FDA, Agency and Vaccine Change
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Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.
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.
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.
FDA chief medical officer Vinay Prasad told reporters that the agency would be changing its vaccine approval process.
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.
In a closed meeting, Vinay Prasad pushes back on criticism of his vaccine policy changes, morale issues at the FDA, and his role in recent drug-approval turbulence.