FDA to Release Report on Child Deaths After COVID Shots

On Sept. 4, 2025, the commissioner of the U.S. Food and Drug Administration (FDA), Marty Makary, MD, announced the agency will release a detailed report investigating deaths among children following receipt of COVID-19 shots.^{1 2}

Dr. Makary stated that officials have begun carrying out an “intensive investigation” into reports submitted to the Vaccine Adverse Event Reporting System (VAERS). He said that the FDA would release a report in the next few weeks.

FDA Examining VAERS, Autopsy Reports for Investigation

“We do know at the FDA, because we’ve been looking into the VAERS system database self-reports, that there had been children who have died from the COVID vaccine,” Makary said in an interview with CNN.²

The Vaccine Adverse Event Reporting System (VAERS) was created under the National Childhood Vaccine Injury Act of 1986 and has been in operation since 1990. About 2.7 million vaccine adverse event reports have been filed with VAERS, of which nearly 1.7 million reports are associated with COVID shots.³

In addition to reviewing VAERS reports, the agency is reviewing autopsy reports and speaking with family members of children who died after they were given COVID shots. Makary said doctors are involved in the investigation.²

Makary stated that the public deserves to have the information. “We want to get good data so people can make … a risk-benefit analysis for their age group,” he said. “We shouldn’t be using dogma to say everybody should get [a COVID vaccine], and regardless of your circumstance.”¹

Makary said that children, particularly boys, are at an increased risk of myocarditis (heart inflammation) following receipt of COVID shots.

Most of the COVID shots administered in the U.S. have been the mRNA COVID biologicals manufactured and marketed by Pfizer/BioNTech and Moderna.⁴

The U.S. Centers for Disease Control and Prevention’s (CDC) safety data notes that “the evidence suggests that, although rare, these events are linked to certain types of COVID-19 vaccinations.” The federal agency added that “surveys of patients diagnosed with myocarditis who developed symptoms at least three months prior to answering the survey showed most patients (80%) were considered by their cardiologist or other healthcare provider to have either fully or probably fully recovered.”²

Despite the information published in the manufacturer’s prescribing information product inserts and statements by federal health officials that COVID shots are associated with an increased risk of heart inflammation, many legacy news outlets and the “experts” they quote deny there is a risk of myocarditis linked to the mRNA biological.  False narratives and headlines, such as “Myocarditis deaths claim is inflammatory nonsense”⁵ and “Myocarditis: COVID-19 is a much bigger risk to the heart than vaccination” continue to try to mislead the public.⁶

U.S. Health Officials Downplayed and Delayed Informing Public of Risk

In May 2025, a 55-page interim report from the U.S. Department of Health and Human Services (DHHS) revealed that during the COVID pandemic response by the previous administration, U.S. health officials were aware of the increased risk of myocarditis in healthy people from COVID shots, but that acknowledgment of those risks were delayed and downplayed in information released to the public. U.S. Senator Ron Johnson of Wisconsin, who is chairman of the Senate Permanent Subcommittee on Investigations, has been investigating the safety and effectiveness of the COVID shots for several years. Throughout the investigation, he has compiled almost 2,500 pages of records that he obtained, which contain evidence that the Biden administration was not transparent about when US health officials knew about the link between myocarditis and COVID shots and that there was a delay in warning the public about those risks.⁷

According to Sen. Johnson’s report, a formal warning about myocarditis after COVID-19 shots was going to be distributed nationwide as a Health Alert Network (HAN) message, which is used by the CDC to share urgent public health information. However, Johnson’s report said that health officials at the CDC and FDA “ultimately decided against issuing a formal HAN and, instead, posted ‘clinical considerations’ on the CDC’s website about myocarditis.”⁷

Israeli Health Officials Warned U.S. in 2021 About Myocarditis in Children After COVID Shots

The Senate committee report also highlights documents detailing the Israeli Ministry of Health notifications CDC officials in February 2021 that the COVID shots were associated with heart inflammation, stating that there were  “large reports of myocarditis, particularly in young people, following the administration of the Pfizer vaccine.”⁷

Makary’s announcement of the investigation into childhood deaths after COVID shots comes in the wake of FDA officials releasing updated guidelines for use of the biological. For children, the guidelines state the COVID shot is authorized for those over age 65 or anyone over age six months old with underlying poor health conditions which make them particularly vulnerable to suffering complications from COVID-19 disease. Following the FDA’s change in guidelines in May 2025, the American Academy of Pediatrics (AAP), a. medical trade organization representing pediatricians, issued its own COVID shot use recommendations in August that directed pediatricians to give the shot to all infants and children over age six months.⁷

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