In a significant move to bolster protection against COVID-19, the U.S. Food and Drug Administration (FDA) has approved Moderna’s latest vaccine, mNEXSPIKE® (mRNA-1283), for use in adults aged 65 and older, as well as individuals aged 12 to 64 who are at heightened risk due to underlying medical conditions identified by the Centers for Disease Control and Prevention (CDC).

This marks Moderna’s third approved product in its COVID-19 vaccine portfolio. Stéphane Bancel, CEO of Moderna, emphasized the vaccine’s role in addressing ongoing public health threats, stating, “The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19. COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”

The FDA’s decision is grounded in data from a large Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which involved approximately 11,400 participants aged 12 and above. The study compared the efficacy and safety of mNEXSPIKE with Moderna’s original COVID-19 vaccine, Spikevax® (mRNA-1273). Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273.

Encouragingly, mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy (rVE) overall, and a 13.5% higher rVE among individuals aged 65 and older. Safety data showed that mNEXSPIKE was well-tolerated, with fewer local reactions and a similar overall safety profile to Spikevax. Common side effects included injection site pain, fatigue, headache, and muscle aches.

Moderna expects to roll out mNEXSPIKE in time for the 2025–2026 respiratory virus season, offering it alongside its existing vaccines, including mRESVIA®, which targets respiratory syncytial virus (RSV).

mNEXSPIKE is also under regulatory review in multiple countries, and Moderna continues to expand its pipeline of mRNA-based vaccines and therapeutics targeting infectious diseases, rare conditions, and autoimmune disorders.

Founded on the transformative potential of mRNA technology, Moderna has become a global leader in vaccine innovation. With mNEXSPIKE, the company aims to extend protection to vulnerable populations and stay ahead in the evolving battle against COVID-19.