The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather ...

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

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

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

The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, ...

FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff Dr. Vinay Prasad personally intervened to place restrictions on COVID shots from vaccine makers.

The U.S. Food and Drug Administration approved "Spikevax," Moderna's vaccine for children aged 6 months to 11 years old. The ...

FDA grants full approval to Moderna's COVID-19 vaccine for children aged 6 months to 11 years with medical vulnerabilities, ...

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.

Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 months through 64 years at increased risk for COVID-19 disease ...