Moderna Completes Submission of its Biologics License Application to FDA for COVID-19 Vaccine

Aug 25, 2021 By MarketDepth

Biotechnology Headlines Healthcare


“We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2.”

Stéphane Bancel, Chief Executive Officer of Moderna

Moderna, Inc. (NASDAQ: MRNA) reported completion of the rolling submission process for its Biologics License Application to the United States Food and Drug Administration for full license of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years or older.  Moderna has requested Priority Review designation.  “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,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2. I want to thank the people who participated in our clinical studies, as well as the staff at clinical trial sites who have been on the front lines of the fight against the virus. I would again like to thank our partners at NIH, NIAID and BARDA who have helped us advance the clinical development of our mRNA COVID-19 vaccine. I would also like to thank the U.S. FDA for their hard work and guidance through the BLA submission process and the entire Moderna team for their relentlessness in pursuing our mission of delivering on the promise of mRNA science.”

Results Released

The finalized submission has included clinical data from its Phase 3 COVE study of the Modern Covid-19 vaccine that held over 30,000 participants within the U.S. and was conducted in collaboration with the National Institute of Allergy and Infectious Diseases, Biomedical Advanced Research Development Authority, National Institutes of Health and the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

Emergency Use Designation

Currently, the Moderna COVID-19 vaccine is available in the U.S. for individuals 18 years or older under an Emergency Use Authorization granted by the FDA on December 18th, 2020.  Moderna has released over 300 million doses of the vaccine to the U.S. government.