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 ...

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

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

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.

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.

NEXSPIKE becomes Moderna’s third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc.

The World Health Organization has tracked a new COVID-19 variant that has emerged across multiple region. Amid this, the Food and Drug Administration has approved a COVID-19 vaccine from Moderna that ...

Moderna’s newest lower-dose COVID-19 vaccine is approved for all adults 65 and older, and for people aged 12 to 64 who are at ...

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

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

Shares of Moderna climbed Monday after the Food and Drug Administration approved a new COVID-19 vaccine from the drugmaker.