The Biologics License Application for full licensure of the Moderna COVID-19 vaccine, mRNA-1273, for active immunization to prevent COVID-19 in individuals 18 years of age and older has been submitted to the Food and Drug Administration.
The mRNA vaccine is currently authorized for emergency use in individuals 18 years of age and older, and is administered intramuscularly in a 2-dose series (0.5mL each), given 28 days apart. The application includes data from the randomized, observer-blinded, placebo-controlled phase 3 COVE study (ClinicalTrials.gov Identifier: NCT04470427), which evaluated the efficacy, safety and immunogenicity of mRNA-1273 in 30,420 adults 18 years of age and older. Based on final analysis, the vaccine demonstrated 93% efficacy through 6 months after administration of the second dose.
The most commonly reported adverse reactions included injection site reactions (pain, swelling, erythema), fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, and fever. The Company has requested a Priority Review designation for the application.
“This [Biologics License Application] submission for our COVID-19 vaccine, which we began in June, is an important milestone in our battle against COVID-19 and for Moderna, as this is the first BLA submission in our company’s history,” said Stéphane Bancel, CEO of Moderna. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through 6 months after dose 2.”
The Company has also filed for an Emergency Use Authorization for the mRNA-1273 vaccine in adolescents 12 to 17 years of age based on data from its phase 2/3 TeenCOVE study (ClinicalTrials.gov Identifier: NCT04649151).
Moderna completes submission of Biologics License Application to the US Food and Drug Administration for its COVID-19 vaccine. News release. Moderna, Inc. Accessed August 25, 2021. https://www.businesswire.com/news/home/20210825005522/en/Moderna-Completes-Submission-of-Biologics-License-Application-to-the-U.S.-Food-and-Drug-Administration-for-its-COVID-19-Vaccine.