Posted by Michael Wonder on 26 Aug 2021
Moderna completes submission of biologics license application to the US FDA for its COVID-19 vaccine
25 August 2021 - Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; efficacy remains durable through six months after second dose
Moderna today announced it has completed the rolling submission process for its biologics license application to the U.S. FDA for the full licensure of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older.
As part of the completed submission, Moderna has requested priority review designation.
