White House Lacked Plan to Compensate People Injured by COVID Shots, as FDA Sped Up Approval

The Trump administration didn’t have an adequate plan for compensating people injured by COVID-19 vaccines before it mandated the shots, Rep. Brad Wenstrup (R-Ohio) told The Defender, following last week’s hearing by the U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic.

Wenstrup, chair of the subcommittee, said:

“We also heard concerning testimony that it appears the FDA U.S. Food and Drug Administration, accelerated the COVID-19 vaccine approval process to seemingly meet arbitrary mandate timelines set by the Biden administration.

“We also were able to delve deeper into why public trust has eroded in public health, particularly when it comes to vaccine safety.”

The Feb. 15 hearing examined the approval process for the COVID-19 vaccines, deficiencies in government vaccine safety surveillance databases and a backlog in vaccine injury compensation cases — but critics say key issues remained unaddressed.

Ray Flores, senior outside counsel for Children’s Health Defense (CHD) and an expert on the Countermeasures Injury Compensation Program (CICP), was critical of the proceedings. He told The Defender:

“This hearing was predominately a disgusting hug box by pharma shills who spoke without candor or compassion by exhibiting willful ignorance of the true depth of the dumpster fire that is the COVID-19 vaccine and CICP in a face-saving display that skillfully misdirected the discussion to figure out how to more efficiently buy off a ‘handful’ of dead for a pittance.

“This was not about vaccine safety or transforming compensation programs, it was about damage control. Don’t forget, COVID-19 vaccines are still covered by the PREP Act until at least the end of this year.”

Dr. Joel Wallskog, a Wisconsin orthopedic surgeon who no longer practices due to injuries he sustained from the Moderna COVID-19 vaccine and co-chairman of React19, a nonprofit representing vaccine injury victims, told The Defender:

“React19 and the COVID-19 vaccine injured community … are very disappointed with the hearing. Most representatives used … their allotted time to pontificate and not ask tough questions.”

Wallskog said the questions “failed to go into any needed detail” and witness statements “were easily taken at their word” without any supporting evidence.

Brianne Dressen, founder of React19, attended Thursday’s hearing. She said it was “obvious” that addressing the problems with compensation is “not a priority” for the health agencies.

“The ‘massive avalanche of reports to VAERS’ should indicate the need for further research and surveillance that is being ignored,” she Dressen said. “Both sides really failed to dig into the true purpose of the hearing.”

Dressen said she submitted questions she wanted the witnesses to respond to during the hearing, but her questions weren’t asked.

Kim Witczak, a member of the FDA’s Psychopharmacologic Drugs Advisory Committee, said she was “not surprised” by the “pretty predictable” testimony.

“[Peter] Marks and others avoided or skirted around the tough questions [and] continue to engage in revisionist history,” she said. “Congress should not accept ‘I don’t recall’ when it comes to the safety and efficacy of products; they must push for answers.”

During questioning, Marks did acknowledge a sped-up timeline for the vaccines’ approval, Witczak said.

The hearing featured testimony from three key public health officials:

  • Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER).
  • Dr. Daniel Jernigan, director of the Centers for Disease Control and Prevention’s (CDC) National Center for Emerging and Zoonotic Infectious Diseases.
  • Dr. George Reed Grimes, director of the Health Resources and Services Administration’s (HRSA) Division of Injury Compensation Programs — which administers the CICP, the agency responsible for handling COVID-19 vaccine injury compensation claims.

During the hearing, the three witnesses sidestepped problems with government vaccine injury databases, such as the Vaccine Adverse Event Reporting System (VAERS) and V-safe, and with the CICP, but praised what they described as the safety and effectiveness of the COVID-19 vaccines.

The witnesses also avoided talking about injuries and severe adverse events related to the COVID-19 vaccines and did not acknowledge vaccine-injured people in attendance.

FDA sped up approval process to facilitate government mandates

Wenstrup described the hearing as “an opportunity to discuss what lessons were learned during the pandemic about our vaccine safety and surveillance systems.”

He said this is “critical” in preparing for future pandemics, adding that “Politicians … drove a lot of distrust in what was coming out of public health.”

Marks admitted that corners were cut. “In order to get the vaccines to people in need when thousands of people were dying, we actually allowed the safety to be authorized with just two months of median follow-up, rather than the normal six to 12. But we were confident that that would capture adverse events.”

According to Marks, those adverse events include “some initial discomfort … in the arm” and “fatigue.” He said “there are rarely more serious side effects,” noting that the FDA “identified myocarditis and rare allergic reactions” but “by putting mitigation strategies in place, both [have] decreased in occurrence.”

In response to a question from Rep. James Comer (R-Ky.), Marks confirmed that the approval process for Pfizer’s COVID-19 vaccine was sped up. This timeline appears to have facilitated subsequent vaccine mandates, including the U.S. military’s vaccine mandate.

