Former FDA Vaccine Chief Says Review Identified Child Deaths Linked to COVID-19 Vaccination

A former senior Food and Drug Administration vaccine official says an internal review conducted by agency scientists identified several deaths among children that were considered possibly or probably related to COVID-19 vaccination.

The disclosure has renewed debate over how rare vaccine-related adverse events are investigated, how causality is determined in individual deaths, and whether safety signals were adequately examined during the COVID-19 pandemic.

Dr. Vinay Prasad, who previously led the FDA's Center for Biologics Evaluation and Research, discussed the findings in a recent interview with Reason. According to documents released publicly, Prasad had ordered an assessment of deaths reported to the Vaccine Adverse Event Reporting System, or VAERS.

The initial assessment examined 96 reported deaths among children between 2021 and 2024. In a November 2025 memorandum, Prasad wrote that FDA staff had concluded that at least 10 deaths were related to COVID-19 vaccination under the agency's attribution framework. FDA documents later released publicly indicated that the number was revised to seven in the final version of the assessment.

The distinction between "related," "possible," "probable," and "certain" is important. A determination that a vaccine was possibly or probably responsible for a death does not mean that investigators established causation with absolute certainty.

Why the FDA Review Matters

Prasad has argued that determining whether a vaccine caused a death is particularly difficult when investigators are dealing with individual case reports rather than controlled clinical trials.

In his November 2025 memorandum, Prasad explained that causality assessments for individual reports commonly use categories ranging from certain to unlikely. He said that "possible/likely" and "probable" classifications are generally considered evidence that a medical product may have contributed to an event.

The FDA's review focused heavily on myocarditis, an inflammation of the heart muscle that has been recognized as a rare adverse event following certain COVID-19 vaccines.

The Centers for Disease Control and Prevention has also acknowledged a causal association between mRNA COVID-19 vaccines and myocarditis and pericarditis. According to the agency, cases have occurred most frequently among adolescent and young adult males, particularly within seven days after a second mRNA vaccine dose.

Most reported myocarditis cases following vaccination have not been fatal. The CDC says most patients have improved with treatment and rest. Nevertheless, myocarditis can be a serious medical condition, making the identification and investigation of severe cases important.

The Number Was Revised

The controversy surrounding the FDA assessment partly concerns how the number of potentially vaccine-related deaths changed during the review process.

According to documents released by Sen. Ron Johnson, FDA personnel initially identified 10 child deaths as possibly or probably related to COVID-19 vaccination. The final assessment subsequently reduced the number to seven. The documents reported that two of the cases involved boys, ages 13 and 7, whose deaths were associated with myocarditis.

The case involving the 13-year-old reportedly occurred three days after vaccination. An autopsy identified myocarditis as the cause of death, although the precise origin of the inflammation was described as uncertain. FDA reviewers subsequently assessed the case as probably related to vaccination.

The reduction from 10 to seven does not necessarily mean that the original assessment was considered fraudulent or that the remaining cases were proven unrelated to vaccination. Rather, it demonstrates how difficult causality assessments can be when investigators are working from medical records, autopsy findings, timing and other available evidence.

Prasad has suggested that professional or political considerations may have played a role in the revision. That allegation, however, should be distinguished from the underlying medical findings. The available documents establish that the assessment changed, but they do not by themselves establish that political pressure caused every change.

VAERS Is a Safety-Reporting System

Another important issue is the role of VAERS.

The Vaccine Adverse Event Reporting System is used by federal health authorities to collect reports of medical events occurring after vaccination. A report to VAERS does not automatically mean that the vaccine caused the reported event.

This distinction is especially important when discussing deaths. People can become ill or die after vaccination for many reasons, including conditions unrelated to the vaccine. Investigators therefore have to examine timing, medical history, autopsy findings, laboratory information and alternative explanations before determining whether a vaccine may have contributed.

Prasad himself acknowledged the limitations of passive reporting in his FDA memorandum. He argued that some events could be missed because VAERS depends on reports being submitted.

