By IDSE News Staff
Moderna has completed the Biologics License Application (BLA) to the FDA for the full licensure of its COVID-19 vaccine in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested priority review designation.
The FDA fast-tracked designation received on May 12, 2020, has 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 messenger RNA (mRNA) vaccine, which enrolled more than 30,000 participants in the United States and was conducted in collaboration with several federal agencies.
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.
The Moderna COVID-19 vaccine is currently available in the United States for individuals 18 years of age and older under an emergency use authorization (EUA) granted by the FDA on Dec. 18, 2020. Since then, Moderna has released more than 300 million doses of the vaccine to the U.S. government.
In addition, Moderna has filed for an EUA for adolescents ages 12 years and older.
“We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2,” said Stéphane Bancel, the CEO of Moderna. “I want to thank the people who participated in our clinical studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus.”
The Moderna COVID-19 vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the spike protein, which permits viral entry into cells.
