{"id":131633,"date":"2020-12-12T06:00:00","date_gmt":"2020-12-12T03:00:00","guid":{"rendered":"https:\/\/en.buradabiliyorum.com\/first-covid-19-vaccine-receives-emergency-approval-in-u-s\/"},"modified":"2020-12-12T12:26:26","modified_gmt":"2020-12-12T09:26:26","slug":"first-covid-19-vaccine-receives-emergency-approval-in-u-s","status":"publish","type":"post","link":"https:\/\/buradabiliyorum.com\/en\/first-covid-19-vaccine-receives-emergency-approval-in-u-s\/","title":{"rendered":"#  First COVID-19 vaccine receives emergency approval in U.S."},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_85 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-6a401c8314e06\" 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-6a401c8314e06\" 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\/first-covid-19-vaccine-receives-emergency-approval-in-u-s\/#Pfizer_and_BioNTech_vaccine_receives_emergency_use_approval_for_use_on_Americans_16_years_old_and_up_drug_could_start_being_administered_within_days\" >Pfizer and BioNTech vaccine receives emergency use approval for use on Americans 16 years old and up, drug could start being administered within days<\/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\/first-covid-19-vaccine-receives-emergency-approval-in-u-s\/#Jaimy_Lee\" >Jaimy Lee<\/a><\/li><\/ul><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<p>&#8220;<strong>#<br \/>\nFirst COVID-19 vaccine receives emergency <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>roval in U.S.<br \/>\n<\/strong>&#8221;<\/p>\n<h2 class=\"article__subhead\"><span class=\"ez-toc-section\" id=\"Pfizer_and_BioNTech_vaccine_receives_emergency_use_approval_for_use_on_Americans_16_years_old_and_up_drug_could_start_being_administered_within_days\"><\/span>Pfizer and BioNTech vaccine receives emergency use approval for use on Americans 16 years old and up, drug could start being administered within days<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>&nbsp;<\/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\" data-sbid=\"WP-MKTW-0000095941\">\n<div class=\"barrons-article-ad-wrapper\">\n<div class=\"barrons-article-ad sticky_item\" data-track=\"barrons-article-ad-wrap\">\n<div class=\"barrons-main-article-ad-target sticky_target body_ad\" aria-hidden=\"true\"><\/div>\n<\/div>\n<\/div>\n<p>The Food and Drug Administration <a class=\"icon none\" href=\"https:\/\/www.fda.gov\/media\/144412\/download\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">authorized<\/a> BioNTech and Pfizer Inc.\u2019s COVID-19 vaccine Friday evening, which will make it the first vaccine to reach Americans during the coronavirus pandemic.<\/p>\n<p>\u201cThe FDA\u2019s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,\u201d FDA Commissioner Dr. Stephen Hahn said in a statement. \u201cToday\u2019s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency\u2019s career scientists to ensure this vaccine met FDA\u2019s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.\u201d<\/p>\n<div class=\"paywall\">\n<p>The vaccine \u2014 which was developed by Germany\u2019s BioNTech BNTX, and is being commercialized by American pharmaceutical giant Pfizer<br \/>\nPFE,<br \/>\n-1.46%<br \/>\n\u2014 is the first COVID-19 vaccine to receive emergency use authorization in the U.S. and the first mRNA product to ever receive any type of regulatory approval.<\/p>\n<p>Since the first efficacy data was shared publicly, anticipation for the highly efficacious vaccine has largely sent up markets, which view vaccination as the beginning of the end of the COVID-19 crisis. Federal health officials have said the administration of the vaccine could begin within days of authorization.<\/p>\n<p>It is also the first vaccine that will be administered to Americans during the pandemic outside of the thousands of volunteers who are participating in the Phase 3 clinical trials currently under way in the U.S. for at least four vaccine candidates. The vaccine, BNT162b2, had already received emergency authorization in Bahrain, Canada, and the United Kingdom.<\/p>\n<p>An emergency use authorization is a less stringent type of regulatory approval that can be used during a public health emergency. It is not a full FDA approval; however, it has become a useful tool for regulators trying to speed up the use of COVID-19 therapies and potentially vaccines during the pandemic.<\/p>\n<p>\u201cWhile not an FDA approval, today\u2019s emergency use authorization of the Pfizer-BioNTech COVID-19 vaccine holds the promise to alter the course of this pandemic in the United States,\u201d said Peter Marks, director of the FDA\u2019s Center for Biologics Evaluation and Research, in a statement.<\/p>\n<p>The two-dose vaccine, which demonstrated a 95% efficacy rate in a late-stage clinical trial, requires people to come back 21 days later to get their second shot of the vaccine. It was tested in roughly 44,000 people in six countries.<\/p>\n<p>An advisory committee convened by the FDA on Thursday voted 17-4-1 in favor of the regulator authorizing the vaccine, saying the benefits outweighed the risks in people who are 16 years old and older. (A second AdCom meeting for Moderna Inc.\u2019s<br \/>\nMRNA,<br \/>\n+0.80%<br \/>\nmRNA-based COVID-19 vaccine is scheduled to take place Dec. 17. An authorization is also expected.)<\/p>\n<p>The FDA label indicates it can be used in people who are at least 16 years old, although the first doses of the vaccine are expected to go to health care workers and nursing-home residents, two groups of people who are at the highest risk of contracting the virus, <a class=\"icon none\" href=\"https:\/\/www.cdc.gov\/mmwr\/volumes\/69\/wr\/mm6949e1.htm\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">according to the Centers for Disease Control and Prevention\u2019s Advisory Committee on Immunization Practices<\/a>.