At the same time, the existence of a VAERS report alone should never be interpreted as proof of causation.

Myocarditis Remains a Recognized Risk

The broader scientific record supports one important part of the discussion: myocarditis following COVID-19 vaccination is a real, recognized, but rare adverse event.

The CDC says myocarditis and pericarditis have been observed following COVID-19 vaccination and occur most frequently among adolescent and young adult males. The agency also advises clinicians to consider myocarditis when patients develop symptoms such as chest pain, shortness of breath or palpitations after vaccination.

The agency's guidance also recognizes the importance of evaluating other possible causes of myocarditis, including COVID-19 infection and other viral infections.

This is significant because identifying a temporal relationship is only one part of establishing causality. A person becoming sick after vaccination does not automatically establish that the vaccination caused the illness.

A Debate About Benefits and Risks

The FDA revelations have also reopened a larger debate over how COVID-19 vaccination policies should have been applied to children.

Prasad has previously said that he believes vaccines can provide meaningful protection against severe disease and death while questioning whether evidence supported certain broad mandates during the pandemic.

The risk-benefit calculation for COVID-19 vaccination has varied according to age, health status, circulating variants, previous infection, vaccine formulation and the individual's risk of severe disease.

Federal health agencies have continued to acknowledge that COVID-19 vaccines can have rare serious adverse effects while also reporting benefits against severe COVID-19 outcomes. In its evidence review, the CDC found evidence of a rare risk of serious adverse events such as myocarditis and pericarditis, while also finding evidence of reduced risks for several COVID-19 outcomes. For young children, however, the agency characterized the certainty of some benefit estimates as very low because much of the evidence was indirect.

That uncertainty makes transparent safety monitoring particularly important.

What the Findings Do Not Prove

The FDA documents should not be interpreted as proving that seven, 10 or any other specific number represents the total number of children who died because of COVID-19 vaccination.

The documents concern deaths that investigators assessed as potentially or probably related to vaccination. They are not equivalent to a randomized clinical trial establishing a population-level mortality rate.

Likewise, the findings do not establish that COVID-19 vaccines are generally unsafe for children. Nor do they establish that vaccination provides no benefit.

Instead, they highlight a narrower but important question: whether individual deaths following vaccination were appropriately investigated and whether recognized safety signals received sufficient attention.

That distinction is essential to a responsible discussion of vaccine safety.

The Need for Transparent Safety Monitoring

The controversy ultimately points to a broader principle in medicine: safety systems must be capable of identifying rare adverse events while avoiding conclusions that go beyond the available evidence.

Vaccines, like other medical products, can have side effects. The CDC explicitly recognizes myocarditis and pericarditis as rare risks associated with certain COVID-19 vaccines.

At the same time, determining whether an individual death was caused by a vaccine requires careful medical investigation.

The FDA review described by Prasad is therefore significant not simply because of the number of deaths identified, but because it raises questions about how federal authorities investigated reports involving children during and after the pandemic.

The most important next step is continued transparency. Families, doctors, researchers and policymakers need access to sufficient information to independently understand how individual cases were evaluated, why some cases were classified as possible or probable, and why the final number changed from the initial assessment.

A credible vaccine-safety system must be willing to investigate concerning reports without dismissing them, while also avoiding claims that cannot be supported by the evidence.

For families making medical decisions, the central lesson is that vaccine risks should be neither ignored nor exaggerated. Rare adverse events deserve serious attention, and claims about causation should be evaluated according to the strength of the available evidence.

Sources: U.S. Food and Drug Administration documents concerning the November 2025 memorandum and child-death assessment; Centers for Disease Control and Prevention guidance on COVID-19 vaccine safety and myocarditis; and reporting by The Epoch Times concerning the subsequently released FDA documents.

Disclaimer: This article is for informational purposes only and is not medical advice. The discussion of individual deaths reflects reported FDA assessments of possible or probable causation and should not be interpreted as proof that every reported death was caused by a COVID-19 vaccine. Readers should consult qualified healthcare professionals for individual medical decisions.