FDA Reviewed 96 Reports of Pediatric Deaths After Covid Vaccination

The U.S. Food and Drug Administration reviewed 96 reports of pediatric deaths submitted to the Vaccine Adverse Event Reporting System after Covid-19 vaccination. Officials examined medical records, autopsy reports, and follow-up investigations for each case.

About 25 of the reports prompted high-level internal discussion. The agency ultimately classified seven cases as either possibly or probably related to vaccination.

An internal FDA review led by a senior scientist in the vaccine division assessed the reports. The findings were initially slated for presentation to an advisory committee but were not publicly discussed after details appeared in news outlets. A November 2025 internal memo stated that at least 10 children had died after receiving Covid-19 vaccination.

A later analysis using a World Health Organization framework classified zero deaths as certain, two as probable or likely, and five as possible.

The agency rejected a proposal for a black-box warning on the vaccines. In December 2025, the FDA commissioner stated that earlier safety concerns might not apply to updated vaccination schedules. In May 2026, Senator Ron Johnson wrote to Health Secretary Robert F.

, citing an FDA memorandum on the pediatric deaths. The letter referenced discussions about revised vaccine warning labels. The FDA has not released the full review or subsequent analyses of the 96 VAERS reports.