The memo stated that some children died following vaccination and faults ‘cultural and systemic’ failures that left early safety signals unexamined for years.
Tom Ozimek Reporter
An internal Food and Drug Administration (FDA) memo obtained by The Epoch Times reveals that career scientists in the agency’s vaccine-safety offices have identified “no fewer than 10” child deaths they consider related to COVID-19 vaccination.
The memo, written by Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research (CBER), marks what Prasad calls the first acknowledgment inside the agency that the vaccines have caused fatal harm in children.
It details findings from a review conducted by staff in the Office of Biostatistics and Pharmacovigilance, which examined 96 death reports voluntarily submitted to the Vaccine Adverse Event Reporting System (VAERS) between 2021 and 2024 and concluded that at least 10 met criteria for a likely, probable, or possible causal link to COVID-19 vaccination.
According to the memo, the true number of vaccine-related child deaths is “certainly an underestimate” because VAERS relies on passive, voluntary reporting and because analysts used “conservative coding” that tended to rule out the vaccine when ambiguity existed.
Delayed Acknowledgment and Early Internal Warnings
Prasad wrote that the findings force the agency—and the nation—to confront whether federal COVID-19 vaccine campaigns “may have harmed more children than we saved,” and he criticized the FDA for allegedly failing to thoroughly investigate pediatric deaths earlier.
The memo states that CBER’s leadership only initiated the internal review in 2025 after staff physician Dr. Tracy Beth Hoeg independently examined death reports and concluded children had indeed died after vaccination—an assessment that had never been publicly admitted by the FDA.
“This is a profound revelation. For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” Prasad wrote. ”Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death. In many cases, such mandates were harmful.”
Prasad attributed the delayed recognition of pediatric vaccine fatalities to “cultural and systemic” failures inside CBER, suggesting that some safety concerns were dismissed due to internal resistance, politics, or pressure to support mass vaccination.
“I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product,” he wrote. “The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm. The same is true for vaccines.”
The memo also states that the FDA never required manufacturers to demonstrate—through randomized controlled trials—that vaccinating children reduced hospitalization or death. Available data, Prasad wrote, are “deeply limited,” rely on methods with “notorious” biases, and fail to establish whether the vaccine saved more children than it harmed.
He criticized common assertions that COVID-19 infection posed a greater myocarditis risk than vaccination, saying that this claim is “wrong” and that existing studies use “a false denominator” and fail to evaluate risk-benefit trade-offs for healthy adolescents and young adults.
Regulatory Shifts Ahead
Prasad said CBER will undertake major reforms, including “swift action” on the new safety signal involving child deaths and ending authorization of vaccines in pregnant women based solely on “unproven” surrogate antibody endpoints.
There will also be a requirement for pre-market randomized clinical trials for most new vaccines, updated guidelines for simultaneous administration of multiple vaccines, and an overhaul of the annual flu vaccine framework, described as a “catastrophe of low quality evidence, poor surrogate assays, and uncertain vaccine effectiveness measured in case-control studies with poor methods.”
Prasad said that vaccine regulation will now be guided by strict evidence-based medicine and that COVID-19 vaccines will no longer receive preferential assumptions of benefit.
“Vaccines will be treated like all other medication classes—no better or worse,” he wrote.
He instructed CBER staff who disagreed with the new direction to submit their resignations.
The Epoch Times has contacted the FDA and the Department of Health and Human Services with a request for comment.