12 former FDA chiefs unite to say agency memo on vaccines is deeply stupid

In a bold move, Vinay Prasad, the chief medical and scientific officer at the FDA and the agency's leading vaccine regulator, sent a controversial memo to staff that quickly garnered media attention. In this memo, Prasad made unfounded claims that COVID-19 vaccines had resulted in the deaths of 10 children in the United States. He subsequently proposed sweeping changes to the FDA's vaccine approval and regulation processes, which now extend to seasonal flu shots as well. Responding to Prasad's alarming assertions, a coalition of twelve former FDA commissioners—who collectively bring over 35 years of experience in overseeing the agency—issued a strong critique. Their response, published in the New England Journal of Medicine, expressed profound concern over the implications of Prasad's memo, which they described as a potential threat to the FDA's integrity and public health. In his communication, Prasad suggested abandoning the current framework used for updating vaccines, including seasonal flu vaccines, which relies on well-established immunobridging studies to assess immune responses. He labeled this method as inadequate and proposed a shift towards costly randomized trials that could extend the timeline for vaccine updates by months or even years. Furthermore, Prasad's memo contained an ultimatum for FDA staff who may disagree with his plans, stating they could submit their resignation letters. He also deemed any expression of dissent as unethical or illegal. The former commissioners condemned Prasad's memo as part of a troubling trend within the FDA and criticized the proposed changes as incoherent. They argued that Prasad's objections to immunobridging misrepresent scientific evidence and the regulatory history of vaccines that target well-known pathogens through established mechanisms.