The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather ...

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

US regulators have fully approved Moderna's Spikevax COVID-19 vaccine for children aged 6 months to 11 years, but only for ...

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 comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...

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

The Food and Drug Administration Thursday granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

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

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 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.