The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...

The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.

An FDA committee on Thursday recommended that COVID-19 vaccines for the 2025-2026 respiratory virus season — which, for the ...

The agency told vaccine makers that COVID-19 vaccines used in the United States starting in fall 2025 should be based on JN.1 ...

The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.

At the outset of the meeting, the FDA's new top vaccine regulator, Vinay Prasad, said he and FDA leaders wanted to "give people a little more time to digest the policy." He said that the FDA is still ...

Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...

The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.

Some members of the Vaccines and Related Biologics Products Advisory Committee worried that a strain change would require new ...

The US FDA may limit Covid-19 boosters to high-risk groups only, citing lack of efficacy in healthy individuals. Meanwhile, ...

The vaccine eligibility change is a threat to the health of Americans, some experts say, adding that the FDA is not being ...