{"id":137120,"date":"2020-12-19T04:02:00","date_gmt":"2020-12-19T01:02:00","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/fda-grants-moderna-authorization-for-a-second-covid-19-vaccine\/"},"modified":"2020-12-19T04:02:00","modified_gmt":"2020-12-19T01:02:00","slug":"fda-grants-moderna-authorization-for-a-second-covid-19-vaccine","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/fda-grants-moderna-authorization-for-a-second-covid-19-vaccine\/","title":{"rendered":"#\n  FDA grants Moderna authorization for a second COVID-19 vaccine"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_84 counter-hierarchy ez-toc-counter ez-toc-custom ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a2400d1e5e81\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #dd3333;color:#dd3333\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #dd3333;color:#dd3333\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a2400d1e5e81\" checked aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/buradabiliyorum.com\/en\/fda-grants-moderna-authorization-for-a-second-covid-19-vaccine\/#Moderna_receives_its_first_ever_FDA_approval_or_authorization_set_to_join_Pfizer_in_distributing_vaccine_in_US\" >Moderna receives its first ever FDA approval or authorization, set to join Pfizer in distributing vaccine in U.S.<\/a><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><ul class='ez-toc-list-level-4' ><li class='ez-toc-heading-level-4'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/buradabiliyorum.com\/en\/fda-grants-moderna-authorization-for-a-second-covid-19-vaccine\/#Jaimy_Lee\" >Jaimy Lee<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<p>&#8220;<strong>#<br \/>\n  FDA grants Moderna authorization for a second COVID-19 vaccine<br \/>\n<\/strong>&#8221;<\/p>\n<h2 class=\"article__subhead\" itemprop=\"alternativeHeadline\"><span class=\"ez-toc-section\" id=\"Moderna_receives_its_first_ever_FDA_approval_or_authorization_set_to_join_Pfizer_in_distributing_vaccine_in_US\"><\/span>\n  Moderna receives its first ever FDA approval or authorization, set to join Pfizer in distributing vaccine in U.S.<br \/>\n<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><\/p>\n<div class=\"column column--full article__content\">\n<div id=\"js-article__body\" class=\"article__body article-wrap at16-col16 barrons-article-wrap\" itemprop=\"articleBody\" data-sbid=\"WP-MKTW-0000105023\">\n<div class=\"barrons-article-ad-wrapper\">\n<div data-track=\"barrons-article-ad-wrap\" class=\"barrons-article-ad sticky_item\">\n<div class=\"barrons-main-article-ad-target sticky_target body_ad\" aria-hidden=\"true\"><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<p>       One week after authorizing the first COVID-19 vaccine for Americans, the Food and Drug Administration granted a second emergency authorization Friday, to Moderna Inc.\u2019s COVID-19 vaccine.<\/p>\n<p> Moderna said it would begin delivering the vaccine to the U.S. government im<a href=\"https:\/\/buradabiliyorum.com\/en\/category\/social-mediaa\/\" data-internallinksmanager029f6b8e52c=\"1\" title=\"Social Media\" target=\"_blank\" rel=\"noopener\">media<\/a>tely, and expects to deliver 20 million doses by the end of December and up to 125 million through the first quarter of 2021. The vaccine is expected to begin reaching patients as early as Monday.<\/p>\n<div class=\"paywall\">\n       \u201cThrough the FDA\u2019s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited time frame while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA,\u201d FDA Commissioner Stephen Hahn said in a Friday statement. \u201cThese standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency\u2019s career staff.\u201d <\/p>\n<p>The regulator\u2019s announcement follows support from an independent advisory committee, which on Thursday voted 20-0, with one abstention, that the vaccine\u2019s benefits outweigh the risks. The vote was not binding but the FDA often follows the advice of the committee.<\/p>\n<p>A similar process took place last week, when the same committee voted 17-4, with one abstention, in favor of BioNTech SE<br \/>\n        BNTX,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/214419716\/composite\" class=\"negative\">-2.06%<\/bg-quote><br \/>\n       and Pfizer Inc.