Moderna Finishes COVID-19 Vaccine BLA Submission
Moderna has completed submitting data for its COVID-19 vaccine’s biologics license application (BLA) and has requested an FDA Priority Review, which would require the FDA to make its decision within 60 days.
The vaccine received Fast Track status from the FDA in May, permitting the company to submit phase 3 data on a rolling basis. The company began the BLA filing process in early June.
The Moderna vaccine is currently cleared for adults over 18 years old under an Emergency Use Authorization (EUA) granted in December. The company filed for a revision to that EUA to cover adolescents ages 12 to 17 in June and is now awaiting the FDA’s decision.