Spikevax is the only COVID‑19 vaccine approved for high-risk children aged 6 months to <5 years2
Talk to the parents of your pediatric patients about Spikevax.
The virus that causes COVID‑19 is constantly changing.3 So we've updated our vaccine.1
Spikevax comes frozen in a single dose of 0.25 mL and 0.5 mL.1
Keep frozen up to the expiration date or thawed in the refrigerator for up to 60 days.1
Protect them with Spikevax.
Spikevax is approved for use in patients aged:
- 6 months to 64 years
with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID‑19 - 65 years and older
See a full list of underlying conditions at https://www.cdc.gov/covid/hcp/clinical-care/underlying-conditions.html
Experts from these leading medical associations have provided COVID‑19 vaccination recommendations for eligible children aged 6 months and older2,4-6:
The CDC and ACIP recommend a 2025-2026 COVID‑19 vaccine for people aged 6 months and older based on individual decision making.
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Please contact us if you have any questions about ordering and product availability or to arrange an appointment with our field staff.
Ordering Spikevax is easy
Get your vaccine supply for the season. We offer multiple ways to order.
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
- Spikevax Prescribing Information. ModernaTX, Inc.
- Centers for Disease Control and Prevention. 2025-2026 COVID-19 vaccination guidance. Updated November 4, 2025. Accessed April 29, 2026. https://www.cdc.gov/covid/hcp/vaccine-considerations/routine-guidance.html
- Centers for Disease Control and Prevention. About COVID-19. Updated June 13, 2024. Accessed July 25, 2025. https://www.cdc.gov/covid/about/index.html
- Committee on Infectious Diseases. Recommendations for COVID-19 vaccines in infants, children, and adolescents: policy statement. Pediatrics. 2025;156(5):e2025073924. doi:10.1542/peds.2025-073924
- American Academy of Family Physicians. Birth through age 18 immunization schedule. Published March 1, 2026. Accessed April 29, 2026. https://www.aafp.org/family-physician/patient-care/prevention-wellness/immunizations-vaccines/immunization-schedules/birth-through-age-18-immunization-schedule.html
- US Department of Health and Human Services. ACIP recommends COVID-19 immunization based on individual decision-making. Published September 19, 2025. Accessed April 29, 2026. https://www.hhs.gov/press-room/acip-recommends-covid19-vaccination-individual-decision-making.html
