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

"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."

"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."

"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."

Vinay Prasad, the FDA's chief medical and scientific officer and top vaccine regulator, emailed a memo claiming without evidence that COVID-19 vaccines have killed 10 children in the US and announced unilateral changes to vaccine regulation. He called for abandoning immunobridging studies used to update seasonal flu and COVID-19 vaccines and proposed requiring expensive randomized trials that can take months to years. Prasad instructed dissenting FDA staff to submit resignations and labeled airing criticisms as unethical and illegal. A dozen former FDA commissioners published a scathing rebuke in the New England Journal of Medicine, calling the memo a threat, misrepresenting science, and deeming the planned policy incoherent.

Read at Ars Technica