mNEXSPIKE allows for up to 90 days of
refrigerator storage1
mNEXSPIKE pre-filled syringes can be stored in a freezer, refrigerator, or at room temperature, with varying storage times1
Store frozen between -40°F to 5°F (-40°C to -15°C)
After thawing, store refrigerated for up to 90 days at 36°F to 46°F (2°C to 8°C) or up to the expiration date printed on the carton, whichever comes first
After thawing, store up to 24 hours at room temperature between 46°F to 77°F (8°C to 25°C)
Available in a pre-filled syringe formulation
Thawing instructions1
Thaw in refrigerator36°F to 46°F (2°C to 8°C) | Thaw at room temperature59°F to 77°F (15°C to 25°C) | |
|---|---|---|
Carton of 1 or 2 syringes | 1 hour and 40 minutes | 40 minutes |
Carton of 10 syringes | 2 hours and 40 minutes | 1 hour and 20 minutes |
One syringe
(removed from carton) | 1 hour and 40 minutes | 40 minutes |
A single dose of mNEXSPIKE is 0.2 mL.1
Administer the dose of mNEXSPIKE at least 3 months after the last dose of COVID-19 vaccine.1
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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