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.

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.

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

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 ...

Discover the latest FDA warning updates for COVID vaccines including increased health risks and new restrictions for healthy adults.

The FDA has approved required updates to the labeling of Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines to include revised warnings about the risk of myocarditis and pericarditis ...

MODERNA mNEXSPIKE - The next-generation COVID-19 vaccine was approved for aged 65 and above in May 2025. Spikevax, Moderna's first COVID-19 vaccine, received its initial FDA approval in January 2022.

The US FDA has approved Moderna's new COVID-19 vaccine, mNEXSPIKE, amidst emerging coronavirus variants. It is approved for adults 65 and older, and individuals aged 12-64 with underlying risk ...