EUA Fact Sheet and full PI for
Vaccination Providers,
Primary Series + Booster EUA Fact Sheet and full PI for
Vaccination Providers,
Booster Dose Only Presentation Look Up Vaccine
Expiration Dates For
Vaccination Providers

  • For certain indications, the Moderna COVID‑19 Vaccine has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by the FDA, under an Emergency Use Authorization (EUA), to prevent Coronavirus Disease 2019 (COVID‑19) in individuals 18 years of age and older. There are two presentations/formulations of the Moderna COVID‑19 Vaccine authorized for use.

  • The EUA for the Moderna COVID‑19 Vaccine 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.

See below for Moderna COVID‑19 Vaccine authorized uses.

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Vaccine Overview for
Vaccination Providers

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
Booster doses at least 5 months after completing primary series and at least 4 months after first booster dose

Booster Dose

The booster dose of the Moderna COVID‑19 Vaccine may be administered from two different vial presentations. When using the 5.5 or 7.5 mL multiple-dose vial with a red cap and a label with a light 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 to individuals 18 years of age and older 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.

See clinical trial data from booster dose study

Third Dose for Immunocompromised Individuals

A third primary series dose of the Moderna COVID‑19 Vaccine (0.5 mL) at least 1 month following the second dose is authorized for administration to individuals at least 18 years 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 & 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
5.5 mL vial for primary series doses or booster doses

5.5 mL vial for primary series doses or booster doses

2.5 mL vial for booster dose only

2.5 mL vial for booster dose only

Dosing & 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 18 years of age or older.

A third primary series dose of the Moderna COVID‑19 Vaccine (0.5 mL) at least 1 month following the second dose is authorized for administration to individuals at least 18 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

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 light 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?
View all FAQs

Authorized Use

Moderna COVID‑19 Vaccine is authorized to provide:

  • a two-dose primary series to individuals 18 years of age and older;

  • a third primary series dose to individuals 18 years of age and older with certain kinds of immunocompromise;

  • a first booster dose to individuals 18 years of age and older who have completed a primary series with Moderna COVID‑19 Vaccine or SPIKEVAX (COVID‑19 Vaccine, mRNA);

  • a first booster dose to individuals 18 years of age and older who have completed 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 to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID‑19 vaccine; and

  • a second booster dose to individuals 18 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID‑19 vaccine.

FDA has approved SPIKEVAX (COVID‑19 Vaccine, mRNA) as a two-dose primary series one month apart for prevention of COVID‑19 in individuals ages 18 years of age and older.

Important Safety Information

Contraindications

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

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 Moderna COVID‑19 Vaccine. Monitor Moderna COVID‑19 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 higher among males under 40 years of age than among females and older males. 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 Moderna COVID‑19 Vaccine.
  • Limitations of Vaccine Effectiveness: The Moderna COVID‑19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Adverse reactions reported in clinical trials following administration of the Moderna COVID‑19 Vaccine include pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, erythema at the injection site, and rash.

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

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Moderna COVID‑19 Vaccine.

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 Multisystem Inflammatory Syndrome (MIS) in adults
  • 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” 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

For information regarding SPIKEVAX, please see the SPIKEVAX Full Prescribing Information.