On Friday, Vinay Prasad — the Food and Drug Administration's chief medical and scientific officer and chief vaccine regulator — wrote in an email awesome note employees, information about which was quickly leaked to the press. Without evidence, Prasad said COVID-19 vaccines have killed 10 children in the U.S. and so announced unilateral, sweeping changes to how the agency regulates and approves vaccines, including seasonal flu shots.
On Wednesday evening, a dozen former FDA members who collectively oversaw the agency for more than 35 years responded to the memo: sharp rebuke. Banding together to publish their response in the New England Journal of Medicine, the former commission members said they were “deeply concerned” by Prasad's memo, which they called a “threat” to the FDA's work and a danger to the health of Americans.
In his note, Prasad called for an end to the FDA's current system for updating seasonal flu shots and other vaccines such as COVID-19. These updates now include studies that measure well-characterized immune responses (called immunobridge studies). Prasad called this approach insufficient and instead plans to require expensive randomized trials that could take months or years for each vaccine update.
FDA employees who disagree with the plans can “submit their resignations,” Prasad wrote. And voicing concerns or criticism is considered “unethical” and “illegal.”
Together, the former commissioners called Prasad's memo “the latest in a series of troubling changes at the FDA” and the planned policy updates “not… coherent.” Prasad's arguments against immune bridging, they add, “misrepresent both the science and the regulatory framework, especially for vaccines that target well-studied pathogens through an established mechanism of action.”
