Overview
- An internal memo by FDA vaccine chief Vinay Prasad alleges at least 10 pediatric deaths were causally tied to COVID-19 vaccination through myocarditis.
- The document has not been publicly released or peer reviewed and, according to reporting, relies on VAERS reports without case-level details such as ages, timelines, autopsies, or alternative causes.
- Public‑health experts and former FDA officials criticize the memo’s methodology and tone and warn that unvetted claims risk eroding vaccine confidence.
- Prasad proposes sweeping changes to vaccine oversight, including broader randomized trials, reassessment of annual flu updates, larger co‑administration studies, and longer-term outcomes research, which analysts say could slow updates and raise costs.
- The memo surfaced just before a reconstituted CDC ACIP meeting, prompting concerns about undue influence on near‑term vaccine policy deliberations as evidence to substantiate the deaths has not been presented.