Bivalent Booster Dear HCP Letter
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  • Emergency uses of the vaccine have not been approved or licensed by the FDA, but have been authorized by the FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19). The Moderna COVID-19 Vaccine is authorized in individuals 6 months of age and older as a primary series. The Moderna COVID-19 Vaccine, Bivalent is authorized as a booster dose in individuals 18 years of age and older.

  • The EUA for these products 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 Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information.

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Moderna COVID-19 Vaccine, Bivalent is now authorized

The updated booster from Moderna is designed to help protect against multiple COVID-19 variants in a single shot.

What is a Bivalent Vaccine?

Bivalent vaccines are designed to protect against 2 strains of a virus providing greater protection against variants.

Why should patients get a Bivalent Vaccine?

A bivalent is recommended because it's the only type of vaccine that can protect against the most dominant Omicron strains of COVID-19 in the US.
With the rise of more contagious variants, people need greater protection, even with prior vaccination or immunity from COVID-19 infection.

Download the Bivalent Booster Guide

Vaccine Overview for
Vaccination Providers

Adult Primary Series Vaccination

Looking for information on adult primary series vaccination?

Visit HCP site for spikevax
(COVID‑19 vaccine, mRNA)
Primary series 1 month between shots

Third Dose for Immunocompromised Individuals

A third primary series dose of the Moderna COVID‑19 Vaccine at least 1 month following the second dose is authorized for administration to individuals at least 6 months of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

A second booster dose at least 4 months after receipt of a first booster dose of any authorized or approved COVID‑19 vaccine is also available for individuals 18 years of age and older with certain kinds of immunocompromise.

Learn more about vaccination for immunocompromised individuals
COVID-19 Moderna Vaccine packaging, both 11 and 15 dose.

About the Moderna COVID‑19 Vaccine

The vaccine was developed by Moderna, a biotechnology company that has focused on mRNA technology since 2010, and is currently being studied in a large Phase 3 trial.

Learn more about the Moderna COVID‑19 Vaccine

Storage and Handling

The Moderna COVID‑19 Vaccine multiple‑dose vials are stored frozen between -50°C to -15°C (-58°F to 5°F). During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Vials can be stored refrigerated between 2°C to 8°C (36°F to 46°F) for up to 30 days prior to first use.

How to properly store and handle
2.5 mL vial for primary series doses only

2.5 mL vial for
primary series doses (age 6 months-5 years)

5.5 mL vial for primary series doses or booster doses

5.5 mL vial for
booster dose (age 18
and older) or primary series doses (age 12 and older)

2.5 mL vial for booster dose only

2.5 mL vial for booster dose (age 18 and older) or primary series doses (age 6-11 years)

Dosing and Administration

The Moderna COVID‑19 Vaccine is administered as a primary series by intramuscular injection of two doses (0.5 mL each) 1 month apart to individuals 6 years of age or older or two doses (0.25 mL each) 1 month apart to individuals 6 months-5 years of age.

A third primary series dose of the Moderna COVID‑19 Vaccine (0.5 mL or 0.25 mL, depending on age) at least 1 month following the second dose is authorized for administration to individuals at least 6 months of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Booster Dosing and Administration

The booster dose of Moderna COVID-19 Vaccine may be administered from two different vial presentations. When using the 5.5 mL multiple-dose vial with a red cap and a label with a blue border, the dose is 0.25 mL. When using the booster-only multiple-dose vial with a dark blue cap and a label with a purple border, the booster dose is 0.5 mL.

A first Moderna COVID‑19 Vaccine booster dose may be administered intramuscularly at least 5 months after completing a primary series of the Moderna COVID‑19 Vaccine or spikevax (COVID-19 Vaccine, mRNA) to individuals 18 years of age or older.

A first booster dose of the Moderna COVID‑19 Vaccine may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID‑19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination.

A second booster dose of the Moderna COVID‑19 Vaccine may be administered to individuals 50 years of age and older at least 4 months after receipt of a first booster dose of any authorized or approved COVID‑19 vaccine.

A second booster dose of the Moderna COVID‑19 Vaccine may be administered at least 4 months after receipt of a first booster dose of any authorized or approved COVID‑19 vaccine to individuals 18 years of age and older with certain kinds of immunocompromise.

Get full dosing details

Clinical Trial Data

The Moderna COVID‑19 Vaccine is being evaluated in an ongoing Phase 3 randomized, placebo‑controlled, observer‑blind clinical trial conducted in the United States.

See clinical trial data

Frequently Asked Questions

Take a look at our answers to the questions we hear most often from healthcare professionals.

How do I order Moderna COVID-19 Vaccine?
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IMPORTANT SAFETY INFORMATION

Contraindications

Do not administer the vaccines 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 vaccines. 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 7 days following the second dose. 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 the vaccines.
  • Limitations of Vaccine Effectiveness: The vaccines may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions reported in clinical trials for individuals 6 years of age and older following administration of the Moderna COVID-19 Vaccine include pain at the injection site, fatigue, headache, myalgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, erythema at the injection site, swelling at the injection site, and arthralgia.

Adverse reactions in children 6 months through 5 years of age following administration of Moderna COVID-19 Vaccine include pain at the injection site, irritability/crying, fatigue, sleepiness, loss of appetite, headache, fever, myalgia, chills, nausea/vomiting, axillary (or groin) swelling/tenderness, arthralgia, erythema at the injection site, and swelling at the injection site.

Anaphylaxis and other severe allergic reactions, myocarditis, pericarditis, and syncope have been reported following administration of the Moderna COVID-19 Vaccine during mass vaccination outside of clinical trials.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the vaccines.

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 EUA” or “Moderna COVID‑19 Vaccine, Bivalent EUA” in the description section of the report.

Report to ModernaTX, Inc. by calling 1‑866‑MODERNA (1‑866‑663‑3762) or provide a copy of the VAERS form by faxing 1‑866‑599‑1342 or emailing .

Please see the Vaccine Fact Sheets for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information for: