Six days after a senior FDA official sent a sweeping internal email claiming that covid vaccines had caused the deaths of “at least 10 children,” 12 former FDA commissioners released an extraordinary warning in the Dec. 3 issue of the New England Journal of Medicine.
They wrote that the claims and policy changes in the memo from Vinay Prasad, the head of the FDA’s Center for Biologics Evaluation and Research, pose “a threat to evidence-based vaccine policy and public health security” and break sharply from long-standing scientific norms.
What is unfolding inside the FDA is not a narrow dispute over covid vaccines. It is an attempt, according to critics and vaccine scientists, to rewrite the rules governing the entire U.S. vaccine system — how risks are weighed, how benefits are proved, and how quickly lifesaving shots reach the public. Former agency leaders warn that if these changes take hold, the consequences could be lasting: fewer vaccines, slower updates, weakened public trust, and more preventable outbreaks.
Prasad made clear he sees the moment as corrective. “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it,” he wrote, telling employees the agency’s mission, and its “worldview,” would change.
Prasad’s email reop …