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 ...

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, ...

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.

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

The approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory winning streak, which has also included nods for a next-gen COVID-19 vaccine ...

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 ...