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

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

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…

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