mNEXSPIKE FDA Approval History

Last updated by Judith Stewart, BPharm on June 4, 2025.

FDA Approved: Yes (First approved May 30, 2025)
Brand name: mNEXSPIKE
Generic name: COVID-19 Vaccine, mRNA
Dosage form: Injection
Company: Moderna, Inc.
Treatment for: COVID-19

mNEXSPIKE (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

• mNEXSPIKE is approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and who are:
  - 65 years of age and older, or
  - 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
• FDA approval of mNEXSPIKE was based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE (mRNA-1283) compared to that after the comparator vaccine, Spikevax (mRNA-1273), Moderna's original COVID-19 vaccine. Participants in the trial 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 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. In the Phase 3 trial, mRNA-1283 was found to have 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.
• mNEXSPIKE is administered by intramuscular injection as a single 0.2 mL dose at least 3 months after the last dose of COVID-19 vaccine.
• Postmarketing data with authorized or approved mRNA COVID19 vaccines have demonstrated increased risks of myocarditis and pericarditis, with onset of symptoms typically in the first week following vaccination. The observed risk has been highest in males 12 years through 24 years of age.
• Commonly reported adverse reactions (≥10%):
  - in trial participants 12 years through 17 years of age include pain at the injection site (68.8%), headache (54.5%), fatigue (47.3%), myalgia (39.2%), axillary swelling or tenderness (34.6%), chills (31.6%), arthralgia (23.9%), and nausea/vomiting (16.1%).
  - in trial participants 18 years through 64 years of age include pain at the injection site (74.8%), fatigue (54.3%), headache (47.8%), myalgia (41.6%), arthralgia (32.4%), chills (24.3%), axillary swelling or tenderness (21.7%), and nausea/vomiting (13.8%).
  - in trial participants 65 years of age and older include pain at the injection site (54.6%), fatigue (43.0%), headache (33.1%), myalgia (30.5%), arthralgia (25.6%), chills (16.5%), and axillary swelling or tenderness (10.7%).

Development timeline for mNEXSPIKE

Further information

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