The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded ...

The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk ...

The FDA will now require clinical trials to approve boosters for healthy Americans under 65, making it unlikely the shots ...

Federal health officials received reports about potential cardiac inflammation effects just months after the mRNA vaccines were approved, but delayed notifying the public about them and ultimately ...

The FDA is moving to restrict COVID vaccination to adults 65 and older and other particularly vulnerable people. Learn what’s ...

Its new guidance would trade the clarity and reach of our current strategy for a confusing framework that simply doesn’t fit reality.

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which ...

The U.S. Food and Drug Administration (FDA) is changing the game on COVID-19 vaccines. Instead of approving yearly boosters ...

The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans, a move that may limit future shots to older Americans and people at higher risk of serious Covid-19 ...

Applied Clinical Trials is the thought leader in pharmaceutical drug development operations and clinical trial design, ...

FDA changes COVID-19 vaccine approval policy, major trials now required for widespread use. Higher risk individuals still ...