On The Coronavirus Pandemic
Brad Wenstrup, Ohio, Chairman
Nicole Malliotakis, New York Raul Ruiz, California, Ranking
Mariannette Miller-Meeks, Iowa Minority Member
Debbie Lesko, Arizona Debbie Dingell, Michigan
Michael Cloud, Texas Kweisi Mfume, Maryland
John Joyce, Pennsylvania Deborah Ross, North Carolina
Marjorie Taylor Greene, Georgia Robert Garcia, California
Ronny Jackson, Texas Ami Bera, California
Rich Mccormick, Georgia Jill Tokuda, Hawaii
C O N T E N T S
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Page
Hearing held on March 21, 2024................................... 1
Witnesses
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Patrick Whelan, M.D., Ph.D., Associate Clinical Professor of
Pediatrics, UCLA Division of Rheumatology
Oral Statement................................................... 5
David Gortler, Pharm.D., Senior Research Fellow for Public Health
Policy and Regulation, The Heritage Foundation
Oral Statement................................................... 6
Renee Gentry, Director, Vaccine Injury Litigation Clinic, George
Washington University
Oral Statement................................................... 8
Yvonne ``Bonnie'' Maldonado, M.D., Chief of the Division of
Infectious Diseases, Department of Pediatrics, Stanford
University School of Medicine
Oral Statement...................................................
Written opening statements and the written statements of the
witnesses are available on the U.S. House of Representatives
Document Repository at: docs.house.gov.
Index of Documents
----------
* Closing Statement; submitted by Rep. Ruiz.
* Closing Statement; submitted by Rep. Wenstrup.
* Statement for the Record, by Richard Hughes; submitted by
Rep. Ross.
* Statement for the Record, by AAP; submitted by Rep. Tokuda.
* Supplemental Information, from Dr. Wiseman; submitted by Rep.
Wenstrup.
Documents are available at: docs.house.gov.
ASSESSING AMERICA'S
VACCINE SAFETY SYSTEMS
PART II
----------
Thursday, March 21, 2024
House of Representatives
Committee on Oversight and Accountability
Select Subcommittee on the Coronavirus Pandemic
Washington, D.C.
The Select Subcommittee met, pursuant to notice, at 2:49
p.m., in room 2247, Rayburn House Office Building, Hon. Brad
Wenstrup [Chairman of the Select Subcommittee] presiding.
Present: Representatives Wenstrup, Malliotakis, Miller-
Meeks, Lesko, Joyce, Greene, Ruiz, Dingell, Mfume, Ross, and
Tokuda.
Dr. Wenstrup. The Select Subcommittee on the Coronavirus
Pandemic will come to order. I want to welcome everyone.
Without objection, the Chair may declare a recess at any
time.
Before I move on to opening statements, I want to go ahead
and remind the Members of all the rules of decorum. The issues
we are debating are important ones that Members feel deeply
about. And while vigorous disagreement is part of the
legislative process, Members are reminded that we must adhere
to established standards of decorum in the debate. This is a
reminder that it is a violation of House rules and rules of the
committee to engage in personalities regarding other Members or
to question the motives of a colleague. Remarks of that type
are not permitted by the rules and are not in keeping with the
best traditions of this committee. The Chair will enforce these
rules of decorum at all times and urge all Members to be
mindful of their remarks. If the Chair finds a Member to be in
violation, the member will be suspended from speaking for the
remainder of the proceedings.
I now recognize myself for the purpose of making an opening
statement, and now I guess I am talking to everyone, not just
the Members who aren't here.
Anyway, I want to welcome everyone to part two of a hearing
which we first held last month. During part one, I began by
saying that vaccines are crucial tools for public health which
save millions of lives, and I want to reiterate that today.
However, the utility of vaccines is dependent on the American
people's trust. Like any other medication, vaccines are only
useful when people trust that they are safe, and patients elect
to get vaccinated.
I have heard criticism that this committee is simply
seeking to rehabilitate the image of Federal agencies despite
their shortcomings during the pandemic, and I disagree with
that characterization. Rather, my goal is to reform these
agencies so they can earn the people's trust. You know, it is
easy to kick and scream about the Federal Government's
failures. It is quite another to actually fix the problems so
that we may do better the next time. That is really the goal,
but this can't be done without buy-in from all parties
involved, including from Federal agencies.
During part one, we heard from three of the Federal
Government's experts on vaccine safety, surveillance, and
compensation. We learned that the government was unprepared for
this massive wave of reports to its surveillance systems and
claims to its compensation programs. You do not expect a
pandemic every day. It is understandable. Today, we will hear
from nongovernmental experts who utilize these systems from the
other side, and it is important that the American people hear
from the doctors who actually treat COVID patients. I've said
that since the beginning of the pandemic. Unfortunately, during
the pandemic, it seemed that the loudest voices were
government, bureaucrats, and politicians, and I have found as a
physician and as a Member of Congress that Americans want to be
educated, not indoctrinated. It is key to the doctor-patient
relationship.
So, one doctor who was bedside during the pandemic is Dr.
Patrick Whelan. Dr. Whelan is a pediatric rheumatologist and an
expert in molecular biology and immunology. Now, Dr. Whelan has
co-authored a paper which studied COVID-19 vaccine trial data
and found excess risk of certain serious adverse events. Dr.
Whelan also submitted a VAERS report for a young child who
experienced a cardiac event after a second COVID vaccination.
Sadly, a week later that young man, that boy died. When Dr.
Whelan tried to update the report, he discovered that the VAERS
system is not set up to acknowledge updates such as this. VAERS
still lists the outcome as cardiac arrest.
Dr. David Gortler is a pharmacist and pharmacologist who
has experience as an investigational medicine scientist at
Pfizer, as a professor at Yale School of Medicine, and as a
medical officer and senior medical analyst at the FDA. Dr.
Gortler has submitted written testimony today which indicates
that the FDA systems and procedures for assessing and
regulating COVID-19 vaccines are inadequate. Among other
things, Dr. Gortler argues that the U.S. MedWatch surveillance
system, which includes VAERS, should be used more aggressively
to warn patients about adverse events.
We will also hear from an expert on vaccine injury
compensation. As I stated at the last hearing, the government
has assumed the responsibility to compensate for vaccine
injuries, however rare they might be. Yet, it appears the
government system may not be properly upholding this
responsibility, especially during a time of a pandemic.
Appearing before us today is Ms. Renee Gentry. Ms. Gentry is
the director of the George Washington University Vaccine Injury
Litigation Clinic and has practiced as a vaccine injury
attorney for more than 20 years. Ms. Gentry will testify
regarding Vaccine Injury Compensation Program and
Countermeasures Vaccine Injury Compensation Program, which
adjudicates claims for COVID-19 vaccines. In her written
testimony, Ms. Gentry has highlighted serious problems with
these systems, which require modernization. Ms. Gentry also
explains that the CICP gives the vaccine injured little more
than a right to file and lose. We can't be fully prepared for a
future pandemic until we properly address the shortcomings in
our vaccine safety systems and any other shortcomings that we
may recognize so that we can correct them.
I look forward to a robust and on topic discussion today,
and I would now like to recognize Ranking Member Ruiz for the
purpose of making an opening statement.
Dr. Ruiz. Thank you, Mr. Chairman, and thank you to the
witnesses for your participation in today's hearing. As we
discussed during the first part of this hearing series, our
Nation's vaccine safety systems play a critical role in
protecting public health. For decades, these systems, which
operate every day, thanks to the tireless work of our Nation's
scientists, physicians, and public health officials, have
helped ensure that the safest and highest quality vaccines and
medical countermeasures reach the American people, protecting
us from the threat of deadly diseases every day. And in the
midst of a once-in-a-century public health crisis, these
systems worked in tandem with the massive rollout of the safe
and effective COVID-19 vaccines, a campaign that allowed us to
put the darkest days of the pandemic behind us.
Working together, our Nation's public health officials,
physicians, and healthcare workers partnered to get shots in
arms, including through Federal initiatives and policies that
increased availability and encouraged uptake. At every step of
the way, they were united in putting patients first, and thanks
to these efforts, we were able to safely reunite loved ones,
turn the corner on the pandemic, and reopen schools,
businesses, and workplaces. In total, 3.2 million lives were
saved, 18.5 million hospitalizations prevented, and an
estimated $1.15 trillion in medical costs avoided.
And along the way, our vaccine safety systems functioned as
they should by collecting a wide breadth of data that has
overwhelmingly reaffirmed the safety and efficacy of COVID-19
vaccines while detecting safety signals for rare adverse
events. For example, during the pandemic, this system detected
cases of thrombosis with thrombocytopenia syndrome, or TTS,
linked to the Johnson & Johnson vaccine. When the safety
signals were identified, the CDC and FDA took swift actions to
update recommendations for vaccine products. During last
month's hearing, we discussed this example as a case study of
why it is so important that we continue to invest in our
vaccine surveillance systems. And we discussed the importance
of ensuring that there are adequate compensation systems in
place so that people who experience rare, yet serious adverse
events can receive timely compensation and access the care that
they need. So, by pursuing these two policies--robust vaccine
surveillance funding and necessary reforms to our Nation's
compensation programs--we can better prepare our Nation for
future public health crises and boost vaccine confidence in the
process. And in doing so we will keep COVID-19 at bay and
improve our defenses against a vast array of viruses that
threaten our public health daily.
So, this work could not be more important than at this
current moment. You see, we are at a tipping point when it
comes to vaccine confidence. A recent survey conducted by the
Annenberg Public Policy Center at the University of
Pennsylvania found that the number of Americans who viewed
vaccines as less than effective has increased since April 2021.
Americans are also now less likely to consider getting the
measles, mumps, and rubella vaccines than they were 3 years
ago. This is extremely troubling as we continue to see
outbreaks of measles due to waning vaccination levels that
threaten children's health across the country. In fact, the
United States may lose our measles elimination status that we
have held for the last 24 years. We must correct course before
it is too late.
Approaching each opportunity to discuss this topic with
care, collaborating with community-based organizations on
vaccine outreach, and strengthening access to care are all
critical components of this work. Just as critically important
is continuing to work with physicians and healthcare leaders to
enhance trust in public health. As a physician, I understand
that stronger collaboration between providers, patients, and
policymakers is the key to solving the challenges in public
health that we face. So, I hope that today's discussion fosters
that collaboration and that we come away from this discussion
better prepared for the future. I yield back.
Dr. Wenstrup. Thank you very much. I am going to introduce
our witnesses now. Some of the accolades I may have already
mentioned, but we will go through them. I think it is
important.
Dr. Patrick Whelan. Dr. Whelan is an Associate Professor of
Pediatrics at UCLA, Adjunct Professor in Molecular Microbiology
and Immunology at USC, and Lecturer in Pediatrics at Harvard
Medical School.
Dr. David Gortler. Dr. Gortler is a pharmacist and
pharmacologist who has worked at Pfizer, Yale Medical School,
and the FDA. Dr. Gortler is currently a Senior Research Fellow
for Public Health Policy and Regulation at the Heritage
Foundation.
Ms. Gentry. Ms. Gentry is the Director of the Vaccine
Injury Litigation Clinic at the George Washington University.
