FDA Shifts COVID Booster Policy, Mandates New Trials for Younger Adults

Silver Spring, Maryland, USA: The FDA announced it will recommend further COVID-19 boosters primarily for older adults and high-risk groups, requiring manufacturers to conduct additional clinical trials before expanding eligibility to younger, healthy populations. This marks a clear pivot from the past emergency stance of rapid booster authorizations. Officials say the U.S. is transitioning to an endemic approach, focusing on groups most vulnerable to severe outcomes. Vaccine makers must provide data showing meaningful benefit before younger demographics see new booster approvals.