{"id":531335,"date":"2021-08-25T09:47:00","date_gmt":"2021-08-25T13:47:00","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/moderna-completes-submission-of-biologics-license-application-to-the-u-s-food-and-drug-administration-for-its-covid-19-vaccine\/"},"modified":"2021-08-25T09:47:00","modified_gmt":"2021-08-25T13:47:00","slug":"moderna-completes-submission-of-biologics-license-application-to-the-u-s-food-and-drug-administration-for-its-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/moderna-completes-submission-of-biologics-license-application-to-the-u-s-food-and-drug-administration-for-its-covid-19-vaccine\/","title":{"rendered":"Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine"},"content":{"rendered":"

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Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine<\/b><\/p>\n

Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; efficacy remains durable through six months after second dose<\/i><\/p>\n

CAMBRIDGE, Mass.–(BUSINESS WIRE<\/a>)–Moderna, Inc.<\/a> (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.\n<\/p>\n

\n\u201cThis 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\u2019s history,\u201d said St\u00e9phane Bancel, Chief Executive Officer of Moderna. \u201cWe 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.\u201d\n<\/p>\n

\nThe FDA Fast Track designation received<\/a> on May 12, 2020 has permitted Moderna to submit sections of the BLA on a rolling basis and Moderna announced<\/a> the initiation of the BLA submission on June 1, 2021. The completed submission includes clinical data<\/a> 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.\n<\/p>\n

\nThe Moderna COVID-19 vaccine is currently available<\/a> 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.\n<\/p>\n

\nModerna has also filed<\/a> for an Emergency Use Authorization (EUA) for adolescents ages 12 and above with the U.S. FDA.\n<\/p>\n

About the Moderna COVID-19 Vaccine<\/b><\/p>\n

\nThe Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO).\n<\/p>\n

\nThe Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) is supporting the continued research and development of the Company\u2019s COVID-19 vaccine development efforts with federal funding under contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to purchase supply of mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.\n<\/p>\n

About Moderna<\/b><\/p>\n

\nIn 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna\u2019s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.\n<\/p>\n

\nModerna\u2019s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 23 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science<\/i> for the past six years. To learn more, visit www.modernatx.com<\/a>.\n<\/p>\n

AUTHORIZED USE IN THE U.S.<\/b><\/p>\n

\nModerna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.\n<\/p>\n

IMPORTANT SAFETY INFORMATION<\/b><\/p>\n