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

Key Takeaways The U.S. Food and Drug Administration gave full approval to Moderna’s COVID shot for kids ages 6 months to 11 ...

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

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

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

Moderna, Inc. (MRNA) on Thursday announced that the U.S. Food and Drug Administration (FDA) has fully approved its COVID-19 ...

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 ...

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.

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.