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Authorization Documents

Fact Sheet for Providers

HCP Letter

Bivalent vaccine authorization

Moderna COVID-19 Vaccine, Bivalent is authorized for use in eligible individuals 6 months of age and older. For more information about the dosing schedule, please see the Vaccine Fact Sheet for Healthcare Providers and the Vaccine Fact Sheet for Recipients. Also, see our vaccine information PDFs for more details.

Dosing schedule updates

Individuals 6 months through 5 years of age will receive a 2-dose regimen if unvaccinated, and a single, age-appropriate dose if previously vaccinated with 1 or more doses of Moderna COVID-19 Vaccine. Individuals 6 years of age and older will receive a single, age-appropriate dose of Moderna COVID-19 Vaccine, Bivalent regardless of vaccination history. Individuals who are 65 years of age and older or who are immunocompromised may receive additional doses of Moderna COVID-19 Vaccine, Bivalent at the discretion of their healthcare provider.

Dosage amount updates

For individuals 6 months through 5 years of age who were previously vaccinated with Moderna COVID-19 Vaccine, a single dose is 0.25 mL or 0.2 mL depending on dose number. For individuals 6 months through 5 years of age who have not been vaccinated, 2 doses of 0.25 mL each are given 1 month apart. Individuals 6 through 11 years of age receive a single dose of 0.25 mL, and individuals 12 years of age and older receive a single dose of 0.5 mL.

The Moderna Call Center is available from 8am to 8pm EST, Monday through Friday, and can be reached at 1-866-MODERNA (1-866-663-3762).

Resources

Provider Quick Guide

Quickly find presentation, dosing and administration, storage, and reimbursement code details.

What to Expect Guide

Help answer questions for patients with additional resources for more information.

Important Safety Information

Contraindications

Do not administer the vaccine to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Moderna COVID-19 Vaccine or Moderna COVID-19 Vaccine, Bivalent.

Warnings and Precautions

  • Management of Acute Allergic Reactions: Appropriate medical treatment to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the 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 demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. The observed risk is highest in males 18 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, Bivalent.

  • Limitations of Vaccine Effectiveness: The Moderna COVID-19 Vaccine, Bivalent 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, and rash

Reporting Adverse Events and Vaccine Administration Errors The vaccination provider is responsible for mandatory reporting of the following 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 reports 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, Bivalent 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 accompanying Moderna COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) Fact Sheet for Healthcare Providers Administering Vaccine for more information.