{"id":16861,"date":"2021-08-25T09:05:18","date_gmt":"2021-08-25T16:05:18","guid":{"rendered":"https:\/\/marketdepth.com\/?p=16861"},"modified":"2021-08-25T09:05:20","modified_gmt":"2021-08-25T16:05:20","slug":"moderna-completes-submission-of-its-biologics-license-application-to-fda-for-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/marketdepth.com\/moderna-completes-submission-of-its-biologics-license-application-to-fda-for-covid-19-vaccine\/","title":{"rendered":"Moderna Completes Submission of its Biologics License Application to FDA for COVID-19 Vaccine"},"content":{"rendered":"\n<blockquote class=\"wp-block-quote is-style-large\"><p>\u201cWe are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2.&#8221;<\/p><cite>St\u00e9phane Bancel, Chief Executive Officer of Moderna<\/cite><\/blockquote>\n\n\n\n<p>Moderna, Inc. (NASDAQ: MRNA) <a href=\"https:\/\/investors.modernatx.com\/news-releases\/news-release-details\/moderna-completes-submission-biologics-license-application-us\">reported<\/a> 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.\u00a0 Moderna has requested Priority Review designation.\u00a0 \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\u00a0Moderna, as this is the first BLA submission in our company\u2019s history,\u201d said\u00a0St\u00e9phane Bancel, Chief Executive Officer of\u00a0Moderna. \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\u00a0who\u00a0participated in our clinical studies, as well as the staff at clinical trial sites\u00a0who\u00a0have been on the front lines of the fight against the virus. I would again like to thank our partners at\u00a0NIH, NIAID and BARDA\u00a0who\u00a0have helped us advance the clinical development of our mRNA COVID-19 vaccine. I would also like to thank the\u00a0U.S.\u00a0FDA for their hard work and guidance through the BLA submission process and the entire\u00a0Moderna\u00a0team for their relentlessness in pursuing our mission of delivering on the promise of mRNA science.\u201d<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">Results Released<\/h5>\n\n\n\n<p>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.<\/p>\n\n\n\n<h5 class=\"wp-block-heading\">Emergency Use Designation<\/h5>\n\n\n\n<p>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 18<sup>th<\/sup>, 2020.\u00a0 Moderna has released over 300 million doses of the vaccine to the U.S. government.<\/p>\n","protected":false},"excerpt":{"rendered":"\u201cWe are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2.&#8221; St\u00e9phane 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&#8230; <a class=\"view-article\" href=\"https:\/\/marketdepth.com\/moderna-completes-submission-of-its-biologics-license-application-to-fda-for-covid-19-vaccine\/\">View Article<\/a>","protected":false},"author":3,"featured_media":16862,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":0,"footnotes":""},"categories":[9,17,8],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Moderna Completes Submission of its Biologics License Application to FDA for COVID-19 Vaccine - MarketDepth<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/marketdepth.com\/moderna-completes-submission-of-its-biologics-license-application-to-fda-for-covid-19-vaccine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Moderna Completes Submission of its Biologics License Application to FDA for COVID-19 Vaccine - MarketDepth\" \/>\n<meta property=\"og:description\" content=\"\u201cWe are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2.&#8221; St\u00e9phane Bancel, Chief Executive Officer of Moderna Moderna, Inc. 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