Vinay Prasad overruled other reviewers for a third time in recent months in clearing only narrow use of Moderna's vaccine in ...

Moderna's Spikevax vaccine has been fully approved for children with high-risk conditions, the first vaccine to do so.

Moderna's Spikevax receives FDA approval for use in high-risk children; Pfizer, BioNTech appeal U.K. ruling in 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 company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

The full approval of Spikevax covers children aged six months through 11 years who are at increased risk for severe COVID-19, transitioning the vaccine from emergency use to full licensure.

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S. that will no longer be administered under an emergency use authorization.

US FDA approves Moderna’s Covid-19 vaccine, Spikevax in children aged 6 months through 11 years at increased risk for Covid-19 disease: Cambridge, Massachusetts Saturday, July 1 ...

The US Food and Drug Administration(FDA) has granted Fast Track designation to two non-mRNA combination vaccine candidates put forward by Sanofi.