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Prescribing information for Spikevax (COVID-19 Vaccine, mRNA) 2025-2026 Formula
Product Information Guide
A quick overview of Spikevax including information about storage, dosing and administration, and billing.
Product & Reimbursement Reference Sheet
A quick overview of important information on administering Spikevax.
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.
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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