FDA Report: No Confirmed Child Deaths Linked to Covid Vaccines

A recent report from the Food and Drug Administration (FDA), released quietly last week, states that there have been no definitive connections between child deaths and Covid vaccines.

This analysis follows claims made nearly six months ago by former FDA vaccine chief Dr. Vinay Prasad, who alleged—without presenting evidence—that at least ten child deaths linked to the vaccines had gone unreported.

Prasad’s assertions contributed to discussions regarding changes in FDA vaccine review processes. He left the agency in April amid criticism related to delays and rejections of treatments for rare diseases.

Dr. Jesse Goodman, a former FDA chief scientist and infectious disease specialist at Georgetown University Medical Center, commented on Prasad’s implications, suggesting that suggesting a significant number of kids died from the vaccine is not supported by the current evidence.

The FDA analysis surfaced in a letter from Senator Ron Johnson to Health and Human Services Secretary Robert F. Kennedy Jr. regarding concerns about Covid vaccine safety transparency. An HHS official has confirmed the validity of the report.

In the analysis dated December 5, the FDA examined 96 reported child deaths submitted to the Vaccine Adverse Event Reporting System (VAERS) until August 14, 2025. VAERS is a system that allows any individual, including healthcare providers and caregivers, to report health issues following vaccinations. However, it’s important to note that these reports do not confirm that a vaccine caused any health problem. The report explicitly mentions that “VAERS data has significant inherent limitations that severely restrict its utility for assessing causality” and warns that it’s often unclear if a vaccine caused an adverse event.

After examining the cases, the FDA determined that none were “certainly” linked to Covid vaccination, which contrasts with Prasad’s description that these children died “after and because of receiving” the vaccine.

There was no immediate comment from an HHS spokesperson or from Prasad.

From the analysis, five deaths were categorized as “possible” and two as “probable,” but the FDA clarified that these classifications do not imply that the vaccine was the cause and other potential explanations remain plausible. The analysis results were based on criteria from the World Health Organization, which indicates that “possible” cases may have other equally likely explanations. “Probable” cases are typically less likely to have alternative causes, though such causes cannot be completely ruled out.

Among the deceased, five were boys and two were girls, with an average age of 13. Most cases involved myocarditis, a rare heart inflammation associated with Covid vaccines, notably in adolescent boys and young men. The FDA instructed Pfizer and Moderna last June to revise vaccine labeling to include myocarditis risk, a condition noted on the labels since its identification in 2021.

Goodman noted that the FDA was fairly lenient in suggesting possible or probable links to the vaccine but did not dismiss the idea of vaccine-associated deaths entirely. He remarked that certainty is challenging to achieve without a specific marker for the vaccine and acknowledged that the report was conducted carefully.

The agency evaluated medical records, death certificates, and sometimes spoke with the deceased children’s parents to ascertain any links to the vaccinations.

Dr. Ofer Levy, director of the Precision Vaccines Program at Boston Children’s Hospital, stated that the myocarditis risk from Covid vaccination could be as high as 100 cases per million doses administered. However, he emphasized that infections remain a primary trigger for myocarditis.

Levy explained that various common infections, primarily viral, can provoke such heart inflammation, including Covid, human herpesvirus 6, and parvovirus B19, in addition to various bacterial and fungal infections.

Typically, mild instances resolve with rest and routine medical follow-up, while severe cases may necessitate hospitalization.