*The U.S. Food and Drug Administration (FDA) will share information next week pointing to a possible connection between COVID-19 shots and the deaths of 25 children, according to a source speaking to NBC News.
The findings will be discussed during a meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP), which will also review updated COVID vaccines for the fall.
The data comes from the Vaccine Adverse Event Reporting System (VAERS), a public database run by the FDA and CDC. However, experts caution that VAERS reports are unverified and cannot prove causation. Dorit Reiss, a vaccine policy expert, explained, “To identify causation to a vaccine you need to show that the cause of death was something the vaccine caused, and by itself, a VAERS report would not show that — you need larger studies comparing incidents of the harm with or without the vaccine.”
FDA head Marty Makary shared with CNN that his team has examined cases of fit children passing away post-vaccination. “We’ve been looking into the VAERS database of self-reports that there have been children that have died from the COVID vaccine,” he stated, indicating a detailed analysis is imminent.
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Dr. Tracy Beth Høeg, a critic of pediatric COVID vaccinations and Makary’s special adviser, is expected to present the findings at the ACIP meeting. A former FDA official disputed the analysis, stating, “I can tell you on a stack of Bibles that we looked through all of the autopsy reports and that we didn’t find anything.”
Multiple studies continue to show that COVID vaccines are safe for children. A 2023 JAMA Pediatrics review involving over 10 million vaccinated children found reduced risks of infection and hospitalization. Similarly, a 2024 Nature Communications study found no overall increase in adverse events, though it did note a slight rise in myocarditis among teenage boys.
Health and Human Services leader Robert F. Kennedy Jr. has overhauled the ACIP by appointing skeptics of vaccine efficacy in place of prior members. Recently, he limited access to the latest boosters to adults over 65 or those with underlying issues, sparking uncertainty among providers and recipients. The ACIP’s decisions could shape vaccine distribution and health strategies as autumn approaches.
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