Overview
- An internal memo from CBER director Vinay Prasad asserted at least 10 child deaths occurred after and because of COVID-19 vaccination based on 2021–2024 VAERS reports, without case-level details or peer-reviewed publication.
- Scientists and former FDA officials challenged the memo’s methods and conclusions, with ex-vaccine chief Peter Marks calling it a troubling mixture of misrepresentation and lies.
- Prasad outlined proposals to tighten vaccine reviews, including rethinking annual flu shots, demanding clinical pneumonia reduction beyond antibody titers, and adding stricter requirements for products targeted to pregnancy.
- Shares fell on Monday following the reports, with Moderna down about 6–7% and declines also hitting BioNTech, Pfizer, Novavax, and Vaxcyte.
- The memo surfaced ahead of a CDC vaccine advisory committee meeting on the childhood schedule and follows leadership changes under HHS Secretary Robert F. Kennedy Jr. that have introduced regulatory uncertainty.