FDA vaccine experts who fought rush to approve jabs, new Twitter Files give GOP boost

The Democratic presidential ticket of Joe Biden and Kamala Harris promoted COVID-19 vaccine hesitancy to defeat President Trump, then made hesitancy inevitable through their administration's contortions of science and regulatory procedure to justify mandates even on populations with an unfavorable harm-benefit profile, according to a new congressional review.

A new batch of Twitter Files given to journalist Alex Berenson shows the social media platform, now called X, perceived Trump's Food and Drug Administration commissioner-turned-Pfizer board member and a recently departed Biden White House COVID adviser as "speaking for the [Biden] administration" in their demands for COVID-related censorship, Berenson said.

Both focus on the summer of 2021, when the Biden administration started laying the groundwork for vaccine mandates through Biologics Licensing Application approval and a booster under emergency use authorization (EUA) against the backdrop of the Delta variant wave contradicting its messaging that vaccination stops infection and transmission.

"The FDA abandoned its congressional directive to protect citizens from false claims and undisclosed side effects, and instead ignored its own rules to pursue a policy of promoting the vaccine while downplaying potential harms," House Judiciary Administrative State Subcommittee Chairman Thomas Massie, R-Ky., said in a press release.

The GOP interim staff report alleges FDA leaders sidelined the agency's top vaccine experts for political reasons and drove them out, invented "implausible" grounds for rushing BLA approval and became a shill for Pfizer's vaccine, which exceeded agency authority, while leaving out "the same disclaimers drug providers are required to provide in their marketing materials."

As it banged the drum for accelerated approval, "the Administration ignored or silenced voices that questioned the merits of universal vaccination and downplayed the serious injuries from the EUA vaccine," the report says.

Its agencies "mishandled reports of vaccine injury, despite requirements to actively obtain, synthesize, and report feedback on the safety and efficacy of the EUA vaccine," it also says. "Biases seemed to emerge that discounted evidence of vaccine injury."

The report refers to former FDA Commissioner Janet Woodcock's statement to The New York Times that "I’m disappointed in myself" as part of the federal neglect toward people who reported COVID vaccine injuries.

"I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously," Woodcock said.

The Centers for Disease Control and Prevention stonewalled Massie when he asked why its in-house journal made Pfizer vaccine-efficacy claims not supported by evidence presented to the FDA's advisory committee for EUA, particularly that it benefits those with natural immunity, the GOP report says.

Republican staff said CDC officials told "third-party scientists who evaluated the vaccine" to ignore Massie's questions and refused to change misleading language in that issue of the Morbidity and Mortality Weekly Report, which is not peer-reviewed, because the agency had higher "priorities" than issuing an erratum.

The full 623-page report with appendices features more than 300 pages of transcribed interviews conducted last year with the FDA's top two vaccine regulators when top brass was pushing an aggressive timeline for BLA approval of Pfizer's vaccine and EUA for boosters, as the Biden administration had promised.

Marion Gruber and Philip Krause, then the director and deputy director of the Office of Vaccines Research & Review, said they endured relentless pressure from Woodcock and Center for Biologics Evaluation and Research Director Peter Marks to rush BLA approval to justify mandates despite their concerns from EUA data about heart inflammation in young men.

Marks' interview from April comprises nearly 200 pages, and nearly 100 pages feature internal communications among Woodcock, Marks, Gruber and Krause over the timeline for BLA approval and internal CDC communications about Massie's complaints, sometimes calling him "Massey." Some communications with Epoch Times reporter Zack Stieber showed up, too. 

The report is a precursor to Massie's hearing Wednesday on the Biden administration's alleged lowering of agency standards, and related threat to public health, in the service of political objectives. Krause is testifying along with vaccine-injury litigator Aaron Siri, who represents groups suing the CDC for COVID vaccine-injury records.

"The FDA stands behind the approvals and authorizations of COVID-19 vaccines, which have been shown to be safe and effective in preventing the most serious consequences of the disease, including hospitalization and death," according to a statement from agency spokesperson Cherie DuvallJones.

"FDA-approved and authorized vaccines have met, and continue to meet, the FDA’s rigorous standards for safety and effectiveness," the statement says. "Additionally, the agency places a high priority on vaccine safety and is committed to the integrity and credibility of our vaccine safety monitoring efforts."

The CDC didn't respond.

In August 2021, when the Pfizer shots received FDA licensure, and just before the booster received EUA, the top two FDA vaccine reviewers with decades of experience announced their departure.

This Wednesday, I will hold a hearing that will uncover what was happening at FDA. pic.twitter.com/Behi4DyFUj

— Thomas Massie (@RepThomasMassie) June 22, 2024

Gruber and Krause publicly aired their objections even before leaving the agency in fall 2021, joining a letter in The Lancet warning against indiscriminate boosting and the policy's effects both on health and vaccine acceptance, and Krause later took to The Washington Post to accuse the administration of "extreme political pressure" on agencies.

She told the subcommittee "it was not clear whether the vaccines were more effective than natural immunity for healthy people with prior COVID-19 infection," while the EUA data made it "evident" they posed a higher risk of myocarditis than benefit for young men, justifying a longer evaluation than Marks and Woodcock were willing to accept.

While Krause said a "prioritized" BLA review should conclude around mid-January 2022, he and Gruber agreed to Marks' proposal to target mid-October. Marks then claimed that was still too long, demanding mid-September, which Gruber called "unprecedented" and the absolute minimum review period without “cutting corners” and lowering FDA standards.

Because the duo was "intransigent," in Marks' term, on completion no earlier than mid-September, he emailed another CBER leader to create what Krause perceived as "human resources consequence[s]" for the duo, the report says. 

Woodcock and Marks removed them from the review four days later, and the CBER director became the face of the agency's "Just a Minute" videos promoting Pfizer's vaccine without any disclaimers. He told the subcommittee, as it paraphrased, "the unique nature of the pandemic and the need to address vaccine hesitancy required" his promoting.

Marks' testimony that he rushed BLA approval because of a surge in COVID hospitalizations and deaths that summer doesn't jibe with his conversations with Woodcock or Gruber's "contemporaneous memorialization of their conversation," or even CDC data showing those rates "were the lowest at any time during the pandemic until 2023" in July 2021.

"In fact, the data show a significant spike in hospitalizations after the Biden FDA cut corners in the BLA process and the Biden Administration started mandating the vaccine," the report says.

The "Pfizer/White House Files" show that Pfizer board member Scott Gottlieb and Democratic operative Andy Slavitt "used careful – almost coded – language" to refer to him in their outreach to Twitter in July 2021, days after Biden accused Facebook of "killing people" for not squelching vaccine skepticism such as Berenson's, the journalist wrote.

The recently departed Biden White House adviser still included his government email address in his signature when Slavitt asked Twitter's lobbyist and White House liaison Todd O'Boyle to join him and Gottlieb, identified as "FDA commissioner under Trump" but not Pfizer board member, for a "fully bipartisan" 20-minute call "about a policy matter."

The next day Gottlieb told O'Boyle – noting his FDA service but, again, not his Pfizer role – that the platform had an "affirmative obligation" to squelch "a handful" of Twitter-verified accounts, "frequently cited to me as authoritative" by conservatives and members of Congress, that are fueling "dangerous and false narratives" on COVID.

O'Boyle showed the conversation to Twitter public policy chief Lauren Culbertson, who told executives it was a signal that "we could be next" in the sights of the White House, which was floating a "review" of Section 230 liability immunity for tech platforms, despite "other backchanneling suggest[ing] that we're on much better footing than FB." 

Four days later, the Pfizer board member implied he would trash Twitter "on TV this weekend" because O'Boyle apparently forgot to set up the call, prompting the Twitter lobbyist to immediately apologize and offer to talk in as little as 20 minutes.

Berenson said he plans to use the new documents to amend his lawsuit against the administration, Slavitt, Gottlieb and Pfizer Chairman Albert Bourla for "conspiring to force Twitter to ban me in 2021."