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2021-09-02
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(NYSE:PFE) today announced the initiation of RENOIR (<b>R</b>SV vaccine <b>E</b>fficacy study i<b>N</b> <b>O</b>lder adults <b>I</b>mmunized against <b>R</b>SV disease), a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older.</p>\n<p>\"RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease,\" said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc. \"The start of this Phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine.\"</p>\n<p>The Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. The primary objectives of the study will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season.</p>\n<p>RSV is a seasonal illness that commonly starts in the fall months, peaking in the winter when colds and other respiratory illnesses are more common.1</p>\n<p><b>Burden of RSV</b></p>\n<p>Respiratory syncytial virus (RSV) is a common and pervasive cause of acute respiratory illness.2,3 The virus is highly contagious and affects the lungs and airways. 4,5 Infections occur in people of all ages and can feel like the common cold for most young adults, but for infants, the immunocompromised, and older adults, it can be potentially life-threatening.3</p>\n<p>The risk of serious infection increases in older adults and for those with chronic heart or lung disease or a weakened immune system.2 In the U.S., it is estimated that more than 177,000 older adults ≥65 years of age are hospitalized and 14,000 of them die each year due to RSV. 2,6 There is no vaccine to prevent RSV and the medical community is limited to offering only supportive care for those with the illness.</p>\n<p><b>About RSVpreF</b></p>\n<p>Pfizer’s investigational RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of a key form of a viral protein that RSV uses to attack human cells. The NIH research showed that the antibodies that protect humans from RSV target this <a href=\"https://laohu8.com/S/AONE.U\">one</a> form of the viral protein. Applying insights from this important work, Pfizer developed and tested numerous candidates and identified those that elicited a strong anti-viral immune response in pre-clinical evaluation, which led to the vaccine candidate that Pfizer is evaluating in human trials.</p>\n<p>In July 2021, Pfizer provided an update on a Phase 2a study evaluating the safety, immunogenicity and efficacy of RSVpreF in a virus challenge model in healthy adults 18 to 50 years of age. The results of the study enabled Pfizer to proceed to Phase 3. Detailed results from the Phase 2a study will be shared in a future scientific forum.</p>\n<p>In April 2020, positive top-line results were achieved for a Phase 2b proof-of-concept study of RSVpreF, which evaluated the safety, tolerability and immunogenicity of RSVpreF in vaccinated pregnant women ages 18 through 49 and their infants. Detailed results from the study will be shared at a future medical conference. In November 2018, the FDA granted Fast Track status to RSVpreF for prevention of RSV-associated lower respiratory tract illness in infants by active immunization of pregnant women.</p>\n<p><b>About Pfizer: Breakthroughs That Change Patients’ Lives</b></p>\n<p>At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on <a href=\"https://laohu8.com/S/TWTR\">Twitter</a> at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on <a href=\"https://laohu8.com/S/FB\">Facebook</a> at Facebook.com/Pfizer.</p>","source":"yahoofinance","collect":0,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nPfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-09-02 18:45 GMT+8 <a href=https://finance.yahoo.com/news/pfizer-announces-start-phase-3-104500020.html><strong>Business Wire</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older\nRSV is a common and pervasive cause of severe acute ...</p>\n\n<a href=\"https://finance.yahoo.com/news/pfizer-announces-start-phase-3-104500020.html\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"PFE":"辉瑞"},"source_url":"https://finance.yahoo.com/news/pfizer-announces-start-phase-3-104500020.html","is_english":true,"share_image_url":"https://static.laohu8.com/5f26f4a48f9cb3e29be4d71d3ba8c038","article_id":"2164684106","content_text":"First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older\nRSV is a common and pervasive cause of severe acute respiratory illness in older adults with no vaccine currently available \n\nNEW YORK, September 02, 2021--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced the initiation of RENOIR (RSV vaccine Efficacy study iN Older adults Immunized against RSV disease), a Phase 3 clinical trial evaluating the efficacy, immunogenicity, and safety of a single dose of its respiratory syncytial virus (RSV) bivalent prefusion F subunit investigational vaccine candidate (RSVpreF) in adults ages 60 years or older.