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

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

Agency leaders said there was evidence to justify approval only for older people and those with medical conditions. Many ...

Federal health officials will no longer routinely approve annual COVID-19 shots for younger adults and children who are ...

Seattle vaccine experts were confused by the country's apparent new direction around updated COVID-19 shots, which top FDA ...

Here’s how COVID-19 vaccine guidance is changing in the U.S. For people at high risk of severe COVID-19. The process of ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...

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

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

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

The FDA recommended different standards of evidence for approval based on patients' risk of getting severely sick from Covid.