On Friday, Vinay Prasad — the Food and Drug Administration’s chief medical and scientific officer and its top vaccine regulator — emailed a surprise memo to employees that was quickly leaked to the press. Without evidence, Prasad claimed that COVID-19 vaccines have killed 10 children in the US, and as such, he announced unilateral, sweeping changes to the way the agency regulates and approves vaccines, including seasonal flu shots.
On Wednesday evening, a dozen former FDA commissioners, who collectively oversaw the agency for more than 35 years, responded to the memo with a sharp rebuke. Uniting to publish their response in the New England Journal of Medicine, the former commissioners said they were “deeply concerned” by Prasad’s memo, which they described as a “threat” to the work of the FDA and a threat to Americans’ health.
In his memo, Prasad called for abandoning the FDA’s existing framework for updating seasonal flu shots and other vaccines like COVID-19. Those updates currently include studies that measure well-characterized immune responses (called immunobridging studies). Prasad called this approach inadequate and instead planned to require expensive randomized trials, which could take months to years, with each vaccine update.
FDA employees who disagree with the plans “may submit their resignation letters,” Prasad wrote. And airing concerns or criticisms is seen as “unethical” and “illegal”.
Together, the former commissioners called Prasad’s memo “the latest in a series of troubling changes at the FDA” and the planned policy update “not…coherent.” Prasad’s arguments against immunobridging, he says, “misrepresent both the science and the regulatory record, particularly in the case of vaccines that target well-understood pathogens through an established mechanism of action.”
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