FDA Investigates Possible Vaccine-Linked Deaths Across Age Groups After Senior Official’s Controversial Claim

The U.S. Food and Drug Administration has opened an inquiry into whether deaths "across multiple age groups" may be linked to Covid-19 vaccines, a Department of Health and Human Services spokesperson said Tuesday. The announcement follows weeks after a senior FDA official publicly asserted — without providing supporting evidence — that Covid-19 vaccinations had caused the deaths of 10 children.

Agency Response and Ongoing Review

Andrew Nixon, an HHS spokesperson, said the FDA is conducting "a thorough investigation," but he declined to specify which data sources are being reviewed or whether the probe could prompt changes to how Covid vaccines are authorized, approved, or marketed.

Claims From A Senior FDA Official

Dr. Vinay Prasad, the FDA's chief medical and scientific officer and director of the Center for Biologics Evaluation and Research, wrote in a memo last month that "healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death."

Prasad did not provide identifying details about the 10 deaths he referenced or explain the methodology used to reach that conclusion. He said an "initial analysis" reviewed 96 deaths and concluded 10 were linked to Covid-19 vaccination.

Context On Vaccine Safety Monitoring

Health agencies report that more than 700 million doses of Covid-19 vaccines have been administered in the United States since late 2020. The vaccines underwent extensive clinical testing prior to authorization and have been continuously monitored for safety. Serious adverse events such as anaphylaxis and myocarditis have generally been rare, according to public health agencies.

Under existing FDA regulations, health care providers are required to report deaths that occur after vaccination to the Vaccine Adverse Event Reporting System (VAERS), even when a causal link to vaccination has not been established. Members of the public may also submit reports to VAERS; federal agencies use the database to detect signals that warrant further study, but VAERS reports alone do not prove causation.

Potential Regulatory Changes Proposed

Prasad said the agency's analysis will lead to a new approval approach that demands stronger evidence of both safety and clinical benefit before vaccines can be marketed. Proposed changes he described include:

• Stricter authorization standards for vaccines intended for pregnant people.
• New efficacy requirements for pneumonia vaccine trials to demonstrate actual disease reduction rather than relying solely on antibody responses as a surrogate.
• A revision of the annual influenza vaccine framework, a re-appraisal of safety data, and clearer, more transparent labeling.

Leadership And Policy Context

The article also notes that HHS Secretary Robert F. Kennedy Jr. has expressed skepticism about vaccine effectiveness and previously founded the advocacy organization Children’s Health Defense. As HHS Secretary, he has taken actions that include cutting some mRNA vaccine development funding, replacing members of the vaccine advisory committee at the Centers for Disease Control and Prevention, and directing changes to CDC website content that public health experts have criticized for including claims linking vaccines and autism.

The FDA's investigation is ongoing. Agency officials have not yet released detailed findings or publicly identified specific data sources under review. Independent public health experts emphasize that formal epidemiologic analysis and transparent data will be necessary to assess any potential causal links.

Reporting contributions: CNN reporters Kaanita Iyer, Adam Cancryn and Amanda Sealy.