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.

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

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

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 (MRNA) stock rises as the company's Spikevax COVID-19 vaccine gets FDA approval for kids 6 months-11 years at higher ...

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

Pfizer's COVID vaccine (Comirnaty) is fully approved for patients ages 12 and up, and authorized for kids ages 6 months ...

Fresh off of the heels of a shakeup at the CDC over vaccine recommendations, many Americans still question the necessity and safety of COVID-19 vaccines for young children.

Pfizer and its German partner BioNTech asked London's Court of Appeal on Thursday to overturn a ruling that their COVID-19 ...

Pfizer (PFE) and BioNTech (BNTX) challenge Moderna's patent win in London court over mRNA COVID-19 vaccine technology. Read ...

The mRNA drug developer said it will begin discussing approval with the FDA, which has adopted stricter vaccine review ...