MRNA wins FDA approval for mNexspike, a fridge-stable COVID shot, but with a narrower use label than it sought.

Approval was based on data from the Phase III NextCOVE trial, which demonstrated that mNEXSPIKE met non-inferiority criteria ...

The product is a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years.

The new vaccine is indicated for individuals who have been previously vaccinated with any COVID-19 vaccine and are 65 years or older, or 12 to 64 years of age with at least 1 underlying condition that ...

A Phase III trial demonstrated mNEXSPIKE’s non-inferior efficacy compared with Moderna’s original COVID vaccine, Spikevax.

From eligibility to dosage and future rollout, here’s what you need to know about the FDA’s latest vaccine approval.

The Food and Drug Administration (FDA) has approved Moderna’s next-generation mRNA COVID-19 vaccine mNexspike ®. The new vaccine is indicated for active immunization to prevent COVID-19 caused ...

FDA approves Moderna’s mNEXSPIKE COVID-19 vaccine for high-risk groups Phase 3 trial shows mNEXSPIKE outperforms original ...

Rep. Marjorie Taylor Greene slams FDA green lighting of Moderna's mNEXSPIKE COVID-19 vaccine, describing the move as "Not ...

The new vaccine, mNexspike, is a step toward next-generation ... high risk of severe disease from COVID-19," Stephane Bancel, Moderna's CEO, said in a statement Saturday. The Food and Drug ...

mNexspike is approved for older adults aged 65 and for individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe COVID-19. Moderna had originally sought ...