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

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.

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

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

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.

US FDA approves Moderna’s Covid-19 vaccine, Spikevax in children aged 6 months through 11 years at increased risk for Covid-19 disease: Cambridge, Massachusetts Saturday, July 1 ...

The FDA has approved required updates to the labeling of Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines to include revised warnings about the risk of myocarditis and pericarditis ...

The US FDA has approved Moderna's new COVID-19 vaccine, mNEXSPIKE, amidst emerging coronavirus variants. It is approved for adults 65 and older, and individuals aged 12-64 with underlying risk ...

Retail investor chatter around vaccine makers Novavax, Moderna, and Pfizer rose on Wednesday, ahead of a closely watched CDC vaccine advisory meeting. At Wednesday’s close, Novavax closed down 0 ...

The government’s top vaccine official working under Health Secretary Robert F. Kennedy Jr. recently restricted the approval of two COVID-19 vaccines, disregarding recommendations from government ...

FDA vaccine official restricted COVID vaccine approvals against the advice of agency staff Top FDA leaders are typically not involved in the review of individual products. Officials like Prasad ...