\u2019s<br \/>\n        PFE,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/202877789\/composite\" class=\"negative\">-0.92%<\/bg-quote><br \/>\n       COVID-19 vaccine. The FDA authorized the vaccine a day later, and it is already being administered to some health care workers and nursing-home residents in the U.S. <\/p>\n<p>Moderna\u2019s<br \/>\n        MRNA,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/205619834\/composite\" class=\"negative\">-2.62%<\/bg-quote><br \/>\n       stock increased more than 2% in after-hours trading following the announcement. <\/p>\n<p>Moderna\u2019s vaccine is authorized for use in adults who are 18 years old and older. That is a slightly different indication than the one received by BioNTech and Pfizer, which is authorized for people who are at least 16 years old; however, allowing the vaccine to be administered to teens who fall in that age bracket was one reason four committee members voted \u201cno\u201d on whether the benefits outweighed the risks during that advisory meeting. <\/p>\n<p>\u201cAll-in-all, both AdComs felt more like a formality than a harsh interrogation of the data (although we believe the FDA has done a full review of both vaccines),\u201d Bank of America analysts told investors this week. \u201cRather,\u00a0the\u00a0panel\u00a0<a href=\"https:\/\/buradabiliyorum.com\/en\/category\/download-scripts-themes-apps\/\" data-internallinksmanager029f6b8e52c=\"9\" title=\"Download Scripts &amp; Themes &amp; Apps\" target=\"_blank\" rel=\"noopener\">app<\/a>ears to\u00a0have\u00a0been more intended to\u00a0provide an opportunity for FDA and its experts to [publicly] review the results and justification for approval.\u201d<\/p>\n<p>The U.S. government has purchased 200 million doses of the Moderna vaccine, which would vaccinate 100 million people in the U.S. (The company\u2019s vaccine, mRNA-1273, is two doses, taken a month apart.)<\/p>\n<p>This is the first FDA approval or authorization that Moderna has ever received for one of its products. The biotech company plans to apply for full licensure in the new year.  <\/p>\n<div id=\"cx-membership-tile\"><\/div>\n<p>\u201cWe were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants,\u201d Chief Executive St\u00e9phane Bancel recounted in Friday\u2019s announcement. \u201cIt has been a 10-year scientific, entrepreneurial and medical journey and I am thankful to all those who have helped us get here today.\u201d<\/p>\n<p>There are several other COVID-19 vaccines still in late-stage development, including candidates from the University of Oxford and AstraZeneca<br \/>\n        AZN,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/200304487\/composite\" class=\"negative\">-1.14%<\/bg-quote><\/p>\n<p>        AZN,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/203048482\/delayed\" class=\"negative\">-0.45%<\/bg-quote><br \/>\n       and Johnson &amp; Johnson<br \/>\n        JNJ,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/201724570\/composite\" class=\"positive\">+0.58%<\/bg-quote><span>.<\/span>\n      <\/p>\n<p>\u201cBigger picture, the possibility of multiple future COVID-19 vaccines (some at potentially much cheaper prices) and the uncertain duration of pandemic leave us relatively cautious on the substantial amount of value that the market is already ascribing to mRNA-1273,\u201d J.P. Morgan\u2019s Cory Kasimov wrote in a note to investors on Thursday. <\/p>\n<p>Moderna\u2019s shares have soared 617% so far this year, while the S&amp;P 500<br \/>\n        SPX,<br \/>\n        <bg-quote field=\"percentchange\" format=\"0,000.00%\" channel=\"\/zigman2\/quotes\/210599714\/realtime\" class=\"negative\">-0.35%<\/bg-quote><br \/>\n       is up 15.2%.<\/p><\/div>\n<\/div><\/div>\n<p><\/p>\n<div class=\"byline article__byline\">\n<p>      <span>By<\/span><\/p>\n<div class=\"author  hasMenu\" data-scrim='{\"type\":\"author\",\"header\":\"Jaimy Lee\",\"subhead\":\"The Wall Street Journal\",\"list\":[]}' itemscope itemprop=\"author\" itemtype=\"http:\/\/schema.org\/Person\">\n<h4 itemprop=\"name\"><span class=\"ez-toc-section\" id=\"Jaimy_Lee\"><\/span>Jaimy Lee<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<\/p><\/div>\n<\/div>\n<blockquote><p><strong><span style=\"color: #ff6600;\">If you liked the article, do not forget to share it with your friends. 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