Lead: An internal Food and Drug Administration (FDA) memo, obtained by NBC News and authored by Dr. Vinay Prasad, asserts that an agency review found at least 10 child deaths “after and because of receiving” COVID-19 vaccines. The 3,000-word document says those 10 are among 96 child deaths reported to VAERS between 2021 and 2024 and outlines sweeping changes the author urges for vaccine evaluation. Agency officials have not published these findings in a peer-reviewed forum, and critics say the memo misinterprets unverified surveillance data. The document arrives as U.S. vaccine policy and advisory meetings are under renewed public scrutiny.
Key Takeaways
- The memo, written by Dr. Vinay Prasad, is roughly 3,000 words and was circulated within the FDA last week.
- Prasad states that at least 10 of 96 child deaths reported to VAERS from 2021–2024 were deemed related to COVID vaccination by his internal review.
- The memo provides no ages, medical histories, timelines, manufacturer names, or supporting clinical documentation for the cited deaths.
- Independent experts warn VAERS is an unverified passive reporting system and can contain inaccurate or biased entries.
- FDA directed media inquiries to HHS; an HHS spokesperson had not responded immediately to requests for comment.
- Former FDA vaccine chief Dr. Peter Marks criticized the memo’s use of VAERS and described the agency atmosphere as “toxic” under current leadership.
- Large peer-reviewed analyses (JAMA Pediatrics 2023; Nature Communications 2024) found COVID vaccines reduce infection and hospitalization in children and showed no broad increase in serious adverse events, though small myocarditis risks in teen males have been reported.
- The memo proposes major changes to how the FDA assesses vaccines, including post-market effectiveness benchmarks for pneumonia vaccines and reviews of annual influenza evaluations.
Background
The memo was written by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), and was obtained and reported by NBC News. It argues that an internal agency review has identified at least 10 child deaths linked to COVID vaccination and criticizes prior FDA and federal public health decisions as misleading. The document also frames past vaccination mandates for schools and workplaces as coercive and urges staff who disagree to resign.
VAERS, the Vaccine Adverse Event Reporting System, is a passive surveillance tool jointly run by CDC and FDA that accepts reports from anyone — clinicians, patients, and caregivers — and is explicitly designed to surface early safety signals, not to prove causation. Historically, the FDA and CDC have used VAERS alongside other data streams to identify potential rare safety issues, such as the rare thrombosis events tied to the Johnson & Johnson COVID vaccine.
Public attention toward internal agency reviews has risen amid leadership changes at the Department of Health and Human Services, public comments by appointees, and upcoming advisory meetings at the Centers for Disease Control and Prevention on childhood vaccine schedules. Those institutional shifts form the wider context for why an internal memo drawing a dramatic safety conclusion is politically and scientifically consequential.
Main Event
The memo states that of 96 child deaths reported to VAERS from 2021 through 2024, internal reviewers concluded “no fewer than 10” were related to COVID-19 vaccination. The document does not attach case-level evidence, ages, timelines, or identify which vaccine products were involved. That lack of case detail is central to expert critiques, which say review conclusions should rest on verifiable clinical records and standardized causality assessments.
Prasad suggests myocarditis — inflammation of the heart muscle — may link several of the cited deaths to vaccination, but the memo does not include supporting medical records or autopsy results in the circulated text. FDA officials declined to provide additional documentation when contacted and routed media queries to HHS; HHS had not provided a public response at the time of reporting.
Experts who reviewed the memo told NBC News that the draft appears to repurpose VAERS reports beyond the system’s intended role. Dr. Paul Offit, a pediatric vaccine specialist, described the approach as effectively issuing conclusions from an unverified dataset. Former FDA vaccine chief Dr. Peter Marks said the agency uses VAERS for signal detection and that the memo’s reclassification of older reports as vaccine-related departs from standard practice.
The memo also includes policy recommendations that reach beyond COVID vaccines, calling for stronger post-market evidence of real-world benefit for pneumonia vaccines and a rethinking of how seasonal influenza vaccines are evaluated. It uses sharp language about past regulatory choices and suggests an institutional reset in how vaccine safety and effectiveness are judged.
