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 ...

The Trump administration's new COVID-19 vaccine plan limits access to high-risk groups, requiring further trials for low-risk individuals, marking a major policy shift amid scientific uncertainty and ...

The FDA's new vaccine guidelines focus on older adults, citing insufficient evidence for the need for additional COVID shots ...

The Food and Drug Administration will no longer approve COVID-19 vaccines for healthy people under 65 without rigorous trials ...

The truth is that for most of that, for many Americans, we simply do not know the answer to whether or not they should be ...

The FDA’s new approach to boosters could mean that kids will no longer be able to get vaccinated against the disease to begin ...

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which ...

FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...

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

The US Food and Drug Administration is about to make it harder for people to get a COVID-19 vaccine. According to new ...

Two weeks into his tenure leading the FDA’s biologics center, Vinay Prasad has made his mark with a new framework for ...