NEXSPIKE becomes Moderna’s third FDA-approved product CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283),

The U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine for everyone aged 65 and above, the company said on Saturday, the first endorsement since the regulator tightened requirements.

This was in addition to $176 million awarded by the U.S. Department of Health and Human Services last year to complete the late-stage development and testing of a pre-pandemic mRNA-based vaccine against the H5N1 avian influenza. Moderna said it plans to explore alternatives for late-stage development and manufacturing of the vaccine.

H5 avian flu vaccine study shows positive interim results Company has been notified that HHS will terminate Moderna’s award for late-stage development of pre-pandemic influenza vaccines CAMBRIDGE, MA / ACCESS Newswire / May 28,

Moderna has withdrawn the BLA for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after consulting with FDA.