Moderna has completed the rolling submission process for its Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the full licensure of the its Covid-19 vaccine for active immunisation 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 two.”
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 III 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 US Department of Health and Human Services.
In final analysis of Phase III 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 US 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 US government.
Moderna has also filed for an EUA for adolescents ages 12 and above with the FDA.
Image credit: Ian Hutchinson