<\/p>\n<div id=\"cx-membership-tile\"><\/div>\n<p>Pfizer and BioNTech first established a partnership in 2018 to develop mRNA, or messenger ribonucleic acid, vaccines that would prevent infection with the seasonal flu. BioNTech and Pfizer announced plans in mid-March to jointly develop a COVID-19 vaccine, meaning the companies developed, tested, and won authorization for a vaccine in less than 10 months. (Their partnership excludes the China market.)<\/p>\n<p>This is the fastest timeline in which a vaccine has ever been developed.<\/p>\n<p>\u201cFor a drug R&amp;D geek like me, this is just the Holy Grail,\u201d said John LaMattina, a longtime pharmaceutical executive who ran Pfizer\u2019s research and development business for 30 years. \u201cAre you kidding me? It\u2019s unprecedented to do something like this.\u201d<\/p>\n<p>Wall Street analysts expect the vaccine to generate billions of dollars in sales within a year. Mizuho Securities\u2019 Vamil Divan expects the vaccine will bring in more than $8 billion in sales by the end of 2021, which could make it Pfizer\u2019s top-selling drug next year. In 2019, Pfizer\u2019s top-performing drug was Prevnar 13, a pneumococcal vaccine that generated $5.8 billion in sales.<\/p>\n<p>Beyond the direct sales impact, analysts also view Pfizer\u2019s quick-moving development of the vaccine as an indicator that it is evolving from a slow-moving corporate pharmaceutical giant into the kind of quick-moving biopharma company that most excite investors.<\/p>\n<p>\u201cThe speed with which Pfizer has moved to develop this vaccine candidate is also encouraging to us and suggests Pfizer may be able to meet its stated objective of being a faster-moving, more nimble biopharmaceutical company, which we believe would allow for further multiple expansion over time,\u201d Divan wrote on Dec. 6.<\/p>\n<p>Unlike some of the other drugmakers developing COVID-19 vaccines, BioNTech and Pfizer did not take federal funding to support development of the candidate. Instead, they brokered a deal this summer for the U.S. government to acquire 100 million doses for $1.95 billion, with the option to buy an additional 500 million doses, with the deal reflecting about $20 per dose in the U.S., according to SVB Leerink\u2019s Geoffrey Porges.<\/p>\n<p>Since the start of the year, stock in both companies has rallied, with shares of BioNTech soaring 269.3% and Pfizer\u2019s stock gaining 12.7%. The S&amp;P 500<br \/>\nSPX,<br \/>\n-0.13%<br \/>\nis up 13.7%.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p>&nbsp;<\/p>\n<div class=\"byline article__byline\">\n<p>By<\/p>\n<div class=\"author hasMenu\" data-scrim=\"{&quot;type&quot;:&quot;author&quot;,&quot;header&quot;:&quot;Jaimy Lee&quot;,&quot;subhead&quot;:&quot;The Wall Street Journal&quot;,&quot;list&quot;:[]}\">\n<h4><span class=\"ez-toc-section\" id=\"Jaimy_Lee\"><\/span>Jaimy Lee<span class=\"ez-toc-section-end\"><\/span><\/h4>\n<\/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. Follow us on\u00a0<span style=\"color: #ff0000;\"><a style=\"color: #ff0000;\" href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMLG0nwswvr63Aw\" target=\"_blank\" rel=\"nofollow noopener noreferrer\">Google News<\/a><\/span>\u00a0too, click on the star and choose us from your favorites.<\/span><\/strong><\/p><\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\">For forums sites go to <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/forum.buradabiliyorum.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Forum.BuradaBiliyorum.Com<\/a><\/span><\/p>\n<\/blockquote>\n<blockquote>\n<p style=\"text-align: center;\"><strong>If you want to read more <a href=\"https:\/\/buradabiliyorum.com\/en\/category\/news\/\" data-internallinksmanager029f6b8e52c=\"2\" title=\"News\" target=\"_blank\" rel=\"noopener\">News<\/a> articles, you can visit our <span style=\"color: #ff9900;\"><a style=\"color: #ff9900;\" href=\"https:\/\/en.buradabiliyorum.com\/news\/\" target=\"_blank\" rel=\"noopener noreferrer\">News category.<\/a><\/span><\/strong><\/p>\n<\/blockquote>\n<p><span style=\"color: black;\"><a style=\"color: #ff9900;\" href=\"http:\/\/www.marketwatch.com\/news\/story.asp?guid=%7B21005575-02D4-D4B5-4572-D176C5F45BAF%7D&amp;siteid=rss&amp;rss=1\" target=\"_blank\" rel=\"noopener noreferrer\">Source<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>&#8220;# First COVID-19 vaccine receives emergency approval in U.S. &#8221; Pfizer and BioNTech vaccine receives emergency use approval for use on Americans 16 years old and up, drug could start being administered within days &nbsp; The Food and Drug Administration authorized BioNTech and Pfizer Inc.\u2019s COVID-19 vaccine Friday evening, which will make it the first&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"fifu_image_url":"https:\/\/images.mktw.net\/im-271342?width=1260&size=1.5005861664712778","fifu_image_alt":"#\n  First COVID-19 vaccine receives emergency approval in U.S.","footnotes":""},"categories":[70897],"tags":[],"class_list":["post-131633","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/131633","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/comments?post=131633"}],"version-history":[{"count":0,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/posts\/131633\/revisions"}],"wp:attachment":[{"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/media?parent=131633"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/categories?post=131633"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/buradabiliyorum.com\/en\/wp-json\/wp\/v2\/tags?post=131633"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}