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

The move makes Moderna’s vaccine, called Spikevax, the first COVID shot for kids in the U.S. to be fully approved, rather ...

The U.S. Food and Drug Administration has granted full approval for Moderna's MRNA.O COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years who are at an increased risk of the disease, ...

The FDA this week fully approved Moderna’s COVID-19 vaccine for children aged 6 months to 11 years but limited the approval ...

Vaccine maker Moderna announced today that the US Food and Drug Administration (FDA) has granted full approval of its ...

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

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

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 ...

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The US FDA has granted full approval to Moderna’s COVID-19 vaccine Spikevax for use in children aged six months to 11 years ...

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