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

A top official at the Food and Drug Administration recently overruled government scientists on the availability of two ...

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

FDA grants full approval to Moderna's COVID-19 vaccine for children aged 6 months to 11 years with medical vulnerabilities, ...

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.

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 Food and Drug Administration said Wednesday it has expanded existing warnings on the two leading COVID-19 vaccines about a rare heart side effect mainly seen in young men.