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 vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

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

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

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

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

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.

Spikevax has the same formulation as the Moderna COVID-19 vaccine that was authorized for emergency use (EUA) by the U.S. Food and Drug Administration (FDA) on Dec. 18, 2020, according to the FDA ...

FDA-approved Spikevax has the same formulation as the Moderna COVID-19 vaccine that was previously authorized for emergency use in the U.S.

Spikevax has the same formulation as the Moderna COVID-19 vaccine that was authorized for emergency use (EUA) by the U.S. Food and Drug Administration (FDA) on Dec. 18, 2020, according to the FDA ...