The FDA is requiring COVID vaccine makers Pfizer and Moderna to update their warnings about the possible risk of myocarditis ...

No, this is not true. Vaccines undergo rigorous safety testing and are continuously monitored for adverse events.

Details of the new rules for COVID-19 vaccine approvals were also outlined in an article published by The New England Journal ...

The FDA will narrow its approval for updated coronavirus vaccines, marking a significant shift in the agency’s approach to ...

This week, mRNA vaccines are set to face intense scrutiny from critics in Congress. Here's an explainer of how we know they are safe and effective.

The FDA has approved Nuvaxovid to prevent COVID-19 in adults 65 years and older and high-risk individuals 12 through 64 years ...

Under a new policy announced Tuesday by the Trump administration, only people age 65 and older and children or young adults ...

The agency will require manufacturers to conduct randomized, controlled trials to secure approval for healthy Americans.

Federal officials unveiled a rigorous regulatory approach to future COVID vaccines that could make it harder for many people ...

The FDA also gave full approval to the Novavax COVID vaccine (Nuvaxovid) using this approach, approving it for those ages 65 ...

U.S. regulators will no longer approve COVID booster shots for healthy adults and children without new studies, adding a ...