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Inadequate vaccine safety surveillance systems “jeopardized the safety and health of Americans during the COVID-19 pandemic,” according to evidence uncovered during a hearing held last week by the U.S. House of Representatives Select Subcommittee on the Coronavirus Pandemic.

Rep. Brad Wenstrup (R-Ohio), chairman of the subcommittee, said last month’s hearing revealed the government was unprepared for “this massive wave of reports to its surveillance systems and claims to its compensation programs.”

During last week’s hearing, “Witnesses testified to personal experience reporting vaccine injuries that were not recognized by the federal government and described the legal ramifications of flooding an overwhelmed system with vaccine injury claims,” according to a press release.

During his opening statement, Wenstrup said he “disagreed” with critics who said the committee “is simply seeking to rehabilitate the image of federal agencies despite their shortcomings during the pandemic.” He said his 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,” Wenstrup said. “It’s quite another to actually fix the problems so that we may do better the next time. That’s really the goal, but this can’t be done without buy-in from all parties involved, including from federal agencies.”

Rep. Raul Ruiz (D-Calif.), ranking member of the committee, said that during the COVID-19 pandemic, vaccine safety surveillance systems “worked in tandem with a massive rollout of the safe and effective COVID-19 vaccines,” which he credited with saving millions of lives and trillions of dollars in medical costs.

“Along the way our vaccine safety systems function 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,” Ruiz said.

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‘System underestimates the incidence of more severe outcomes’

Witnesses at the March 21 hearing largely disagreed with Ruiz’s characterization.

Patrick Whelan, M.D., Ph.D., a pediatric rheumatologist at UCLA, told the panel that in December 2020, he wrote a letter to the U.S. Food and Drug Administration (FDA) “pointing out a new study that found enduring myocarditis in two-thirds of healthy young people who had been infected with COVID.”

He called on the FDA to “specifically assess the effects of vaccination in the heart.”

Whelan also said that in his letter, he suggested that although everyone wanted to “quickly bring the pandemic to an end, it would be worse if we fail to anticipate long-lasting side effects of these new vaccines.” He didn’t hear anything back from the FDA, he said.

Whelan said:

“I subsequently joined a group of epidemiologists who analyzed the data that had been collected by Pfizer and Moderna in their randomized controlled trials … and we attempted to calculate the precise incidents for serious adverse events or SAEs in adults who receive these experimental vaccines.”

He said the epidemiologists discovered that in the Pfizer trial, there was one additional serious adverse event for every 556 people vaccinated — findings they subsequently published in the Vaccine journal. Yet, “regulators at that time conveyed the impression that there were no major safety concerns,” he said.

He added that the Pfizer and Moderna COVID-19 vaccine clinical trials had “significant problems … as they were performed [and with] the data as it was reported,” noting that there were “some flaws” in the way that both Pfizer and Moderna reported their data that hid some of the adverse effects.

“For instance, the Pfizer population — their data was reported in a form that included a very large number of people who had only gotten a single vaccination and people who did not have adequate follow-up afterward,” Whelan said.

By removing this population, Whelan said that a “significant signal emerged, which showed that the Pfizer vaccine had associated adverse events that, at least by pediatric standards, were pretty high.”

Whelan also addressed a personal experience he had with a patient who sustained a COVID-19 vaccine injury and subsequently died. He said he filed “various reports” at the time with the Vaccine Adverse Event Reporting System (VAERS).”

Yet, when the patient died a week later, he said, “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.”

Voice of vaccine-injured ‘often gets lost in the debate’

Another witness, Renée Gentry, director of George Washington University’s Vaccine Injury Litigation Clinic, told the subcommittee she aimed to provide “the perspective of the vaccine-injured — a voice that often gets lost in the debate.”

“My colleagues and I believe strongly in the importance vaccines play in our society in eradicating diseases and curbing pandemics,” Gentry said. “Having said that, vaccine injuries, while rare in the vaccinated population, are real.”

When such injuries are not compensated appropriately, public trust in vaccines wanes, Gentry said.

She added:

“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.”

A step in accomplishing this involves “modernizing” the National Vaccine Injury Compensation Program (VICP) and coverage of COVID-19 vaccine injuries under VICP instead of in the Countermeasures Injury Compensation Program (CICP) — a program that makes it more difficult for vaccine injury victims to receive compensation.

