FDA Memo Reveals Child Deaths Linked to COVID Vaccine: What We Know and What’s Next

FDA Memo Raises Alarming Questions About COVID Vaccine Safety in Children

In late November 2025, the U.S. Food and Drug Administration (FDA) faced renewed scrutiny after an internal memo surfaced, revealing a finding that at least 10 children died “after and because of” receiving a COVID-19 vaccine. The memo, authored by Dr. Vinay Prasad, director of the agency’s vaccine division, was obtained by The New York Times but has not been released publicly. The revelation comes at a time when vaccine policies and public trust are at a crossroads, and the details raise more questions than answers.

What the Memo Says—and What It Doesn’t

Dr. Prasad’s statement marks the first time the FDA has formally acknowledged a direct connection between COVID vaccination and child deaths in the United States. According to the memo, the suspected cause in these cases was myocarditis, an inflammation of the heart muscle that has been associated with certain COVID vaccines, especially in younger recipients. However, the memo lacks crucial specifics: there is no information on the children’s ages, underlying health conditions, the criteria used to link the deaths to the vaccine, or which vaccine manufacturers were involved.

This lack of detail has left many medical experts and the public alike in a state of uncertainty. Dr. Paul Offit, a leading vaccine expert at the Children’s Hospital of Philadelphia, criticized the memo as “science by press release,” noting the absence of context such as the overall risk of COVID-related deaths in vaccinated versus unvaccinated children. “We treated children who developed vaccine-related myocarditis, and most recovered quickly. In contrast, we saw children with severe myocarditis from the virus itself, requiring intensive care,” Offit explained.

Policy Shifts and Political Tensions

The memo was released amid sweeping changes to U.S. COVID vaccine policy. Health Secretary Robert F. Kennedy Jr., who has a history of skepticism toward vaccines, has moved to restrict COVID vaccine access to those 65 and older and individuals with underlying conditions. Kennedy’s rise to the nation’s top health post under President Donald Trump has been marked by attempts to revise longstanding immunization policies, including controversial suggestions of links between vaccines and autism.

These shifts represent a dramatic departure from previous federal stances, which promoted widespread vaccination for all eligible groups, citing their role in saving lives and controlling the pandemic. The new restrictions and public statements have polarized opinion among medical professionals and public health advocates, some of whom worry that such messaging could undermine broader vaccine confidence.

Expert Reactions and the Path Forward

Reactions to Dr. Prasad’s memo have been mixed. While some welcome greater transparency, others caution that premature or incomplete disclosures can fuel misinformation and public anxiety. Michael Osterholm, an infectious disease expert at the University of Minnesota, described the timing of the memo’s release as “irresponsible,” suggesting it may have been intended to influence the upcoming CDC vaccine committee meeting.

Notably, the FDA’s findings have not yet been published in a peer-reviewed medical journal, meaning they have not undergone the usual scientific scrutiny. The CDC’s vaccine advisory committee is expected to meet next week, and their deliberations may shed more light on the review’s methodology and implications.

Context: Myocarditis, COVID, and Risk Assessment

Myocarditis is a rare but recognized side effect of mRNA COVID vaccines, particularly in adolescent males. Most cases reported in clinical settings have been mild, with patients recovering after short hospital stays. However, COVID-19 itself can also cause myocarditis—sometimes more severely—along with other complications. Balancing these risks has been a persistent challenge for health authorities and families alike.

Public health experts continue to emphasize that, for most children, the risk of severe outcomes from COVID-19 remains low. But individual risk factors, such as pre-existing conditions, can change the calculus. The lack of clear data in the FDA memo leaves parents, physicians, and policymakers grappling with difficult decisions and calls for more comprehensive research.

The Debate Over Evidence and Oversight

Dr. Prasad’s memo also criticized longstanding practices for vaccine approval, including the annual flu vaccine selection process, which he described as a “catastrophe of low-quality evidence.” He announced that future randomized studies for vaccine approval would require representation from all subgroups, including pregnant women—a move intended to bolster the evidence base and address historical gaps.

This push for more rigorous oversight is likely to be welcomed by advocates for medical transparency, but it may slow the process for bringing vaccines to market and could complicate future public health responses.

What Happens Next?

As of now, the memo’s findings have yet to be confirmed by independent review, and many questions remain. The CDC’s upcoming committee meeting will be a focal point for further discussion, and the medical community is watching closely for any additional disclosures or policy changes. Meanwhile, the FDA faces pressure to provide more detailed data and ensure that its communications do not inadvertently erode public trust in vaccines more broadly.

In the absence of full transparency, families and clinicians are left to weigh the known risks of COVID-19 against the limited but troubling reports of adverse events from vaccination. The debate underscores the importance of clear, evidence-based guidance—and the need for ongoing vigilance as scientific understanding evolves.

Assessment: The FDA memo has injected new urgency into the debate over COVID vaccine safety for children, but the absence of detailed data means this story is far from complete. While transparency is vital, responsible communication and rigorous peer review are essential to maintaining public trust and ensuring sound policy. The coming weeks will be crucial in clarifying the facts, evaluating the risks, and defining the future of vaccination strategy in the United States.