Dr. Yvonne ``Bonnie'' Maldonado. Dr. Maldonado is the Chief
of the Division of Infectious Diseases, Department of
Pediatrics at Stanford School of Medicine.
Pursuant to Committee on Oversight and Accountability Rule
9(g), the witnesses will please stand and raise their right
hands.
Do you solemnly swear or affirm that the testimony that you
are about to give is the truth, the whole truth, and nothing
but the truth, so help you God?
[A chorus of ayes.]
Dr. Wenstrup. Thank you. Let the record show that the
witnesses all answered in the affirmative. The Select
Subcommittee certainly appreciates you all being here today for
this event, and we look forward to your testimony.
Let me remind the witnesses that we have read your written
statements. They will appear in the full record on the hearing,
but please limit your oral statements to 5 minutes at this
time. And as a reminder, press the button in front of you on
the microphone so that it is on, and members can hear you. And
when you begin to speak, the light in front of you will turn
green. After 4 minutes, the light will turn yellow, and when
the red light comes on, your 5 minutes has expired, and we ask
that you wrap things up.
I now recognize Dr. Whelan to give an opening statement.
STATEMENT OF PATRICK WHELAN, M.D., PH.D.
ASSOCIATE CLINICAL PROFESSOR, PEDIATRICS
UCLA DIVISION OF RHEUMATOLOGY
Dr. Whelan. My thanks to Dr. Wenstrup and Dr. Ruiz and all
the members of the subcommittee for inviting me today to
contribute to your deliberations on our vaccine safety systems.
Allow me to make clear that I am speaking in my own capacity as
a physician and researcher and not on behalf of any of the
institutions with which I have been affiliated. I completed a
Ph.D. in microbiology and immunology and had the privilege as a
young man to care for Dr. Jonas Salk when he was a patient
toward the end of his life. My day job is as a rheumatologist
in Los Angeles, and as Dr. Wenstrup mentioned, I have been
lecturing for the past 13 years in virology at the University
of Southern California. And I have also had the privilege of
being affiliated for nearly 30 years with Harvard Medical
School in Boston, and I still teach a Harvard extension course,
an undergraduate course in the spring.
During the pandemic, I cared for innumerable pediatric and
adult COVID patients, and I hold the CDC and the FDA in the
highest regard. In November 2020, I chaired a study group for
the American College of Rheumatology that was focused on COVID
vasculitis, and it was attended virtually by nearly a thousand
rheumatologists. I appreciated that day that the mRNA vaccines
then under development were novel in a way that was not widely
appreciated. They encode the very protein that itself is
causing the respiratory failure in those who were most severely
affected by the disease. This is in contrast to the other
vaccines that we depend on, which are either attenuated live
virus vaccines like measles, mumps, rubella; non-pathogenic
component vaccines like the Hepatitis B virus; or inactivated
toxins like tetanus toxin.
In December 2020, on the eve of the first advisory
committee hearing to consider approval of the Pfizer vaccine, I
wrote a letter to the FDA pointing out a new study that found
enduring myocarditis in two-thirds of healthy young people who
had been infected with COVID. I urged the committee then to
specifically assess the effects of vaccination on the heart and
suggested that although everyone wanted to quickly bring the
pandemic to an end, it would be worse if we failed to
anticipate long-lasting side effects of these new vaccines. I
never heard back from anyone at the FDA, but no vaccine or
other drug is perfect, and we shouldn't have been surprised
when a few months later reports emerged about young people
presenting in emergency rooms with elevated heart enzymes
following vaccination.
I subsequently joined a group of epidemiologists who
analyzed the data that had been collected by Pfizer and Moderna
in their randomized controlled trials prior to the emergency
use authorizations, and we attempted to calculate the precise
incidence for serious adverse events, or SAEs, in adults who
receive these experimental vaccines. We discovered that in the
Pfizer trial, there was one additional serious adverse event
for every 556 people vaccinated, or about 1,800 for every
million. Yet, the regulators at that time conveyed the
impression that there were no major safety concerns. Our peer-
reviewed study was published in the journal, Vaccine, in 2022.
At a personal level, as Dr. Wenstrup mentioned at the
beginning, I took care of a young boy who suffered a cardiac
arrest in our emergency room shortly after receiving his second
COVID vaccination. I filed the VAERS report at the time, and I
felt it was my civic duty. I had filed other VAERS reports
previously, but when the patient died a week later, I tried to
update the report, and the system is not set up to do that,
which led me to believe that the system underestimates the
incidence of more severe outcomes since many children and
adults who are very sick and later die, they are going to get a
VAERS report filed initially.
I do not know how many people are available at the FDA to
followup on the more than 1.7 million VAERS complication
reports that have been filed the past 3 years. But I feel
strongly that we must work proactively in our public health
system, both to accurately identify the true risks of all
medications, including vaccines, but also that we must have the
courage to trust Americans with this information in a spirit of
ethical informed consent. Hopefully, we will ultimately know
the true long-term risks and benefits of these vaccines that
have been given now to nearly three-quarters of the world's
population. Thank you again for the honor of meeting with you
today.
Dr. Wenstrup. Thank you. I now recognize Dr. Gortler to
give an opening statement.
STATEMENT OF DAVID GORTLER, PHARM.D.
SENIOR RESEARCH FELLOW
PUBLIC HEALTH POLICY AND REGULATION
THE HERITAGE FOUNDATION
Dr. Gortler. Thank you, Dr. Wenstrup, Dr. Ruiz, and
Members. The views I express in this testimony are my own and
do not necessarily represent any official position of the
Heritage Foundation.
The drugs we take and the food we eat are the most
regulated things in the world, despite many people thinking
that it is things like guns or airplanes or cars. Since most
people know at least a little bit about cars, I am going to use
a car analogy to compare COVID mRNA injections to development
of a new car. Let's say that it normally takes 10 to 12 hours
to assemble a car, representing the 10 to 12 years that it
takes to bring a vaccine to market. Let's also say that due to
some sort of emergency, new cars would be jammed down the same
assembly line in just 45 minutes instead of 10 to 12 hours,
representing the relative 9 months it took to bring COVID RNA
injections to market. Let's also suppose that those cars are
something completely different from what you know as cars. I
don't just mean the next cool-looking car. I mean something
visibly and technologically unrecognizable.
Whatever advanced car you are picturing in your head right
now, it is not that. It is something more complex. On top of
the novel design of the car, all of the parts of that car are
new. The new car being produced might not have wheels, a brake
pedal, a windshield, for instance. Let's also say that it was
not powered by electricity or combustion either. Instead, it
uses your body as a fuel source. Not only are all the parts
new, but the materials used to manufacture those parts are new,
with decades of research showing them to often be extremely
delicate, finicky, or toxic, representing the fully synthetic
RNA nucleotide and lipid nanoparticle components. Of note,
since the development and review time was reduced by over 90
percent, even if the slightest error was made to those ultra
complex cars, the car might not work at all and/or could be
extremely unsafe and/or highly unpredictable for you, your
family, friends, and fellow drivers.
Let's also say that the new car was so novel and different
from every other car on the road that it did not even meet the
current definitions of car. Rather than call it what it was,
the National Highway Traffic Safety Administration unilaterally
altered its 100-year-old plus definition of a car on its
website overnight without seeking outside input. This
represents the CDC's fall of 2021 abrupt definition change of
vaccines versus gene therapy.
If a curious material scientist or engineer wanted to
perform research about the design and materials used in this
new car and replace some critical technical information, 70
percent of the document would be grayed out with (b)(4)
redactions, translating to ``protects trade secrets and
confidential commercial or financial information.'' In other
words, the engineering blueprints and materials used to build
that car were secret despite taxpayer dollars being used to
research and produce those cars.
Let's compare that new car to an existing car. To keep
expenses low, I personally prefer to drive a very specific
older car, which is a true story, by the way. It is nowhere
near as fancy or elaborate or laden with features, but it is
inexpensive and quite safe, just like ivermectin,
hydroxychloroquine, vitamin D, and other COVID treatments.
Let's also say my old car was so safe and reliable that it won
the Nobel Prize. While my 1995 Lexus LS400 never received a
Nobel Prize for medicine, the Japanese inventor of ivermectin
did in 2015.
Despite that, 1 day the government, who does not have
congressional authority to recommend what available cars to buy
or not buy and has never done so in the past, proclaims that my
Nobel Prize-winning car should now only be driven by horses and
cows, as per the FDA's famous tweet. Now, they are not
recalling the car, but they are screaming from on high their
unmistakable disapproval, mocking patients and physicians who
drive it. Of note, the FDA has no congressional authority to
recommend one drug or medical treatment over another and has
never done so in the past. Several obsequious state pharmacy
boards take it to the next level and use the FDA's implication
to forbid the use of my traditional car to anyone other than
horses or cows as 20,000 career FDA employees remain
conspicuously silent.
Today, over a hundred studies published by over 1,100
authors conducted in over 140,000 patients in 29 countries show
a statistically significant lower risk for mortality,
ventilation, ICU, hospitalization, recovery incidents and viral
clearance for ivermectin. Similarly, positive data is
associated with the use of vitamin D and hydroxychloroquine.
How peculiar is it that some of the same politicians who
believe it is OK to legalize hard street drugs such as heroin
and methamphetamines have a cow when it comes to ivermectin,
hydroxychloroquine, vitamin D, and other protocols to COVID? To
the country's physicians and pharmacists who prescribed
ivermectin or hydroxychloroquine, I would like to tell you
right now, you were right. The pharmacy boards were wrong,
period. I would bet you my prized 1995 LS400 on it.
To summarize, medical scientists not only have the right,
but the duty to ask questions about the safety and
unnecessarily complex pharmaceuticals jammed through an
expedited review process when there are inexpensive,
undebatably safe, and effective alternatives available.
Academic medical discourse should be encouraged, not quelled.
Thank you very much. I look forward to cultivating an academic
exchange with everybody here.
Dr. Wenstrup. Thank you. I now recognize Ms. Gentry to give
an opening statement.
STATEMENT OF RENEE GENTRY
DIRECTOR
VACCINE INJURY LITIGATION CLINIC
GEORGE WASHINGTON UNIVERSITY
Ms. Gentry. Thank you, and good afternoon. Thank you to
Chairman Wenstrup, Ranking Member Ruiz, and members of the
subcommittee for this opportunity to discuss a critical
national public health issue. This afternoon, I hope to be able
to give you the perspective of the vaccine injured, a voice
that often gets lost in the debate. My colleagues and I believe
strongly in the importance that vaccines play in our society in
eradicating diseases and curbing pandemics. Having said that,
vaccine injuries while rare in the vaccinated population, are
real.
Routine and pandemic immunization programs are the
cornerstone of our public health policies. The success of those
immunization programs relies on public confidence in vaccines.
A critical component of vaccine confidence is ensuring that
those rare individuals who are injured by vaccines have a
reasonable and effective forum in which to make their claims
and an experienced bar to represent them. The VICP needs
modernizing to shift from the aspirations of 1986 when it was
created to reflect the realities of 2024 and our current public
health needs. Much has changed in the nearly 40 years this
program has existed. Congress intended that the VICP provide
individual petitioners a swift, flexible, and non-adversarial
alternative to the often costly and lengthy traditional tort
civil litigation system. You cannot file a lawsuit against a
manufacturer or administrator of a covered vaccine without
going through our program first.
