On Aug. 25, 2021, Moderna announced it had completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (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 BLA submission, Moderna has requested Priority Review designation.

The FDA Fast Track designation received on May 12, 2020 permitted Moderna to submit sections of the BLA on a rolling basis and Moderna announced the initiation of the BLA submission on June 1, 2021. The completed submission includes clinical data from the Phase 3 COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the U.S. and was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services.

In final analysis of Phase 3 COVE study data, the Moderna COVID-19 vaccine showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose. In the COVE study, reported adverse reactions included pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.