mNEXSPIKE was studied in a noninferiority trial:
Immunogenicity results1
Neutralizing antibody responses against Omicron BA.4/BA.5 compared to Spikevax1
mNEXSPIKE (10 µg)
n=621 | Spikevax (50 µg)
n=568 | |
|---|---|---|
Day 29* | ||
GMC (95% CI) | 2340.9 (2167.0, 2528.8) | 1753.8 (1618.2, 1900.7) |
GMC ratio (95% CI)† | 1.3 (1.2, 1.5) | |
Seroresponse rate, % (95% CI) | 79.9 (76.5, 83.0) | 65.5 (61.4, 69.4) |
Seroresponse rate difference, % (95% CI)† | 14.4 (9.3, 19.4) | |
GMC ratio defined as the ratio of GMC of mNEXSPIKE at Day 29 over the GMC of Spikevax at Day 29.1
Seroresponse is defined as an antibody value change from baseline below the LLOQ to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and <4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ, where baseline refers to pre-dose.1
SRR difference defined as the SRR of mNEXSPIKE against Omicron BA.4/5 at Day 29 minus the SRR of Spikevax against the same variant at Day 29.1
mNEXSPIKE satisfied the primary criterion for noninferiority.1
*Day 29 defined as 28 days after administration of the first dose of mNEXSPIKE or Spikevax.1
†Lower bound of the 95% CI of GMC ratio >0.667. Lower bound of the 95% CI of the SRR-difference >-10% for seroresponse rates.1
GMC = geometric mean concentration.
n = number of participants with non-missing data at the corresponding timepoint(s).
LLOQ = lower limit of quantitation.
Immunoresponse at Day 29* by age group2
BA.4/BA.5 neutralizing antibody response2
GMR (95% Cl) =
(95% Cl)
GMR (95% Cl) =
(95% Cl)
GMR (95% Cl) =
(95% Cl)
GMR (95% Cl) =
(95% Cl)
Analysis Limitation: This endpoint was not powered for statistical analysis and should be considered descriptive only. Therefore, results require cautious interpretation and could represent chance findings.
*Day 29 defined as 28 days after administration of the first dose of mNEXSPIKE or Spikevax.1
†GMC estimated based on ANCOVA model.
Highest GMR observed in participants ≥65 years old where the highest VE point estimate was also seen.2
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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 have been previously vaccinated with any COVID-19 vaccine and 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. Efficacy, immunogenicity, and safety of a next-generation mRNA-1283 COVID-19 vaccine compared with the mRNA-1273 vaccine: results from NextCOVE, a phase 3, randomized, observer-blind, active-controlled trial. 2025. supplementary appendix.
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure