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Frank Han, Assistant Professor of Pediatric Cardiology, University of Illinois Chicago

FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access

Vaccine FDA Covid-19 VAERS Vinay Prasad Food and Drug Administration United States Disease Influenza
The FDA has provided no evidence that children died because of receiving a COVID-19 vaccine. Anchiy/E+ via Getty Images

The Food and Drug Administration is seeking to drastically change procedures for testing vaccine safety and approving vaccines, based on unproven claims that mRNA-based COVID-19 vaccines caused the death of at least 10 children.

The agency detailed its plans in a memo released to staff on Nov. 28, 2025, which was obtained by several news outlets and published by The Washington Post.

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