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

Under the new FDA guidelines, only people 65 and older and others with one or more health risk factors will be able to ...

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

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

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

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 processes.

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