12 former FDA chiefs unite to say agency memo on vaccines is deeply stupid
In a shocking development, Vinay Prasad, the Food and Drug Administration’s (FDA) chief medical and scientific officer, sent an email to staff on Friday that has since made headlines. In this memo, Prasad made the unsubstantiated claim that COVID-19 vaccines have resulted in the deaths of 10 children in the United States. This assertion has raised significant concerns, particularly given the lack of evidence to support such a serious allegation. Following this controversial claim, Prasad announced sweeping changes to the FDA’s regulatory framework for vaccines, including seasonal flu shots. His proposed changes would abandon the current methodology, which relies on immunobridging studies that assess immune responses, in favor of requiring costly randomized trials for vaccine updates—a process that could delay necessary vaccinations for months or even years.
The memo sparked immediate backlash, culminating in a united response from a dozen former FDA commissioners who collectively oversaw the agency for over 35 years. In a letter published in the New England Journal of Medicine, they expressed their “deep concern” regarding Prasad’s assertions and the potential ramifications for public health. The former commissioners described Prasad’s memo as a “threat” to the FDA’s mission and warned that it could undermine the agency’s credibility and its ability to respond effectively to public health needs. They emphasized the importance of maintaining a robust and scientifically grounded regulatory framework, particularly in the context of vaccines that play a critical role in protecting public health.
The implications of Prasad’s memo and the subsequent response from former commissioners highlight the ongoing tensions within the FDA regarding vaccine regulation. Critics argue that the proposed changes could hinder timely updates to vaccines, which are essential in adapting to emerging variants and seasonal strains. The situation underscores the delicate balance between ensuring vaccine safety and efficacy while also responding swiftly to public health challenges. As the debate continues, the FDA’s credibility and its role in safeguarding public health remain at the forefront of discussions surrounding vaccine regulation in the United States.
On Friday, Vinay Prasad—the Food and Drug Administration’s chief medical and scientific officer and its top vaccine regulator—emailed
a stunning memo
to staff that quickly leaked to the press. Without evidence, Prasad claimed 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 scathing 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 framed as a “threat” to the FDA’s work and a danger to Americans’ health.
In his memo, Prasad called for abandoning the FDA’s current framework for updating seasonal flu shots and other vaccines, such as those for COVID-19. Those updates currently involve studies that measure well-characterized immune responses (called immunobridging studies). Prasad dismissed this approach as insufficient and, instead, plans to require expensive randomized trials, which can take months to years for each vaccine update.
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