\n\"RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease,\" said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer Inc. \"The start of this Phase 3 study is an important step forward towards our goal of comprehensive immunization against RSV disease, which includes developing a potential first vaccine to help prevent RSV disease in adults as well as the ongoing efforts to help protect infants through maternal immunization, subject to regulatory approval of the candidate vaccine.\"\nThe Phase 3 RENOIR trial of RSVpreF is a global, randomized, double-blind, placebo-controlled study that expects to enroll approximately 30,000 participants 60 years and older. The primary objectives of the study will assess safety and efficacy for the prevention of moderate to severe lower respiratory tract illness (msLRTI-RSV) during the first RSV season.\nRSV is a seasonal illness that commonly starts in the fall months, peaking in the winter when colds and other respiratory illnesses are more common.1\nBurden of RSV\nRespiratory syncytial virus (RSV) is a common and pervasive cause of acute respiratory illness.2,3 The virus is highly contagious and affects the lungs and airways. 4,5 Infections occur in people of all ages and can feel like the common cold for most young adults, but for infants, the immunocompromised, and older adults, it can be potentially life-threatening.3\nThe risk of serious infection increases in older adults and for those with chronic heart or lung disease or a weakened immune system.2 In the U.S., it is estimated that more than 177,000 older adults ≥65 years of age are hospitalized and 14,000 of them die each year due to RSV. 2,6 There is no vaccine to prevent RSV and the medical community is limited to offering only supportive care for those with the illness.\nAbout RSVpreF\nPfizer’s investigational RSV vaccine candidate builds on foundational basic science discoveries including those made at the National Institutes of Health (NIH), which detailed the crystal structure of a key form of a viral protein that RSV uses to attack human cells. The NIH research showed that the antibodies that protect humans from RSV target this one form of the viral protein. Applying insights from this important work, Pfizer developed and tested numerous candidates and identified those that elicited a strong anti-viral immune response in pre-clinical evaluation, which led to the vaccine candidate that Pfizer is evaluating in human trials.\nIn July 2021, Pfizer provided an update on a Phase 2a study evaluating the safety, immunogenicity and efficacy of RSVpreF in a virus challenge model in healthy adults 18 to 50 years of age. The results of the study enabled Pfizer to proceed to Phase 3. Detailed results from the Phase 2a study will be shared in a future scientific forum.\nIn April 2020, positive top-line results were achieved for a Phase 2b proof-of-concept study of RSVpreF, which evaluated the safety, tolerability and immunogenicity of RSVpreF in vaccinated pregnant women ages 18 through 49 and their infants. Detailed results from the study will be shared at a future medical conference. In November 2018, the FDA granted Fast Track status to RSVpreF for prevention of RSV-associated lower respiratory tract illness in infants by active immunization of pregnant women.\nAbout Pfizer: Breakthroughs That Change Patients’ Lives\nAt Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.","news_type":1},"isVote":1,"tweetType":1,"viewCount":110,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"hots":[{"id":812229956,"gmtCreate":1630591204775,"gmtModify":1676530350006,"author":{"id":"4092375527552130","authorId":"4092375527552130","name":"sundram","avatar":"https://static.laohu8.com/default-avatar.jpg","crmLevel":2,"crmLevelSwitch":0,"followedFlag":false,"authorIdStr":"4092375527552130","idStr":"4092375527552130"},"themes":[],"htmlText":"Going up","listText":"Going up","text":"Going up","images":[],"top":1,"highlighted":1,"essential":1,"paper":1,"likeSize":0,"commentSize":0,"repostSize":0,"link":"https://ttm.financial/post/812229956","repostId":"2164684106","repostType":2,"isVote":1,"tweetType":1,"viewCount":110,"authorTweetTopStatus":1,"verified":2,"comments":[],"imageCount":0,"langContent":"EN","totalScore":0}],"lives":[]}
