Moderna submits application to the FDA for full approval of their COVID-19 vaccine

Aug. 27, 2021

Moderna has 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.

Moderna began the submission process in June, which applies specifically to use of the vaccine in people 18 years of age and older.

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), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services.

In the final analysis of Phase 3 COVE study data, the Moderna COVID-19 vaccine showed 93% efficacy, which remained durable through six months after administration of the second dose.

Moderna has also filed for an emergency use authorization (EUA) for the use of its vaccine in adolescents ages 12 and above with the U.S. FDA.

Moderna release

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