Summarised by Centrist
The FDA has officially revoked emergency use authorisation (EUA) for all COVID vaccines in the United States.
EUAs were first granted in late 2020 when no approved vaccines were available. EUAs were the regulatory pathway that once allowed for sweeping mandates and mass distribution.
The Pfizer and Moderna vaccines are now approved only for those aged 65 and older or individuals with at least one risk factor.
With full approvals now in place for Pfizer, Moderna, and Novavax, most healthy children and adults under 65 no longer have any FDA-approved option.
Moderna’s is the only vaccine still authorised for infants and toddlers. “The emergency use authorisations for COVID vaccines, once used to justify broad mandates… are now rescinded,” said US Health Secretary Robert F. Kennedy Jr. He added that the vaccines remain available to patients in consultation with their doctors.
Dr Vinay Prasad, the FDA’s vaccine chief, said the agency could no longer approve shots for low-risk populations without clinical trial evidence showing benefit. “We simply need more data to have that confidence for younger individuals at low risk of severe disease,” he said.
The change comes after the CDC stopped recommending COVID vaccines for healthy children and pregnant women. Most Americans had already opted out: by April 2025, just 13% of children and 23% of adults had received the most recent version.
The COVID vaccine access cuts have triggered resignations at the CDC, with senior leaders claiming science is being sidelined by politics.
