The head of the Food and Drug Administration's vaccine division claimed in a leaked email that “at least 10 children" died from COVID-19 vaccination, using that to justify major vaccine regulatory changes.

The memo did not disclose the health conditions of the children, or the vaccine manufacturers involved. The findings were based on an initial analysis of 96 deaths between 2021 and 2024, which Prasad said "concludes that no fewer than 10 are related" to COVID-19 vaccinations.

Food and Drug Administration officials say they will ratchet up requirements for vaccine studies, citing concerns about COVID shots for kids. But public health experts question the agency's analysis.

The FDA’s top vaccine regulator asserted in a staff email that the Covid vaccine caused at least 10 kids' deaths, but experts told STAT they are skeptical of the “extraordinary” claim because it was not presented with detailed data.

U.S. Food and Drug Administration officials said COVID-19 vaccines killed at least 10 children, providing no evidence for the statement. Citing these deaths, the agency said it plans to make existing vaccine regulations more strict.

The Biden administration withheld data from the public on the risks of myocarditis from the Covid vaccine, FDA Commissioner Marty Makary claimed Thursday.

The federal agency has not publicized how it reached its conclusions.

Vaccine advisers to the US Centers for Disease Control and Prevention may vote this week to make a major change to the childhood vaccine schedule, potentially delaying a dose of the hepatitis B vaccine given to newborns by weeks or even years.