BOSTON (SHNS) – Moderna has completed the rolling process to submit its COVID-19 vaccine for full licensure, and requested “priority review designation” from the U.S. Food and Drug Administration (FDA), the company announced Tuesday.
The Cambridge-based company on June 1 announced the initiation of its biologics license application, or BLA, and the completed submission includes clinical data from a Phase 3 study that enrolled more than 30,000 participants in the U.S.
“This BLA 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 Moderna CEO Stéphane Bancel. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93 percent through six months after dose 2. 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 company has released more than 300 million doses of its vaccine since the FDA granted it emergency use authorization on Dec. 18, 2020. The Moderna vaccine is available in the U.S. for individuals 18 or older and the company has also filed with the FDA for an emergency use authorization for adolescents ages 12 and above.