FDA Memo Claims COVID Vaccine Linked to 10 Child Deaths, Faces Expert Skepticism and Criticism

An internal FDA memo from CBER Director Vinay Prasad, leaked in late November 2025, claims COVID-19 vaccines caused at least 10 child deaths based on VAERS reports from 2021-2024, prompting calls for stricter vaccine regulations.1

Experts, including former FDA and CDC officials, express skepticism, noting the memo lacks detailed data, transparency on causality assessment, and that VAERS reports do not prove causation.12

The memo has been criticized by 12 former FDA commissioners and current staff for using unverified VAERS data, potentially increasing parental uncertainty about child COVID vaccines.2

No public release of detailed data or formal publication has occurred, and next steps remain unclear as of late 2025.1

COVID posed a real risk to children, with 821 deaths in those 19 and under during a 12-month period ending July 2022.1

Sources:

1. https://www.statnews.com/2025/11/29/covid-vaccine-deaths-fda-memo-vinay-prasad/

2. https://www.kff.org/quick-take/fda-memo-linking-covid-vaccines-to-child-deaths-may-boost-uncertainty-among-parents/