Moderna is seeking the United States Food and Drug Administration’s entire approval for their COVID-19 vaccine for those 18 and older, CNN reported Tuesday.
According to CNN, Moderna will resume sending in trial statistics “on a rolling basis” and request a priority review. A priority review expedites FDA’s review process to complete within six months in contrast to the usual 10 months.
“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,” Moderna CEO Stéphane Bancel said in a statement Tuesday. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”
The FDA authorized the Moderna vaccine for emergency use in December 2020.
