FDA claims on COVID-19 vaccine safety are unsupported by reliable data - and could severely hinder vaccine access [View all]

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FDA claims on COVID-19 vaccine safety are unsupported by reliable data – and could severely hinder vaccine access
Published: December 3, 2025 4:16pm EST

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


(The Conversation) 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.

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Citing an internal, unpublished review, the memo, written by the agency’s top vaccine regulator, Vinay Prasad, attributes the children’s deaths to myocarditis, an inflammation of the heart muscle. And it says the deaths were reported to the Vaccine Adverse Event Reporting System, or VAERS, but provides no evidence that the vaccines caused the deaths.

The death of children due to an unsafe vaccine is a serious allegation. I am a pediatric cardiologist who has studied the link between COVID-19 vaccines and heart-related side effects such as myocarditis in children. To my knowledge, studies to date have shown such side effects are rare, and severe outcomes even more so. However, I am open to new evidence that could change my mind.

But without sufficient justification and solid evidence, restricting access to an approved vaccine and changing well-established procedures for testing vaccines would carry serious consequences. These moves would limit access for patients, create roadblocks for companies and worsen distrust in vaccines and public health. ....................(more)

https://theconversation.com/fda-claims-on-covid-19-vaccine-safety-are-unsupported-by-reliable-data-and-could-severely-hinder-vaccine-access-271028