The agency will now require randomized, controlled data before approving new COVID shots for healthy children and adults, ...

"The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

The requirement for placebo-controlled trials isn’t expected to affect the rollout this fall for older adults and other groups at high risk for severe illness.

The FDA announced it will limit full approval of future COVID-19 booster vaccines to individuals older than 65 and those at high risk for severe disease, marking a shift from the agency’s previous one ...

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...