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

Spikevax storage & handling²

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 instructions²

Thaw in the refrigerator

Thaw between 2°C to 8°C (36°F to 46°F) for 1 hour and 40 minutes for a single syringe/carton of 2 syringes or 2 hours and 40 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 40 minutes for a single syringe/carton of 2 syringes or 1 hour and 20 minutes for a carton of 10 syringes.

Storage after thawing²

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 or up to the expiration date printed on the carton, whichever comes first	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) Store between 2°C to 8°C (36°F to 46°F) until use

Spikevax (2025-2026 Formula) Dosing Regimen, Dose and Schedule²

Spikevax is administered intramuscularly as a single 0.25 mL or 0.5 mL dose.

Individuals 6 Months Through 23 Months of Age

Number of Previous Doses of Moderna COVID-19 Vaccine(s)	SPIKEVAX Dosing Regimen, Dose and Schedule
0^b	2 doses^c, 0.25 mL each Dose 1: month 0 Dose 2: month 1
1	Single dose, 0.25 mL One month after receipt of a previous dose of Moderna COVID-19 vaccine^a
≥2	Single dose, 0.25 mL ≥2 months after receipt of the last previous dose of Moderna COVID-19 vaccine^a

Number of Previous Doses of Moderna COVID-19 Vaccine(s)

SPIKEVAX Dosing Regimen, Dose and Schedule

0^b

2 doses^c, 0.25 mL each

Dose 1: month 0

Dose 2: month 1

Single dose, 0.25 mL

One month after receipt of a previous dose of Moderna COVID-19 vaccine^a

≥2

Single dose, 0.25 mL

≥2 months after receipt of the last previous dose of Moderna COVID-19 vaccine^a

^a Previous dose refers to a dose of any authorized Moderna COVID-19 Vaccine.

^b Not previously vaccinated with any COVID-19 vaccine.

^c Individuals turning from 23 months to 2 years of age during the vaccination series should receive both doses with SPIKEVAX.

Individuals 2 Years of Age and Older

Age	SPIKEVAX Dosing Regimen, Dose and Schedule
2 years through 11 years	Single dose, 0.25 mL
12 years and older	Single dose, 0.5 mL

If previously vaccinated with any COVID-19 vaccine, administer the dose ≥2 months after the last dose of COVID-19 vaccine

Administration instructions²

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).

SPIKEVAX is approved for use in individuals who are:

65 years of age and older, or
6 months 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 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 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 SPIKEVAX.
Limitations of Vaccine Effectiveness: SPIKEVAX may not protect all vaccine recipients.

Adverse Reactions

The most commonly reported (>10%) adverse reactions in participants 6 - 36 months of age: irritability/crying, pain at the injection site, sleepiness, loss of appetite, fever, erythema, swelling at the injection site, and axillary (or groin) swelling/tenderness.

The most commonly reported (>10%) adverse reactions in participants 37 months - 11 years of age were: pain at the injection site, fatigue, headache, myalgia, chills, nausea/vomiting, axillary (or groin) swelling/tenderness, fever, erythema, swelling at the injection site, and arthralgia.

The most commonly reported (≥10%) adverse reactions in participants 12 years and older were: pain at the injection site, headache, fatigue, myalgia, arthralgia, chills, and 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 https://vaers.hhs.gov.

Please click for Full Prescribing Information.

References

Centers for Disease Control. About COVID-19. Updated June 13, 2024. Accessed July 25, 2025. https://www.cdc.gov/covid/about/index.html
Spikevax. Prescribing Information. ModernaTX, Inc.
Food and Drug Administration. COVID-19 vaccines (2025-2026 Formula) for use in the United States beginning in fall 2025. Updated May 22, 2025. Accessed August 7, 2025. https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025

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