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

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

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

Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...

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

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

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.

In a July 9 memo, the director of the FDA's Center for Biologics Evaluation and Research contended there was not enough ...

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 ...

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 ...

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.