FDA review finds no confirmed pediatric vaccine deaths; labeling updates on the horizon
An op-ed analyzing a December 2025 FDA OBPV post-market safety review argues that, while myocarditis after mRNA COVID vaccines is a real and rare risk, the 96 pediatric deaths reviewed were not proven to be vaccine-caused and did not reveal a hidden FDA effort to conceal deaths; using the WHO-UMC causality framework, most cases were deemed unlikely or unassessable, with only a few probable or possible links largely tied to alternate explanations. The report recommends a safety-labeling update (Boxed Warning, updated Warnings/Precautions, Adverse Reactions, and Patient Insert) but stops short of a benefit-risk conclusion, contrary to political framing that labeled it a scandal.