While imperfect, the VICP was tremendously successful in
its first 30-plus years. New vaccines were developed at such a
rate that the program grew from six covered vaccines to 16.
Very few petitioners rejected the decision of the vaccine court
and filed suit against a manufacturer, and fewer still opted
out of the program at the 240-day mark when they are permitted
to pursue civil litigation if their claim has not been
processed. This reality perfectly reflected Congress' intent
that petitioners be compensated quickly and generously by
making the VICP a reasonable and meaningful alternative to
civil litigation.
Three procedural events have resulted in the VICP being
overwhelmed at this point. The addition of the influenza
vaccination in 2005 resulted in the pool of potential
petitioners being exponentially increased as obviously the
influenza vaccination is generally recommended to everyone,
adults and children, every year as opposed to the typical
childhood vaccines. In 2015, two additional vaccines were
added, the HPV and meningitis vaccines, which once again opened
the VICP up to additional potential claims. Finally, in 2017,
two significant table injuries were added: SIRVA, the shoulder
injury related to vaccine administration, which is associated
with nearly all the covered vaccines on the vaccine injury
table, and Guillain-Barre Syndrome, following the influenza
vaccination.
The collective effect of these procedural changes was to
triple the workload of the special masters in the vaccine
court, the number of whom are still statutorily restricted to
eight--eight special masters with a caseload, as of last
Friday, of 3,618 cases. As a result, it is now the norm in the
vaccine court to wait 2 years for a trial date after having
already waited, in some instances, years for a record to be
ripe for trial. There are simply no spaces on the court's
docket. Today, through no fault of the special masters,
vaccine-injured children and adults wait years, often without
the ability to pay for critical time-sensitive therapies for
the vaccine court to even be able to award compensation. To be
clear, these crushing delays are not because vaccines are less
safe but because the VICP's infrastructure has not been updated
to reflect current public health policy, and we fully expect
the ongoing development of new lifesaving vaccines. Children
are not the only ones that get vaccinated anymore, as we all
know.
Even more concerning is the fact that this reality does not
yet reflect the addition of the COVID-19 vaccines, which I
strongly believe are more suited to the VICP than the
Countermeasures Program. Unlike the VICP, those injured by
COVID-19 vaccines and restricted to the Countermeasures Program
have no right to counsel, no right to appeal, no pain and
suffering awards, and significant limitations on economic
damages. I have not heard of a single person currently engaged
with the Countermeasures Program for the COVID-19 vaccine that
feels as though their voice was being heard. This is driving
vaccine hesitancy in individuals who have previously been
vaccinated and were pro-vaccine.
Finally, it is critical to distinguish the vaccine injured
from the anti-vax. All of my clients were vaccinated. They
suffered real and often catastrophic injuries that are
supported by medical and scientific literature and expert
opinion. The well-meaning, the often dismissive and critical
comments of the pro-vaccine side directed at those individuals
asserting vaccine injury also creates and bolsters vaccine
hesitancy in those individuals who were previously vaccinated
and are pro-vaccine. The vaccine injured that I and my
colleagues represent are not anti-vax. That is a critical
distinction that I hope you take with you as you look for
solutions to the challenges the VICP currently faces. Thank
you.
Dr. Wenstrup. Thank you. I now recognize Dr. Maldonado to
give an opening statement.
STATEMENT OF YVONNE ``BONNIE'' MALDONADO, M.D.
CHIEF OF THE DIVISION OF INFECTIOUS DISEASES
DEPARTMENT OF PEDIATRICS
STANFORD UNIVERSITY SCHOOL OF MEDICINE
Dr. Maldonado. Thank you, and good afternoon. Chairman
Wenstrup, Ranking Member Ruiz, and distinguished members of the
subcommittee, thank you for the opportunity to testify. I am a
pediatric infectious disease physician, epidemiologist, and
vaccine researcher at Stanford University School of Medicine. I
led the COVID-19 response at my institution, including scaling
up testing capacity and clinical trials for vaccines and
therapeutics, as well as caring for thousands of seriously ill
patients.
The decision at its core to use any medical product is a
risk-benefit analysis. Decades of data underscore the enormous
benefits of vaccines. Early in my career, I routinely saw
children dying or suffering from severe health problems due to
infectious diseases. We no longer see these deaths and
complications in the United States thanks to vaccines, and, as
a result, some individuals may not understand the benefits that
vaccines have provided, especially to our children. But
vaccines remain critically important, as you have heard, and
prevent tens of thousands of deaths from vaccine-preventable
diseases every year.
COVID-19 vaccines are safe and provide protection against
hospitalization and death and reduce the risk of long COVID
and, in children, MIS-C. COVID-19 vaccination has also had
tremendous societal benefits, including preserving our health
system's capacity to care for patients and facilitating a
return to normalcy. Early in the pandemic, there were rare
instances of teenage boys and younger men experiencing heart
inflammation, which happened about as frequently as being
struck by lightning, about 1 in 10,000 vaccinations. Most of
these people responded well to medicine and rest and felt
better quickly. This small risk is even less now that we have
safety recommendations like spacing out vaccines for young men
and women. COVID-19 infection is also much more likely to cause
heart damage and other severe events than the vaccine. A study
of over 20 million people published this month found, for
example, that COVID-19 vaccination significantly reduced post
COVID-19 cardiovascular complications, including myocarditis,
heart attack, and stroke.
COVID-19 vaccines were rigorously evaluated in large
clinical trials, through which scientists gathered significant
safety and efficacy data from diverse populations. Healthcare
workers like myself were among the first to be vaccinated,
demonstrating that experts across the country had great
confidence in the vaccine safety and effectiveness. As I said,
any medical product carries some risk, and it is critical to
have robust systems in place to monitor for adverse events and
compensate individuals who are harmed. These programs are a key
component of broader efforts to boost vaccine confidence.
Sometimes rare events may occur after vaccination that are
too rare to be identified within clinical trials. Vaccine
Adverse Event Reporting System, or VAERS, is explicitly
designed to cast a very broad net to capture all potential
adverse events that may occur following a vaccine. Reports are
investigated, and most severe events are ultimately found to be
unrelated to the vaccine. In other words, correlation does not
equal causation, and severe adverse events associated with
COVID-19 vaccines continue to be rare.
When investigations indicate a serious risk associated with
a vaccine and vaccine policies and recommendations are updated
accordingly, this indicates that our vaccine safety systems are
working. One example is the investigation into reports of TTS,
which we heard earlier, which led to a pause in the use of the
Janssen COVID-19 vaccine and, ultimately, a recommendation for
the preferential use of mRNA COVID-19 vaccines over the Janssen
product, which is no longer used in the United States. In the
rare event when an individual is harmed by a vaccine, it is
important that they can receive compensation, which is the
purpose of the Vaccine Injury Compensation Program, the VICP,
and the Countermeasures Injury Compensation Program, CICP.
COVID-19 vaccines are currently covered by the CICP, which has
been underfunded as compared to the VICP. Bipartisan
legislation has been proposed to move COVID-19 vaccines to the
VICP and strengthen the Federal response.
In the years leading up to the COVID-19 pandemic, our
public health system was chronically underfunded, which has
negative repercussions across public health, including vaccine
safety monitoring. While Congress appropriated emergency
funding for the COVID-19 response, providing adequate funding
for public health before an emergency occurs is critical to
ensure that we have a sufficiently trained work force and
infrastructure. Thank you again for the opportunity to testify
and for your efforts to boost vaccine confidence and uptake.
Dr. Wenstrup. Thank you. I now recognize myself for
questions and a few comments.
You know, one of the things with COVID itself that makes it
very difficult is there is so many people that got COVID and
did not even know they had it. And so, if you are trying to say
that it was safer to have the vaccine as opposed to getting
COVID, it is very difficult because many patients got COVID and
did not know. I did not know until I could not smell garlic
salt. So, I just think we have to keep that in mind when we
have a frank discussion about the benefits and risks of getting
COVID, getting COVID at a certain age, getting COVID with
certain comorbidities. All those things have to be discussed,
but we can't ignore the fact that many people got COVID and did
not even know it, so that is one thing. But Dr. Maldonado, do
you think it is important to have a frank discussion with
patients or, in your case, the parents of children to discuss
the benefits and risks of virtually any medication, but
especially vaccines?
Dr. Maldonado. Absolutely. I believe that the bond between
a physician and a parent and a patient is sacred and really
should be transparent.
Dr. Wenstrup. Yes, and I think that is one of the things
that we missed. When we started putting out mandates, you
eliminated the physician, and that is what a lot of people
struggled with, which, in my opinion, has led to many people
having vaccine hesitancy. When I say, ``my opinion,'' it is
because we are out with our constituents all the time and we
get their opinion. And so that is a difference between, say,
just working in a lab or in an agency. You know, we are
actually out with the people and understand what is going
through their minds.
You know, during part one, I asked our government witnesses
to acknowledge that they were, well, too general in their
assertions that the vaccine was safe and effective. I said at
the time, to the American public, many of them heard ``100
percent safe and effective.'' That is what they interpreted
that to be, but they never qualified their statement. You know,
like any drug you see on TV, they say talk to your doctor. That
wasn't happening. You had the government saying safe and
effective, no qualifier, not talk to your doctor. And so, from
what I understand, the FDA standard of safe and effective is
actually very specifically defined. So Dr. Gortler, if you can
very quickly let me know, does the FDA have different standards
for EUA and full BLA approval? Could you explain the
difference, if there is one?
Dr. Gortler. Oh, sure, and Dr. Wenstrup, I appreciate the
question. I would also like to point out that one of my
colleagues, Dr. David Weisman, pointed out to me yesterday that
the approval language in Europe is actually a little bit
different where it says, ``safe and effective.'' I think they
precursor those words with maybe ``safe and effective.''
Dr. Wenstrup. So, what about ours?
Dr. Gortler. So, with ours, I believe the way the approval
process works is, once it is authorized one way or another, it
is authorized. You know, we heard, like, Operation Warp Speed,
and, you know, Operation Warp Speed, while it was kind of, you
know, a cool idea with underlying themes of, you know, the
person who conceptualized it with Yale and ham radio and Star
Trek, of course, I would have just liked to have seen something
a little bit simpler.
Maybe I am a little bit of a Luddite, a Philistine,
perhaps, but I would be interested in seeing what already
exists in our toolbox that isn't quite as complicated. And for
instance, just to let you know, the molecular weight of
hydroxychloroquine is about the same molecular weight, size as
Tylenol, about 300 daltons. In contrast to that, we do not know
what the exact structure is, or the exact molecular weight is
for the spike protein encoding for RNA, but just the spike
protein alone is, like, 4,000 bases, which is about 200,000
daltons compared to about 300 daltons. I would have liked to
have seen an Operation Warp Speed for things like ivermectin,
hydroxychloroquine, vitamin D, maybe colchicine, midodrine,
metformin----
Dr. Wenstrup. Let me get to a different question or maybe
get more specific. Are the systems that we have in place, in
your opinion, adequate in ensuring the safety of COVID-19
vaccines?
Dr. Gortler. The question is for me, sir?
Dr. Wenstrup. Yes.
