mNEXSPIKE
DEMONSTRATED
IMPROVED rVE1
mNEXSPIKE
DEMONSTRATED
IMPROVED rVE1
rVE increase of 9.3% over Spikevax1,2
rVE against COVID-19* of mNEXSPIKE vs Spikevax
Per-protocol set for efficacy | mNEXSPIKE (10 µg)n=5679 | Spikevax (50 µg) n=5687 |
|---|---|---|
Number of participants with COVID-19, n (%) | 9.9% (560) | 10.8% (617) |
Incidence rate per 100 person-months | 1.4 | 1.5 |
Relative vaccine efficacy(99.4% CI)† | 9.3% (-6.6, 22.8) | |
Success Criteria Met | Lower bound of 2-sided 99.4% (alpha-adjusted) CI of rVE >-10% (2-sided alpha spending function: 0.0028).
Study was not designed to evaluate superiority.
rVE = relative vaccine efficacy.
In a subgroup analysis, mNEXSPIKE rVE increased by 13.5% in patients aged 65+1,2
rVE against COVID-19* of mNEXSPIKE vs Spikevax
≥65 years | ||
|---|---|---|
COVID-19 events through January 31, 2024—per-protocol set for efficacy | mNEXSPIKE (10 µg) n=1630 | Spikevax (50 µg) n=1635 |
COVID-19 cases | 149 | 172 |
Incidence rate per 100 person-months (95% CI) | 1.3 | 1.5 |
Relative vaccine efficacy (95% CI) | 13.5% (-7.7, 30.6) | |
- rVE for 18 to 64 year age group: 9.7% (-3.8%, 21.3%); mNEXSPIKE (10 μg) n=3558, Spikevax (50 μg) n=3562
- rVE for 12 to 17 year age group: -29.2% (-123.3%, 25.3%); mNEXSPIKE (10 μg) n=491, Spikevax (50 μg) n=490
*Presence of at least 1 symptom from a list of COVID-19 symptoms and a positive NP swab for SARS-CoV-2 by RT-PCR. Listed symptoms were fever (temperature ≥38°C/ ≥100.4°F) or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle aches or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.
†Lower bound of two-sided 99.4% (alpha-adjusted) Cl of rVE >-10% (1-sided alpha spending: 0.0028).
rVE analyses by subgroups were descriptive without P values.
Relative vaccine efficacy (rVE) = 1-hazard ratio (mNEXSPIKE vs Spikevax). Hazard ratio and CI are estimated using a stratified Cox proportional hazard model with Efron’s method of tie handling and with the treatment group as a fixed effect.
NP = nasopharyngeal; RT-PCR = reverse transcription polymerase chain reaction; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
Clinical trial overview for mNEXSPIKE1,2
mNEXSPIKE was studied in a phase 3 randomized, observer-blind, active-controlled clinical trial that evaluated the relative vaccine efficacy (rVE), safety, and immunogenicity of mNEXSPIKE in participants 12 years of age and older in the United States, United Kingdom, and Canada.
11,454 people
≥12 years of age
5728 received
mNEXSPIKE(10 ug mRNA)
1630 aged 65+
received mNEXSPIKE
5726 received
Spikevax® (50 µg mRNA)
1635 aged 65+
received Spikevax
The primary efficacy analysis population (referred to as the per-protocol set for efficacy) included 11,366 participants who received either mNEXSPIKE (n=5679) or Spikevax (COVID-19 Vaccine, mRNA) (n=5687).
The primary efficacy objective in this study was to demonstrate the noninferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after Spikevax.
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Indication and Important Safety Information
INDICATION
mNEXSPIKE (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
mNEXSPIKE is approved for use in individuals 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.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer mNEXSPIKE to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of mNEXSPIKE or to individuals who had a severe allergic reaction following a previous dose of SPIKEVAX (COVID-19 Vaccine, mRNA) or any Moderna COVID-19 vaccine authorized for emergency use.
Warnings and Precautions
- Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mNEXSPIKE.
- Myocarditis and Pericarditis: Postmarketing data with authorized or approved mRNA COVID-19 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.
- Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to mNEXSPIKE.
- Limitations of Vaccine Effectiveness: mNEXSPIKE may not protect all vaccine recipients.
Adverse Reactions
The most commonly reported (≥10%) adverse reactions were pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, axillary swelling or tenderness, and nausea/vomiting.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov or by calling 1-800-822-7967.
Please click for mNEXSPIKE Full Prescribing Information.
References
- mNEXSPIKE Prescribing Information. ModernaTX, Inc.
- Chalkias S, Dennis P, Petersen D, et al. Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine (NextCOVE): results from a phase 3, randomised, observer-blind, active-controlled trial. Lancet Infect Dis. 2025;S1473-3099(25)00236-1. doi: 10.1016/S1473-3099(25)00236-1
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure