Food and Drug Administration (FDA) Commissioner Marty Makary announced an investigation into whether the COVID-19 vaccine caused deaths in children, citing self-reported adverse events in the agency’s database. A report is expected within weeks, according to unspecified sources.

In interviews, Makary emphasized concerns about unexplained pediatric deaths linked to the vaccine, though he did not provide specific data connecting the cases to the shots. He argued that the public deserves transparency, stating, “The American people deserve to see the data on children who died from the Covid vaccine.”

Makary also highlighted ongoing efforts to reassess vaccine policies, including stricter eligibility criteria and a push for studies to evaluate long-term risks versus benefits. A new trial involving vaccine manufacturers aims to deliver results by May, focusing on whether the protections of the vaccine outweigh potential dangers.

The commissioner’s remarks come amid broader debates over vaccine access and safety, with calls for clearer evidence to guide future decisions.