Alarm Over FDA Memo: Top Vaccines Official Says 10 Children Reported Dead After Covid Shots — Experts Demand Evidence

Overview

America's top vaccines regulator, Vinay Prasad, sent a contentious internal memo claiming that at least 10 children aged 7–16 who died between 2021 and 2024 had reports in the Vaccine Adverse Event Reporting System (VAERS). The memo offered few case details, no published evidence tying the deaths to Covid vaccination, and proposed sweeping changes to vaccine regulation. Public-health experts warn the communication and proposed rules could reduce vaccine availability and erode public trust.

What the Memo Says

Prasad, director of the FDA's Center for Biologics Evaluation and Research (CBER), wrote that these VAERS reports indicated child deaths after Covid vaccination and called for an overhaul of how vaccines are evaluated and authorized. He highlighted myocarditis — a rare heart inflammation seen after some Covid vaccinations — as a potential concern but did not provide autopsy data, clinical details, or evidence that would establish causation.

'For the first time, the US FDA will acknowledge that Covid vaccines have killed American children,' Prasad wrote, and suggested the reported total may be an underestimate.

Experts' Response

Leading scientists and former agency officials criticized the memo's assertions and the way it was distributed. Paul Offit, an infectious-diseases physician and former VRBPAC member, said: 'When you make that kind of sensational claim, I think it’s incumbent upon you to provide evidence that supports that claim. He didn’t supply any evidence.'

Dan Jernigan, who previously led the CDC's National Center for Emerging and Zoonotic Infectious Diseases, described the memo and its internal-only release as highly unusual and potentially damaging to public trust. He emphasized that claims based on VAERS reports require rigorous follow-up using verified data sources.

VAERS, VSD and the Question of Causation

VAERS is a crowdsourced early-warning system that accepts unverified reports from anyone. Its purpose is to identify possible safety signals, not to establish causation. By contrast, the Vaccine Safety Datalink (VSD) links electronic medical records for about 10% of the US population — including roughly 500,000 children — and is used to validate signals detected in VAERS.

Experts note that myocarditis after vaccination is rare and that myocarditis from Covid infection is both more common and often more severe. Establishing that a death was caused by vaccination would typically require clinical evidence such as autopsy findings and careful exclusion of other causes, including Covid infection or other viruses.

Proposed Regulatory Changes And Potential Consequences

Prasad's memo said the FDA will require more randomized trials that demonstrate clinical outcomes (for example, reductions in illness) rather than relying primarily on surrogate immune-response measures for many future vaccines. He also pledged to revise the annual influenza vaccine framework and examine surrogate assays used to assess vaccine performance.

Experts warned that requiring randomized clinical-outcome trials for seasonal respiratory vaccines — especially yearly flu shots, and rapidly updated Covid vaccines — could be impractical or impossible to complete in time. Paul Offit noted that flu vaccine trials would need to run during each season, by which point the vaccine composition could be outdated. Dorit Reiss, a law professor who studies vaccine policy, warned that changing rules without evidence could hinder new vaccine approvals and jeopardize future supply.

Broader Concerns

• Transparency: Critics said it is unusual to circulate such claims internally without first convening advisory committees or publishing supporting data.
• Public Trust: Scientists warned the memo and abrupt policy shifts risk undermining confidence in immunization programs and could lead to preventable illness and deaths.
• Concomitant Vaccination: The memo also raised questions about coadministration of multiple vaccines. Experts stressed there is no evidence this practice causes harm and that cutting back on coadministration could reduce access and uptake.

What Remains Unanswered

Key unresolved questions include: what clinical evidence (if any) links the reported VAERS records to vaccination; whether autopsy or medical-record reviews confirm a causal relationship; and precisely how the FDA intends to revise approval pathways and the flu vaccine framework.

Conclusion

Prasad's memo has prompted demands for transparency and evidence from peers and outside experts. While vaccine safety monitoring rightly seeks to identify and address rare harms, experts say rigorous, public, and methodical review is essential before reshaping policy — particularly when changes could reduce access to widely used vaccines and diminish public confidence.