Pfizer submitted its full approval application on May 18, 2021, with Jan. 18, 2022, originally set as the required action due date, Marks said. According to Comer, during the summer of 2021, Pfizer requested a faster approval of the vaccine, proposing late October 2021. In turn, Marks continued to request earlier approval dates, Comer said.

Comer said that two former FDA scientists “felt substantial pressure” from Marks to facilitate this quick approval, but Marks claimed that “an increasing number of deaths from COVID-19” prompted the sped-up approval process, as “having an approved vaccine would help Americans feel more comfortable getting vaccinated.”

“There was an acknowledgment that an approval could allow vaccine mandates to occur,” Marks said, although he denied that the approval process was connected to pending mandates.

Comer noted that the Pfizer vaccine “was ultimately approved on Aug. 23 … and just for the record, the military mandate was issued on the 24th.”

“Prioritizing speed over accuracy in FDA politics should never be encouraged,” Witczak said. “This raises suspicion about the timing of authorization and the swift implementation of military mandates within days. The public should have been informed about the limitations of a rapid review process.”

Dr. Danice Hertz, a retired gastroenterologist from California who was injured by Pfizer’s vaccine, said:

“Marks conveniently glossed over the fact that there were many serious adverse reactions as well as deaths in the clinical trials. What were the results of the clinical trials as far as adverse reactions and deaths? These were recorded but have never been publicized. Why was the public never apprised of these results?”

Testimony on VAERS ‘very disingenuous’

Wenstrup told the subcommittee, “VAERS reports for COVID-19 vaccines total significantly higher than all other vaccines combined since 1990.”

Jernigan countered that VAERS is “not intended to determine if a vaccine is causing an adverse event.” He said each of the “exceedingly rare” adverse events has “a follow-up.”

But Wenstrup said, “People who have submitted reports to VAERS have told my staff that they were never contacted.”

In an exchange between Marks and Rep. Debbie Lesko (R-Ariz.), Marks said the public-facing information on VAERS “is just a small fraction of the information that we ultimately collect and sift through that is very important to determining whether an adverse event is truly related to the vaccine.”

Marks testified that more VAERS data are not made publicly available due to patient privacy concerns.

But Albert Benavides, founder of VAERSAware.com, told The Defender such statements are “very disingenuous,” noting that “Protecting victim identifiable data is as easy as hiding columns in an Excel spreadsheet.”

When Lesko pressed Marks on why the number of confirmed deaths related to vaccine-related adverse events is not released via VAERS, he said the number was presented “in various settings,” and that “we probably have not done a good enough job of communicating sometimes the actual numbers of deaths versus what’s in VAERS.”

Marks did not respond to Lesko’s question about whether “there is an easy place for the public to find this [information].”

Jernigan said VAERS and other government databases have shown there were lower rates of death and complications in the vaccinated compared to the unvaccinated.

Rep. Marjorie Taylor Greene (R-Ga.) was critical of Marks’ testimony. “I’m not a doctor, but I have a Ph.D. in recognizing bull****.” She said the FDA “rushed through this process of authorizing” the vaccines despite knowing of adverse events.

“Some people in here are trying to belittle these VAERS reports, but these reports come from people, people that died, people that got injured,” Greene said.

“Marks continues to pick and choose which safety monitoring system they want to use that best supports their narrative,” Witczak said. “The FDA and CDC consistently mislead the public and Congress by claiming to have the world’s most robust safety monitoring systems. Marks and the FDA continue to turn a blind eye on the injured.”

‘Many of our reports disappeared’

Marks said federal agencies “encourage[e] safety reporting” of vaccine-related adverse events, but Benavides called this “a lie,” saying that “physicians and nurses have been fired for submitting reports, especially at the institutional level, like hospitals.”

“The general population has no idea of VAERS,” Benavides said. “Most vaccine victims are lucky to even have a hotline number to call.”

In one instance, Marks claimed that numerous false reports are submitted to VAERS, citing as an example submitted reports where a recently vaccinated individual was killed in an automobile accident. Benavides disputed such claims:

“Motor vehicle accidents keep getting thrown around to dismiss VAERS, yet there are only a couple dozen at most in VAERS. Why didn’t this expert panel discuss the 150 victims minimum having died within three hours of their vaccination?”

Benavides said, “It is accepted fact that at least 75% of all reports are submitted by healthcare professionals not related to the victims.”

He added that the witnesses did not address “the atrocious quality of the data” in VAERS, citing figures showing that 32% of all domestic COVID-19 death reports list an “unknown” state, 34% do not list the victim’s age, and 29% list an “unknown” age.

“VAERS is difficult to use and mostly a black hole,” Dressen said. “React19 conducted an audit on the failing VAERS system that showed 1 in 3 reports is missing from the system. We requested the FDA conduct an external audit. The FDA has no more interest in interacting with us.”

Hertz said, “It took three years and 11 reports to VAERS for someone to contact me from the CDC and request my records,” adding that it is “a very difficult system to navigate.” After submitting her 11th report on Dec. 24, 2023, Hertz said the CDC employee who spoke with her said the agency was “swamped with reports of injury.”

