The FDA's approval was based on a study of 11,400 people age 12 and older that compared the new low-dose vaccine with Moderna ...

By Stephanie Brown HealthDay ReporterTUESDAY, June 3, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...

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 ...

Moderna said mNEXSPIKE was approved by the FDA for use in adults aged 65 and up, as well as some individuals aged 12 to 64.

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

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

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.

Moderna, over the weekend, announced that the U.S. Food and Drug Administration had approved its second-generation COVID ...

Moderna MRNA announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a ...

Moderna's mNexspike COVID vaccine approved by FDA for older adults and at-risk groups after Phase 3 trial shows improved ...

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