An FDA advisory committee unanimously recommended Thursday that the next COVID vaccine should be a monovalent one in the JN.1 ...

Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.

FDA leaders say the agency will require more clinical trials to show the benefits of annual COVID shots for healthy adults.

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels ...

A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make a broad recommendation about which lineage of the coronavirus should be ...

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

The FDA’s recent activities regarding Covid-19 vaccines stray far from the well-established standards of vaccine regulatory ...

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

On May 20, 2025, the Food and Drug Administration announced a new stance on who should receive the COVID-19 vaccine.

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to receive booster shots. FDA officials are asking for more data around the ...