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,
Speaking for the remainder of the proceedings, I now recognize myself for the purpose of
making an opening statement.
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.
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 if people trust that they are safe and patients elect to get vaccinated.
I've 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. 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 1, 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 don't expect a pandemic every day. It's understandable. Today, we will hear from non-governmental
experts who utilize these systems from the other side, and it's important that the American
people hear from the doctors who actually treat COVID patients? We'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's key to the doctor-patient
relationship. So one doctor who was bedside during the pandemic is Dr. Patrick Whelan. Dr.
rheumatologist and an expert in molecular biology and immunology. Now, Dr. Whalen has co-authored a
paper which studied COVID-19 vaccine trial data and found excess risk of certain serious adverse
events. Dr. Whalen 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. 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
and 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's 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 stay 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. Thank you, Mr. Chairman, and
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 a 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 functions
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 crisis and boost vaccine confidence
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 three
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've 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.
Thank you very much.
I'm going to introduce our witnesses now, some of the accolades I may have already mentioned,
but we'll go through them.
I think it's important.
Dr. Patrick Whalen.
Dr. Whalen is an Associate Professor of Pediatrics at UCLA, Adjunct Professor in Molecular Microbiology
and Immunology at USC and lecture in Pediatrics at Harvard Medical School.
Dr. David 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. Renee Gentry is the Director of the Vaccine Injury Litigation Clinic at the George Washington
University. Dr. Yvonne Bonny 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 9G, 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.
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.
We look forward to your testimony.
Let me remind the witnesses that we have read your written statements.
They will appear in full record on the hearing, but please limit your oral statements to five
minutes at this time.
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 four minutes, the light will turn yellow.
And when the red light comes on, your five minutes has expired.
And we ask that you wrap things up.
I now recognize Dr. Whalen to give an opening statement.
My thanks to Dr. Wendstrup 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 PhD 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. Winstrup mentioned, I've been lecturing
for the past 13 years in virology at the University of Southern California and I've also had the
for nearly 30 years with Harvard Medical School in Boston,
and I still teach a Harvard Extension course,
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 1,000 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
in 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 received these experimental vaccines.
We discovered that in the Pfizer trial,
there was one additional serious adverse event
for every 556 people vaccinated,
were 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 a VAERS report at the time
and I felt it was my civic duty.
I had filed other various 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're going to get
a various report filed initially.
I don't know how many people are available
at the FDA to follow up on the more
than 1.7 million VAERS complication reports
that have been filed the past three 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.
Thank you.
I now recognize Dr. Gortler to give an opening statement.
Thank you, Dr. Weinstraub, Dr. Weiss, and members.
The views I express in this testimony are my own
and don't 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's things like guns or airplanes or cars.
Since most people know at least a little bit about cars, I'm going to use a car analogy
to compare COVID mRNA injections to the 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 nine 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're picturing in your head right now, it's not that.
It's something more complex.
On top of its 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 wasn't 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 of time was reduced by over 90%, 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 didn't 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
in 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, in place of critical technical information,
70 percent of the document would be grayed out with B4 redactions, translating to, quote,
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 pharmaceuticals.
I mean 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's nowhere near as fancy or elaborate or laden with features, but it's 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, one 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 aren't 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 100 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, incidence, and viral clearance for ivermectin. Similarly positive data
is associated with use of vitamin D and hydroxychloroquine. How peculiar is it that some
of the same politicians who believe it is okay to legalize hard street drugs such as heroin,
methamphetamines, have a cow when it comes to ivermectin, hydroxychloroquine, vitamin D,
and other protocols to COVID.
To the countries, 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 pharmaceutical
jammed through an expedited review process
when there are inexpensive, undebatably safe and effective alternatives available.
There is an academic medical discourse should be encouraged it should be
encouraged not quelled. Thank you very much. I look forward to cultivating an
academic exchange with everybody here. Thank you. I now recognize Ms. Gentry to
give an opening statement. Thank you and good afternoon. Thank you to Chairman
Winstrip, 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
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 of 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 individuals,
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's 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, CERVA, the shoulder injury related to
vaccine administration, which is associated with nearly all the covered
vaccines on the vaccine injury table, and Guillain-Barré 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, 3,618 cases. As a result, it is now the
norm in the vaccine court to wait two 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 life-saving 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's critical to distinguish the vaccine injured from the anti-vax. All of my
clients were vaccinated. They suffered real and often catastrophic injuries that
supported by medical and scientific literature and expert opinion. Though 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 or 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.