She added that, having spoken to thousands of vaccine-injured individuals through her advocacy work, “many say their physicians refused or failed to file a report to VAERS, often claiming they didn’t have time,” while “Only a few in our support groups of many thousands have been recently contacted by the FDA or CDC for information. Many of our reports disappeared,” Hertz said.

Claims about ‘rare’ COVID vaccine adverse events ‘patently false’

Marks claimed that “COVID vaccines are the most closely monitored vaccines that have ever been rolled out in U.S. history,” citing identification of a rare blood clotting disorder identified among six recipients of the Johnson & Johnson (Janssen) COVID-19 vaccine.

Jernigan claimed that systems like VAERS picked up myocarditis safety signals associated with the COVID-19 vaccines in April 2021, particularly in young men. But, according to Jernigan, “Further research has shown that the risk of myocarditis is substantially lower following vaccination than following infection.”

“There was a signal for myocarditis or pericarditis only after the primary vaccination series with the Pfizer mRNA vaccine in those 12 to 17 years of age, and that now that signal is not being seen more recently,” Marks said.

“These examples show vaccine safety monitoring by CDC and our partners is rigorous and transparent,” Jernigan claimed.

But Brian Hooker, Ph.D., CHD’s senior director of science and research, said the CDC and FDA “covered up” the safety signal.

“Jernigan’s claims are patently false,” Hooker said. “If Marks could read and do basic math, he would know that the myocarditis signal for COVID-19 vaccines first appeared in VAERS on Feb. 19, 2021. There was other evidence of myocarditis reported to CDC even prior to Feb. 19, 2021, yet CDC officials ignored it.”

Only 11 COVID vaccine injury compensation claims approved

The slow pace of resolving vaccine injury claims through CICP was also addressed at Thursday’s hearing, with Wenstrup noting that, as of Jan. 20, “CICP has compensated 11 claims out of the more than 12,000 that have been filed for COVID-19 vaccines.”

He also said CICP payouts are “significantly smaller than VICP” — the Vaccine Injury Compensation Program, which handles injury claims for vaccines on the childhood vaccination schedule — at “about $3,700 compared with almost $500,000 in VICP.”

In his testimony, Grimes said CICP received over 12,000 claims related to COVID-19 countermeasures, compared to “about 500 claims over its 10-year history prior to COVID-19.” He said these claims “represent a small fraction, less than 0.001%, of all COVID-19 vaccine administrations in this country,” arguing that “injuries are rare.”

“Making an assumption that the low number of applications somehow reflects the number of true injuries in the U.S. doesn’t add up,” Dressen said. “Far too many barriers exist to provide fair compensation.”

Grimes blamed a lack of resources and the “high evidence standard for an individual to be compensated by the CICP” for the backlog of claims. Yet, he admitted that CICP has not yet developed an injury table for COVID-19 countermeasure injuries.

Hooker said the CICP “is intentionally kept secret from the American public to avoid bankrupting the vaccine injury fund. Also, the onerous process of becoming a petitioner in the CICP would scare away the rest of the individuals who were planning on filing a claim.”

Referring to her own experience with the CICP, Hertz said she filed a report “shortly after the one-year statute of limitations two years ago and never heard back.”

‘No response’ from public health agencies

Greene said safety signals related to the COVID-19 vaccines were immediately evident on VAERS.

“Boom, 10,596 reports in less than a month,” she said, adding that VAERS injury and death reports totaled 706,767 in 2021 and 206,676 in 2022. She added that there are 18,372 reports of deaths, 17,842 reports of permanent disability, 86,452 reports of hospitalizations, 113,449 serious adverse event reports and 315,048 reports of emergency room or office visits. Yet, “Only 11 people have been compensated.”

Greene referred to Dressen, who was in attendance at the hearing:

“She’s met with you, Dr. Marks. She’s met privately with you about her vaccine injuries. She participated in a clinical trial. She was injured and then she was dropped from the trial for the COVID-19 vaccines. Her medical expenses are $433,000 a year. She filed with CICP, Mr. Grimes. She’s gotten no response.”

Greene also referenced the National Institutes of Health’s (NIH) study of vaccine-injured individuals that was quietly abandoned by the agency in early 2022 — and for which CHD recently obtained documents via a Freedom of Information Act request.

“The [NIH] also saw Ms. Dressen for her neurological complications that have been quite severe,” Greene said. “They studied her and then they dropped the study and asked her to be quiet about it. These are the real stories of the vaccine-injured. They were totally, completely wiped off of social media.”

Lesko mentioned one of her vaccine-injured constituents, Steve Wenger, who was diagnosed with Guillain-Barré syndrome. “Wenger’s injury was also reported to VAERS, and he filed a claim with CICP about two years ago, but has not heard back at all … not even a form letter.”

Wenstrup told The Defender that part two of the hearing “will focus on similar topics,” but testimony will be provided by doctors, patients or other individuals who” interact with these systems.”

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