The Food and Drug Administration has released an analysis finding that no child deaths have been definitively linked to Covid-19 vaccination, directly contradicting claims made by the agency’s former vaccine chief. The December 5 report reviewed 96 reports of child deaths submitted to the federal vaccine adverse event reporting system, concluding that none reached the threshold of certainty for being caused by the shots.
The findings come nearly six months after Dr. Vinay Prasad, who served as the FDA’s vaccine chief, claimed in a November memo to agency staff that at least 10 previously unreported child deaths had been tied to the vaccines. Prasad left the FDA in April following criticism over delays and rejections involving treatments for rare diseases.
Main developments
The FDA analysis examined 96 reports of child deaths that had been submitted to the Vaccine Adverse Event Reporting System through August 14, 2025. The review classified five deaths as possible and two deaths as probable in relation to Covid vaccination. However, the agency emphasized that these classifications do not mean the vaccines caused the deaths.
According to the FDA report, it is important to note that possible cases could also be explained by alternative causes. Among the seven deaths classified as possible or probable, five were boys and two were girls. The average age among these deaths was 13 years old. Most of the cases involved myocarditis, an inflammation of the heart muscle.
Dr. Jesse Goodman, former FDA chief scientist and infectious disease specialist at Georgetown University Medical Center, reviewed the findings and said that to sort of imply that there was a wholesale or large number of kids killed by the vaccine goes beyond what the evidence seems to be here.
What we know so far
The FDA report was dated December 5 and was included in a letter sent this month by Senator Ron Johnson, a Republican from Wisconsin, to Health and Human Services Secretary Robert F. Kennedy Jr. The analysis covered VAERS data through August 14, 2025.
The classification system used by the FDA does not confirm causation. Even when deaths are labeled as possible or probable, these designations indicate only that a temporal or clinical relationship exists, not that the vaccine definitively caused the outcome. The VAERS system itself is designed to collect reports of adverse events following vaccination, but reports alone cannot prove that a vaccine caused a particular health problem.
Goodman acknowledged the inherent difficulty in establishing causation, stating that there is not a way to be certain unless we found some specific marker for the vaccine. All that said, I think this report was carefully done.
Context on myocarditis risk
Myocarditis has been a known but rare side effect associated with Covid-19 vaccination. The FDA instructed Pfizer and Moderna to update their vaccine labels about myocarditis risk last June. The condition was first identified on vaccine labels in 2021.
According to the available data, the myocarditis risk from Covid vaccination is as high as 100 cases per million doses administered. However, experts note that the condition can have multiple causes unrelated to vaccination.
Dr. Ofer Levy, head of the Precision Vaccines Program at Boston Children’s Hospital, explained that there is a range of common infections, mostly viruses, that can trigger this kind of inflammation of the heart. This context is significant because it illustrates the challenge in determining whether myocarditis cases following vaccination were caused by the shots or by other factors such as viral infections.
Former vaccine chief’s departure
Dr. Vinay Prasad issued a memo to FDA staff in November claiming the agency had identified at least 10 previously unreported child deaths tied to Covid vaccines. The FDA report findings appear to contradict this characterization, as no deaths were classified with certainty as being caused by vaccination.
Prasad departed from the FDA in April following criticism related to his handling of treatments for rare diseases. The nearly six-month gap between his November claims and the December-dated FDA report that contradicts those claims has raised questions about the basis for his original statements.
Understanding VAERS limitations
The Vaccine Adverse Event Reporting System is a passive surveillance system that accepts reports from anyone, including healthcare providers, patients, and family members. A report to VAERS does not mean that a vaccine caused an adverse event, only that the event occurred sometime after vaccination.
Health officials have repeatedly emphasized that VAERS data requires careful analysis and cannot be used alone to determine whether a vaccine caused a particular adverse event. The system is designed to detect potential safety signals that warrant further investigation, not to establish causation.
The 96 reports of child deaths reviewed by the FDA represent a small fraction of the millions of Covid vaccine doses administered to children in the United States. The classification of only seven cases as possible or probable, with zero classified as certain, reflects the rigorous standards used to evaluate potential vaccine-related adverse events.
What happens next
Senator Ron Johnson’s letter to HHS Secretary Robert F. Kennedy Jr. included the FDA analysis, suggesting that congressional interest in vaccine safety issues continues. However, the factual brief does not include information about any official response from HHS or any planned follow-up actions.
The FDA continues to monitor vaccine safety through multiple surveillance systems. Parents and healthcare providers are encouraged to report any adverse events following vaccination to VAERS, understanding that such reports contribute to ongoing safety monitoring even when causation cannot be immediately established.
Frequently asked questions
Has the FDA confirmed any child deaths from Covid vaccines?
No. The FDA analysis found no child deaths that were classified as certain to be linked to Covid vaccination. Five were classified as possible and two as probable, but these classifications do not confirm that vaccines caused the deaths.
What does a possible or probable classification mean?
These classifications indicate a temporal or clinical relationship between vaccination and the adverse event but do not establish causation. The FDA noted that possible cases could also be explained by alternative causes.
What is the myocarditis risk from Covid vaccines?
According to available data, the myocarditis risk from Covid vaccination is as high as 100 cases per million doses. The FDA instructed Pfizer and Moderna to update their vaccine labels about this risk last June.
How many child death reports did the FDA review?
The FDA reviewed 96 reports of child deaths submitted to the Vaccine Adverse Event Reporting System through August 14, 2025.
The FDA report represents the most comprehensive federal analysis to date of reported child deaths following Covid vaccination. While the findings acknowledge that some deaths had possible or probable temporal relationships to vaccination, the absence of any cases classified as certain underscores the difficulty of establishing definitive causation and contradicts earlier claims of confirmed vaccine-related child deaths.
