mNEXSPIKE clinical trial design
mNEXSPIKE was studied in a phase 3, randomized, observer-blind, active-controlled clinical trial in the United States, United Kingdom, and Canada1*
people≥12 years of age
receivedmNEXSPIKE (10 µg mRNA)
receivedSpikevax® (COVID-19 Vaccine, mRNA) (50 µg mRNA)
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.1
rVE subgroup analysis population by age group1
Age subgroup(years) | mNEXSPIKE | Spikevax |
|---|---|---|
12 to <18 | 491 | 490 |
18 to <65 | 3558 | 3562 |
≥65 | 1630 | 1635 |
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 (n=5687).1
*1:1 randomization was stratified by age: 12 years through 17 years, 18 years through 64 years, and 65 years of age and older.1
rVE = relative vaccine efficacy.
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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.
Reference
- mNEXSPIKE Prescribing Information. ModernaTX, Inc.
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure