FDA Looks Into Reports of Deaths After COVID Vaccination

Key Takeaways

• The U.S. Food and Drug Administration is reviewing possible deaths after COVID-19 vaccination in both children and adults

• Leaked internal FDA emails suggest the agency may set stricter rules for vaccine approval in the near future

• Health Secretary Robert F. Kennedy Jr. has issued statements questioning the safety of COVID vaccines

THURSDAY, Dec. 11, 2025 (HealthDay News) — Federal officials say the U.S. Food and Drug Administration (FDA) is reviewing reports of possible deaths in adults and children following COVID-19 vaccination.

“FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to coronavirus vaccines,” said Andrew Nixon, spokesperson for the U.S. Department of Health and Human Services (HHS).

The review follows a leaked email from Dr. Vinay Prasad, who leads the FDA’s vaccine division. In the email, Prasad wrote that the agency had identified “at least 10 children” who died “after and because of” COVID-19 vaccination, but he didn't provide details.

Public health experts have since asked the FDA to release data showing how those conclusions were reached.

COVID vaccines have been studied widely and have shown a strong safety record, with known side effects listed on their labels.

Prasad’s email also suggested the FDA may set a higher bar for vaccine approval, requiring companies to show that vaccines prevent disease after they reach the market, rather than simply generating infection-fighting antibodies.

A group of 12 former FDA commissioners wrote last week in The New England Journal of Medicine that these proposed changes could weaken the nation’s ability to respond to infectious disease threats.

Under U.S. Health Secretary Robert F. Kennedy Jr., HHS statements have questioned the safety of mRNA COVID-19 vaccines, The Washington Post reported.

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Nixon said health officials “will soon release documents laying out that framework and data confirming how the coronavirus vaccine resulted in children’s deaths that previous leadership failed to properly investigate.”

Meanwhile, the FDA has contacted multiple companies, including Merck, Sanofi and AstraZeneca, regarding the safety of RSV monoclonal antibodies used to protect infants against respiratory syncytial virus. It’s a common infection that infects the nose, throat and lungs. 

Merck met with the agency last week and said it is “confident in the safety profile” of its RSV product, Enflonsia, The Post said.

Sanofi, whose RSV preventive treatment Beyfortus has been given to more than 400,000 infants in trials and real-world studies, stated that “no safety issue has been identified.”

More information

The U.S. Centers for Disease Control and Prevention has more on COVID vaccines.

SOURCE: The Washington Post, Dec. 9, 2025

What This Means For You

If you have questions about COVID or RSV vaccines, speak with your health care provider.