On Friday, a major controversy erupted within the FDA as its chief medical and scientific officer, Vinay Prasad, disseminated an alarming memo that quickly surfaced in the media. Despite lacking evidence, Prasad alleged that COVID-19 vaccines have resulted in the deaths of 10 children across the United States. Citing these unfounded claims, he declared unilateral and extensive changes to the FDA’s vaccine regulation process, impacting even seasonal flu shots.
The memo prompted a forceful response from a collective of a dozen former FDA commissioners who have overseen the agency across more than three and a half decades. On Wednesday evening, they published a critical response in the New England Journal of Medicine. These former leaders expressed profound concern over Prasad’s assertions, labeling them a threat to the integrity of the FDA's mission and a potential risk to public health.
Prasad proposed dismantling the FDA’s established method of updating vaccines, such as seasonal flu vaccines and those for COVID-19. The current process relies on immunobridging studies, which assess well-characterized immune responses. However, Prasad dismissed these studies as inadequate, advocating instead for the implementation of costly and time-consuming randomized trials for each vaccine update.
Prasad’s memo declared that FDA personnel opposed to the proposed changes should “submit your resignation letters,” and warned that expressing concerns or critiques would be considered “unethical” and “illegal.”
In their joint response, the former commissioners criticized Prasad’s memo as the “latest in a series of troubling changes at the FDA,” deeming his policy revisions incoherent. They argued that Prasad’s stance against immunobridging both misrepresents the scientific basis and undermines the established regulatory framework, especially regarding vaccines targeting well-understood pathogens through proven action mechanisms.