In a Phase 3 trial of roughly 11,400 people aged 12 and older, Moderna’s new COVID-19 vaccine mNEXSPIKE did better than the company’s original shot. Relative vaccine efficacy was 9.3% higher than Spikevax overall, Moderna said, and 13.5% higher in a descriptive analysis of adults 65 and older.
Those results underpinned the FDA’s approval of mNEXSPIKE (mRNA-1283), announced by the company in a release dated May 31, 2025. Moderna calls it its third FDA-approved product.
Who can get it
Approval covers all adults 65 and older. People aged 12 to 64 qualify if they have at least one underlying risk factor as defined by the Centers for Disease Control and Prevention. The label is aimed at people who have had a COVID-19 vaccine before.
How the trial worked
The study was randomized, observer-blind and active-controlled. Its main goal was to show mNEXSPIKE protected against COVID-19 from 14 days after vaccination at least as well as Spikevax (mRNA-1273). Participants got either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273.
Moderna reported a similar safety profile for the two, with fewer local reactions after the new vaccine and comparable systemic ones. Injection site pain, fatigue, headache and myalgia were the effects people reported most.
Stéphane Bancel, Moderna’s chief executive, said the approval “adds an important new tool to help protect people at high risk of severe disease from COVID-19.” He added that more than 47,000 Americans died from the virus last year, and thanked the FDA for what he called a timely review.
Side effects and precautions
Trial participants also reported swelling and tenderness of lymph nodes in the injected arm, redness and hardness at the site, joint pain, chills, nausea, vomiting and fever.
The vaccine should not be given to anyone who had a severe allergic reaction to a previous Moderna COVID-19 dose or any of its ingredients. Myocarditis and pericarditis have been seen after mRNA COVID-19 vaccines, most commonly in males aged 12 to 24, and symptoms like a pounding or fluttering heart call for prompt medical attention. Side effects can be reported to VAERS at 1-800-822-7967.
Moderna expects supplies for eligible people in the U.S. in the 2025-2026 respiratory virus season. Regulators in multiple markets are reviewing mRNA-1283. Patients with questions about eligibility should consult their doctor.
Sources
Sources
- US FDA approves Moderna's new COVID-19 vaccine mNEXSPIKE…
- Moderna Receives U.S. FDA Approval for COVID-19 Vaccine…
