What is the FDA's proposed change for vaccine safety testing?

The FDA is considering changes to vaccine safety testing and approval procedures, reportedly influenced by claims of child deaths linked to mRNA vaccines.

What is VAERS and why is it insufficient for vaccine claims?

VAERS is a reporting system for adverse events. It is insufficient alone for proving vaccine causality, requiring corroboration from other safety data.

How does COVID-19 vaccine risk compare to COVID-19 disease risk in children?

Data shows COVID-19 disease is significantly more dangerous to children than the vaccine, causing more deaths and heart-related side effects.

Home / Health / FDA Vaccine Review: Child Death Claims Questioned

FDA Vaccine Review: Child Death Claims Questioned

4 Dec, 2025

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Summary

FDA memo cites unproven claims of child deaths from mRNA vaccines.
Myocarditis link to vaccines in children remains unproven by solid evidence.
Rigorous safety data is crucial, not just VAERS reports.

FDA Vaccine Review: Child Death Claims Questioned

The Food and Drug Administration is contemplating significant shifts in vaccine safety testing and approval processes. These proposed changes are reportedly influenced by claims that mRNA COVID-19 vaccines led to the deaths of at least 10 children, a link attributed to myocarditis in an internal memo. However, this memo lacks concrete evidence, relying on unverified reports from the Vaccine Adverse Event Reporting System (VAERS).

Experts, including a pediatric cardiologist, argue that current data indicates myocarditis from COVID-19 vaccines is rare in children, with severe outcomes even less common. They assert that altering established safety procedures based on insufficient evidence could have severe repercussions, including limiting patient access and fostering distrust in public health initiatives. Proving a causal link requires more than just VAERS data, necessitating corroboration from other robust safety monitoring systems.