Gentry said that when the VICP was established in 1986, Congress intended that it “provide individual petitioners a swift, flexible and non-adversarial alternative to the often costly and lengthy traditional tort civil litigation system.”

According to Gentry, the VICP functioned as intended for approximately 30 years, but “three procedural events have resulted in the VICP being overwhelmed at this point,” she said.

She cited the inclusion of the influenza vaccine in 2005, the human papillomavirus, or HPV, and meningitis vaccines in 2015 and the addition of further conditions to the VICP injury table in 2017.

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These developments overwhelmed the VICP, Gentry said.

“The collective effect of these procedural changes was to triple the workload of the special masters in the vaccine court,” she said. “The number of whom are still statutorily restricted to eight special masters with a caseload — as of last Friday — 3,618 cases,” she said, noting that, as a result, cases may take upwards of two years just to reach the trial stage.

“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,” Gentry added. She explained that under the CICP, claimants “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 … their voice was being heard,” Gentry said.

Other witnesses agreed with Gentry’s assessment. Whelan said when he told Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, about his patient who died of vaccine injuries, there was no follow-up.

“It was a whole month before I was able to speak with somebody, and I’ve never received any follow-up about it later. I’m not sure that they ever obtained the records on that particular case,” Whelan said.

Dr. Yvonne “Bonnie” Maldonado, chief of the Division of Infectious Diseases at the Stanford University School of Medicine, defended the COVID-19 vaccines, downplayed the frequency of adverse events and credited vaccine injury surveillance systems with detecting safety signals.

However, she acknowledged that “In the rare event when an individual is harmed by a vaccine, it is important that they can receive compensation.” She called the CICP “underfunded.”

Government had no authority to suppress COVID treatments

David Gortler, who holds a doctorate in pharmacy and is a senior research fellow for public health policy and regulation at The Heritage Foundation, told the panel the vaccine injury surveillance systems failed during the COVID-19 pandemic, and that this failure occurred in parallel with government efforts to dissuade the use of alternative COVID-19 treatments, such as ivermectin and hydroxychloroquine.

“The FDA has no congressional authority to recommend one drug or medical treatment over another and has never done so in the past,” Gortler said. But it did so during the COVID-19 pandemic, along with changing the definition of “vaccines,” he said.

Gortler said that today, “20,000 career FDA employees remain conspicuously silent” regarding “over 100 studies published by over 1,100 authors conducted in over 140,000 patients in 29 countries” that show positive health outcomes following the use of ivermectin and hydroxychloroquine to treat COVID-19 patients.

“How peculiar is it that some of the same politicians who believe it is okay to legalize hard street drugs such as heroin and methamphetamines have a cow when it comes to ivermectin, hydroxychloroquine, vitamin D and other protocols to COVID,” Gortler said.

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Mandates, censorship true cause of ‘vaccine hesitancy’

Whelan told members of the hearing, “We must work proactively … both to accurately identify the true risks of all medications, including vaccinations” and also “have the courage to trust Americans with this information in a spirit of ethical informed consent.”

Gentry called for VICP “to be modernized,” with “an increase in special masters” and “adequate funding,” adding that current VICP compensation levels for deaths and for pain and suffering have been capped at the same level — $250,000 — since the 1980s.

Gortler called for “transparency, period,” highlighting the “lack of information both in the label and the technical documentation” of medications and vaccines.

But Rep. Marjorie Taylor Greene (R-Ga.) addressed concerns expressed by both Democrat and Republican members of the subcommittee about “vaccine hesitancy” by stating that vaccine mandates are what “creates vaccine hesitancy.”

“We can talk about funding these government programs and throwing more money at these government programs, but that isn’t going to change the fact that vaccines should have never been forced on all these people to begin with,” Greene said.

“The other problem is when you get censored on the internet or you get permanently banned on social media when you are a victim of a vaccine injury or a doctor trying to report what you were seeing in your patients from vaccines,” she added.

Greene cited the example of Maddie de Garay, a child who experienced severe adverse events after participating in the Pfizer vaccine trial, but whose mother was banned from online platforms when she shared her story.

Greene called such censorship “a coordinated effort” involving the White House, the surgeon general, the Centers for Disease Control and Prevention, the U.S. Department of Homeland Security, the Cybersecurity Infrastructure Security Agency and entities such as Stanford’s Virality Project — mirroring claims made in the ongoing Murthy v. Missouri First Amendment lawsuit.