A leaked memo circulating within the U.S. Food and Drug Administration (FDA) could undermine the entire COVID-19 vaccination program after Dr. Vinay Prasad, Director of the Center for Biologics Evaluation and Research (CBER), revealed 10 deaths in children “after or because of receiving COVID-19 vaccination.”
Prasad states plainly that these deaths are “related to vaccination,” with staff classifying the cases as likely, probable, or possible. He also warns that the number is “certainly an underestimate” because of underreporting and bias in how deaths have been attributed.
This is the first time the FDA has been forced to acknowledge that children died after receiving federally recommended COVID vaccines. It is also the first time the public is seeing written proof that the agency’s scientists reached conclusions that contradict the FDA’s official public messaging.
Prasad, in the letter, recounts how myocarditis, an inflammatory heart condition, emerged early as a serious concern in young males after COVID-19 vaccination. He notes that, unlike the virus, which has a steep age gradient, myocarditis risk after the vaccine ran in the opposite direction, hitting “young, healthy boys and men” who were “least likely to experience bad COVID outcomes.” Foreign regulators identified the myocarditis signal before the United States, and that former CDC Director Rochelle Walensky publicly claimed in May 2021, “We have not seen a signal, and we’ve actually looked intentionally for the signal,” a statement that was nothing short of dishonest.
Prasad describes how he and others, including the current commissioner and Dr. Tracy Beth Hoeg, published peer-reviewed work in 2022 showing that COVID-19 boosters and the mandates that accompanied them were harmful for young men. He writes that “the FDA and CDC abdicated their duty to the American people,” failed to adopt straightforward mitigation strategies such as spacing doses, lowering doses, or omitting doses in those with prior infection, and even “delayed acknowledgement” of the myocarditis signal until after extending authorization to younger boys.
In the summer of 2025, Dr. Hoeg began investigating VAERS reports of children who died after COVID-19 vaccination and concluded “there were in fact deaths,” something “this agency had never publicly admitted.” After her internal presentation, leaks to the media framed her work as an attempt to create “false fear” about vaccines and claimed that CBER staff disagreed that the deaths were vaccine-related.
In response, Prasad states that he formally requested the Office of Biostatistics and Pharmacovigilance (OBPV) to conduct a detailed analysis of deaths reported to VAERS. Outside randomized trials, causality is judged on a scale that ranges from certain to unlikely, and that “certain, possible, or likely, and probable are broadly considered as related to the product,” Prasad wrote. Within that framework, OBPV’s “initial analysis of 96 deaths between 2021 and 2024” concluded that at least ten deaths belong in that related category.
Some children are now likely dead because they complied with vaccine directives, Prasad said. “It is difficult to read cases where kids aged 7 to 16 may be dead as a result of COVID-19 vaccines,” he added.
The letter does more than admit deaths. It directly questions whether the pediatric COVID-19 vaccination program ever made sense. In a section titled “Did COVID-19 vaccine programs kill more healthy kids than it saved,” Prasad writes that FDA has “never requested the manufacturers demonstrate in randomized fashion that vaccinating children improves” severe outcomes such as hospitalization and death. He notes that the available randomized data in children are “deeply limited” and “broadly negative for symptomatic infection” and that COVID-19 “was never highly lethal for children.” He concludes that “the truth is we do not know if we saved lives on balance.”
Prasad then turns to the Vaccine Adverse Event Reporting System (VAERS) itself. He points out that the system is passive and relies on motivated doctors or family members to navigate a lengthy, tedious reporting process, with many people giving up before completion. “Many more deaths may be unreported,” he writes, and he faults the FDA for failing to enforce required postmarketing commitments for COVID-19 vaccines, including in pregnant women and in tracking subclinical myocarditis.
“Putting these facts together,” the memo states, “it is horrifying to consider that the U.S. vaccine regulation, including our actions, may have harmed more children than we saved. This requires humility and introspection.” That is the head of CBER, on FDA letterhead, acknowledging that United States vaccine policy, as well as the conduct of his own division, may have resulted in a net loss of children’s lives.
He then asks the question that every parent will ask after reading the memo: “Why did it take the FDA Commissioner to identify these deaths?” Prasad notes that, without the current commissioner, the investigation would never have occurred. He asks why the deaths “were not actively reviewed in real time” and why it took until 2025 to perform the analysis when “deaths were reported between 2021 and 2024, and ignored for years.”
Prasad does not condemn vaccines as a category. He acknowledges that many vaccines “have saved millions of lives” and that COVID-19 vaccination likely benefited an “elderly, un-immune American” who received doses in 2020. However, he draws a sharp distinction between that high-risk population and the young. The government’s “coercive and unethical COVID-19 vaccine mandates in young people,” he writes, “may have been harmful.”
Prasad also argues that studies claiming higher myocarditis rates after infection rely on a distorted denominator that counts only those sick enough to seek medical care, ignore demographic differences in risk, and pretend the choice is virus or vaccine, when in reality the comparison is “vaccine plus virus versus virus alone.”
Taken together, the letter is not a minor internal disagreement. It is a formal admission by the FDA’s top biologics regulator that American children have died following COVID-19 vaccination, that the shot did not benefit healthy kids, and that deaths reported for years were not meaningfully examined.
For parents who were told the shots were “safe and effective,” for schools that did the government’s bidding, and for families who lost a child after vaccination and were told it was a coincidence, this memo is not just a document. It is evidence that the truth was known within the walls of the FDA and kept there until someone finally put it into writing and released it.
Read the full letter below.
