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.
When Are My Patients Eligible for a Booster?
A single Moderna COVID‑19 Vaccine booster dose (0.25 mL) 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 single booster dose of the Moderna COVID‑19 Vaccine (0.25 mL) 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.
The most current information on booster dose eligibility criteria is available from the US Centers for Disease Control and Prevention (CDC).
Where Is the Vaccine Available?
Moderna has been contracted by the United States Government to provide the Moderna COVID‑19 Vaccine under the EUA. For details on vaccine distribution, including where and how much vaccine is supplied, you should contact your state, territorial, tribal or local health department.
How Can My Practice Get the Vaccine?
For details on vaccine distribution, including getting vaccine for your practice, you should contact your state, territorial, tribal or local health department. More information on providing COVID‑19 vaccination at your practice is available from the US Centers for Disease Control and Prevention.