An internal memo from a top official at the U.S. Food and Drug Administration (FDA) claims that at least 10 children have died as a result of receiving COVID-19 vaccines, sparking concern within the agency and renewed scrutiny of pediatric vaccine policy.

FDA Chief Medical Officer Dr. Vinay Prasad, who also leads the agency’s Center for Biologics Evaluation and Research (CBER), shared the findings in an email sent to staff on Friday. He described the deaths as “after and because of receiving COVID-19 vaccination,” citing an internal review of VAERS reports and safety data collected between 2021 and 2024.

“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.”

The children identified in the analysis were between the ages of 7 and 16. The cases were categorized as having a “likely, probable or possible” link to vaccination based on available documentation. Prasad stressed that the number is almost certainly an undercount, noting the passive and incomplete nature of the federal VAERS system.

The analysis comes after years of internal debate and, according to Prasad, institutional hesitation. 

“Why did it take until 2025 to perform this analysis, and take necessary further actions?” he asked in the memo. 

He attributed the delay to what he called “cultural and systemic” resistance within the agency to acknowledge risks tied to the COVID-19 vaccines.

Prasad credited current FDA Commissioner Dr. Marty Makary with uncovering the missed safety signal, after Makary asked staff to re-examine adverse event reports from the pandemic period. Makary, who was appointed earlier this year, told Fox News the agency will make the case files public—files he says were not disclosed by the previous administration.

In Prasad’s view, the agency failed in its duty to scrutinize vaccination risk for young people—a group he argued was at extremely low risk from COVID-19. 

“It is difficult to read cases where kids aged 7 to 16 may be dead as a result of COVID vaccines,” he wrote.

The claim stands in contrast to earlier public health messaging. During the pandemic, federal officials widely recommended COVID vaccination for children, arguing it would reduce transmission, prevent serious illness and help resume in-person schooling. But Prasad asserts that many of those decisions were not supported by sufficient pediatric data.

He referenced research showing that COVID-19 was rarely lethal in children. A 2023 meta-analysis published in Environmental Research estimated the infection fatality rate for individuals under age 20 to be about 0.0003 percent—equivalent to roughly 3 deaths per 1 million infections.

Prasad also raised concerns about myocarditis, an inflammatory heart condition linked to the mRNA vaccines, particularly in adolescent boys and young men. While most cases of post-vaccine myocarditis have been mild and short-lived, studies cited by the FDA acknowledge a small but elevated risk among males ages 12 to 24.

According to an FDA presentation from 2022, the rate of myocarditis in this group is approximately 27 cases per million doses. That figure is higher than the general population but still considered rare. The FDA has maintained that, on balance, the benefits of vaccination outweigh the risks, including for younger people.

Prasad disagreed with that assessment, writing that even rare side effects should be carefully weighed when the benefit to healthy children is marginal. 

“The truth is we do not know if we saved lives on balance,” he wrote. “This requires humility and introspection.”

The memo also reveals internal divisions at the agency over pandemic-era vaccine policy. Prasad sharply criticized former CBER Director Dr. Peter Marks, who led the office during the height of the pandemic and was a prominent advocate for vaccine booster campaigns. Prasad said that decisions made under Marks, including the push for annual boosters for all age groups, reflected a disregard for age-based risk and evidence-based review.

That internal conflict isn’t new. In 2021, two senior FDA vaccine regulators, Dr. Marion Gruber and Dr. Philip Krause, resigned amid disagreement with White House pressure to authorize widespread boosters. Prasad referenced their departures as evidence that dissenting scientific voices were marginalized during that period.

The latest findings emerged after FDA advisor Dr. Tracy Beth Høeg began investigating VAERS reports of post-vaccine deaths in children. Prasad said she found several credible cases that had never been acknowledged publicly. When she shared her findings with internal working groups, some staff reportedly leaked the information to the media and portrayed the analysis as fearmongering.

Prasad said those leaks were “unethical” and undermined the agency’s commitment to transparent safety monitoring. 

“Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it,” he wrote. He called on any FDA employees who do not agree with the new operating principles to submit their resignations.

He also proposed several reforms, including requiring more rigorous trials for vaccine approvals in pregnant women, revising the annual flu shot authorization process, and increasing research into the effects of giving multiple vaccines in a single visit.

While the memo has triggered concern, many vaccine experts and public health officials have urged caution. They note that the FDA has not yet made the supporting data public, and that causality in post-vaccine deaths is notoriously hard to establish. 

Critics argue that extraordinary claims require extraordinary evidence—and that the agency must provide detailed case reviews before drawing definitive conclusions.

STAT News reported that several experts are skeptical of the memo’s conclusions, noting the absence of peer-reviewed data or autopsy-confirmed links. Dr. Paul Offit, a vaccine advisor to the FDA, said the cases must be made available for independent scrutiny.

Prasad acknowledged that most vaccines are safe and have saved millions of lives. But he believes that the FDA lost credibility during the pandemic by failing to properly account for uncertainty and by aligning too closely with political agendas.

He called the memo a “wake-up call” for the agency and urged a recommitment to transparency, scientific rigor and public accountability.