FDA

Moderna’s next-generation COVID-19 vaccine approved

June 6, 2025

Brand name: mNEXSPIKE

Generic name: mRNA-1283

Manufacturer: Moderna

Approval date: May 31, 2025

FDA approved mNEXSPIKE (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12 to 64 years with at least one underlying risk factor as defined by CDC.

Efficacy

Approval was based on results from a randomized, observer-blind, active-controlled phase 3 NextCOVE trial (NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective was to demonstrate non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared with that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine. Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared with 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.

Safety

In the phase 3 trial, mRNA-1283 demonstrated a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache, and myalgia.

Sources:

mNEXSPIKE (mRNA-1283) [package insert]. Moderna. https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6/9f00fca4-1dca-4c9e-9bdd-d21a1c0bf5c6_viewable_rendition__v.pdf Revised May 2025. Accessed June 5, 2025.

Moderna receives US FDA approval for COVID-19 vaccine mNEXSPIKE. [News release]. 2025. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx