Spikevax® (COVID-19 Vaccine, mRNA) Storage & Dosing

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 in the refrigerator

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.

Thaw at room temperature

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

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.

1Remove the tip cap

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.

2Attach the needle

Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.

3Administer

Administer the entire dose intramuscularly.

4Discard

Discard syringe after use.

Indication and Important Safety Information

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 (SARS-CoV-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.

References

Spikevax. Prescribing Information. ModernaTX, Inc; 2024.

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