Dr. Gortler. No, they are not, and I can explain why. I do
not think the collection systems are adequate for the following
reasons. As a physician, you will know, and there are other
physicians in here, a normal physician visit is usually billed
out as a code, not ICD-10, but whatever the code is. It is
99213 for a 15 minute----
Dr. Whelan. CPT.
Dr. Gortler. A CPT code--thank you--is a 99213, and 99213
pays a physician something like $75 to be able to, you know,
interview, assess, diagnose, and prescribe. And if a patient
were to report an adverse event during one of those events, a
physician wouldn't really have the time to collect it and go on
the phone and spend an hour with the FDA MedWatch system.
Likewise, a pharmacist is also someone who receives quite a bit
of safety complaints. But a poor pharmacist, you know, working
behind the counter at one of these grueling chain pharmacies,
you know, they have metrics by their employer, and their
metrics are to hammer as many round pegs in a round hole as
fast as they can, and there is no protocol. There is no way to
reimburse for them to be able to report adverse events.
And so, because of that, there was a study funded by the
AHRQ that came through out of Harvard that found that it is
only the very, very low digits, like 1 percent, the very, very
low single digits of adverse events ever reported to VAERS, and
I think there needs to be a better collection method. There
needs to be more vigilance about reporting by healthcare
professionals. Does that answer your question?
Dr. Wenstrup. Thank you. Yes, it does, and, yes, we also
have concerns of reported versus verified significant event, et
cetera, and that is the type of stuff we want to be better at.
Dr. Whelan, do you believe that it is appropriate to house all
of the potential updates and corrections to VAERS on a non-
public data base?
Dr. Whelan. I think that there is a lot of trust involved
in the medical community, but also for the general public, that
something is happening behind the scenes when you can't see it
right out in front. And I think, two, that people were very
aware that you did not have the kind of followup on vaccination
generally that we expect, for instance, from our pediatricians,
where you got a nurse who is going to call the following week
and make sure that your child is doing OK. And, I mean, my own
strong feeling is that we really needed a much more proactive
surveillance mechanism, and I think that many of us understand
that the FDA was under enormous pressure and also that it was
an overwhelming task. And just judging by the number of VAERS
reports that there have been and knowing how challenging it can
be to actually file a VAERS report, the task could have been
even vastly larger than the large task that it already is.
I mean, you have to have some level, I think, of internal
dialog that takes place. But I think ultimately, as you alluded
earlier, you have to be able to create some level of trust
among people, and I think the system currently does not
cultivate that.
Dr. Wenstrup. Yes. Look, there is no doubt it is a
challenge, you know. You might have 10 adverse events from
vaccines in a year, and then all of a sudden you have a
pandemic and a new vaccine, and the numbers are huge. How do we
prepare for that? And those are some of the things that we
wanted to discuss here. I will say, Dr. Whelan, the government
witnesses in part one of this told us that all serious reports
to VAERS are followed up on, and there is not a timeline on
that statement. But do you believe that the government is
adequately following up on all serious reports to VAERS, and
what might we do to improve on that?
Dr. Whelan. I do not have any high-level view of how often
and how closely they followup, but in my own anecdotal
experience, there was not a sense of urgency. Because I was a
co-author on this paper, I had an opportunity to speak directly
with Dr. Marks, who spoke at your previous hearing, and they
were in the process of sort of, you know, critiquing our work.
When I mentioned that I had had this patient who died, the
whole tenor of the discussion completely changed. But even then
it was a whole month before I was able to speak with somebody,
and I have never received any followup about it later. I am not
sure that they ever obtained the records on that particular
case, so we were kind of left with the sense that if there was
followup, they didn't do much in the way of follow through
afterwards.
Dr. Wenstrup. Thank you. Just a quick question for Ms.
Gentry because I think in your opening statement you made many
good points in your concerns for the compensation systems in
place. And can you give us some idea of how we should change
how our system works currently?
Ms. Gentry. The VICP specifically?
Dr. Wenstrup. Oh, we can start with that. Yes.
Ms. Gentry. Sure. I think certainly the main thing with the
VICP that we have seen is that it just needs to be modernized.
I mean, this was originally the National Childhood Vaccine
Injury Compensation Program. And as we all know, adults
routinely get vaccines now, and they have always been covered,
but it needs to be expanded. Certainly, when I say
``infrastructure,'' we need to have an increase in special
masters, to be sure.
HHS and the Department of Justice that represents the
Secretary in these cases needs to have adequate compensation or
adequate funding rather to make sure that they can do that. We
see long delays at HHS in processing petitions because they
have so few reviewers to do that. And they were also deployed
during COVID away from it, so I think there is certainly some
delays in that. That needs to be updated. We are still looking
at compensation from the 1980's for these cases, so you are
looking at a death case being capped at $250,000 in the VICP.
Pain and suffering is capped at $250. There are, thankfully, no
caps on economic damages in the VICP, which is great. Those
rare individuals with serious injuries have additional care,
life care plans that can come into effect. That is critical.
From the standpoint of the Countermeasures Program, you
know, when you don't hear much about it, it usually means it is
doing fairly well, and when it starts to have an issue is when
you start to hear about it. And I think the first big hit that
it took was with the H1N1 vaccine back in 2009, and those cases
went into to the Countermeasures Program. That was a big chunk
of cases, but nowhere near what we are seeing with COVID. And
that vaccine came over because it was included in the
formulation for the seasonal flu vaccine.
The COVID vaccine, though, I just think it is not the
appropriate program for it. We saw Commander Grimes speak at
your last hearing, and he gave the burden of proof in the
Countermeasures Program. The burden of proof in the
Countermeasures Program is higher than in our program, and you
do not have attorneys or experts or anything like that, so I
think that is a really difficult burden to meet. And when I
speak of causation, I appreciated in your last hearing that
both you and Ranking Member Ruiz, we have talked about words
matter, so I want to be clear with my words. When I speak of
causation in these cases, I am talking about legal causation in
the vaccine court, not medical certainty, not a causal analysis
as Dr. Maldonado spoke of. We will never have epidemiology in
support of our cases because they are rare events. That is what
you want them to be is rare events.
So, when I speak of legal causation, it is still much
harder in legal causation to prove causation in the
Countermeasures Program than in the Vaccine Program than the
VICP. I try to use the ``Vaccine Program'' and
``Countermeasures,'' a little less alphabet soup, but that is
very difficult. And when you do not have right to counsel, it
is incredibly difficult to prove, particularly if you are
injured or you are sick or your family member is sick, to do
that.
So, I think there is no improvement that can be made to the
Countermeasures Program that would make it appropriate for
COVID-19 vaccine cases. There are improvements that could
certainly be made to the Countermeasures Program for everything
else. Statute of limitations can certainly be increased and
different things like that on compensation, but that would be
my recommendation for those improvements.
Dr. Wenstrup. I appreciate that. I now recognize Dr. Ruiz
for questions.
Dr. Ruiz. Thank you. During last month's hearing, we heard
from Federal officials at the FDA, CDC, and HRSA, who are
tasked with overseeing America's various vaccine safety
systems. Their testimony walked us through the multi-step
process that ensures vaccines available to the American public
are safe and effective as possible. Dr. Maldonado, I would like
to get your perspective on how these systems worked for the
COVID-19 vaccines. Is it true that COVID-19 vaccines underwent
rigorous evaluation for safety and effectiveness as part of the
FDA's emergency use authorization and approval process?
Dr. Maldonado. Yes. I won't go through the various phases,
but the process by which the Federal Government oversees
regulation of vaccine, clinical and other products, devices, as
well as other biologics is quite rigorous and very well defined
in terms of steps that are laid out for industry and others to
participate in these. And the steps taken for the COVID-19
vaccines were similar to those that were used for all the other
vaccines that have been studied over the many decades that we
have these programs in place. Obviously they were accelerated
because of the nature of the pandemic that we were in, but the
processes were followed.
Dr. Ruiz. And what did clinical trial data collected as
part of these processes show about the safety of the COVID-19
vaccines?
Dr. Maldonado. Well, as we know, there were adverse events,
and that is where our VAERS, VSD, and V-safe systems, among
others, really took those into account. But overall, as we went
through the process and as I testified earlier, as safety
events were identified, they were explored more deeply. And
again, within the constraints of the work force and the volume
of the claims that were coming through, they were addressed,
with the highest priority being to the most important safety
considerations. But certainly, they were addressed as they went
forward, the example being the J&J, for example, and other
issues. But in general, the safety issues were the most common
ones that we see with vaccines, which are pain at the site of
injection, fever, swelling, and myolysis. But again, at the
other end of the spectrum were the more serious things, like
TTS, et cetera.
Dr. Ruiz. Yes. And we talked in more detail about the
various systems that were in place to identify adverse
reactions, and we talked about how VAERS was the most
nonspecific in the sense that it was where patients could write
in about anything that they felt, any symptom, any occurrence
that they felt was related to the vaccine and that would
overcount what one individual would think was related. And in
fact, many of the patient-driven were investigated and were not
found not to be associated with COVID, but we have to cast a
wide net like that so that we can identify any possibility of a
true, serious adverse effect. And with Johnson & Johnson, of
course, they found that and they made modifications with a
recommendation. So once the COVID-19 vaccines were brought to
market, multi-layered surveillance systems operated by the CDC
monitored for adverse events.
Dr. Maldonado, has data collected through the surveillance
systems genuinely reaffirmed the safety of the COVID-19
vaccines?
Dr. Maldonado. Yes, they have. Generally, they have
reaffirmed the safety, but also reaffirmed whether or not SAEs,
or serious adverse events, were truly related or not related to
the vaccines, and those are done by separate methods. That is
by verifying through massive surveillance efforts. Again, no
surveillance system is perfect, which is why you need multiple
layers of surveillance and strengthening of those surveillance
systems over time. The other way to do it is to confirm by
using other datasets, for example, Medicare claims datasets,
emergency room visit datasets. There are numerous other
datasets where you can take large populations and verify what
you see in your surveillance through these----
Dr. Ruiz. In the medical and public health world, we want
to know, we want to verify, we want to identify the adverse
effects so that we can make the adjustments, the changes, the
recommendations, find the populations who are contraindicated
from taking that vaccine, et cetera. So, you know, I see how we
take it very seriously and want to identify them so we can rule
them out in order to give the best recommendations as possible.
And is it true that in cases where an elevated risk of adverse
events has been detected, such as with the J&J vaccine, our
Federal public health officials have used this data to swiftly
update their vaccination recommendations?
Dr. Maldonado. Yes, absolutely that is the case, and it
just happened recently with the followup of the potential for a
risk of stroke from the COVID-19 vaccine, which was a signal
that was identified and further investigated and found not to
be a true signal.
Dr. Ruiz. OK. But they are taken seriously, and they are
looked into further, correct?
Dr. Maldonado. Yes, they are.
Dr. Ruiz. OK. So, it seems like that is the system that we
want, is to be hyper vigilant and then do the investigation to
determine to make the changes or adjustments. But overall, the
vaccine has shown in a population health base to be safe and
effective, correct?
Dr. Maldonado. Yes, with the data that has come from a
multiple surveillance systems.
Dr. Ruiz. And so, has any data collected through CDC
surveillance systems drawn into question your recommendation as
a physician that patients should receive the COVID-19 vaccine?
Dr. Maldonado. No, I think the data has been very
supportive of my decision to counsel my patients.
Dr. Ruiz. OK. Thank you. And in the case that rare but
serious adverse events occur after vaccination, such as severe
allergic reaction, HRSA operates a system to evaluate claims
and adjudicate them for compensation. Ms. Gentry, you represent
patients who have gotten vaccinated and experienced these
serious adverse events as they navigate this system, and thank
you for doing that. What role does the efficient processing of
these claims and meaningful compensation when appropriate play
in encouraging patients to receive safe and effective vaccines
and reducing vaccine hesitancy across the United States?
Ms. Gentry. Thank you. I think it is absolutely critical
that they have that. I mean, the whole system was designed to
be faster than the 240 days. And prior to the three events that
I talked about, procedural things, we were processing claims at
the vaccine court, some claims in under a year. I think it is
very critical, and what you are seeing also with the COVID
cases is the frustration of the delays. It is starting to turn
people who, again, are pro-vaccine and got the vaccine and want
to do the right thing turning away from it----
Dr. Ruiz. Yes. So----
Ms. Gentry [continuing]. And being very concerned. It is
very disconcerting.
Dr. Ruiz. So, it is a systematic issue that needs to be
fixed, and----
Ms. Gentry. Absolutely, in both programs.
Dr. Ruiz. Yes, and I am very in support of making sure that
the claims are processed faster and that we update the
compensation amount when appropriate to ensure that people are
adequately compensated. That is something that I think we can
have bipartisan consensus on.
Now, I would like to turn my attention to the physician-
patient relationship during the COVID-19 pandemic. As I have
stated before in previous Select Subcommittee hearings, the
relationship between a patient and their doctor is sacred, a
cornerstone of healthcare delivery that is rooted in trust,
empathy, and the oath to do no harm. As a physician, it is
something I deeply valued when I treated and cared for my
patients in the emergency department. And for our Nation's
physicians who served on the frontlines of the COVID-19
pandemic, I know it is something they deeply value too.
Yet, over the past year, we have had hearings in this
committee on the patient-doctor relationship during COVID and
heard allegations that the government overreach and so-called
one-size-fits-all vaccine requirements eliminated the
decisionmaking power of patients and physicians. I would like
to dwell on this a little further. Dr. Maldonado, were
requirements a clinically appropriate tool to encourage vaccine
uptake, and how did they help to save lives and prevent severe
hospitalizations in the United States?
Dr. Maldonado. So, I was also the Chair of the Committee on
Infectious Diseases for the American Academy of Pediatrics
during the period of the pandemic. It just happened to occur at
the same time. And I found that our relationship with the
67,000 pediatricians who we represent in the American Academy
were highly supportive of the programs and processes that we
had in place and actually worked very closely with us on a
daily basis during this pandemic to help message not only to
providers in, for example, rural areas that had poor access to
information, but also to those providers' patients. So, I found
that during the pandemic we had a stronger relationship with
our providers and patients than I have seen actually in my
career.
Dr. Ruiz. So, physicians weren't left out in these
recommendations for requirements. In fact, they gave their
input, and they supported them?
Dr. Maldonado. Our opinions were sought out, and when we
requested, for example, discussions with, say, Dr. Marks, Dr.
Wharton, and others from CDC, FDA, and others, we were at the
table, and we were able to put in our opinion in as frontline
providers around what would work for our providers and what
would work for our patients in terms of communication. And it
all has----
Dr. Ruiz. So, you were consulted on even how to better
communicate with patients regarding the vaccine and the
requirements.
Dr. Maldonado. Yes, I----
Dr. Ruiz. And you gave your input, and the association gave
their input, too?
Dr. Maldonado. Yes, I believe that our input was solicited
on a regular basis.
Dr. Ruiz. And do you agree with the allegation that doctors
were sidelined, and that the physician-patient relationship was
disregarded in the discussion surrounding COVID-19 vaccine
requirements?
Dr. Maldonado. I did not find that to be the case either at
the local level or at the national level in the patients that--
--
Dr. Ruiz. How did you communicate with your patients during
this time, and was there any scenario where you advised for any
contraindicated reasons not to take the vaccine and what to do
about it?
Dr. Maldonado. So, what I will say is all of us probably
here at the table, we worked probably 24/7 for those, you know,
several years. And much of that time was spent in communicating
with families, with adults, who also wanted advice for their
own selves, and not only their children, in dealing with
numerous town halls, webinars. I remember we were on Zoom for a
lot of this too, but in person as well seeing patients. We set
up large clinics where we could actually see people, talk to
them in English, Spanish, Tagalog, whatever language we needed
to really get to people so that they could ask the questions
that they needed to have answers for.
Dr. Ruiz. Thank you. Before I conclude, I would like to
make one thing clear, which is that the physician-patient
relationship is not one that occurs in spite of our
government's public health institutions. Rather, it is a
relationship that is complemented and fortified and perhaps
even enhanced by the tireless work of our Nation's public
health officials and experts, particularly during times of
crisis because let's face it, we need each other. We need
everybody in our communities to pull through in a crisis. And
we need to be able to work with one another in a very trusting
relationship, getting all the input that we need, and then use
science to determine the right course of action so that we are
not leaving it up to ideology, we are not leaving it up to
partisanship, we are not leaving it up to chance, because,
ultimately, science and epidemiology is the ruling out of
chance in our recommendations to determine patterns that we can
get close to the truth in order to provide the best
recommendations that we can. And so that is why I see, because
of these studies in science, that we are in a much better
place. And so, with that, I yield back.
Dr. Wenstrup. I now recognize Ms. Malliotakis from New York
for 5 minutes for questions.
Ms. Malliotakis. Thank you very much. I want to thank our
witnesses today for being here to discuss a very critical
issue, vaccine safety. And I know many of my constituents have
concerns about the government's handling of the COVID-19
vaccine rollout, the communication issues that there were, and
the adequacy of our safety monitoring systems. And today, I
hope we can have an open and transparent discussion about how
to improve these programs to better protect public health,
restore trust, and ensure accountability as we move forward, so
I appreciate your insights and your recommendations.
My question is for Dr. Whelan. In your testimony, you
discussed your research that re-analyzed the Pfizer and Moderna
clinical trial data and found a higher risk of serious adverse
events compared to a placebo. Did your analysis reveal any
safety signals or increased risk of cardiovascular issues like
myocarditis, especially in the younger vaccine recipients? And
based on your findings and your expertise as a pediatric
rheumatologist, do you believe the risk of myocarditis after
COVID-19 vaccination has been adequately investigated and
communicated to the public, particularly for young males?
Dr. Whelan. So, thank you for that question. The study that
we performed was based on the original Pfizer and Moderna
vaccine data in adults, so it didn't address children. And the
studies in children which used populations that were
considerably smaller and not powered to find the kind of
signals, you know, that were apparent in the data for the
adults. There were significant problems with the studies as
they were performed or, rather, the data as it was reported.
And I think that the value added for our group was that we went
in, we re-analyzed the data with objective criteria--it hadn't
been done that way previously--and we discovered that there was
some flaws in the way that both Pfizer and Moderna reported
their data that hid some of the adverse effects.
Ms. Malliotakis. Would you care to share an example?
Dr. Whelan. I don't know that this was an intentional
thing, and I don't know that the FDA was even aware that this
was going on, but, for instance, the Pfizer population, their
data was reported in a form that included a very large number
of people who had only gotten a single vaccination and people
who did not have adequate followup afterwards.
Ms. Malliotakis. Uh-huh.
Dr. Whelan. So, the number of people that we analyzed were
just the individuals who received two vaccinations and received
at least 2 months of followup afterwards. What that did was it
contracted the total population that we studied by about 5,000
individuals. And all of a sudden, this significant signal
emerged, which showed that, you know, the Pfizer vaccine had
associated adverse events that, at least by pediatric
standards, were pretty high.
So, with regard to, you know, finding myocarditis in young
people, I did get phone calls from around the country from
providers who were anxious about, you know, young people that
came into the emergency room with elevated troponin values and
so on. We really don't know what the long-term consequences of
having myocarditis as a teenager are, but it was pretty scary,
of course, you know, when a child is coming into the emergency
room with chest pain and then it turns out that they have got
elevated troponin levels, which suggest, you know, that they
might be having a heart attack. So----
Ms. Malliotakis. Well, it is interesting because
myocarditis is one of the vaccine injuries that are actually
being compensated for, but I think you made a really good point
in terms of the followup for long-term effects, right? We
really don't know what the long-term effects of not just
myocarditis, but also of the vaccine itself. So, in your
opinion, how could the vaccine safety surveillance systems be
improved to better detect and characterize rare but serious
adverse events?
Dr. Whelan. As I alluded before, I think that the system
was under resourced, and I don't fault the individuals
involved. I have discussed this with Dan Jernigan, who spoke to
the committee last month. And I think they were just approached
with an impossible task, which was, you know, how do you
vaccinate an entire country and adequately followup on, you
know, the individual vaccinations? I just think that they
really needed to have an army of people who could have gotten
in there and started calling people who got vaccinated and then
find out exactly, you know, what was that person experiencing.
Ms. Malliotakis. So in my last, like, 20 seconds, I just
want to ask Dr. Gortler a question. You have written about the
FDA's dependence on vaccine manufacturers for certain safety
assessments, which some view as a conflict of interest that
could compromise the integrity of the approval process and
undermine public trust. In your expert opinion what are the
most critical weaknesses in the government's vaccine safety
surveillance systems? What specific steps could the FDA take to
reduce reliance on manufacturers and increase transparency to
strike a balance between promoting vaccine confidence while
allowing space for addressing legitimate concerns openly?
Dr. Gortler. So, the one-word answer is transparency,
period. The FDA isn't perfect, and when they do things that are
a little bit shortcoming, I don't have a problem, you know,
speaking up and saying something about it. But when you look at
the lack of information, both in the label and the technical
documentation of how its manufactured, how the mRNA shots, in
particular, are evaluated for safety, there is just too much
information missing. Honestly, I don't know if I can blame the
FDA for the transparency or some component of the emergency use
authorization or the PREP Act that doesn't allow that
information in there. But there is information conspicuously
lacking, not only from the label, comparing it to other drugs
that utilize RNAs as a mechanism of action, especially because
this drug is so much more complex.
I mentioned there are about 4,000 base pairs. Another drug,
Onpattro, which is also an RNA technology, contains all the
information you need, you know, molecular weight, number of
strands, you know. It even shows a picture of the structure,
and that is only 20 base pairs. And so, we don't have the
transparency for something that is a lot more complex, per the
introduction that I talked, the car reference. Thank you.
Dr. Wenstrup. I now recognize Mr. Mfume from Maryland for 5
minutes of questions.
Mr. Mfume. Thank you very much, Mr. Chairman. I want to
thank you and Ranking Member Ruiz for calling today's hearing.
Obviously, I want to thank all four of our witnesses for
traveling here to share your thoughts and your understandings,
your recommendations, and your suggestions. As an aside, Dr.
