FDA vaccine regulator shunned COVID booster, warns the system lets 'hierarchy overrule science'

A 30-year veteran of the Food and Drug Administration said at a congressional hearing this week he resigned in part because top brass sidelined his office to rush the full approval of Pfizer's COVID-19 vaccine in August 2021, apparently to legally enable a vaccine mandate, then a booster under emergency use authorization over the objections of the agency's outside advisers.

But former Office of Vaccines Research and Review Deputy Director Philip Krause perhaps saved his biggest embarrassment to the FDA for the end of Wednesday's hearing on alleged Biden administration political interference in COVID vaccine review: He declined the booster.

Krause didn't explain his personal choice to the House Judiciary Administrative State Subcommittee – a disclosure prompted by Chairman Thomas Massie, R-Ky. – but gave both parties ammunition against each other's COVID narratives.

He said primary-series vaccination provided a "very strong benefit" against COVID complications versus risk of adverse events, but "very good studies" showed natural immunity was even more protective. By contrast, boosters were beneficial to "many" people, "especially in the elderly and the immunocompromised."

Early vaccination data showing a "quite high" 1-in-5,000 rate of heart inflammation in young men gave "pause" to Krause and his boss, Director Marion Gruber, he said. Even though most cases are "mild," he said worse cases of myocarditis have lifelong consequences, such as difficulty playing sports.

Krause's testimony includes examples as recently as last week of "a senior leader interfering with the usual review process or single-handedly overruling the scientific recommendation of review teams," he said. "The system is set up to permit hierarchy to overrule science," and one fix is requiring leaders to cite the "support of outside experts" to overrule review teams.

Rep. Hank Johnson, D-Ga., asked whether Krause was a disgruntled employee to blunt his allegations against then-Commissioner Janet Woodcock and Center for Biologics Evaluation and Research Director Peter Marks, saying he was "passed over" for Gruber's job. 

"There was no hat [in the ring], there was no search," Krause shot back, saying he and Gruber resigned on "essentially the same day" in November 2021. Johnson thanked him for his public service.

Nearly half of Tuesday's 623-page interim GOP staff report is transcribed interviews with Krause and Gruber, plus their combative communications with Woodcock and Marks for demanding an "unprecedented" approval timeline that risked "cutting corners" and harming public trust.

One of Gruber's concerns about rushing Biologics License Application approval for Pfizer was the requisite "pediatric plan," since its efficacy trials didn't include children under 12 and safety is "more paramount" in younger groups, Massie said, recounting her interview.

While Gruber told GOP staff she opposed booster authorization for the general public, she didn't leave out of disagreement with that policy but because she had already delayed her planned retirement from June 2020 to help with COVID. She said Krause "didn't want to let me go" and announced less than a week later he was leaving.

Massie opened the hearing with a Pfizer commercial in which the celebrity cooking host Martha Stewart claimed she got boosted because it "help[s] protect against recent Omicron variants" – for which Pfizer had no data – and showed it later to ask witnesses whether it complied with legal requirements to stick to FDA-approved claims.

"It does seem like something is missing here," Krause said. Vaccine-injury lawyer Aaron Siri said the FDA ignored his complaint about that ad and others – one was shown on "Sesame Street" – for lacking disclaimers on products not yet licensed as "safe and effective."

Marks made claims "not vetted" by the FDA in his dozens of "Just a Minute" videos promoting COVID vaccines, Massie said. 

Microvascular Research Foundation founder and doctor Jordan Vaughn, whose Birmingham, Ala. clinic serves many military patients, said young male service members came in shortly after vaccination with "shortness of breath, myocarditis" and "basically are now being medically discharged because they're unable to complete their physical requirement."

Vaughn has seroprevalence records for about 7,000 patients, and until Omicron the reinfection rate among the previously infected was "basically zero," he said.

Unknown physicians reported Vaughn to the Board of Medicine for saying vaccination "did not necessarily prevent transmission," requiring him to have a "discussion" with the regulator, Vaughn said, "but at that time it was proven that I was correct." The same happened when he spoke against masking children at the school board, he said.

The Department of Health and Human Services is "structurally conflicted" because it evaluates safety and promotes vaccines, defending companies against consumers, Siri said. 

Marks' office considers COVID vaccine trials "robust" because they were more reliable than those for most of the childhood vaccine schedule, he also said. They are "anemic" by contrast with most drug trials, which happen over years with placebo controls because, unlike vaccine makers, other drug makers can be held liable for injuries, he said.

One of his clients, 15-year-old Maddie de Garay, is now in a wheelchair with a feeding tube because of Pfizer's trial on her age group, which the company reported as "functional abdominal pain, that she had a tummy ache," Siri said. After several letters to the FDA about her case, "they shrugged and whitewashed" the injury, he claimed.

Even as they denounced purported COVID misinformation from the GOP and witnesses, Democrats and their witness made their own questionable statements.  

Ranking Member Lou Correa, D-Calif., faulted Republicans for "hyper-focusing on the potential misstatements" about COVID vaccines and held up a chart of "misrepresentations and untruths," including that vaccines don't stop infection or transmission.

"We have the responsibility to all Americans to shoot down conspiracy theories, misstatements that can cause grave harm," Correa said. "Another piece of misinformation is that natural immunity isn't real," Massie retorted.

Judiciary Committee Ranking Member Jerry Nadler, D-N.Y., inexpliably claimed that "every witness [Republicans] brought in" testified the vaccine review was "complete, thorough and scientifically rigorous." 

He may have conflated the initial EUA for COVID vaccines in the Trump administration with the BLA approval for Pfizer's vaccine under President Biden, which Gruber and Krause faulted. Nadler invoked their statements in support of the EUA, which Krause said "blew away" FDA criteria.

Rep. Lucy McBath, D-Ga., claimed that Siri said, "and I quote, 'no children have died from COVID,'" shortly after Siri said a 1,700-death figure invoked by Correa was not based on "reliable" data and that "healthy children" were not among them.

University of Utah pediatrics professor Andrew Pavia, testifying on behalf of the Infectious Diseases Society of America, said "many" of Siri's statements were "patently not correct" while falsely claiming children were never required to get COVID vaccines. Siri shot back that he got a court injunction against a San Diego school district's student mandate.

Correa cited a modeling study by the Commonwealth Fund, a favorite of Democrats in COVID hearings, that speculates COVID vaccines saved 3.2 million lives between December 2020 and November 2022.

"These are just not numbers, folks – these are real people," he said.