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

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

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

The FDA said moving forward, it will adopt a framework requiring proof that a vaccine can generate antibodies in people over ...

The FDA plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65.

The Food and Drug Administration says it has decided to continue approving COVID-19 vaccine updates for seniors and others at ...

New guidelines for COVID vaccine. Prior to the new guidelines, it was recommended that everyone who is 6 months and older get ...

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

“The 2024–2025 COVID vaccine, which was released last fall, is still recommended for everyone aged six months or over,” the ...

For groups younger than 65 or without specific chronic conditions, postmarketing trials will be needed to open access.

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

New requirements for clinical testing of vaccines, announced this month, may delay the availability of shots that had ...