• 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.

Authorized Uses

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.