Analysis & Implications
Methodologically, VAERS is not designed to establish causality. It is an early-warning system that picks up temporal associations; each report requires follow-up and clinical adjudication to determine whether a vaccine contributed to an outcome. Reclassifying passive reports as definitive evidence of vaccine-caused deaths without transparent case-level review risks conflating coincidence with cause.
If an FDA internal review did identify credible, well-documented cases in which vaccination was a probable cause of death, that would be a major finding requiring publication, independent peer review, and transparent case documentation. Without those steps, the memo’s assertions will remain contested and could erode public trust in both vaccines and the regulatory process.
Policy implications are broad: Prasad’s proposed criteria would raise the evidentiary bar for post-market authorization and for products that currently rely on immunobridging (antibody responses) as a surrogate for clinical benefit. That shift would lengthen and complicate approvals, increase post-market surveillance costs, and might slow updates to vaccines intended to protect vulnerable populations.
Politically, the memo lands amid heightened polarization over vaccine policy and administration turnover. Critics say selective public release of internal memos can be weaponized by anti-vaccine actors to sow doubt, while proponents of the memo argue it reflects overdue scrutiny of regulatory decisions. Either way, the episode highlights tensions between rapid public-health action in a pandemic and rigorous, transparent scientific review.
Comparison & Data
| Study | Population | Primary Finding |
|---|---|---|
| JAMA Pediatrics (2023) | >10 million children ages 5–11 | Vaccinated children had lower infection and hospitalization rates than unvaccinated peers |
| Nature Communications (2024) | Young children and adolescents (varied cohorts) | No overall rise in serious adverse events; small myocarditis increase in teen boys after initial doses |
These peer-reviewed analyses examined large datasets and found overall benefits of pediatric COVID vaccination, with myocarditis risk identified as small and mostly mild in adolescent males. By contrast, the memo cites a small series of VAERS reports; the methodological differences explain much of the divergent conclusions.
Reactions & Quotes
“This is sort of science by press release,”
Dr. Paul Offit, Pediatrician and Vaccine Educator
Offit criticized the memo’s reliance on VAERS reports without published case review, calling the approach irresponsible. His concern reflects mainstream vaccine-safety practice that requires clinical verification before asserting causation.
“For the first time, the U.S. FDA will acknowledge that COVID-19 vaccines have killed American children,”
Dr. Vinay Prasad, CBER Director (memo)
Prasad framed the memo as a watershed acknowledgment and used it to press for regulatory changes. His language drew immediate pushback from agency veterans and external experts who called for transparent evidence backing such claims.
“The climate within the agency is incredibly toxic right now,”
Dr. Peter Marks, former FDA vaccine chief
Marks, removed from his post earlier this year, criticized the memo’s methods and warned against adopting conclusions based on unvetted passive reports. He emphasized that VAERS should trigger follow-up, not final determinations.
Unconfirmed
- The ages, medical histories, timelines, and clinical documentation for the 10 deaths cited in the memo have not been released publicly.
- The memo does not identify which vaccine products (Pfizer, Moderna, or others) were allegedly involved in the cited deaths.
- The FDA’s internal conclusions referenced in the memo have not been published in peer-reviewed literature or accompanied by case-level adjudication available for independent review.
Bottom Line
The memo obtained by NBC News raises an alarming claim — that at least 10 child deaths reported to VAERS were related to COVID vaccination — but it stops short of providing the clinical detail and transparent case review necessary to shift the scientific consensus. Independent experts and prior large-scale studies continue to find net benefits of pediatric COVID vaccination, with only small, generally mild myocarditis risks concentrated in teen males.
How the FDA responds matters for public trust. If the agency has validated cases that change risk estimates, those findings should be published with full case documentation and peer review. If the memo’s claims cannot be substantiated with verifiable clinical evidence, circulating them as definitive conclusions risks undermining vaccine confidence and confusing clinicians, parents, and policymakers.
Sources
- NBC News — Report on internal FDA memo (news)
- Vaccine Adverse Event Reporting System (VAERS) — official surveillance database (government)
- JAMA Pediatrics — peer-reviewed analysis (2023) on pediatric COVID vaccine safety/effectiveness (peer-reviewed)
- Nature Communications — 2024 study referenced on adverse events (peer-reviewed)
- U.S. Food and Drug Administration — official statements and guidance (government)