FDA cut child COVID vaccine death count from 10 to 7, newly released records show

Scientists at the U.S. Food and Drug Administration (FDA) revised internal assessments of child deaths potentially linked to COVID-19 vaccinations, reducing the number of cases initially identified as vaccine-related from 10 to seven, according to documents released by Senator Ron Johnson of Wisconsin.

The records, which Johnson disclosed as part of an ongoing investigation into federal handling of COVID-19 vaccine safety data, indicate that the FDA’s Center for Biologics Evaluation and Research (CBER) initially identified 10 pediatric deaths in November 2025 that were believed to be associated with COVID-19 vaccinations.

However, a subsequent review in December 2025 reduced that figure to seven cases and lowered the level of certainty regarding the connection between the deaths and vaccination.

The disclosures have reignited controversy over the government’s monitoring of vaccine-related adverse events and prompted renewed calls for transparency from lawmakers and vaccine critics.

Johnson, chairman of the U.S. Senate Permanent Subcommittee on Investigations, included the documents in a letter addressed to U.S. Health Secretary Robert F. Kennedy Jr., Acting Centers for Disease Control and Prevention (CDC) Director Dr. Jay Bhattacharya, and Acting FDA Commissioner Kyle Diamantas.

In the letter, Johnson questioned the rationale behind the reclassification of three cases and argued that even the reduced number of deaths warranted serious safety concerns.

According to the documents, FDA officials still considered seven deaths sufficiently concerning to recommend updating the safety labels of Pfizer and Moderna’s mRNA COVID-19 vaccines to include warnings about the risk of myocarditis with potentially fatal outcomes.

Myocarditis, an inflammation of the heart muscle, has been identified as a rare adverse event associated with mRNA COVID-19 vaccines, particularly among adolescent and young adult males.

Internal FDA communications cited in the released records show that among the seven remaining cases, two were categorized as “probable” and five as “possible” vaccine-related deaths. Five of those seven cases reportedly involved myocarditis.

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The FDA’s Division of Pharmacovigilance subsequently recommended that vaccine labels be amended to reflect concerns about myocarditis and its potential fatal consequences.

One of the key documents released was a December 5, 2025 email from Dr. Meghna Alimchandani, deputy director of the FDA’s Division of Pharmacovigilance, informing then-CBER Director Dr. Vinay Prasad that the number of cases under review had been reduced from 10 to seven.

The communication followed a November 2025 memo in which Prasad reportedly stated that evidence suggested “at least 10 children” had died after receiving COVID-19 vaccines and linked the issue to vaccination mandates implemented during the Biden administration.

The memo reportedly leaked to the media shortly after circulation, generating widespread public attention and internal pressure on FDA staff conducting the review.

Several of the downgraded cases involved the detection of parvovirus B19, a common virus that often causes mild illness and can remain present in human tissues long after infection.

According to the documents, the presence of parvovirus contributed to decisions to reduce the likelihood that some deaths were vaccine-related.

One involved 16-year-old Micah Williamson, whose death certificate reportedly cited stress cardiomyopathy associated with vaccination. While the CDC pointed to the presence of parvovirus B19 as a possible alternative explanation, FDA reviewers classified the death as possibly related to COVID-19 vaccination.

Another case involved Jacob Clynick, who died days after receiving a second dose of Pfizer’s vaccine in 2021. Although CDC reviewers reportedly attributed the death to bacterial sepsis, FDA officials concluded that vaccination was the probable cause.

Differences between the conclusions reached by the two agencies have fueled criticism from some researchers and advocacy groups who argue that federal authorities have not been sufficiently transparent about vaccine safety investigations.

Federal health agencies, however, have long maintained that COVID-19 vaccines underwent rigorous safety monitoring and that the benefits of vaccination significantly outweighed the risks during the pandemic.

The release of the FDA documents comes amid continuing debate over vaccine safety, regulatory transparency, and the future use of mRNA technology in other vaccines, including those targeting influenza.

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While critics argue that the documents reveal shortcomings in federal oversight, public health officials and many medical experts continue to emphasize that serious adverse events following COVID-19 vaccination remain rare relative to the millions of doses administered worldwide.

Johnson’s investigation is ongoing, and the senator has requested additional records from federal agencies as lawmakers continue to scrutinize the government’s pandemic-era decision-making and vaccine safety monitoring practices.