The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...

Pfizer's COVID vaccine (Comirnaty) is fully approved for patients ages 12 and up, and authorized for kids ages 6 months ...

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in COVID-19 ...

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

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

Federal documents show he disagreed with conclusions the benefits outweighed the risk of side effects, which are rare.

FDA vaccine head Vinay Prasad restricted Moderna and Novavax COVID vaccines to high-risk groups, overriding staff advice amid ...

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

The new memos from the Food and Drug Administration show how the agency’s vaccine chief, Dr. Vinay Prasad, personally ...

Peter Marks, who headed the FDA’s Center for Biologics Evaluation and Research before being forced to resign in March, said ...