Whelan, let me thank you for referencing Dr. Jonas Salk, who
was an indirect hero of mine. I was in the second grade when
the polio vaccine was first approved and distributed. And I say
``hero'' because it was a small Black school on the edge of the
Chesapeake Bay that had attached to it a small, underfunded
nursery. And I remember my mother taking me to that nursery as
a young person, under the age of 5, and going back the next 2
years and not seeing any of those kids because so many of them
had contracted the virus and had passed away, so Salk was a big
hero. In fact, my second and third grade teachers collaborated
and threw a party to tell us why the polio vaccine was
important and how it was going to save lives. So let me get
away from that side talk for just a moment, but thank you for
what you did toward the end of his life. It is very important.
It is not lost on me.
I want to talk about a couple of things, and on this
committee, I have tried to be straightforward about what it was
like then because the further we get away from the pandemic,
recollections fade, memory serves us less. But fear was the
order of the day, absolute stark fear, and it was fear among
all of us. It was pain. It was anguish. There was death, and
obviously there was a great deal of sorrow that some people are
still experiencing. People wanted help then and they wanted it
right away, and they looked to all of us, whether we were in
government or not or, as you are in medicine or not, to figure
it out because they thought that they were going to find
themselves stricken or losing a loved one.
So, today is a cautionary tale. That is why these hearings
are important. We can learn what we did, what we didn't do, how
do we do it better, how do we fix it, what were our
shortcomings, what do we own up to. But back then, 4 years ago,
caution went out the window, and as a result of that, many of
the things that we are talking about today developed.
Ms. Gentry, I really want to land on where you were because
victims concern me, and being able to find a way to get
compensation is important. And I am not here as a commercial
for the Trial Lawyers Association, but I can tell you that
people who don't have a voice who were somehow, or another
injured by the vaccine and unable to get injury compensation
just concerns me, and I hope it concerns all of us. The VICP
shortage of masters tells me that things don't move through the
courts as they should for many of them. The litigation backup
concerns me because it says it is only probably going to get
worse unless we put resources to it. It is kind of like what
Dr. Whelan said about the systems that are in place. They
probably were meant well, but we didn't do the right thing to
resource them.
And so, this litigation and the appeal process, can you
take just a moment to talk about the time problems that come
about and the cap problems that really get in the way of
everything?
Ms. Gentry. Certainly, and in my written testimony, I talk
about the various lengths of time. So, when you file a claim in
the VICP right now, in a regular lawsuit, you file a lawsuit
and there is an answer. In our program, we file a petition and
there is the rule for response. Right now, it is taking between
12 and 16 months for HHS to do that because of the lack of
reviewers on that end, so that is just the beginning. That is
when everything is in. If you have a table case, which means
you have a presumption of causation based on certain specified
injuries in the vaccine injury table, those will move slightly
faster, but in those cases, you are still looking at times
upwards of a year in some circumstances to get a decision,
again, just for the sheer volume of cases.
If you have a non-table case, which is going to proceed as
what we call a causation in fact case, it is going to look more
like a regular lawsuit, even though I would stress these are
no-fault compensation claims. So, you are not proving fault in
this. It is just legal causation. In those circumstances, you
may have several rounds of expert reports that go back and
forth.
Mr. Mfume. I see.
Ms. Gentry. And nothing in our program is anything less
than 60 days at a time. It could take 2 years to get to the
point of a trial, 2 years to get to the trial.
Mr. Mfume. Yes. I have got to reclaim my time. I am sorry.
We have a limit here, unlike the Senate, where they just go on
forever.
Ms. Gentry. It is long, yes.
Mr. Mfume. But this is why I want to go back to what Mr.
Ruiz said that we could probably find bipartisan consensus on
trying to figure out how we make that better. And I heard
someone say that the severe events are rare and not always
captured by clinical trials. Let's not forget that clinical
trials are inadequate. They are not diverse. They don't come up
with the right sort of findings. And year after year, we talk
about finding a way to expand them, and we don't expand them at
all, so we get results that are inadequate and cures that don't
always cure.
My time is up. I just want to thank all of you for what you
are doing. Ms. Maldonado, I wanted you to talk about equity and
your opinions, but I don't know if the Chair is going to allow
any more time. So, thanks to all of you for being here.
Dr. Wenstrup. We can certainly make a request for the
record.
Mr. Mfume. Yes. And my request would be to Dr. Maldonado to
tell the committee how, in her opinion, we can enhance equity
in future pandemic responses and rollouts of vaccine
initiatives to ensure that the most vulnerable among us have
access to the care that they need. And I say that particularly
because of the fact that in the U.S., mortality and morbidity
rates, Mr. Chairman, were the highest among Black communities,
Hispanic, Asian-American, Pacific Islanders, at-risk
populations. And those communities deserve equity or at least a
response about how we get to equity in terms of servicing them
and in terms of their followup.
I yield back, and I thank you for your consideration, Mr.
Chair.
Dr. Wenstrup. Thank you. I now recognize Mrs. Lesko from
Arizona for 5 minutes of questions.
Mrs. Lesko. Thank you, Mr. Chair, and thank you to all the
witnesses. This has been very interesting and informative.
I am glad to hear that we actually may have bipartisan
support in helping the victims because the system is obviously
broken, and I just want to emphasize that by saying what
happened to my office, OK. So as of January 1 of 2024, this
year, the total number of CICP COVID claims filed was 12,854. I
have a constituent that had a very severe reaction to the COVID
vaccine. He filed a claim. He hasn't heard anything. He hasn't
heard anything back.
So my staff, who is sitting in the back, called or
contacted the CICP legislative affairs person and said, OK.
What is the update on this person? They couldn't give him any
update. He asked, how many of the claims have you processed,
you know, have you done, and the answer was, ``We don't have
that information.'' I mean, how can you not have that
information? This is absolutely ridiculous, and, Mr. Chairman,
I think this is a really big problem if they don't even have
the information of how many claims they have processed or they
have awarded. I mean, $41,000, I believe, has been awarded in
the CICP, and, you know, with how many claims: 12,854 claims. I
mean, that is, like, nothing.
All right. Well, that is my rant. But then I do have
another question, and that is, Dr. Whelan, you had testified
that you had a boy in your care that died. You had done an
initial report and then you tried to followup. Am I correct?
And then say, you know, he passed away, and they didn't update
it. You didn't hear anything? Is that accurate?
Dr. Whelan. Yes, it is.
Mrs. Lesko. OK. Well, I have a story also of a New York man
who suffered from--and I can't even pronounce this--H-L-H after
the COVID vaccine. His initial report was classified as life
threatening. Then his second report filed after his death was
classified as hospitalized. After their initial complaint
inquiring about why his report is not indicated as a death, his
family subsequently received the following email: ``Good
afternoon. Thank you for contacting the Vaccine Adverse Event
Reporting System, VAERS, Program. Thank you for taking the time
to file the report. VAERS data available to the public include
only the initial report data to VAERS. Updated data, which
contains data from medical records and corrections reported
during followup, are used by the government for analysis.
However, for numerous reasons, including data consistency,
these amended data are not available to the public.'' And then
the family subsequently sent an automated message at the end of
2023 to update their VAERS report on his condition saying he is
dead, and the family has just been totally distressed because,
you know, it is not reported accurately.
And so, do you have any suggestions? I mean, I know you
haven't gotten anything back. Do any of you have any
suggestions in how we can improve this process? It sounds like
it is absolutely messed up.
Dr. Gortler. If I may, Ms. Lesko. I am also from the state
of Arizona. My family has lived there since the 1940's, and I
live in Rio Verde. The information that is contained in VAERS
is not complete. The information you can download online is not
complete, and it can be complex to do. I personally had to
learn how to do SQL programming and use data bases and buy some
expensive software to get all the information to be able to
view, but there is information which is also not submitted
electronically.
I mean, this is an unrelated matter. Right now, one of the
things I am looking at are the safety of puberty modulating
drugs, and I want to tell you about a story that I had when I
called the FDA to request some of that information. When you
look at all adverse events over a long period of time, I found
about 70,000 hits. And I am not sure what those hits are made
up of, but when I spoke with the director at the FDA, the head
of FOIA, my first request got lost. And my second followup when
I asked for it, I said, I would like this information, and he
said, well, that is going to take us about 30,000 hours to get
to you, and then he asked me for $1.2 million just to be able
to review those data, just to be able to go over them.
But it boils down to what one of the other Congresswomen
was saying: it is transparency. There is a lack of
transparency, and there is too much information that is
redacted, and in order to redact that information, it takes
time, right? It would take $1.2 million in salaries and 30,000
hours for those employees to have it. But if someone who is,
you know, familiar with the rules of HIPAA in keeping medical
records a secret, I don't understand why they have to be
redacted. I could just sign a form saying, OK, I promise not to
release this information,'' and that is that. And so, there is
a blockade, there is, like, an embargo in trying to get this
information so that drug safety people like myself can at least
take a look at it and see what to make of it, see if there is a
pattern, and cross-reference it to clinical trials, et cetera.
Thank you.
Mrs. Lesko. Thank you all of you. It has been very
interesting. And it is very interesting, Ms. Gentry, of what
you said, and what the deficiencies are in the number of people
that are processing, and that you think that the COVID vaccine
should go under VICP. I didn't realize that under CICP, they
couldn't have an attorney. I didn't realize that until you said
it.
Ms. Gentry. Well, obviously, there is no right to counsel,
that people have their attorneys, but it is not a court
process, so there is not really much that the attorneys can do.
Mrs. Lesko. Got it. Thank you.
Dr. Wenstrup. I now recognize Ms. Tokuda from Hawaii for 5
minutes of questions.
Ms. Tokuda. Thank you, Mr. Chair. Strengthening our
Nation's vaccine safety systems is critical for us to advance
public health--I think we can all agree on that--whilst
especially addressing deficiencies in our Nation's compensation
programs so that those who experience rare, yet serious adverse
events can receive the compensation and care they need. That is
important, you know, to bolster vaccine confidence in our
country.
Yesterday, our committee received a letter from the
American Academy of Pediatrics, noting that, ``It is imperative
that Congress increase funding so that the United States can
maintain the world's most robust and effective vaccine safety
monitoring system and help improve public understanding of and
confidence in our vaccine safety system.'' Mr. Chairman,
permission to enter this into the record.
Dr. Wenstrup. Without objection.
Ms. Tokuda. Thank you. And I think based upon the previous
speaker's comments, she would actually agree with the American
Academy of Pediatrics' recommendations, that they need to
increase funding so that we can increase capacity to address a
number of these NVICP claims, as noted in their letter that we
will be putting in.
Since Fiscal Year 2012 to 2021, claims have increased more
than fivefold, from 402 claims in 2012 to 2,057 in 2021, and
that the steep increase is largely, in part, due to the
influenza vaccine being administered to adults. In fact, more
than 92 percent of those claims in the last 2 fiscal years were
filed for adults, with 74 percent of all claims being filed for
alleged injuries from the influenza virus. Unfortunately, while
you have seen this dramatic increase, their budget has barely
increased from $6.5 million to $11.2 million during the same
period, and so clearly, funding for capacity is required for us
to maintain these systems.
