The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval ...

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

Following the dismissal of members from the CDC's vaccine advisory committee, a federal health expert predicts the changes on ...

Myocarditis, when the heart muscle gets inflamed, can make it harder for the heart to pump blood possibly causing chest pain, ...

The FDA has updated labels on the top two COVID-19 vaccines to warn of a rare heart side effect, mostly seen in young men.

U.S. health officials have expanded warnings about a rare heart side effect associated with the two leading COVID-19 vaccines ...

As a new variant that causes 'razor blade throat' spreads, the FDA updates vaccine warnings to include information on heart ...

The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna's existing vaccine. It found the new vaccine was safe and was at least as ...

In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the Center for Biologics Evaluation and research at the FDA, and Dr. Martin ...

FDA Commissioner Dr. Marty Makary has called into question whether the agency will approve and authorize the COVID-19 vaccine for winter, saying that more data is needed.

The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart ...