Moderna Seeks Full Licensure for Covid Vaccine

Moderna has completed a rolling BLA and requested a priority review for the submission seeking full licensure of its Covid-19 vaccine for use in individuals 18 years of age and older. The vaccine was granted an emergency use authorization by FDA 12/18/2020.

The completed submission includes clinical data from the Phase 3 COVE study, which enrolled more than 30,000 participants in the U.S. and was conducted in collaboration with the National Institutes of Health. “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,” the company says. “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.”