WASHINGTON, D.C. — The Food and Drug Administration released an analysis dated December 5, 2025, concluding that no child deaths have been definitively linked to Covid-19 vaccines. The report was made public last week without a public announcement and surfaced in a letter Sen. Ron Johnson sent to Health and Human Services Secretary Robert F. Kennedy Jr. regarding transparency around Covid vaccine safety.

An HHS official confirmed that the report was authentic. The analysis was made public nearly six months after former FDA vaccine chief Dr. Vinay Prasad said the agency had identified at least 10 previously unreported child deaths tied to the vaccines without releasing evidence. In a November memo to FDA staff, Prasad said the children died "after and because of receiving" the Covid shot.

The FDA reviewed 96 reports of child deaths submitted to the Vaccine Adverse Event Reporting System through August 14, 2025. VAERS allows anyone, including doctors, patients and caregivers, to report health problems that occur after vaccination. The report states that "VAERS data has inherent limitations that severely restrict its utility for assessing causality."

After reviewing the cases using medical records, death certificates and, in some cases, interviews with the children's parents, the FDA reported that no cases were certain to be linked to Covid vaccination. Five deaths were classified as "possible" and two as "probable." The report states that "possible cases could also be explained by alternative causes." Under World Health Organization criteria, "possible" cases are those for which there may be another equally likely explanation for the event, and "probable" cases are those unlikely to be attributed to alternative causes but for which an alternative cause cannot be ruled out.

Five of the children who died were boys and two were girls, with an average age of 13. 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. Myocarditis has been on Covid vaccine labels since it was first identified in 2021, and in June 2025, the FDA instructed Pfizer and Moderna to update their Covid vaccine labels to include a myocarditis risk.

Dr. Jesse Goodman, a former FDA chief scientist and infectious disease specialist, said the report appeared overly broad in its classifications. "They were pretty liberal about saying something was possibly or probably associated with the vaccine," Goodman said. "All that said, I think this report was carefully done." He also said, "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."

Dr. Ofer Levy, head of 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. He said infections are the primary cause of myocarditis, and that common infections, mostly viruses, including Covid, human herpesvirus 6 and parvovirus B19, as well as various bacterial and fungal infections, can trigger the condition. Levy said mild cases usually clear up on their own with rest and routine monitoring by a doctor, while severe cases typically require hospitalization.