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 about heart inflammation.

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

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

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

The Food and Drug Administration is implementing more rigorous standards for administering the COVID-19 vaccine and experts ...

The change marks a shift in the Food and Drug Administration’s policy on approving COVID-19 vaccines, which the new ...

The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to ...

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

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

With new testing requirements, it’s not even clear whether new Covid or flu shots can be made available this fall.

Agency will ask drugmakers for large trials for new versions of vaccines meant for healthy adults and children.