You know, I could not agree with them more in terms of the
matter and importance of improving public confidence, as I
think all of us agree. In our vaccine safety systems, we need
to continue to support and enhance these vaccine safety
monitoring and post market surveillance systems currently in
place. We must handle each opportunity to discuss this matter
with care because the consequences if we don't, quite frankly,
are far too great. And since the start of the pandemic, we have
seen growing distrust in vaccines overall. And while
misinformation about COVID-19 vaccines have proliferated
online, it has had ripple effects, as we know, and perhaps
unintended consequences across our Nation's broader public
health. A recent survey from the Annenberg Public Policy Center
found that the proportion of respondents who believe in the
safety of vaccines fell from 77 percent in April 2021 to 71
percent in the fall of 2023. And while a decrease of 6 percent
may not sound like a lot, it does have serious and real
consequences for our Nation's health.
As we hold today's hearings, the United States is at the
precipice of losing our measles elimination status that we
gained in 2000 due to repeated outbreaks of the disease that
have popped up across the country from Florida to Ohio, to
Missouri, to California. So far this month, we have already
seen 58 cases of measles, many of which have occurred among
unvaccinated children. That is just as many cases as there were
during the entirety of 2023. This is especially concerning as
250,000 kindergarteners nationwide haven't received their
updated measles immunizations, leaving them unprotected from
this deadly disease. Dr. Maldonado, why is any decrease in
immunization levels, big or small, troubling for our overall
public health?
Dr. Maldonado. Well, thank you for allowing me to talk
about this. This is something that we talk about with our
families as providers. There is still, again, that sacred
trust, and I think our families really continue to trust, at
least in the pediatric population. I am sure that is true in
other fields, but this is my field. And I think that our
ability to have doubled our lifespan since 1900 in large part
is due to clean water, sanitation, and vaccination. We have
made remarkable progress in our ability to stay alive and to be
healthy.
And several generations have never seen these diseases that
I have cared for in the past. And so, it is understandable that
people think, well, they are not here. Why should I take a
vaccine? It is going to hurt my child's arm. They are going to
be uncomfortable. What is the good? And the good is that these
diseases are not eliminated. I was on the panel that sought the
certified elimination of measles in 2000. It is very sad to see
that we may head away from that after 20 remarkable years.
These diseases kill. They cause neurologic damage and
developmental delay. I have seen all of this on a regular
basis. I don't see it anymore, and I don't want to see it
again. These diseases will come back, and they will come back
with a fury if we don't continue to vaccinate, and especially
if we don't continue to build that trust and confidence that
families have in our ability to provide the safest care and be
transparent about that.
Ms. Tokuda. And real quick in the brief time I have, how
have you seen medical misinformation impact patients in the
field, directly resulting in some of these things we are
experiencing?
Dr. Maldonado. Is that a question? I am sorry. Yes,
absolutely. Young people get their information from social
media, and there are good things and bad things about that, but
we need to make sure that, again, we don't just dismiss it, but
listen and understand----
Ms. Tokuda. So, we could essentially see measles, you know,
elimination status removed because of medical misinformation,
misinformation online, in the community?
Dr. Maldonado. Absolutely.
Ms. Tokuda. Thank you. I yield back.
Dr. Wenstrup. I now recognize Dr. Joyce from Pennsylvania
for 5 minutes of questions.
Dr. Joyce. Thank you for convening this hearing today and
to our panel for taking part in this. This is an important
followup to the hearing that this subcommittee held last month,
where we heard from government witnesses responsible for
overseeing Federal vaccine safety systems. We now have the
opportunity to hear from experts who have directly interacted
with these systems and that, in many cases, found them to be
woefully inadequate.
Physicians are on the frontline during any public health
emergency, and the Federal response should be guided by the
firsthand experience of healthcare providers. Instead, the
current administration failed to provide an adequate mechanism
for doctors to raise concerns about vaccine safety. Reports of
serious injuries were ignored, causing serious damage to the
public trust, I might add, fracturing the doctor-patient
relationship. As a doctor myself, I also worry that not all
adverse vaccine events were accounted for, whether because a
healthcare practitioner did not know where and how to report an
event, or because the system that they reported it to were not
properly monitored.
The doctor-patient relationship needs to be reemphasized as
we discuss how to restore public confidence in vaccines. To
accomplish this, we must seriously examine the failures of our
vaccine safety system and reform these systems to better
support patients and to better support doctors. Doctors must
have the most up-to-date information on any potential vaccine
side effect in order to appropriately counsel patients. Our
current vaccine safety mechanisms are insufficient to
accomplish this goal, and patients ultimately suffer the
consequences.
Dr. Whelan, what reforms are necessary to ensure vaccine
injuries are being monitored proactively, and that when
problems do arise, that they clearly are communicated to the
doctors and the patients in a timely fashion?
Dr. Whelan. Thank you for that question, Dr. Joyce. I
should start by just saying I don't see that the Biden
Administration has done things any differently than the
previous administration, and I think big wheels move slowly.
So, my sense is there is more of an institutional ennui than
there is any kind of malintent on the part of, you know, the
current administration.
But I do think that, as Dr. Maldonado was saying, you know,
doctors want to be heard. They want to know that their concerns
are being taken seriously. As I said earlier, I believe that
there should be a more robust system for following up
vigorously after people get vaccines and that we don't put the
burden on the individual to report, you know, the things that
they are experiencing, but rather, that the system really
express an interest in finding these kinds of adverse events.
Dr. Joyce. Can you speak about the benefits of ongoing and
effective communications for physicians on the frontline and
those who are responsible for providing healthcare guidelines?
Dr. Whelan. I run a center at UCLA dealing with children
who have neuroimmune problems, so I see a lot of kids that have
autism and OCD and tic disorders. And so, I am confronted
constantly with this question, you know, should my child be
vaccinated, and I also have a lot of kids in our practice who
have not been vaccinated at all. So, it is really an
interesting balancing act because, on the one hand, I want to
be sensitive to the concerns that these families have. I also
want to, you know, express sensitivity to the fact that we
really don't know a lot about where autism comes from. And so,
I can't make a categorical statement to the family that
vaccines played no role, although I share unhesitantly the data
that we have so far. And I also think that, as Dr. Maldonado
alluded to, you have to be able to communicate to people that
things like measles have the capacity to permanently damage the
immune system of that child and could potentially kill them.
Dr. Joyce. And during the COVID crisis, did you see an
accentuation of children or young adults with autism who were
exposed to or received the COVID-19 vaccine?
Dr. Whelan. So, that is a very interesting question. Did
the vaccines play any role? Interestingly, in the Pfizer trial
on 11-to 15-year-olds, there was an increased incidence of
psychiatric hospitalizations.
Dr. Joyce. I think this is an important point, and as a
physician and as a parent of a child with autism, I am aware of
that information. And I think that information needs to be
shared, and I think we need to explain that to parents. I think
it needs to be explained to healthcare providers, and,
particularly, it is information that we have a responsibility
of sharing to those who deal with an autistic child. I thank
you for that candid information. Mr. Chairman, my time has
expired, and I yield back.
Dr. Wenstrup. I now recognize Ms. Ross from North Carolina
for 5 minutes of questions.
Ms. Ross. Thank you very much, Mr. Chairman, and thank you
so much to the witnesses for being with us today.
In the written testimony and during today's hearing one of
the majority's witnesses has referenced redactions in documents
that FDA produced through FOIA, and I would like to take a
moment to round out that discussion. While I profoundly
appreciate the important role that taxpayer funding played in
the research that propelled development of the COVID-19
vaccines, we must recognize that this feat of modern science
was a partnership between the Federal Government and industry.
And we have to acknowledge that there are proprietary elements
to the manufacturing process that are fundamental to
encouraging and ensuring robust market participation for
manufacturers of not just vaccines, but a wide variety of
medical products essential to our public health.
In the course of responding in good faith to
investigations, it is commonplace for commercially sensitive
information, such as the exact composition of products to be
redacted, and FOIA cases are no different. The redaction of
this proprietary information has no bearing on the robust
process that the FDA conducts to evaluate the safety of
vaccines and countless other medical products before they are
brought to market. And for what it is worth, the ingredients of
the vaccines are included on the products' labels and available
for anyone and everyone to evaluate for themselves, as many
preeminent researchers, including those at the University of
Cincinnati, have already done.
With that, I would like to turn back to the suggestion that
COVID 19 vaccine policies infringed on the doctor-patient
relationship. Much to the contrary, several of America's
leading physician societies have conveyed their strong support
for COVID-19 vaccines, and, in various cases, have filed briefs
memorializing their support for pandemic-era COVID-19 vaccine
requirements. For example, ahead of the Select Committee's
first vaccine safety systems hearing, six leading medical
associations representing nearly 600,000 physicians issued a
joint statement reiterating that, ``COVID-19 vaccines are one
of the most effective public health tools we have to prevent
spread of the virus, hospitalizations, and deaths.'' This is
consistent with the views many of America's leading medical
societies expressed when legal challenges were mounted against
vaccine requirements.
The American Medical Association led dozens of other
groups, including the American Academy of Pediatrics and the
American Academy of Family Physicians, in filing amicus briefs
in support of these policies in cases such as BST Holdings v.
OSHA, Kentucky v. Biden, and Georgia v. Biden. In their amicus
brief for BST Holdings versus OSHA, the AMA stated that halting
enforcement of Federal vaccine requirements would ``severely
and irreparably harm the public interest'' due to the ``grave
danger to public health'' that COVID-19 posed.
Dr. Maldonado, would America's major physician societies
have filed these briefs in support of the vaccine requirements
if they felt that these policies infringed on the doctor-
patient relationship?
Dr. Maldonado. No.
Ms. Ross. Thank you. With my remaining time, I would like
to discuss written testimony submitted to the Select Committee
from Professor Richard Hughes at George Washington University
Law School. Professor Hughes is one of the Nation's preeminent
experts in systems we are examining today, and his statement
explains the importance of vaccine injury programs in ensuring
a robust market of vaccine manufacturers and an orderly
processing of claims, albeit imperfect. He also reminds us of
the importance of keeping today's conversation rooted in the
facts and not letting opinions about proven safety and
effectiveness of COVID-19 vaccines mislead the discussion. Mr.
Chairman, I ask unanimous consent to submit Professor Hughes'
written statement to the record.
Dr. Wenstrup. Without objection.
Ms. Ross. Thank you, Mr. Chairman, and I yield back my
time.
Dr. Wenstrup. I now recognize Ms. Greene from Georgia for 5
minutes of questions.
Ms. Greene. Thank you, Mr. Chairman. Nothing creates
vaccine hesitancy like ignoring people when they are reporting
problems with vaccines that they are being mandated and forced
to take; vaccines that they have to take in order to keep their
job; vaccines that they have to take in order to be able to go
to restaurants, go into stores, go into public places; vaccines
the doctors are telling them to take. But yet when they are
screaming from the rooftops something is wrong with the
vaccines, I am telling you that creates vaccine hesitancy. The
other problem is, is when you get censored on the internet, or
you get permanently banned on social media when you are a
victim of a vaccine injury or a doctor trying to report what
you were seeing in your patients from vaccines.
[Chart]
Ms. Greene. This chart right here, this represents vaccine
reports from all vaccines since 1990, 34 years. This represents
reports on the COVID-19 vaccines since December 2020, less than
4 years. Something is wrong with the vaccines, and just because
people are walking around and they have been vaccinated and
they are not reporting a problem, doesn't mean other people
aren't having problems, and this has been virtually ignored.
