Updated · University of Minnesota Twin Cities · May 27
FDA Review Finds 0 Certain Pediatric COVID Vaccine Deaths, Contradicting Claim of 10 Cases
Updated
Updated · University of Minnesota Twin Cities · May 27
FDA Review Finds 0 Certain Pediatric COVID Vaccine Deaths, Contradicting Claim of 10 Cases
2 articles · Updated · University of Minnesota Twin Cities · May 27
A 73-page FDA safety review of 96 pediatric deaths reported after COVID-19 vaccination from 2021 to 2024 found 0 certain cases, 2 probable, 5 possible, 62 unlikely and 27 unassessable.
Career scientists used the WHO-Uppsala causality framework, medical records, autopsies and CDC pathology; the report says those categories cannot definitively prove a vaccine caused a death.
All 7 probable or possible cases involved cardiac events, including 4 myocarditis cases, and the review recommended stronger class labeling—boxed warning, updated precautions and patient information—but no change in who should be vaccinated.
The findings undercut a 2025 memo by then-CBER chief Vinay Prasad that said at least 10 of the 96 deaths were caused by vaccination and suggested the true number was higher.
The report places the signal against more than 138 million U.S. pediatric-labeled doses and aligns with broader studies showing vaccine-linked myocarditis is rare, usually mild, and only occasionally fatal.
An FDA report found zero certain vaccine-linked child deaths. Why did a top director claim otherwise?
New research links vaccine side effects to our cell's mitochondria. Could this lead to safer vaccines?
With myocarditis linked to vaccine components, not just mRNA, how will future vaccine design change?
Pediatric COVID-19 Vaccines: FDA Finds No Confirmed Deaths, Assesses Myocarditis Risk and VAERS Data (2025)
Overview
The FDA conducted a detailed review of 96 pediatric deaths reported to VAERS after COVID-19 vaccination through August 2025, marking the first structured analysis of its kind. Released by Senator Ron Johnson in December 2025, the memo found that none of these deaths were classified as 'certainly' caused by the vaccine, despite earlier claims by FDA vaccine chief Dr. Vinay Prasad that at least 10 deaths were vaccine-related. The FDA's analysis identified only two 'probable' cases, highlighting the complexity of determining causality and underscoring the importance of rigorous, evidence-based review in vaccine safety monitoring.