Moderna's Spikevax vaccine is the first to receive full approval for use in children aged 6 months to 11 years with a high-risk health issue.

Cambridge: Moderna has received approval from the U.S. Food and Drug Administration (FDA) for the supplemental Biologics ...

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 approval of Moderna's Spikevax for kids at higher risk of contracting the disease continues the company's regulatory ...

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.

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

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

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 ...

What Happened? Shares of biotechnology company Moderna (NASDAQ:MRNA) fell 3.6% in the morning session after JPMorgan added ...

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 ...

On June 25, the FDA announced it had approved updates for the Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) COVID-19 mRNA vaccines to include new safety data regarding the risks of ...