Not only has it been ignored, it has also been censored and
banned and labeled misinformation. This was a coordinated
effort with the White House, the Surgeon General, the CDC, the
Department of Homeland Security, CISA, Stanford, and the
Virility Project.
As a matter of fact, real people with real problems got
censored, such as Maddie de Garay. Maddie was a young child who
developed severe symptoms and still has a feeding tube today.
She is a very sick child. That happened from the COVID vaccine,
but her mother was taken off of the internet when she tried to
report the problem. Can you imagine trying to report a problem
with your child who is having a real vaccine injury, but yet
social media takes you off and the White House says it is OK
and Department of Homeland Security says it OK, and they label
it misinformation?
We can talk about funding these government programs and
throwing more money at these government programs, but that
isn't going to change the fact that vaccines should have never
been forced on all these people to begin with. And if we want
to talk about diseases like measles being transmitted among
Americans, then perhaps we should talk about border security
and stopping people who are unvaccinated from coming across our
border and allowed to come into our country and then supporting
them with taxpayer funds. I think that is a serious issue.
Dr. Maldonado, you are from Stanford. I am assuming you
participated in the censorship program of so-called vaccine
misinformation. I have got documents here showing Stanford ran
a censorship program with the White House, commissioned by Bill
Gates Foundation, tasked specifically with censoring content
that would drive vaccine hesitancy, including true stories of
vaccine injury, because this project led to the severe
censorship of many people, including my own personal Twitter
account, by the way, that was banned for an entire year because
I apparently spread COVID information, things like information
about myocarditis among our military members, neurological
problems being reported. And I said that people shouldn't be
forced to take a vaccine, especially like when Dr. Wenstrup
talked about he didn't even know he had COVID until he couldn't
smell garlic. That was the case for many people, including
myself. I hardly had any symptoms when I had COVID. I certainly
didn't need a vaccine. I have never had the vaccine, and I have
never gotten COVID since.
While some people in our society are more susceptible to
COVID because of maybe certain conditions that they have, not
everyone should have been forced to take a vaccine. And
certainly, people should be heard when they suffer a vaccine
injury, and they want to tell others about it on their own
personal social media accounts. Just a small example of this.
Stanford identified and directed the White House to censor two
COVID vaccine injured clinical trial participants, true stories
of injury, one of whom is a child trapped in a wheelchair with
a feeding tube; Stanford, an institution that actively
suppressed the repeated cries for help from those who were
injured by these shots is now being sued for it. As an example,
it is pretty interesting that a witness from Stanford brought
in by the Democrats today who participated in censoring these
true stories is going to give the witness testimony about
vaccine hesitancy and about our hearing today on all of these
reports.
I really don't have any questions today, Mr. Chairman. What
I would like to echo is, is that there are so many people that
have suffered injuries from these vaccines, and there are
continuing problems, and now this vaccine is recommended by the
CDC for children. There are also serious issues with blood
clots that are being completely ignored, and it is not
misinformation. Not at all. And so, for all the people that no
one ever listens to about vaccines and that were suppressed and
censored and banned on social media when they reported it, I
would like to speak up for them. Their voices deserve to be
heard, and a lot of them deserve a lot more money than the
$41,000 that has been awarded to vaccine victims. I yield back.
Thank you.
Dr. Wenstrup. Thank you. I now recognize Mrs. Dingell from
Michigan for 5 minutes of questions.
Mrs. Dingell. Thank you, Mr. Chairman. Right now, we are at
a pivotal moment for vaccine confidence in the United States.
In recent years, we have witnessed a startling decline in
immunization levels across the board, and I am deeply concerned
about what this means for our Nation's ability to respond to
public health threats in the future, especially today as the
CDC issues an alert over rising measles cases and is urging
families traveling to a measles-affected country to get
vaccinated. And as I was sitting here, my Washtenaw County
Health Department just sent a notice that another child has
measles in Washtenaw County. I think that is a problem.
And listening to my colleague, the last victim of polio
just died who lived in an iron lung. I am not old, but I am
seasoned. I am really glad we were required to get polio
vaccines, and I am somebody who, by the way, can't get a flu
shot. We have got to focus on what we can and should do to
strengthen our vaccine safety systems, which are crucial tools
for promoting vaccine confidence. As I have said during our
previous hearings, we need to do this by approaching people
with compassion, empathy, make sure their questions are
answered with trustworthy, accurate information that breaks
through some of the noise that can come through, and they know
if they are at risk, they have got a doctor to talk to.
Many of my colleagues here have heard me tell my own story
of my experience with Guillain-Barre syndrome following a flu
shot, but because I have got Guillain-Barre doesn't mean people
should never get a flu shot. We need to put this all in
perspective. And I asked a lot of questions before I got my
COVID vaccine, and I was scared to death, but I got it, and I
am alive, and I am here. And as we discuss these topics today,
I personally appreciate the importance of patients knowing that
meaningful compensation is available if they experience a
severe adverse event and need it.
So Ms. Gentry--and we are going to run out of time, and we
have got votes--can you answer this question? Why are efficient
and adequately resourced compensation programs for patients who
experience adverse events an important tool for improving
vaccine confidence?
Ms. Gentry. Because it makes them feel comfortable getting
the vaccine, that, if something happens in those rare events,
that they will be taken care of and compensated.
Mrs. Dingell. So, I understand that Congress has an
important role to play in strengthening these programs and
streamlining the process of compensating patients with vaccine-
related injuries. For example, under the current statute, in
order to move the COVID-19 vaccines from the Countermeasures
Injury Compensation Program to the more appropriate Vaccine
Injury Compensation Program, Congress must pass an excise tax.
And to facilitate the more timely processing of claims before
the VICP, Congress can increase the number of special masters
to adjudicate the claims and increase the cap on damages
provided, including to account for inflation. A number of these
reforms or more are included in two bipartisan pieces of
legislation led by Congressman Lloyd Doggett, H.R. 5142 and
5143.
Mrs. Dingell. Ms. Gentry, how would these reforms and
others proposed in these two bills improve the processing of
claims brought forward by people who experience serious adverse
events from vaccines?
Ms. Gentry. It would bring the infrastructure up to date in
those programs and allow those claims to be processed. You
would have more special masters to process claims, modernize
the program to where it is supposed to be in 2024, and allow
the excise tax which the manufacturers want to pay.
Mrs. Dingell. Thank you. Now, Dr. Maldonado, do you agree
that reforms, like increasing the number of special masters to
process claims and ensuring that damages paid out reflect
inflation, will strengthen how the Vaccine Injury Compensation
Program operates?
Dr. Maldonado. Yes, I do.
Mrs. Dingell. And, Dr. Maldonado, do you agree that
strengthening compensation programs for people who experience
rare--I was one--but serious vaccine adverse events is an
important tool for fortifying vaccine confidence?
Dr. Maldonado. Yes, it is.
Mrs. Dingell. Thank you, and I yield back, Mr. Chairman.
Dr. Wenstrup. I now recognize Dr. Miller-Meeks from Iowa
for 5 minutes of questions.
Dr. Miller-Meeks. Thank you, Mr. Chair, and I thank our
witnesses that are here today. I am both a physician, a
military veteran, and former director of the Iowa State
Department of Public Health, so this is an important hearing.
And vaccine hesitancy is certainly important, although it is
also not new, but I think the COVID-19 pandemic has exacerbated
vaccine hesitancy and reticence. Ms. Gentry, when a new vaccine
is approved and marketed and you may have answered this--what
steps are required to ensure access to liability compensation
under the VICP program, and what happens if a new vaccine is
not added to the list of taxed vaccines?
Ms. Gentry. To get a new vaccine on, well, first, the ACIP
has to make a recommendation for routine administration to
children under the age of 5. The Secretary has to take that and
make a recommendation to add it to the table, and then it goes
to the regulatory processes. At the same time, the excise tax
has to be instituted on that. If it is not, it is not there.
Dr. Miller-Meeks. And do you believe CICP is adequate for
adjudicating COVID-19 vaccines claims?
Ms. Gentry. No, I do not.
Dr. Miller-Meeks. Thank you for that. Do any of you believe
that the CDC's reluctance to identify and, in fact, deny
adverse reactions related to the COVID-19 vaccine and I will
specifically point out to myocarditis and pericarditis--and a
MMWR that the CDC put out saying that there was no greater
risk. And I think looking at the data and looking at the data
from overseas, to me, looking at that data, that is not true.
Does that, in fact, affect the adjudication of claims, or does
that have no bearing on the adjudication of claims?
Ms. Gentry. Generally speaking, we never have
epidemiological support because vaccine injuries are rare, so
it is very difficult for us to get an increased rate of
incidence. If you see that, the vaccine is generally pulled
before we would ever get that, so the significant thing for us
is that is not our burden of proof in the program. And again, I
am speaking of legal causation and not scientific certainty and
causation in that term.
Dr. Miller-Meeks. And like Representative Dingell, when I
was Director of the Iowa Department of Public Health, soon into
my first year, my Public Information Officer got her flu
vaccine, and within several days, she called me up, on a
Sunday. She was in the hospital. I went to go see her. It was
obvious to me she had Guillain-Barre. I asked about her
vaccination. She had just received her vaccination.
So, I would say these conditions, they may be uncommon, but
I would not say that they are rare. Is the compensation for
injuries related to vaccines, is the compensation enough?
Someone that has Guillain-Barre and is paralyzed and on a
ventilator and then out of work for months. It was about 6
months I was helping her to work remotely. That, to me, does
not seem like a mild injury and would bear compensation, and
for any other medication or drug, there certainly would be
compensation.
Ms. Gentry. Yes, Guillain-Barre syndrome would be a typical
vaccine injury that we get compensated. You may have a life
care plan that is substantial compensation in addition to lost
wages, but the pain and suffering is still limited at 250.
Dr. Miller-Meeks. And what advantages do claimants to the
VICP have that CICP claimants do not because you answered that
in the negatory?
Ms. Gentry. Correct. For one, it is an actual court process
in the VICP. You have right to counsel. You are not responsible
for attorney's fees. You have appropriate ability to appeal
cases. You have full compensation and not restrictions on
compensation, at least for economic damages and future care.
Dr. Miller-Meeks. Thank you very much. I thank all of our
witnesses. I thank the Chair for this important hearing, and I
yield the balance of my time.
Dr. Wenstrup. Thank you. Listen, I would like to thank all
of you for being here today, and I am sorry you were squeezed
between vote series. Here, typically at this time, the Ranking
Member and I would make some closing statements. Well, part of
that is thanking you all for your testimony and your written
testimony as well. I think it has been very valuable what each
of you has had to offer into the conversation today. And moving
forward, I encourage all of you to reach out with us further if
any concerns you may have or recommendations you may have in
the future.
I am going to suggest because of this squeeze on time that
the Ranking Member and I submit our closing statement for the
record, and we will be glad to share those with you and make
them public.
In closing, I would like to thank our panelists once again
for your testimony.
With that and without objection, all Members will have 5
legislative days within which to submit materials and to submit
additional written questions for the witnesses, which will be
forwarded to the witnesses for their response.
If there is no further business, without objection, the
Select Subcommittee stands adjourned.
[Whereupon, at 4:40 p.m., the Select Subcommittee was
adjourned.]
[all]