FDA and Vaccine Policy

A CBS News investigation details a major internal clash at the Food and Drug Administration after Dr. Vinay Prasad, head of its Center for Biologics Evaluation and Research, sent a sweeping email claiming COVID vaccines caused 'at least 10' child deaths based on VAERS reports and calling for a fundamental overhaul of how vaccines are approved. Within days, 12 former FDA commissioners warned in a Dec. 3 New England Journal of Medicine article that Prasad’s claims and proposed shift to large placebo‑controlled outcome trials for most vaccines threaten evidence‑based vaccine policy, could slow lifesaving shots, and risk more preventable outbreaks, while an internal Dec. 5 memo reportedly put confirmed pediatric vaccine‑related deaths somewhere between zero and seven. The article describes an ongoing HHS/FDA investigation of the alleged deaths, sharp criticism from vaccine and bioethics experts over Prasad’s interpretation of VAERS and myocarditis risk, and fears that new standards would be unethical where vaccines are already known to be safe and effective.