Moderna Completes BLA Submission for COVID-19 Vaccine

Moderna said it has completed submitting data for its COVID-19 vaccine’s rolling 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.

Moderna has said its vaccine remains 93 percent effective six months after receiving a second shot, based on a final analysis of the late-stage data (DID, Aug. 6). But the Cambridge, Mass., drugmaker is also developing booster shots to protect against new variants, including the Delta strain which is now the dominant version of the virus. ― Jason Scott