Moderna applies for full U.S. licensure of its COVID-19 vaccine following Phase 3 study success

With data from its Phase 3 COVE study showing a COVID-19 vaccine with 93 percent effectiveness, Moderna, Inc. has officially filed for a biologics license application (BLA) to the United States Food and Drug Administration (FDA) that would lead to full licensure.

It’s an important step, which would allow for the vaccine to be utilized without emergency use authorization (EUA) restrictions among anyone 18 years of age and older. With the COVID-19 pandemic ongoing, Moderna has also requested Priority Review designation, urging the continued speed that has surrounded the entire vaccine development process. If approved, the application would put Moderna on par with Pfizer-BioNTech, which saw their own COVID-19 vaccine fully approved earlier this week.

“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,” Stéphane Bancel, CEO of Moderna, said. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93 percent through six months after dose two. 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 currently available in the U.S. to those 18 years old and older, through an EUA first announced in December last year. A separate EUA is being considered for adolescents between ages 12 and 18. Since the first authorization, though, Moderna has released more than 300 million doses of the vaccine to the U.S. government, and determined its efficacy remains for at least six months following a second dose.

Moderna has been submitting sections of its BLA on a rolling basis since June.