Moderna’s mNEXSPIKE COVID-19 Vaccine Approved by U.S. FDA
Saturday, May 31, 2025
Moderna has received approval from the U.S. Food and Drug Administration (FDA) for its latest COVID-19 vaccine, mNEXSPIKE® (mRNA-1283).
The vaccine is authorised for use in adults aged 65 and older, as well as individuals aged 12 to 64 who have one or more underlying health conditions identified by the Centers for Disease Control and Prevention (CDC).
This marks the third approved product in Moderna’s vaccine portfolio. The approval is based on data from a Phase 3 clinical trial (NCT05815498), which included around 11,400 participants aged 12 years and older. The trial compared mNEXSPIKE to 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.
mNEXSPIKE demonstrated a 9.3% higher relative vaccine efficacy (rVE) in individuals aged 12 and over compared to mRNA-1273. Among adults aged 65 and older, the vaccine showed a 13.5% higher rVE in a subgroup analysis. The safety profile of mNEXSPIKE was similar to that of the original vaccine, with fewer local reactions and comparable systemic side effects such as injection site pain, fatigue, headache and muscle aches.
Moderna plans to make mNEXSPIKE available in the United States for the 2025–2026 respiratory virus season, alongside its existing vaccines, Spikevax and mRESVIA®, the latter approved for respiratory syncytial virus (RSV).
Source: modernatx.com
