by Greg Piper
A 30-year veteran of the Food and Drug Administration told a congressional hearing this week that he resigned in part because top executives sidelined their office to expedite full approval of the company’s Covid-19 vaccine Pfizer in August 2021, apparently to legally enable vaccine mandate , then booster placed under Emergency Use Authorization by objections from external advisors to the agency.
But former deputy director of the Office of Vaccine Research and Review Philip Krause probably saved his biggest embarrassment to the FDA for last Wednesday’s hearing into alleged political interference by the Biden administration in COVID vaccine review: He refused to take the booster.
Krause did not explain his personal choice to the House Judiciary and Administrative State Subcommittee — which Chairman Thomas Massie, R-Ky., helped uncover — but it gave both sides ammunition against each other’s COVID narratives.
He said primary vaccinations have “very large benefits” compared to the risk of adverse events, but “very good research” has shown that natural immunity is even more protective. Booster doses, meanwhile, were beneficial for “many” people, “particularly the elderly and immunocompromised.”
Early vaccination data showing a “fairly high” rate of 1 in 5,000 of heart inflammation in juvenile men has given Krause and his boss, Director Marion Gruber, a “pause,” he said. While most cases are “mild,” he added that worse cases of myocarditis have lifelong consequences, such as difficulty playing sports.
Krause’s Testimony includes examples last week in which “a senior leader interfered with the normal review process or single-handedly overrode the scientific recommendations of peer review teams,” he said. “The system is set up to allow the hierarchy to overturn science,” with one solution requiring leaders to invoke “external expert support” to overturn peer review teams.
Representative Hank Johnson of Georgia asked if Krause was a disgruntled employee, seeking to blunt his allegations against then-Commissioner Janet Woodcock and Center for Biological Evaluation and Research Director Peter Marks that he was “passed over” for Gruber’s position.
“There was no hat” [in the ring]there was no search,” Krause fired back, saying he and Gruber resigned “basically on the same day” in November 2021. Johnson thanked him for his public service.
Almost halfway through Tuesday 623-page Republican Party interim staff report These are transcripts of interviews with Krause and Gruber, as well as their aggressive communications with Woodcock and Marks, in which they demanded an “unprecedented” approval timeline that risked “cutting corners” and endangering public trust.
One of Gruber’s concerns about the rush to approve Pfizer’s biologics license application was the required “pediatric design” because studies of the drug’s effectiveness did not include children under 12 and safety is “most important” in younger age groups, she said Massie, recounting his interview.
Although Gruber told GOP staffers she opposed authorizing booster shots for the general public, she didn’t leave because she disagreed with the policy, but because she had already delayed her planned retirement from June 2020 to support fight COVID. She said Krause “didn’t want to let me go” and announced less than a week later that she was leaving.
Massie opened the hearing with a Pfizer ad in which celebrity food presenter Martha Stewart claimed she was given the stimulants because they “helped her[s] “protect against recent Omicron variants” – which Pfizer had no data on – and showed it later to ask witnesses whether it met legal requirements to stick to FDA-approved claims.
“There seems to be something missing here,” Krause said. Vaccine Injury Lawyer Aaron Siri said the FDA ignored his complaint about this and other ads – one appeared on “Sesame Street” – because of the lack of claims for products that were not yet licensed as “safe and effective.”
Massie said Marks made claims in his dozens of “Just a Minute” videos promoting COVID vaccines that “have not been verified” by the FDA.
Founder and physician of the Microvascular Research Foundation Jordan Vaughnwhose Birmingham, Alabama, clinic serves many military patients, said the juvenile men came in shortly after getting vaccinated with “shortness of breath and myocarditis” and “are basically being discharged from the hospital right now because they are unable to take care of their physical needs.”
Vaughn has seroprevalence data on about 7,000 patients, and until the Omikron study, the reinfection rate among previously infected people was “virtually zero,” he said.
Unknown doctors reported Vaughn to the Medical Board for saying that vaccination “does not necessarily prevent transmission,” which required him to “have a conversation” with the regulator, Vaughn said, “but at that time I was proven right.” The same thing happened when he opposed children wearing masks on the school board, he said.
The Department of Health and Human Services is “structurally conflicted” as it evaluates the safety and promotes vaccines while defending companies over consumers, Siri said.
He also said Marks’ office considered the Covid-19 vaccine trials “robust” because they were more reliable than those of most childhood vaccination programs. Unlike most drug trials, which take years under placebo control, they are “anemic” because, unlike vaccine makers, other drugmakers can be held liable for injuries, he said.
One of his clients, 15-year-old Maddie de Garay, now uses a wheelchair with a feeding tube because of a Pfizer study in her age group that the company reported as “functional abdominal pain, that she had abdominal pain,” Siri said. After several letters to the FDA about her case, they “shrugged and whitewashed” the injury, he claimed.
Even while condemning alleged misinformation about the virus from the Republican Party and witnesses, Democrats and their witness made questionable statements of their own.
Ranking Member Lou Correa, D-Calif., accused Republicans of “over-focusing on potential errors” about COVID vaccines and offered a table of “misleading statements and falsehoods,” including that the vaccines do not stop infection or transmission.
“We have a responsibility to all Americans to debunk conspiracy theories, which are false statements that can cause serious harm,” Correa said.
“Another misinformation is that natural immunity does not exist,” Massie replied.
Judiciary Committee Ranking Member Jerry Nadler, D-N.Y., inexplicably stated that “every witness [Republicans] “testimony was brought in that the vaccine review was “complete, thorough, and scientifically exacting.”
He may have confused the Trump administration’s initial EUA for COVID vaccines with the BLA approval for Pfizer’s vaccine under President Biden, which Gruber and Krause have criticized. Nadler cited their statements supporting the EUA, which Krause said “destroyed” the FDA criteria.
Rep. Lucy McBath, a Georgia Democrat, claimed that Siri said, “and I quote, ‘no children have died from COVID,’” shortly after Siri claimed that Correa’s 1,700 death figure was not based on “credible” data and that “healthy children” were not among them.
Professor of Pediatrics at the University of Utah Andrew Pavia, testifying on behalf of the Infectious Diseases Society of Americasaid “many” of Siri’s statements were “patently incorrect” while falsely claiming that children were never required to be vaccinated against COVID. Siri responded that it had obtained a court order against the San Diego school district’s student vaccination mandate.
Correa cited a modeling study by the Commonwealth Fund, a Democratic favorite in the Covid-19 hearings, that found that Covid-19 vaccines saved 3.2 million lives between December 2020 and November 2022.
“These aren’t just numbers, these are people – these are real people,” he said.
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Greg Piper is a reporter for Just the News.
