FDA and Public Health

An internal FDA memo from vaccine chief Dr. Vinay Prasad — reported by NPR and CBS — urges tighter vaccine approval standards (revising the annual flu framework, stricter labeling and authorizations including for pregnant women, requiring disease‑reduction endpoints for pneumonia vaccines, and questioning simultaneous administration) and cites an internal review of 96 pediatric death reports that it says shows at least 10 children died “after and because of” COVID‑19 vaccination, with myocarditis suggested as a likely cause; the findings have not been peer‑reviewed and omit detailed case data. Twelve former FDA commissioners and other public‑health experts denounced the claims in a NEJM letter, arguing surveillance reports cannot prove causation and that the proposals could harm high‑risk patients, while HHS defended the effort and some professional societies (AAP, IDSA) continue broader pediatric recommendations amid the shift in ACIP guidance.