On Mar. 17, 2022, Moderna announced that it had submitted a request to the U.S. Food and Drug Administration (FDA) for an amendment to the emergency use authorization (EUA) to allow for a fourth dose of its COVID-19 vaccine (mRNA-1273) in adults 18 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines.

The U.S. FDA approved the Biologics License Application (BLA) for SPIKEVAX (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 18 years of age and older on January 31, 2022. Moderna’s COVID-19 vaccine was previously available under EUA in the U.S. from December 18, 2020.

A booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level was authorized for emergency use in the U.S. under EUA for adults 18 years and older. A third dose of the Moderna COVID-19 vaccine at the 100 µg dose level was authorized for emergency use in immunocompromised individuals 18 years of age or older in the United States who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.