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Moderna shares surged 4% in morning trading on completing submission of BLA to U.S. Food and Drug Administration for its COVID-19 Vaccine.

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the full licensure of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older. As part of the completed BLA submission, 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.”

The FDA Fast Track designation received on May 12, 2020 has permitted Moderna to submit sections of the BLA on a rolling basis and Moderna announced the initiation of the BLA submission on June 1, 2021. The completed submission includes clinical data from the Phase 3 COVE study of the Moderna COVID-19 vaccine, which enrolled more than 30,000 participants in the U.S. and was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. In final analysis of Phase 3 COVE study data, the Moderna COVID-19 vaccine showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose. In the COVE study, reported adverse reactions included pain at the injection site, fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting, axillary swelling/tenderness, fever, swelling at the injection site, and erythema at the injection site.

The Moderna COVID-19 vaccine is currently available in the U.S. for individuals 18 years of age and older under an Emergency Use Authorization (EUA) granted by the FDA on December 18, 2020. Since then, Moderna has released more than 300 million doses of the vaccine to the U.S. government.

Moderna has also filed for an Emergency Use Authorization (EUA) for adolescents ages 12 and above with the U.S. FDA.