Americans would be scared to drive cars designed like COVID vaccines: ex-Pfizer trial pioneer

COVID-19 vaccines are safe and effective – assuming the federal government consistently updates vaccine-injury reports, assigns sufficient resources to adjudicating claims and subjects vaccines to the same safety standards as cars.

None of those assumptions is correct, medical and legal witnesses told the House Select Subcommittee on the Coronavirus Pandemic at the second of two hearings on vaccine injuries Thursday.

They included David Gortler, the first pharmacologist to serve as senior adviser to the Food and Drug Administration commissioner, pioneer of human "investigational medicine clinical trials" at Pfizer and former Yale School of Medicine professor, now at the Heritage Foundation.

Republican and Democratic members of the subcommittee agreed that America's vaccine-injury payment programs need reform, the subject of a bipartisan bill, but split on what they and the national Vaccine Adverse Events Reporting System could currently confirm about vaccine safety, given a spike in injury reports and built-in limitations.

The Vaccine Injury Compensation Program case load has tripled while the number of "masters" who review cases is capped by statute, George Washington University Vaccine Injury Litigation Clinic Director Renee Gentry testified. 

This is despite COVID vaccines being covered by the more victim-unfriendly "countermeasures" program, she said, recommending those vaccines be added to VICP and the program get more resources.

"I have not heard of a single person" injured by COVID vaccines "that feels as though their voice was being heard" in the countermeasures program, Gentry said.

She urged lawmakers to distinguish those with "real and often catastrophic" vaccine injuries from "anti-vax" people and consider that "dismissive and critical comments" about the injured increases hesitancy.

UCLA pediatrics professor and Harvard Medical School affiliate Patrick Whelan said VAERS did not update his COVID vaccine injury report after Whelan told a top FDA official and "press officer" that a 7-year-old boy hospitalized for cardiac arrest had died.

The inability for filers to update their own reports "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" have earlier VAERS reports, he said. 

Texas Attorney General Ken Paxton questions both the safety and efficacy of COVID vaccines.

The Republican told "Just the News, No Noise" this week that findings so far from his misrepresentation lawsuit against Pfizer suggest the pharmaceutical company's vaccine's clinical-trial efficacy was "below 1%," not the 95% touted by Pfizer based on a "stretched definition." He previously put Pfizer's efficacy range at 1-10%.

Vaccine makers "felt comfortable going forward, even knowing that there were adverse effects" and inability to stop transmission, "because there's no downside legally" under their federal liability shield, Paxton said. 

Subcommittee Chairman Brad Wenstrup, R-Ohio, opened the hearing by rebutting criticism that his panel is "seeking to 'rehabilitate'" – written in quotes in his prepared remarks – "the image of federal agencies." He aims to "reform" them "so they can earn the people’s trust." 

Subcommittee Republicans have sometimes pulled their punches, such as failing to challenge questionable factual assertions by the White House pandemic preparedness office director. The biggest exception is likely Rep. Marjorie Taylor Greene, R-Ga., who told agency officials at the first vaccine-injury hearing she recognized their "bullsh*t."

"The Chairman’s opening statement speaks for itself," a spokesperson told Just the News when asked who used the word "rehabilitate" to criticize the subcommittee's approach. 

Wenstrup emphasized that the phenomenon of symptom-free COVID infections leaves the feds without enough data to declare vaccination is always the safer choice, regardless of age or comorbidities. 

He repeated his garlic-salt story from the first hearing about detecting his infection only after vaccination because he lost his smell.

California Rep. Raul Ruiz, the subcommittee's top Democrat, by contrast, used forms of the word "safe" four times in his opening statement to refer to vaccines.

Vaccine injury compensation systems worked "in tandem with the massive rollout of the safe and effective" vaccines to put the "darkest days of the pandemic behind us" and "safely reunite loved ones, turn the corner on the pandemic and reopen schools, businesses and workplaces," Ruiz said. Their data have "overwhelmingly reaffirmed the safety and efficacy" of the vaccines.

America faces a "tipping point" for vaccine confidence, Ruiz said, citing an Annenberg Center survey that found more Americans see COVID vaccines as "less than effective" compared to April 2021 and falling numbers getting the measles-mumps-rubella vaccine.

The mRNA vaccines made by Pfizer and Moderna are categorically different than the MMR, hepatitis B and tetanus shots, Whelan testified. 

As chairman of an American College of Rheumatology committee on COVID vasculitis the month before emergency use authorization, Whelan realized mRNA technology was "novel in a way that was not widely appreciated," by encoding the same protein causing respiratory failure.

He said he asked the FDA to "anticipate long-lasting side effects" of spike-based mRNA vaccines on the heart because a new study showed COVID's spike was causing "enduring myocarditis in two-thirds of healthy young people." The agency never responded, Whelan said.

Pfizer and Moderna trial data suggested that mRNA vaccines caused one serious adverse event for every 556 people vaccinated, according to an analysis by an epidemiologists' group Whelan joined, but regulators "conveyed the impression" of "no major safety concerns" when EUA was granted, he said.

If cars were assembled and tested like COVID vaccines were, a 10-12 hour assembly would be squeezed into 45 minutes, the vehicles would be "visibly and technologically unrecognizable" as cars, they would be fueled by a person's body, and "decades of research" would show the materials were often "extremely delicate, finicky or toxic," Gortler said.

"Even if the slightest error was made" during the rushed assembly, "the car might not work at all," could be "extremely unsafe" or "highly unpredictable," if not all three, he said. 

The National Highway Traffic Safety Administration would have to unilaterally change its definition to even call it a car, which is what the Center for Disease Control and Prevention did in fall 2021 to classify the mRNA products as vaccines rather than gene therapy, he said.

Any researcher trying to understand the taxpayer-funded build would be given predominantly redacted Freedom of Information Act productions under the trade-secrets exemption, while the feds would decree that Gortler's own "Nobel Prize-winning car" – ivermectin – "should now only be driven by horses and cows," he said, referring to the FDA's "you are not a horse" tweet.

Yvonne "Bonnie" Maldonado, chief of infectious diseases in Stanford's pediatrics department and the Democrats' lone witness, acknowledged "the decision at its core to use any medical product is a risk-benefit analysis" but it tipped in favor of COVID vaccines across ages.

They reduced long COVID and multi-system inflammatory syndrome in children while "preserving our health systems' capacity to care for patients and facilitating a return to normalcy early in the pandemic," she said, echoing Ruiz's claims.

Maldonado twice used "rare" to describe severe adverse events, claiming vaccinated young men experienced heart inflammation as often as lightning strikes – about 1 in 10,000 – and the rate has gone down since safety recommendations were changed to space out doses.

Not addressing the inability of COVID vaccines to stop infection, she said COVID itself is much more likely to cause heart damage than the vaccine, citing a 20 million-person study this month.