After months of operating under the ongoing pandemic, Moderna, Inc. announced this week that it has initiated the Biologics License Application (BLA) process with the United States Food and Drug Administration (FDA) to gain full approval of its mRNA COVID-19 vaccine.
This approval would make the vaccine fully licensed for use on adults, carrying it beyond the emergency use authorization under which it currently operates. As part of this effort, Moderna will continually submit data supporting the application on a rolling basis over the coming weeks. Once complete, the FDA will notify Moderna when the vaccine has been accepted for review.
“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” Stéphane Bancel, CEO of Moderna, said. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
So far, the Moderna vaccine has produced an efficacy rate of approximately 94 percent against the SARS-CoV-2 virus that causes COVID-19. It has operated under an EUA in the United States since Dec. 18, 2020. In that time, more than 124 million doses of it have been administered, according to the Centers for Disease Control and Prevention (CDC).
The vaccine was co-developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center, with funding help from the Coalition for Epidemic Preparedness Innovations and the Biomedical Advanced Research and Development Authority.