AUTHORIZED USE

  • 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 6 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.

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.

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Overview for Vaccine Recipients

Primary series 1 month between shots

Initial Adult Vaccination

Looking for information on adult primary series vaccination?

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(COVID‑19 vaccine, mRNA)

Bivalent Booster Dose

The Moderna COVID-19 Vaccine, Bivalent has received emergency use authorization from the FDA to provide individuals 6 years of age and older a single booster dose administered at least 2 months after:

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine
mRNA in a fatty particle

What are the Moderna COVID‑19 Vaccines?

In five clinical trials, approximately 40,000 participants aged 6 months and older received at least one dose of Moderna COVID-19 Vaccine.

Learn more about the vaccine

What Do We Know About the Safety of the Vaccines?

In five clinical trials, approximately 40,000 participants aged 6 months and older received at least one dose of Moderna COVID‑19 Vaccine.

See what is known about vaccine safety

Frequently Asked
Questions

Do you have more questions about the vaccines? Take a look at our answers to the questions we hear most often.

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