Thank you.
I now recognize Dr. Maldonado to give an opening statement.
Thank you, and good afternoon.
Chairman Westrop, Ranking Member Reese,
and distinguished members of the subcommittee,
thank you for the opportunity to testify.
I'm 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've 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
of 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 vaccinations 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's safety and effectiveness.
As I said, any medical product carries some risk,
and it is critical to have robust symptoms 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 workforce
and infrastructure.
Thank you again for the opportunity to testify and for your efforts to boost vaccine confidence and uptake.
Thank you. I now recognize myself for questions and a few comments.
One of the things with COVID itself that makes it very difficult is there are so many people that got COVID and didn't even know they had it.
And so if you're trying to say that it was safer to have the vaccine as opposed
to getting COVID, it's very difficult because many patients got COVID and
didn't know. I didn't know until I couldn't 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
ignore the fact that many people got COVID and didn't even know it. So that's one thing. But
Dr. Maldonado, do you think it's 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? Absolutely. I believe that the bond between a physician and a parent and a patient
is sacred and really should be a transparent. I think that's one of the things that we missed
when we started putting out mandates you eliminated the physician and that's what a lot of people
struggled with which has in my opinion has led to many people having vaccine hesitancy and I say my
opinion it's because we're out with our constituents all the time and we get their opinion and and so
that's a difference between say just working in a lab or in an agency you know we're actually out
with the people and understand what's going through their minds.
During part one, I asked our government witnesses to acknowledge that they were a little 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% safe and effective.
That's what they interpreted that to be, but they never qualified their statement.
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 if there is one? Oh sure and Dr. Weinstrup I
I appreciate the question. I'd also like to point out that one of my colleagues, Dr. David Wiseman,
pointed out to me yesterday that the language, 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. So what about ours?
So with ours, I believe the way the approval process works is once it's, I mean, EUA,
once it's authorized one way or another, it's authorized. The question is, though,
is that we heard Operation Warp Speed.
And Operation Warp Speed, while it was kind of a cool idea
with underlying themes of 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.
I mean, per my opening statement,
maybe I'm 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
is complicated.
And for instance, just to let you know, the molecular weight of ivermectin is about the
same, excuse me, of hydroxychloroquine, is about the same molecular weight size as Tylenol,
about 300 Daltons.
In contrast to that, we don't know what the exact structure is, the exact molecular weight
is for the spike protein encoding for RNA.
And we also don't know, but just the spike protein alone is like 4,000 bases, which is
is about 200,000 Daltons compared to about 300 Daltons.
So it may have been an unnecessarily,
it seems like I would have liked to have seen
an Operation Warp Speed for things like
ivermectin, hydroxychloroquine, vitamin D,
maybe colchicine, bumetidine, metformin.
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?
The question's for me, sir?
Yes.
No, they aren't.
and I can explain why. I don't think the collection systems are adequate for the following reasons.
As a physician, you'll know, and there's other physicians in here, a normal physician visit is usually billed out as a code, not ICD-10,
but the,
whatever the code is, it's a 99213 for 15 minutes. A CPT code, thank you, is a 99213.
And a 99213 pays a physician something like
$75 for
or to be able to 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 working behind the counter
at one of these grueling chain pharmacies,
you know, they have metrics by their employer and their their metrics are to
Hammer as many round pegs in a round hole as fast as they can and they don't there's nothing. There's no protocol
There's 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 Pfizer
scratched out of Harvard that
Found that it's there it's only the very very low digits the single like 1%
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 a more vigilance about reporting by health care professionals.
Does that answer your question?
Yeah, it does. And yeah, we also have concerns of reported versus verified
significant events, et cetera.
And that that's the type of stuff we want to be better at.
Dr. Whalen, do you believe that it's appropriate to house all of the potential updates and
corrections to VAERS on a non-public database?
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 too that people were very aware that you didn't have the kind of follow-up
on vaccination generally that we expect, for instance,
from our pediatricians where you've got a nurse who's going
to call the following week and make sure
that your child is doing okay.
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 various reports that there have been, and knowing
how challenging it can be to actually file a various report, the task could have been
even vastly larger than the large task that it already is.
So I mean, you have to have some level, I think, of internal dialogue 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 yeah, you know, look, there's no doubt. It's a challenge, you know when you 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
I will say, Dr. Wynne, the government witnesses in our part one of this told us that all serious
reports to VAERS are followed up upon.
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?
I don't have a high-level view of how often and how closely they follow up, 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, and I mentioned that I had had this
patient who died. The whole tenor of the discussion completely changed, but even
Even then, it was a whole month before I was able to speak with somebody, and I have never
received any follow-up 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 follow-up, they didn't do much
in the way of follow-through afterwards.
Thank you.
Just a quick question for Ms. Gentry, because I think in your opening statement you made
You made many good points in your concerns for the compensation systems in place.
Can you give us some idea of how we should change how our system works currently?
The VICP specifically?
Well, we can start with that, yes.
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's certainly some delays in that.
That needs to be updated.
We're still looking at compensation from the 1980s
for these cases.
So you're looking at a death case being capped
at $250,000 in the VICP.
There are some additional other compensation,
pain and suffering is capped at 250.
There are thankfully no caps on economic damages
in the VICP, which is great.
Future care for people with those rare individuals
with serious injuries have additional care,
lifelong life care plans that can come into effect, that is critical.
From the standpoint of the countermeasures program,
in looking at the history of the countermeasures program, I think 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. I think the first big hit that it took was with the H1N1 vaccine
back in 2009, and those cases went into the countermeasures program.
system. That was a big chunk of cases, but nowhere near what we're 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's not an appropriate program
for it. We saw Mr. Grimes speak, 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 don't have attorneys or experts or anything like
that. So I think that's 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 talked about words matter,
so I want to be clear with my words. When I speak of causation in these cases,
I'm talking about legal causation in the vaccine court, not medical certainty,
not on 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.
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 to a little less alphabet soup, but that is very
difficult. When you don't have right to counsel, it is incredibly difficult, particularly if you
are dealing with if you are injured or you are sick or your family member is sick, to do that.
So I think there's 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's would be my recommendations for those improvements. Appreciate that
And I'll recognize dr. Weiss for questions
Thank you during last month's hearing. We heard from federal officials at the F
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 as safe and effective as possible.
Dr. Maldonado, I'd 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?
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've had these programs in place.
Obviously they were accelerated
because of the nature of the pandemic that we were in,
but the processes were followed.
And what did clinical trial data collected
as part of these processes show about the safety
of the COVID-19 vaccines? Well, as we know, there were adverse events, and that's 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 workforce 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 myalgias.
But again, at the other end of the spectrum were the more serious things like TTS.
And we talked in more detail about the various systems
that were in place to identify adverse reactions.
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 over count what one individual would think was
And in fact, many of the patient-driven were investigated and were 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
their recommendation.
So, once the COVID-19 vaccines were brought to market, multilayered surveillance systems
operated by the CDC monitored for adverse events.
Dr. Maldonado, has data collected through these surveillance systems generally reaffirmed
the safety of the COVID-19 vaccines?
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 data sets, for example, Medicare claims data
sets, emergency room visit data sets. There are numerous other data sets where you can
take large populations and verify what you see in your surveillance through these.
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 so we can rule them out
and 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?
Yes, absolutely.
That's the case.
And it just happened recently with the follow-up
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. Okay, but they're taken seriously and they're looked into further,
correct? Yes, they are. Okay. So it seems like that's the system that we want is to be hyper
vigilant and then do the investigation to determine to make the changements or adjustments.
But overall, the vaccine has shown in a population health base to be safe and effective, correct?
Yes, with the data that's come from multiple surveillance systems.
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?
No, I think the data has been very supportive of my decision to counsel my patients.
Okay, thank you.
And in the case that rare but serious adverse events occur after vaccination, such as severe
allergic reactions, 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?
Thank you.
I think it's absolutely critical that they have that.
I mean, the whole system was designed to be faster, 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's very critical and what you're seeing also with the COVID cases is the frustration of the delays is
Starting to turn people who again are pro vaccine and got the vaccine and want want to do the right thing
Turning away from it and being very concerned. It's very disconcerting. So so it's a systematic
Issue that needs to be fixed and absolutely in both programs. Yeah, and and 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 that is that is something that I think we can have bipartisan consensus on
Now I'd like to turn my attention to the physician-patient relationship during the kovat 19
pandemic. As I've stated before in previous select subcommittee hearings, the relationship
between a patient and their doctor is sacred, a cornerstone of health care 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 front lines 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 decision-making power of patients and physicians.
