Spikevax storage & handling1
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 2 or 10 pre-filled syringes, with each syringe containing a single dose of either 0.5 mL or 0.25 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 and 40 minutes for a single syringe/carton of 2 syringes or 2 hours and 40 minutes for a carton of 10 syringes.
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 thawing1
Refrigerated storage | Room temperature 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 |
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 Schedule1
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 |
|---|---|
0b | 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 vaccinea |
≥2 | Single dose, 0.25 mL ≥2 months after receipt of the last previous dose of Moderna COVID‑19 vaccinea |
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 instructions1
Do not shake. Do not dilute the vaccine.
1
Remove 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.
2
Attach the needle
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
3
Administer
Administer the entire dose intramuscularly.
4
Discard
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.
Reference
- Spikevax. Prescribing Information. ModernaTX, Inc.