On Mar. 29, 2022, Moderna announced that it had received approval from the U.S. Food and Drug Administration (FDA) for its amendment to the emergency use authorization (EUA) to allow for a second booster dose of its COVID-19 vaccine (mRNA-1273) at the 50 ﾵg dose level in adults 50 years of age and older who have received an initial booster of any of the authorized or approved COVID-19 vaccines and adults 18 years of age and older with certain kinds of immunocompromise.

The application to amend the EUA was based on published data from Israel indicating the safety and effectiveness of administering a fourth dose of mRNA vaccine during the Omicron variant surge.

On January 31, 2022, 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. Previously, Moderna’s COVID-19 vaccine was 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 is 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 is authorized for emergency use in immunocompromised individuals 18 years of age with certain kinds of immunocompromise.

Moderna continues to collect and monitor real-world data on its COVID-19 vaccine. Real-world evidence continues to confirm the effectiveness and robust safety profile of the Moderna COVID-19 vaccine. Clinical trials are ongoing for Moderna’s Omicron-specific booster (mRNA-1273.529) and a bivalent Omicron-specific booster (mRNA-1273.214).

SPIKEVAX (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.