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 ModernaPV@modernatx.com.

Please see the

• Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information (Booster Dose Only Presentation)
• Moderna COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccine Providers) and Full Prescribing Information (Primary Series and Booster Dose Presentation)

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