Authorized Use
Moderna COVID-19 Vaccine (2024-2025 Formula) has not been approved or licensed by the FDA, but has been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months through 11 years of age.
The EUA for this product is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of the product, unless the declaration is terminated or the authorization is revoked sooner.
For more information on the EUA authorized uses of the vaccine, refer to the Fact Sheet for Healthcare Providers Administering Vaccine.
Why vaccinate?
Moderna COVID-19 vaccine (2024-2025 Formula) is designed to build immunity to the SARS-COV-2 virus in order to help prevent severe illness. Learn more about how it can help protect your patients.
Resources
Vaccine authorization
Moderna COVID-19 Vaccine (2024-2025 Formula) is authorized for use in eligible individuals 6 months through 11 years of age. For more information about the dosing schedule, please see the Vaccine Sheet for Healthcare Providers and the Vaccine Fact Sheet for Recipients
Dosing updates1
For individuals 6 months through 11 years of age, a single dose of Moderna COVID-19 Vaccine (2024-2025 Formula) is 0.25 mL regardless of age and number of vaccines previously received.
Age and number of previous doses of Moderna COVID-19 vaccine(s)* | Dose regimen and dose | Schedule‡ |
|---|---|---|
6 months through 4 years, Unvaccinated† | 2 doses,§ 0.25 mL each | Dose 1: month 0 Dose 2: month 1 |
6 months through 4 years, 1 previous dose | Single dose, 0.25 mL | 1 month after receipt of a previous dose of Moderna COVID-19 vaccine* |
6 months through 4 years, ≥2 previous dose(s) | Single dose, 0.25 mL | ≥2 months after receipt of a previous dose of Moderna COVID-19 vaccine* |
5 years through 11 years, Irrespective of COVID-19 vaccination status | Single dose, 0.25 mL | If previously vaccinated, ≥2 months after receipt of the last dose of COVID-19 vaccine¶# |
Dosing updates for individuals with certain kinds of immunocompromise1
Individuals 6 months through 11 years of age with certain kinds of immunocompromise‡ should complete at least a three-dose series with a COVID-19 vaccine, each dose one month apart.¶ At least 1 dose should be with a Moderna COVID-19 Vaccine (2024-2025 Formula).
Number of previous dose of Moderna COVID-19 vaccine* | Dose regimen | Schedule |
|---|---|---|
Unvaccinated | Complete the three-dose series with Moderna COVID-19 Vaccine (2024-2025 Formula). | At least 2 months following the last dose of a COVID-19 vaccine (2024-2025 Formula). |
1 or 2 previous dose | Complete the remaining dose(s) in the three-dose series with Moderna COVID-19 Vaccine (2024-2025 Formula). | At least 2 months following the last dose of a COVID-19 vaccine (2024-2025 Formula). |
≥3 previous dose(s) | Administer a single dose of Moderna COVID-19 Vaccine (2024-2025 Formula) at least two months following the last previous dose. | At least 2 months following the last dose of a COVID-19 vaccine (2024-2025 Formula). |
Additional doses of Moderna COVID-19 Vaccine (2024-2025 Formula) may be administered at the discretion of the healthcare provider, taking into consideration the individual’s clinical circumstances. The timing of the additional doses may be based on the individual’s clinical circumstances.
Dosage amount updates
For individuals 6 months through 11 years of age, a single dose of Moderna COVID-19 Vaccine (2024-2025 Formula) is 0.25 mL regardless of age and number of vaccines previously received.
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Contraindications
Do not administer Moderna COVID-19 Vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of Moderna COVID-19 Vaccine 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 Moderna COVID-19 Vaccine. Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
- Myocarditis and Pericarditis: Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 years through 24 years of age. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).
- 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 response to Moderna COVID-19 Vaccine.
- Limitations of Vaccine Effectiveness: The Moderna COVID-19 Vaccine may not protect all vaccine recipients.
Adverse Reactions
Solicited adverse reactions included:
- 6 months through 36 months of age: Injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness.
- 37 months of age and older: Injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia, nausea/vomiting
Reporting Adverse Events and Vaccine Administration Errors
Vaccination providers must report the listed events following administration of the Moderna COVID-19 Vaccine (2024-2025 Formula) to the Vaccine Adverse Event Reporting System (VAERS):
- vaccine administration errors whether or not associated with an adverse event
- serious adverse events (irrespective of attribution to vaccination)
- cases of myocarditis
- cases of pericarditis
- cases of Multisystem Inflammatory Syndrome (MIS)
- cases of COVID-19 that result in hospitalization or death
Complete and submit a report to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS, call 1-800-822-7967. Reports should include the words “Moderna COVID-19 Vaccine (2024-2025 Formula) EUA” in the description section of the report.
In addition, you can report side effects to ModernaTX, Inc. at 1-866-MODERNA (1-866-663-3762) or by visiting https://report.moderna.convergehealthsafety.com/
Please see the Moderna COVID-19 Vaccine (2024-2025 Formula) Fact Sheet for Healthcare Providers Administering Vaccine and Letter of Authorization for more information.
- Fact sheet for healthcare providers administering vaccine: Emergency use authorization of Moderna COVID-19 Vaccine (2024-2025 Formula), for individuals 6 months through 11 years of age. Moderna, Inc.; 2024.
*Previous dose(s) of Moderna COVID-19 vaccine(s) refers to Moderna COVID-19 Vaccine (Original monovalent) and Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). These vaccines are no longer authorized for use in the United States.
†Not previously vaccinated with any COVID-19 vaccine.
‡Individuals with certain kinds of immunocompromise 6 months through 11 years of age should complete at least a 3-dose series with a COVID-19 vaccine, each dose 1 month apart. At least 1 dose should be with a COVID-19 vaccine (2023-2024 formula). “Certain kinds of immunocompromise” refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
§Individuals turning from 4 years to 5 years of age during the vaccination series should receive both doses with Moderna COVID-19 Vaccine (2023-2024 Formula).
||COVID-19 vaccine refers to the monovalent COVID-19 vaccines that encode the spike protein of the original SARS-CoV-2 and the bivalent COVID-19 vaccines encoding the spike protein of original SARS-CoV-2 and of the Omicron variant lineages BA.4 and BA.5 that are no longer authorized for use in the United States.
¶COVID-19 vaccine, each dose of the 3-doses series given one month apart, refers to Moderna COVID-19 vaccines. Individuals turning from 11 to 12 years of age during the vaccination series may complete the series with doses of Moderna COVID-19 Vaccine (2023-2024 Formula).
#For immunocompromised individuals 6 months through 4 years of age, the last previous dose refers to the last dose of Moderna COVID-19 Vaccine (Original monovalent) or Moderna COVID-19 Vaccine, Bivalent which are no longer authorized for use in the U.S.
**For immunocompromised individuals 5 years through 11 years of age, the last previous dose refers to the last dose of a COVID-19 vaccine (original monovalent) or bivalent COVID-19 vaccine which are no longer authorized for use in the U.S.
††For immunocompromised individuals 6 months through 4 years of age, the last dose of a COVID-19 vaccine (2023-2024 formula) refers to a dose with Moderna COVID-19 Vaccine (2023-2024 Formula).
‡‡For immunocompromised individuals 5 years through 11 years of age, the last dose of a COVID-19 vaccine (2023-2024 formula) refers to a dose with Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) or Moderna COVID-19 Vaccine (2023-2024 Formula).
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