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.

Who Is Moderna?

Moderna is a biotechnology company founded in 2010. At Moderna, we are pioneering a class of medicines based on messenger RNA (mRNA).

Every cell in your body uses mRNA, which gives instructions to make the proteins your body needs. This affects many aspects of your biology, including health and disease.

We are currently developing mRNA-based vaccines and medicines for a variety of conditions, including COVID‑19.

Founded in 2010
Emergency Use Authorization

Why Is the Vaccine Available Now?

Moderna COVID-19 Vaccine, Bivalent and certain authorized uses of the Moderna COVID-19 Vaccine in children and teens have not yet undergone the same type of review as an FDA‑approved or cleared product. FDA may issue an "Emergency Use Authorization" when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of the scientific evidence available showing that the product may be effective to prevent COVID‑19 during the COVID‑19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product.

mRNA in a fatty particle

What Do the Vaccines Do
in the Body?

The Moderna vaccines use mRNA to provide a blueprint for your cells to build your body’s defense against SARS‑CoV‑2, the virus that causes COVID‑19. The Moderna COVID‑19 Vaccines do not contain SARS‑CoV‑2, or any virus—just the blueprint to help fight against it. The Moderna vaccines may not protect everyone.