I'd 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?
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 that I've seen actually in my career.
So physicians weren't left out in these recommendations for requirements.
In fact, they gave their input and they supported them.
Well, yeah, 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 our opinion in as front line providers around what would
work for our providers and what would work for our patients in terms of communication.
So you were consulted on even how to better communicate with patients regarding the vaccine
and the requirements.
Yeah.
And you gave your input and the association gave their input too.
Yes, I believe that our input was solicited on a regular, a regular basis.
And, and do you agree with the allegation that doctors were sidelined and that the
physician-patient relationship was disregarded in the discussions
surrounding COVID-19 vaccine requirements? I did not find that to be
the case either at the local level or at the national level in the in the
patients. How did you communicate with your patients during this time and, and
Was there any scenario where you advised for any contraindicated reasons not to take the
vaccine and what to do about it?
So I will say, as all of us probably here at the table, we worked probably 24-7 for
those 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.
and in dealing with numerous town halls, webinars,
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.
Thank you.
Before I conclude, I'd 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're not leaving it up to ideology,
we're not leaving it up to partisanship, we're not leaving it up to chance, because ultimately
science and epidemiology is the ruling out of chance in our recommendations to determine
patterns and that we can get close to the absolute, get close to the truth in
order to provide the best recommendations that we can and so
that's why I see because of these studies and science that we're in a much
better place and so with that I yield back. Now recognize Miss Malliotakis
from New York for five minutes. 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, appreciate your insights and your recommendations.
My question's for Dr. Whalen.
In your testimony, you discussed your research
that reanalyzed 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 finding 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.
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 that, 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 and we reanalyzed the data
with objective criteria. It hadn't been done that way previously and we
discovered that there were some flaws in the way that both Pfizer and Moderna
reported their data that hid some of the the adverse effects. Here to share an example.
Uh and and incidentally I don't know that this was an intentional thing and I don't know that
the FDA was even aware that that this was going on but for instance the um the Pfizer population
their data was reported in a form that included a very large number of people who had only gotten
in a single vaccination and people
who did not have adequate follow-up afterwards.
So the number of people that we analyzed
were just the individuals who received two vaccinations
and received at least two months of follow-up 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 the Pfizer vaccine
had associated adverse events that, at least by pediatric standards, were pretty high.
So with regard to finding myocarditis in young people, I did get phone calls from around
the country from providers who were anxious about 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've got elevated troponin levels,
which suggests, you know, that they might be having a heart attack.
Well, it's 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 follow-up
for long-term effects, right?
We really don't know what the long-term effects of not just the 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? As I alluded before, I think that the system was under-resourced and I
don't fault the individuals involved. I've 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 follow
up 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.
So my last, like, 20 seconds,
just want to ask Dr. Gortler a question.
You've written about the FDA's dependence
on vaccine manufacturers for certain safety assessments
with 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 also allowing space
for addressing legitimate concerns openly?
So, the one-word answer is transparency, period.
But it's not clear to me, you know, when the FDA, 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 on the label and the technical documentation
of how it's manufactured, how the mRNA shots in particular are evaluated for safety, there's
too much, there's just too much information missing.
And so we can't the bottom line is just we'd like and I don't know if the transparency honestly
I don't know if I can blame the FDA for the transparency or it's some component of
The emergency use authorization or whatever the PrEP act that just doesn't have that it doesn't allow that information in there
But there is conspicuously there's information conspicuously lacking not only from the label you comparing it to other drugs that utilize RNA as a mechanism of action
Especially because this drug is is so much more complex
I mentioned there's about 4,000 base pairs.
Another drug on Proto, which is also an RNA technology, contains all the information you
need.
You know, molecular weight, number of strands.
You know, she even shows a picture of the structure.
And that's only 20 base pairs.
And so this is – and so we don't have transparency for something that's a lot
more complex per the introduction that I talked – the CAR reference.
Thank you.
Thank you.
I now recognize Mr. Mfume from Maryland for five 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. Whalen, 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 there was a small black school on the edge of the Chesapeake Bay
that had attached to it a small
underfunded nursery and I remembered my mother taking me to that nursery as a
young person under the age of five and
going back the next two 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's very important.
