FDA safety officers identified at least 10 cases in which children likely or possibly died as a result of receiving mRNA Covid-19 vaccines, according to internal agency emails and records reviewed by RealClearInvestigations. Despite these findings, the agency has not updated vaccine labels or issued public warnings about the risk of fatal myocarditis in children, nearly a year after the safety team recommended such action.

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The core dispute centers on whether the FDA and other authorities have adequately disclosed and responded to evidence of rare but serious vaccine-related harms, especially in children, amid political and industry pressures.

The controversy follows years of debate over Covid vaccine safety, with critics arguing that federal agencies and major media outlets have downplayed or dismissed reports of harm, while supporters maintain that the benefits of vaccination outweigh the risks and that adverse event reports do not establish causality.

FDA Safety Team’s Findings

In December, Dr. Meghna Alimchandani, leading the FDA’s vaccine safety team, emailed agency leadership recommending that mRNA Covid-19 vaccine labels be updated to warn of the risk of cardiac death, specifically fatal myocarditis, in children. The team had reviewed thousands of adverse event reports and autopsy records, ultimately identifying 10 cases—3 deemed probable and 7 possible vaccine-related deaths among children.

Dr. Vinay Prasad, who succeeded Peter Marks as head of the FDA’s vaccine office, alerted staff to the findings, calling it “a profound revelation” and stating, “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children.”

"Advertising allowed Big Pharma to not only capture our medical colleges, medical journals, and Congress, but now the media. They’ve run the table. That’s why this isn’t covered."

— Sen. Ron Johnson, U.S. Senate

Despite these internal communications, the FDA has not changed vaccine labeling or issued new warnings to parents. The agency previously denied a citizen’s petition led by former FDA advisor Kim Witczak and several academics, which requested updated warnings about vaccine risks. The denial letter, signed by Dr. Peter Marks, stated that adverse event reports alone do not prove causation.

Political and Media Response

Reporting by RealClearInvestigations found that both the Trump and Biden administrations had political reasons to avoid publicizing potential vaccine harms. Trump officials were concerned about undermining the legacy of Operation Warp Speed, while Biden administration officials and pharmaceutical companies sought to protect vaccine mandates and profits. The New York Times, which obtained leaked internal FDA discussions, characterized the renewed focus on vaccine deaths as politically motivated and cited experts who defended the vaccine’s safety record.

Dr. Tracy Beth Høeg, an FDA advisor who raised the issue at a September FDA meeting, told RealClearInvestigations that she was surprised the agency had not disclosed its findings earlier. “The fact that they didn’t disclose any of this earlier, it makes you think, ‘What is even the point of them doing these investigations?’” Høeg said. She criticized media coverage for misrepresenting the internal debate as an “antivaccine” campaign.

The New York Times quoted Dr. Paul Offit, a vaccine expert, who dismissed the FDA safety officers’ findings as “science by press release.” The Times also cited a New England Journal of Medicine essay by former FDA leaders, including Dr. Robert Califf and Dr. Janet Woodcock, who argued that previous reviews had not found evidence linking vaccines to child deaths. RealClearInvestigations noted that Califf and Woodcock led the FDA during the period when the deaths occurred and that another essay author, Dr. Scott Gottlieb, sits on Pfizer’s board.

Ongoing Debate and Lack of Action

Emails show that after the internal findings were leaked and covered in the press, the FDA’s safety office reduced the number of suspected vaccine-related child deaths it was willing to confirm. Several former FDA officials told RealClearInvestigations that the media attention unsettled the safety office and contributed to the lack of public disclosure.

The CDC and FDA have previously stated that reports to the Vaccine Adverse Event Reporting System (VAERS) do not establish causality and that all signals are thoroughly reviewed by agency physicians. In a joint statement, CDC Director Rochelle Walensky and FDA Commissioner Robert Califf emphasized that “reports of adverse events to VAERS following vaccination do not mean that a vaccine caused the event.” CDC-FDA joint letter

Supporters of the current vaccine policy argue that the benefits of Covid vaccination continue to outweigh the risks, and that rare adverse events are monitored and investigated. The FDA and CDC have not issued new public statements in response to the latest internal findings.

The House Judiciary Committee released a report in 2024 concluding that FDA leadership removed key safety researchers who were seen as slowing vaccine approval timelines, and that the agency became an advocate for the Pfizer vaccine, a role investigators called unprecedented. House Judiciary Committee report

As of the latest reporting, the FDA has not updated mRNA Covid-19 vaccine labels to include warnings about cardiac death in children, and agency officials have not publicly addressed the internal safety team’s findings.