FDA’s Analysis of Child Deaths After COVID Shot Released by Senator

Sen. Ron Johnson (R-Wis.) released the FDA analysis on pediatric deaths tied to COVID shots that was touted by former FDA leadership but never made public.

Last November, former Center for Biologics Evaluation and Research Director Vinay Prasad, MD, MPH, issued a memo to staff claiming that at least 10 children died due to a COVID shot.

But the number in the analysis is lower, and there’s much less certainty about the links between the vaccines and the deaths.

Five deaths were “possibly” related to the shots, and two were “probably” related, according to the analysis, which was dated Dec. 5, 2025. There were no deaths that were “certain” to be related to the shots.

The review also noted that more than 95 million doses of Pfizer’s Comirnaty and more than 42 million doses of Moderna’s Spikevax had been given to kids under age 12 by Aug. 14, 2025, the cutoff date for the review.

The author of the report is redacted, but it states that officials reviewed reports to the FDA’s Vaccine Adverse Event Reporting System (VAERS), turning up 96 unique U.S. pediatric death reports as of the August date — 79 after Pfizer’s shot and 17 after Moderna’s original shot. There were no reports related to Novavax’s Nuvaxovid or Moderna’s mNexspike.

Medical officers reviewed and discussed each individual case, including any available medical records and autopsy reports. Causality assessment was based on group discussion and consensus using the WHO’s Uppsala Monitoring Centre system for standardized case causality assessment. Cases were classified as certain; probable/likely; possible; unlikely; or conditional/unassessable. Autopsy reports were available for all seven possible/probable cases.

The five “possible” and two “probable” cases involved cardiac events; most were myocarditis (4) or myocarditis with stress cardiomyopathy (1). The other cases described cardiomyopathy without myocarditis (1) and cardiac arrhythmia (1).

Five cases were males, two were females, and they ranged in age from 7 to 16 years. All events occurred after the Pfizer vaccine — six after the original monovalent shot and one after the bivalent shot — and the median time to symptom onset was 3 days.

The report noted that “possible” cases could also be explained by an alternative etiology, and the “probable” cases are unlikely to be attributed to an alternative etiology, but one cannot be ruled out.

Of the remaining cases, 62 were classified as “unlikely” and 27 as “unassessable/unclassifiable.”

The analysis described the findings as “new safety information,” recommending potential safety labeling changes.

Johnson, who is the chair of the Permanent Subcommittee on Investigations, said he sent a letter to HHS Secretary Robert F. Kennedy Jr. in mid-December, calling for the immediate release of records relating to pediatric deaths after COVID shots.

“I suspect there are many additional records that are responsive to my Dec. 15, 2025 request about pediatric deaths following COVID-19 vaccination and I respectfully ask for HHS to immediately provide my office with those documents,” Johnson said in a recent press release.

Prasad left the agency in March, and other top officials involved in the pediatric deaths memo were recently pushed out of the agency, including former Commissioner Marty Makary, MD, MPH, and former Acting Director of the Center for Drug Evaluation and Research Tracy Beth Hoeg, MD, PhD.

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