Moderna's COVID-19 Vaccine Gains FDA Authorization

The Moderna COVID‑19 Vaccine (mRNA-1273) was authorized on December 18, 2020, for use under an Emergency Use Authorization (EUA) for active immunization in individuals 18 years of age and older to prevent COVID‑19 that is caused by the SARS‑CoV‑2 coronavirus.

Moderna's COVID‑19 Vaccine is investigational and not approved by the FDA.

Stéphane Bancel, CEO of Moderna, stated, “We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization while advancing clinical development with a Phase 1, Phase 2, and pivotal Phase 3 study of 30,000 participants. We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease.”