Lifestyle

The FDA Quietly Released a Vaccine Safety Report That Contradicts Its Own Former Director

By Mike Harper · May 24, 2026

Two documents. Both from the FDA. Both reviewing the same 96 cases. Opposite conclusions.

In November 2025, Dr. Vinay Prasad — then director of the FDA’s Center for Biologics Evaluation and Research — told agency staff in an internal memo that at least 10 children had died “after and because of receiving” the Covid vaccine. He said the true number was likely higher and accused the agency of ignoring the safety concerns for years. His memo did not include the underlying evidence. It did include a proposal to significantly tighten how the FDA reviews future vaccines.

Prasad’s claims generated significant public attention and were cited widely in debates about vaccine policy for children.

This week, a separate FDA analysis — dated December 5, 2025, and quietly made public after Senator Ron Johnson sent it to HHS Secretary Robert F. Kennedy Jr. — reviewed the same 96 pediatric death reports and reached a different conclusion. No cases were classified as “certain” in relation to Covid vaccination. Seven were classified as “possibly” related. Two were classified as “probably” related. Zero were classified as definitive.

“No cases were classified as certain in relation to COVID-19 vaccination.”

The FDA’s own report — reviewed by NBC News and confirmed as authentic by an HHS official — made clear that the seven possibly related deaths and two probably related deaths involved primarily myocarditis, a known and labeled risk of Covid vaccines particularly in teenage boys. The report also noted that “possible cases could also be explained by alternative etiology” — meaning other causes could not be ruled out for even the seven flagged cases.

The FDA analysis reviewed medical records, death certificates, and in some cases interviewed the children’s parents before assigning each case a causality classification. Prasad’s memo did not describe that methodology.

Prasad left the FDA in April 2026 after facing criticism unrelated to the vaccine memo — he had been involved in delays and rejections of treatments for rare diseases that drew scrutiny from patient advocates and medical organizations. He was not available for comment on the newly published report.

Dr. Steven Goodman of Stanford, who reviewed the FDA’s December analysis for NBC News, said the report appeared to have been “carefully done.” He noted that it is genuinely difficult to establish certain causation in cases like these — “there’s not a way to be certain, unless we found some specific marker for the vaccine” — but that the methodology was sound.

The Vaccine Adverse Event Reporting System, from which the 96 cases were drawn, is a passive surveillance database in which anyone — doctors, patients, parents, or caregivers — can submit reports of health events following vaccination. VAERS reports do not establish causation. They are designed as an early warning system. The FDA’s own December report cited the “significant inherent limitations” of VAERS data in assessing whether a vaccine caused a specific outcome.

What the two documents establish, together, is a genuine internal disagreement within the FDA about how to interpret the same evidence — and a disclosure process in which a dramatic internal claim circulated publicly for six months before the more methodologically rigorous counter-analysis was made available.