It's 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.
There was anguish.
There was death, and obviously there was a great deal of sorrow that some people are
still experiencing.
people wanted help and they wanted it right away and they looked to all of us
whether we were in government or not or in as you are in medicine or not to
figure it out because they thought that they were going to find themselves
stricken or lost losing a loved one so today is a cautionary tale that's 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, four years ago, caution went out the window, and as a result of
that, many of the things that we're 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'm 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 BICP 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.
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?
Certainly. Right now, and in my written testimony, I talk about the various lengths of time.
So when you file a claim in the VICP right now, the average time for the government's
response in a regular lawsuit, you file a lawsuit and there's an answer.
In our program, we file a petition and there's the rule for response.
Right now, it's taking between 12 and 16 months for HHS to do that because of the lack of
reviewers on that end.
So that's just at the beginning.
That's when everything's in.
If you have a table case, which means you have a presumption of causation based on certain
the 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.
I see.
And nothing in our program is anything less than 60 days at a time.
It could take two years to get to the point of a trial, two years for the trial to get
to the trial.
I've got to reclaim my time.
I'm sorry.
We have a limit here, unlike the Senate, where they just go on forever.
But this is why I want to go back to what Mr. Reeves 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 us not forget that clinical trials are inadequate.
They're 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 wanna thank all of you for what you're doing.
Ms. Maldonado, I wanted you to talk
about equity in your opinions,
but I don't know if the Chair is going to allow any more time. So my thanks to all of
you for being here.
We can certainly make a request for the record.
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 follow-up.
I yield back, and I thank you for your consideration, Mr. Chair.
Thank you. Now I recognize Ms. Lesko from Arizona for five minutes of questions.
Thank you, Mr. Chair, and thank you to all the witnesses. This has been very
interesting and informative. I'm glad to hear that we actually may have
bipartisan support in helping the victims because the system is
obviously broken. I just want to emphasize that by saying what
happened to my office, okay? So as of January 1st 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, hasn't heard anything back. So my staff, who's sitting in the back, called
and or contacted the CICP legislative affairs person and said okay what's the
update on this person they couldn't give them any update then they said well how
many of the he asked how many of the claims have you processed have you 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. They don't even have the
information of how many claims they've processed or they've awarded.
I mean it was $41,000 I believe has been awarded in the CICP and you know
with how many claims? 12,854 claims? I mean that's like nothing. All right, well
that's my rant but then I do I do have another question and that is Dr. Whalen
you had testified that you had a boy in your care that died you had done initial
report and then you tried to follow up 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? Yes, it is. Okay. Well, I have a story also of a New York man who suffered from, and I
can't even pronounce this, HLH 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.
Quote, 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 follow-up 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
Reported accurately and so do you have any suggestions?
I mean, I know you have you haven't got anything back to any of you have any suggestions and how we can improve this
Processes. It sounds like it's absolutely messed up
If I may miss let's go. I'm also from the state of Arizona. My family's lived there since the 1940s and I live in Rio Verde
There is a problem with getting because what the information that that's contained in there's is not complete the on the
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 databases and buy some expensive software
to get all the information to be able to view.
But there's information which is also
not submitted electronically.
And this is, I mean, this is an unrelated matter,
but I mean, there's, right now,
one of the things I'm 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.
So I found out, when you look at all adverse events
over a long period of time, I found about 70,000 hits.
And I'm not sure what those hits are made up of,
but when I spoke with the person, with the director,
who's the head of, at the FDA, the head of FOIA,
my first request got lost.
And my second follow-up, when I asked for it,
I said, I would like this information.
And he said, well, that's 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.
And so I think the problem, the fact that it's, again, but it boils down to what one of the
other Congresswomen was saying.
It's transparency.
There's a lack of transparency, and there's too much information that's 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 as someone who's familiar with the rules of HIPAA
and keeping medical records 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's that.
And so there's a blockade.
There's 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, etc. Thank you.
Thank you, all of them, all of you. It's been very interesting and it's 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
I didn't realize that under CICP, they couldn't have an attorney.
I didn't realize that until you said it.
Well, I would say there's no right to counsel that people have their attorneys, but it's
not a court process, so there's not really much that the attorneys can do.
Got it.
Thank you.
Okay.
Now, recognize Ms. Dakota from Hawaii for five minutes of questions.
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, most especially addressing deficiencies in our nation's compensation
program so that those who experience rare yet serious adverse events can receive the
compensation and care they need.
That's 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?
Without objection. 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 this
NVICP claims. As noted in their letter that we'll 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 this steep increase is largely in part due to the influenza vaccine being administered
to adults. In fact, more than 92% of those claims in the last two fiscal years were filed
for adults, with 74% of all claims being filed for alleged injuries from the influenza virus.
Unfortunately, while you've seen this dramatic increase, their budget has barely increased
from 6.5 million to 11.2 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 this pandemic, unfortunately, we have seen growing distrust in vaccines overall.
And while misinformation about COVID-19 vaccines have proliferated online, it's 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% in April 2021 to 71% in the
fall of 2023.
And while a decrease of 6% 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 to California. So far this month,
we have already seen 58 cases of measles, many of which have occurred among unvaccinated children.
That's just as many cases as there were during the entirety of 2023. This is especially concerning
as 250,000 kindergartners nationwide haven't received their updated measle 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?
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 that, again, that sacred trust.
And I think our families really continue
to trust, at least in the pediatric population.
I'm sure that's 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.
All of our generation, several generations, have never seen these diseases that I've
cared for in the past. It's understandable that people think, well, they're not here.
Why should I take a vaccine that's going to hurt my child's arm? They're going to be uncomfortable.
what's the good? And the good is that these diseases are not eliminated. I was
on the panel that sought the elimination, that certified elimination of measles in
2000. It's very sad to see that we may head away from that after 20 remarkable
years. These diseases kill. They cause neurologic damage and developmental
damage. I've 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.
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're experiencing?
Is that a question?
I'm sorry.
Yes.
Yes, absolutely.
Well, I mean, everybody gets, especially the 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.
So we could essentially see a measles elimination status
removed because of medical misinformation,
misinformation online in the community.
Thank you.
Now recognize Dr. Joyce from Pennsylvania
for five minutes of questions.
Thank you for convening this hearing today,
and to our panel for taking part in this.
This is an important follow-up 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 front line during any public health emergency and federal
response should be guided by the first-hand experience of health care
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
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. Whalen, 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? 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's more of an institutional ennui
than there is any kind of malintent
on the part of the current administration.
But I do think that, as Dr. Maldonado was saying,
doctors want to be heard.
They want to know that their concerns
are being taken seriously.
And I think that, 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're experiencing.
But rather that the system really express an interest
in finding these kinds of adverse events.
Can you speak about the benefits of ongoing and effective communications for physicians
on the front line and those who are responsible for providing health care guidelines?
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 tick disorders.
And so I'm 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's 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 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,
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.
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?
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.
I think this is an important point, and as a physician and as a parent of a child with
autism, I'm 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 health care providers, and particularly it means
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.
I now recognize Ms. Ross from North Carolina for five minutes of questions.
Thank you very much, Mr. Chairman, and thank you so much to the witnesses for being with
us today.
In their 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'd 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,
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's 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's worth, the ingredients of the vaccines are included on the product's
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'd 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, I quote, COVID-19 vaccines are one of the most effective public
health tools we have to prevent spread of the virus, hospitalizations, and death.
This is consistent with the views of 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 briefs for BST Holdings v. OSHA, the AME stated that
halting enforcement of federal vaccine requirements would, quote, severely and irreparably harm
the public interest," end quote, due to the, quote,
grave danger to public health, end quote,
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?
No. Thank you.
With my remaining time,
I'd 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're 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.
Without objection.
Thank you, Mr. Chairman, and I yield back my time.
Now recognize Ms. Green from Georgia for five minutes of questions.
Thank You, Mr. Chairman
Nothing creates vaccine hesitancy like ignoring people when they're reporting problems with vaccines that they're 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're screaming from the rooftops
something's wrong with the vaccines, I'm 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 were a victim of a vaccine
injury or a doctor trying to report what you were seeing in your patients from
vaccines. 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
of 2020, less than four years. Something's wrong with the vaccines. It's just because
people are walking around and they've been vaccinated and they're not reporting a problem
doesn't mean other people aren't having problems. And this has been virtually ignored. So much so,
not only has it been ignored, it's 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 Maggie Day Gray. Maggie was a young child who developed severe
symptoms and is still in, has a feeding tube today. She's 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's having a real vaccine injury, but yet social media
takes you off, and the White House says it's okay, and Department of Homeland
Security says it okay, and they label it misinformation. We can talk about funding
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's a serious issue.
