Moderna Files BLA with FDA for its COVID-19 Vaccine
The company announced it filed its submission to prevent COVID-19 in individuals 18 years of age and older.
Moderna announced it has submitted its formal Biologics License Application (BLA) with the Food and Drug Administration (FDA) for its COVID-19 Vaccine, mRNA-1273.
“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,” Moderna CEO Stéphane Bancel, said. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through 6 months after dose 2.
The filing come from data collected in the company’s phase 3 COVE study. Peer-reviewed data from the COVE Study Group confirmed that mRNA-1273 has shown 93% efficacy in COVID-19 among adult trial participants at high risk for SARS-CoV-2 infection or its complications.
The COVE Study Group reported results from the randomized, observer-blind, placebo-controlled trial underway in 99 centers throughout the US. The study included 30,420 volunteers who had been randomly enrolled 1:1 to either intramuscular two-dose 100mcg vaccine or placebo (n = 15,210 each)
Full licensure of the vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older.
The FDA has not set a timeline yet for review of the Moderna vaccine.