Panel members had questions about whether a new FDA proposal to require randomized trials for vaccines in healthy adults ...

The FDA expects that randomized, controlled trial data on clinical outcomes will be needed before COVID-19 vaccines can be approved for patients who are 6 months to 64 years of age and do not have ...

Bartholomew County health officials said they are taking a wait-and-see approach after the Trump administration said it plans to limit approval for seasonal COVID-19 shots to seniors and others at ...

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

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

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

The question was asked by Capt. Sarah Meyer, a pediatric vaccine expert with the Centers for Disease Control and Prevention and member of the committee, the Vaccines and Related Biological Products ...

Historically, almost everyone has been eligible for Covid vaccines; the C.D.C. recommended the most recent vaccine for all ...

The advisory committee, which met after the agency rolled out new vaccine guidelines, said companies should tailor their ...

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