Dr. Maldonado, you're from Stanford.
I'm assuming you participated in the censorship program
of so-called vaccine misinformation.
I've 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. Winstrup 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've never had the vaccine and I've 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. It's been
brought in today as an example. It's 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 that there are so many people that have suffered
injuries from these vaccines and there's continuing problems, and now this vaccine
is recommended by the CDC for children. There's also serious issues with blood clots that are
being completely ignored, and it's 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.
Thank you.
And now I'll recognize Ms. Dingell from Michigan
for five minutes of questions.
Thank you, Mr. Chairman.
Right now, we are at a pivotal moment for vaccine confidence
in the United States.
In recent years, we've witnessed a startling decline
in immunization levels across the board.
And I'm 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's a problem.
And I also, in listening to my colleague, the last victim of polio just died, who lived in an iron
I'm not old, but I'm seasoned.
I'm really glad we were required to get polio vaccines.
And I am somebody who, by the way, can't get a flu shot.
We've 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've 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 comes through.
And they know.
And if they're at risk, they've 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 got Guillain-Barre doesn't mean people
should never get a flu shot.
There, 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'm alive and I'm 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're gonna run out of time
and we've 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? 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. 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 and more are included in two bipartisan pieces of legislation
led by Congressmen Lloyd Doggett, H.R. 5142 and 5143. 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.
It would bring the infrastructure up to date in those programs and allow those claims to
be processed.
You have more special masters to process claims, modernize the program to where it's
supposed to be in 2024, and allow the excise tax, which the manufacturers want to pay.
Thank you.
Now, Dr. Maldonado, do you agree that reforms like increasing the number of special masters
to process claims and ensuring that damage is paid out reflect inflation will strengthen
and how the Vaccine Injury Compensation Program operates?
Yes, I do.
And Dr. Medina, do you agree
that strengthening compensation programs for people
who experience rare, I was one,
but serious vaccine adverse effects is an important tool
for fortifying vaccine confidence?
Yes, it is.
Thank you, and I yield back, Mr. Chairman.
I now recognize Dr. Miller-Meeks
from Iowa for five minutes of questions.
Thank you, Mr. Chair, and I thank our witnesses
that are here today.
I am both a physician, 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 conduct during 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?
To get a new vaccine on the secretary, well, first,
the ACIP has to make a recommendation
for routine administration to children under the age of five.
The secretary has to take that and make a recommendation
to add it to the table, and then it goes
through the regulatory processes.
At the same time, the excise tax has to be instituted on that.
If it's not, it's not there.
And do you believe CICP is adequate
for adjudicating COVID-19 vaccine's claims?
No, I do not.
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'll specifically point out to myocarditis and pericarditis
and in 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's not true. Does that, in fact, affect
the adjudication of claims, or does that have no bearing on the adjudication of claims?
Generally speaking, we never have epidemiological support because vaccine injuries are rare,
so it's 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's
not our burden of proof in the program. And again, I'm speaking of legal causation and
not scientific certainty and causation in that term.
And like Representative Dingell, when
I was the 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 are actually,
they may be uncommon, but I would not
say that they're rare.
Is the compensation for injuries related to vaccines, is the compensation enough?
Someone that has Guillain-Barre and is paralyzed and then out and on a ventilator and then
out of work for months, it was about six months I was helping her to work remotely, that to
me does not seem like a mild injury and would bear compensation.
If for any other medication or drug, there certainly would be compensation.
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.
What advantages do claimants to VICP have that CICP claimants do not, because you answered
that in the negatory?
For one, it is an actual court process in the VICP.
You have a 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.
Thank you very much. I thank all of our witnesses. I thank the chair for this
important hearing. I yield the balance of my time. Thank you. Listen, I'd like to
thank all of you for being here today. I'm 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's been very valuable what each of you
has had to offer into the conversation today and moving forward, and I
encourage all of you to reach out with us further if any concerns you may have,
recommendations you may have doing better 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. We will be glad to share those with you and
make them public.
In closing, I would like to thank our panelists again, once again, for your testimony. With
that, and without objection, all members will have five 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.