No child deaths have been definitively linked to Covid vaccines, according to a report from the Food and Drug Administration that was quietly made public last week.
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The analysis comes nearly six months after former FDA vaccine chief Dr. Vinay Prasad said, without releasing evidence, that the agency had identified at least 10 previously unreported child deaths tied to the vaccines.
Prasad’s claims were used to help justify proposed changes to how the FDA reviews vaccines. He left the agency in April after facing criticism over delays and rejections involving several treatments for rare diseases.
“To sort of imply that there was a wholesale or large number of kids killed by the vaccine, I think, goes beyond what the evidence seems to be here” in the report, said Dr. Jesse Goodman, a former FDA chief scientist and an infectious disease specialist at Georgetown University Medical Center.
The FDA’s analysis surfaced in a letter Sen. Ron Johnson, R-Wis., sent this month to Health and Human Services Secretary Robert F. Kennedy Jr. regarding transparency around Covid vaccine safety. An HHS official confirmed the report was authentic.
In the analysis, dated Dec. 5, the FDA reviewed 96 reports of child deaths submitted to the Vaccine Adverse Event Reporting System through Aug. 14, 2025.
VAERS is a vaccine safety system in which anyone — including doctors, patients and caregivers — can report health problems that happen after vaccination. The reports alone don’t mean a vaccine caused the problem. The report itself states “VAERS data has significant inherent limitations that severely restrict its utility for assessing causality” and the VAERS website warns “it is generally not possible to find out from VAERS data if a vaccine caused the adverse event.”
After reviewing the cases, the FDA reported that no cases were “certain” to be linked to Covid vaccination. The conclusions differ from Prasad’s characterization of the deaths, who said in a November memo to FDA staff that the children died “after and because of receiving” the Covid shot.
An HHS spokesperson did not respond to a request for comment. Prasad did not immediately respond to a request for comment.
In the analysis, five deaths were classified as “possible” and two as “probably,” though the agency said those categories don’t mean the vaccine caused the deaths and that other explanations could not be ruled out. “It is important to note that possible cases could also be explained by alternative” causes, it wrote. The classifications were based on criteria from the World Health Organization, which says that for “possible” cases, there “may be another equally likely explanation for the event.” “Probable” cases, the FDA wrote, are “unlikely to be attributed” to alternative causes, but an alternative cause “cannot be ruled out.”
Five of the dead were boys and two were girls, and the average age was 13, according to the report. Most of the cases involved myocarditis, a rare inflammation of the heart that has been linked to Covid shots, particularly in teen boys and young men. Last June, months before Prasad’s memo, the FDA instructed Pfizer and Moderna to update the labels on their Covid vaccines about myocarditis risk. The condition has been on the vaccine labels since it was first identified in 2021.
Goodman said the FDA authors “were pretty liberal about saying something was possibly or probably associated with the vaccine,” though he didn’t rule out that there could be vaccine-associated deaths.
“There’s not a way to be certain, unless we found some specific marker for the vaccine,” he said. “All that said, I think this report was carefully done.”
The agency had reviewed medical records, death certificates and, in some cases, interviewed the children’s parents when determining whether the deaths were linked to Covid shots.
Dr. Ofer Levy, who heads the Precision Vaccines Program at Boston Children’s Hospital, said the risk of myocarditis from Covid vaccination is as high as 100 cases per million doses. But it’s important to note, he said, that infections are the primary cause of myocarditis.
“There is a range of common infections, mostly viruses, that can trigger this kind of inflammation of the heart,” he said. That includes viruses such as Covid, as well as human herpesvirus 6 and parvovirus B19. It can also be caused by various bacterial and fungal infections.
Mild cases usually clear up on their own with rest and routine monitoring by a doctor, Levy said. Severe cases, however, typically require hospitalization.
