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# Moderna Wins OK for Next-Gen Covid Vaccine
- URL: https://www.fdaweb.com/moderna-wins-ok-for-next-gen-covid-vaccine/
- Published: 2025-06-02T12:00:00.000Z
- Updated: 2026-09-14T15:13:11.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5159279

FDA has approved a Moderna BLA for mNexspike (mRNA-1283), the company’s next-generation vaccine against Covid-19 for use in all adults 65 and older, and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the CDC. The company notes that Covid-19 remains a serious public health threat, with almost 50,000 Americans dying from it last year alone.

Approval was based on data from an active-controlled Phase 3 clinical trial that enrolled about 11,400 participants aged 12 years and older. The primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against Covid-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna’s original vaccine. “mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older,” the company says.

In the trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions, Moderna says, adding that the most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.

Moderna expects to have the new vaccine available for eligible populations in the U.S. for the 2025-2026 respiratory virus season.