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Trust the Science? Former No. 2 FDA Vaccine Reviewer Asked Whether He Got a Booster...

Leah Barkoukis
Leah Barkoukis  |  July 01, 2024 8:00 AM

With the GOP in control of the House, Republicans can finally dig deeper into what went on behind the scenes as COVID-19 vaccines were going through the authorization process, which ultimately allowed the government, businesses, hospitals, and universities to mandate the jabs. 

The House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust, led by Chairman Thomas Massie (R-KY), released a report last week examining that process, finding that the Food and Drug Administration, under pressure from the Biden administration, upended its typical procedures to get Pfizer’s COVID-19 vaccine authorized, pushing aside concerns about how the shot was hurting some healthy young Americans. 

Massie, seeing what was occurring while in the minority, knew that where there’s smoke, there’s fire, and got to work on the issue once the GOP was back in the majority. One development that stood out to him at the time was when two of the FDA’s top vaccine regulators announced their departures in the fall of 2021. Reports at the time indicated their decision to leave the agency was over their objection to the Biden administration’s announcement that adults should get boosters eight months after their second COVID vaccine because they did not believe there was sufficient data to support pushing a third shot. Plus, the announcement was seen as pressuring the FDA to authorize them with haste. As Politico described at the time, it wasn’t just the resignations of Marion Gruber and Philip Krause that were a red flag, there was reported “mutiny” among staff and outside vaccine advisers who also felt the plan to offer boosters was “premature and unnecessary.” The two ended up testifying to the subcommittee, which a summary of the report explains:

The Subcommittee's investigation also revealed that the administrative state mishandled reports of vaccine injury, despite requirements to actively obtain, synthesize, and report feedback on the safety and efficacy of the Emergency Use Authorization (EUA) vaccine. Two former FDA scientists, Dr. Marion Gruber and Dr. Philip Krause, testified to the Subcommittee that they felt pressure to cut corners on the vaccine review, which was due to outside pressure to provide immediate approval so that the government could mandate vaccines. Despite evidence of harms from the EUA vaccine, the Biden Administration sought to fully approve the Pfizer vaccine through the Biologics Licensing Application (BLA) process.

Under the leadership of then-Acting FDA Commissioner Dr. Janet Woodcock, a long-time FDA staffer who the Biden Administration promoted to Acting Commissioner, and Dr. Peter Marks, head of the FDA's Center for Biologics Evaluation and Research (CBER), the agency cut corners in its usually rigorous BLA process to brand the Pfizer EUA vaccine as the only fully licensed "safe and effective" COVID-19 vaccine on the market at the time.  Today, former Acting FDA Commissioner Woodcock says that, as it relates to vaccine-related injury, she is "disappointed in [her]self" and that the FDA did not do enough to address vaccine-related injury.

The FDA succumbed to the Biden Administration's pressure to act beyond its authority, which may have long-term impacts on the agency's ability to confidently serve the American public. This poor policy by the Biden Administration reveals many significant problems related to accountability and good decision making in the administrative state that warrant legislative reform. (Judiciary Committee)

As Massie explained to journalist Sharyl Attkisson, the saga of Gruber and Krause being pushed out of the agency by Dr. Peter Marks was the “genesis” for last Wednesday’s hearing titled “Follow the Science?: Oversight of the Biden Covid-19 Administrative State Response,” where Krause was one of the witnesses.

When asked what news he thought came out of the hearing, Massie pointed to a “big revelation” from Krause about the booster.

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The man who was the No. 2 vaccine reviewer in the United States, who worked at the FDA for three decades, told Massie he didn’t get it. In this short clip, you'll see Krause address other issues once dismissed as conspiracy theories as well. 

In his interview with Attkisson, Massie went on to discuss another important topic to come out of the hearing, which is that the FDA no longer sees itself as a regulator of drug companies when it comes to vaccines; they see themselves as partners. This is a huge problem since there's no liability for vaccine manufacturers, as witness Aaron Siri testified. This, in turn, means there's less incentive for regulators like the FDA to ensure the safety of vaccines.