Spikevax storage & handling
Do not refreeze once thawed. Store frozen between -50°C to -15°C (-58°F to 5°F).
Spikevax is shipped frozen and supplied as a carton of 10 single dose pre-filled syringes, each syringe containing 0.5 mL. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Thawing instructions1
Thaw between 2°C to 8°C (36°F to 46°F) for 1 hour for a single syringe or 2 hours and 30 minutes for a carton of 10 syringes. Let each syringe stand at room temperature for 15 minutes before administering.
Alternatively, thaw between 15°C to 25°C (59°F to 77°F) for 45 minutes for a single syringe or 2 hours and 15 minutes for a carton of 10 syringes.
Storage after thawing1
To determine storage requirements, locate the production date on your vial then follow the guidelines below.
| Refrigerated storage | Room temperature storage | Transport storage |
|---|---|---|
Store refrigerated between 2°C to 8°C (36°F to 46°F) for up to 60 days prior to use | Store at room temperature between 8°C to 25°C (46°F to 77°F) for up to 12 hours | Transport between 2°C to 8°C (36°F to 46°F) for up to 12 hours |
Spikevax (2024-2025 Formula) Dosing Regimen, Dose and Schedule1
Spikevax is administered intramuscularly as a single 0.5 mL dose.
Vaccination Status | Individuals 12 years of age and older |
|---|---|
Previously vaccinated against COVID-19 | Single dose, 0.5 mL If previously vaccinated, ≥2 months after receipt of the last previous dose of COVID-19 vaccine |
Never vaccinated against COVID-19 | Single dose, 0.5 mL |
Administration instructions1
Do not shake. Do not dilute the vaccine.
With tip cap upright, remove tip cap by twisting counterclockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting.
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Administer the entire dose intramuscularly.
Discard syringe after use.
Indication
SPIKEVAX (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 (SARSCoV-2) in individuals 12 years of age and older.
Important Safety Information
Contraindications
Do not administer SPIKEVAX to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of SPIKEVAX or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Moderna COVID-19 vaccine.
Warnings and Precautions
- Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of SPIKEVAX.
- Myocarditis and Pericarditis: Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 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 SPIKEVAX.
- Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.
Adverse Reactions
The most commonly reported (≥10%) adverse reactions following any dose in any indicated patient population were pain at the injection site, fatigue, headache, myalgia, chills, arthralgia, axillary swelling/tenderness, nausea/vomiting, and swelling at the injection site.
Reporting Adverse Events and Vaccine Administration Errors
To report suspected adverse reactions, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please click for SPIKEVAX Full Prescribing Information.
- Spikevax. Prescribing Information. ModernaTX, Inc; 2024.
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