12 former FDA chiefs unite to say agency memo on vaccines is deeply stupid
In a controversial move that has sent ripples through the medical community, Vinay Prasad, the FDA’s chief medical and scientific officer, issued a memo claiming that COVID-19 vaccines have resulted in the deaths of 10 children in the United States. This assertion, made without substantiated evidence, has raised significant concerns among public health experts and prompted Prasad to propose sweeping changes to the agency’s vaccine approval and regulatory processes. His recommendations include abandoning the FDA’s current framework for updating vaccines, such as seasonal flu shots, which relies on established immunobridging studies that assess immune responses. Instead, Prasad advocates for the implementation of costly randomized trials, a shift that could delay vaccine updates for months or even years.
The memo has sparked a fierce backlash, particularly from a coalition of twelve former FDA commissioners who have collectively overseen the agency for over 35 years. In a letter published in the New England Journal of Medicine, these former officials expressed their “deep concern” regarding Prasad’s assertions and the potential implications for public health. They characterized his memo as a “threat” to the FDA’s credibility and a danger to the health of Americans, emphasizing the importance of maintaining a robust and scientifically sound regulatory framework for vaccines. The former commissioners argue that the proposed changes could hinder timely access to updated vaccines, potentially compromising the effectiveness of immunization efforts against seasonal flu and other infectious diseases.
This incident underscores the ongoing debate surrounding vaccine safety and regulation, particularly in the wake of the COVID-19 pandemic. As public trust in health agencies fluctuates, the FDA’s decisions and communications are under heightened scrutiny. The response from former commissioners highlights the critical need for evidence-based practices in vaccine regulation, as well as the potential consequences of unfounded claims that could undermine confidence in vaccination programs. As the situation develops, it remains to be seen how the FDA will navigate these challenges and what impact Prasad’s memo will have on vaccine policy and public health moving forward.
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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Eric
Eric is a seasoned journalist covering US Tech & AI news.
