The FDA has expanded its internal review of potential COVID-19 vaccine-related deaths to include adults, building on an inquiry that initially focused on children.
The broadened review follows sustained pressure from HHS Secretary Robert F. Kennedy Jr. and growing political scrutiny of vaccine safety, The New York Times reported Dec. 9.
The update comes after a November memo from Vinay Prasad, MD, the agency’s top vaccine official, who claimed the FDA had linked about 10 children’s deaths to COVID-19 vaccination. Dr. Prasad did not provide evidence to support the claim, and the agency has not released data or case details to substantiate it.
Public health experts continue to emphasize that scientific evidence overwhelmingly supports the safety and efficacy of COVID-19 vaccines. More than 1.2 million Americans, including over 2,000 children, have died from COVID-19, according to the CDC.
The review coincides with broader efforts by the Trump administration to reshape vaccine policy. On Dec. 5, President Donald Trump directed HHS and the CDC to compare the U.S. childhood immunization schedule with that of peer nations. Days earlier, a CDC advisory panel recommended ending the long-standing guidance to administer hepatitis B vaccines at birth for infants of virus-negative mothers.
Dr. Prasad has also proposed significant changes to the FDA’s vaccine approval process, including longer clinical trials and broader efficacy measures. The Infectious Diseases Society of America called the agency’s recent claims “vague” and “reckless,” warning that a lack of transparency could erode public trust in vaccines that have years of validated safety data.
