A confidential internal memo from Food and Drug Administration (FDA) has stirred controversy after its chief vaccine regulator, Vinay Prasad, claimed that between 2021 and 2024, at least 10 children died “after and because of” receiving COVID-19 vaccination. The memo — first reported by a correspondent from PBS NewsHour and subsequently published by The Washington Post — says the deaths were likely or possibly attributed to vaccination-related heart inflammation.
Prasad described the finding as “a profound revelation,” and said the FDA will now seek stricter review and approval protocols for vaccine trials, including rethinking the framework for respiratory vaccines, annual flu shots, and simultaneous immunizations.
But the memo has triggered an immediate backlash from many public-health experts. Critics argue that the claims are unsupported because the memo provides no concrete data — no details on the children’s ages, their health conditions, which vaccine products were involved, or the methodology used to link deaths to vaccination. The review has not been published in any peer-reviewed medical journal.
Some experts warn that using internal, non-public, unverified findings to overhaul decades-old vaccine-approval standards is “irresponsible” and potentially harmful to public trust in vaccines. They note that while vaccine-associated heart inflammation (myocarditis) has been recognized — especially in younger males — the risk from actual COVID-19 infection often remains higher than the risk from vaccination.
For now, the FDA and the U.S. Department of Health and Human Services have not released full data or publicly responded to detailed requests for clarification. The agency says only that it intends to re-evaluate its approach to vaccine approvals, especially for children and other vulnerable populations.
As the debate intensifies, many in the scientific community are calling for complete transparency: they want the underlying death reports, autopsy findings, and statistical analyses made public — and subjected to independent peer review — before any sweeping changes are made to vaccine policy.