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AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease<blockquote>阿斯利康Covid-19抗体被FDA授权作为预防症状性疾病的新型工具</blockquote>
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That may be because they have cancer or another illness or take medications or undergo treatments such as chemotherapy that inhibit an immune response to Covid-19 vaccines, the FDA said in a statement.</p><p><blockquote>这种名为Evusheld的抗体鸡尾酒主要用于少数12岁及以上免疫系统中度至重度受损的青少年和成人。FDA在一份声明中表示,这可能是因为他们患有癌症或其他疾病,或者正在服用药物或接受化疗等抑制对Covid-19疫苗免疫反应的治疗。</blockquote></p><p> AstraZeneca said earlier this year that it would aim the antibody combination, called AZD7442 and delivered as two consecutive shots, at preventing Covid-19 symptoms, like a vaccine. Emergency-use authorization from the FDA offers a new preventive option in addition to widely deployed vaccines.</p><p><blockquote>阿斯利康今年早些时候表示,它将把这种名为AZD7442的抗体组合作为连续两次注射的目标,像疫苗一样预防Covid-19症状。除了广泛部署的疫苗之外,FDA的紧急使用授权还提供了一种新的预防选择。</blockquote></p><p> AstraZeneca said about seven million people in the U.S. may benefit from Evusheld to reduce their risk of symptomatic Covid-19 if taken before exposure.</p><p><blockquote>阿斯利康表示,如果在接触前服用Evusheld,美国约有700万人可能会受益于Evusheld,以降低出现症状性Covid-19的风险。</blockquote></p><p> Monoclonal antibodies are the only drug treatments authorized for mild to moderate Covid-19 cases in people who aren’t sick enough to be hospitalized. The drugs, which are given by infusion or injection, provide a temporary substitute for the antibodies produced by the immune system to fight the virus after infection or vaccination.</p><p><blockquote>单克隆抗体是唯一被授权用于治疗轻中度Covid-19病例的药物治疗方法,这些患者的病情尚未严重到需要住院。这些药物通过输注或注射给药,为免疫系统在感染或接种疫苗后产生的对抗病毒抗体提供了临时替代品。</blockquote></p><p> AstraZeneca’s drug is the first to get U.S. clearance to prevent Covid-19 in people who aren’t yet infected, but the company could face competition in the coming months. Rivals including Regeneron Pharmaceuticals Inc. are also seeking authorization for drugs to temporarily defend against infection.</p><p><blockquote>阿斯利康的药物是第一个获得美国批准的用于预防尚未感染Covid-19的人的药物,但该公司可能在未来几个月面临竞争。包括再生元制药公司在内的竞争对手也在寻求暂时预防感染的药物授权。</blockquote></p><p> Regeneron said in November that its antibody drug REGEN-COV was 82% effective at preventing infection at least eight months after infusion in a study that included patients who hadn’t yet been exposed to the virus. Pfizer Inc. is also testing its antiviral pill Paxlovid to prevent infections in people recently exposed to the virus, which could provide another option for people with weakened immune systems.</p><p><blockquote>再生元(Regeneron)去年11月表示,在一项包括尚未接触过该病毒的患者的研究中,其抗体药物REGEN-COV在输注后至少八个月预防感染的有效性为82%。辉瑞公司也在测试其抗病毒药物Paxlovid,以预防最近接触过该病毒的人感染,这可能为免疫系统较弱的人提供另一种选择。</blockquote></p><p> The FDA said the authorization is for individuals not infected or recently exposed to someone infected with the virus. It said that vaccines remain “the best defense available against Covid-19.” In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that Evusheld could help reduce the risk of Covid-19 in a subset of the population with a history of adverse reactions to Covid-19 vaccines or their components or with compromised immune systems.</p><p><blockquote>FDA表示,该授权适用于未感染或最近接触过病毒感染者的个人。报告称,疫苗仍然是“针对Covid-19的最佳防御手段”。在该机构的声明中,FDA药物评估和研究中心主任Patrizia Cavazzoni表示,Evusheld可以帮助降低对Covid-19疫苗或其成分有不良反应史或免疫系统受损的部分人群的Covid-19风险。</blockquote></p><p> “Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended,” the FDA said.</p><p><blockquote>FDA表示:“对于建议接种Covid-19疫苗的个体,使用Evusheld进行暴露前预防并不能替代疫苗接种。”</blockquote></p><p> The antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford. That vaccine is one of the most broadly distributed globally, with more than 2.2 billion doses delivered, but it isn’t authorized for use in the U.S.</p><p><blockquote>这种抗体治疗与阿斯利康与牛津大学合作开发的广泛使用的Covid-19疫苗是分开的。该疫苗是全球分布最广泛的疫苗之一,已交付超过22亿剂,但尚未获准在美国使用。</blockquote></p><p> AstraZeneca said it’s testing Evusheld against the new Omicron variant. It “neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” said Mene Pangalos, the company’s executive vice president for biopharmaceuticals research and development, in a statement.</p><p><blockquote>AstraZeneca表示,正在针对新的奥密克戎变种测试Evusheld。该公司负责生物制药研发的执行副总裁Mene Pangalos在一份声明中表示,它“迄今为止中和了所有以前的新型冠状病毒病毒变种,我们正在迅速确定其对新的奥密克戎病毒变种的功效”。</blockquote></p><p> Some scientists think that Omicron may have developed in a patient whose immune response was too weak to clear the virus, allowing it time to adapt and mutate. The rise of variants like Omicron highlights the need for treatments to better protect people who mount weak immune responses to the virus causing Covid-19, scientists say.</p><p><blockquote>一些科学家认为,奥密克戎病可能是在一名免疫反应太弱而无法清除病毒的患者身上发展起来的,让病毒有时间适应和变异。科学家表示,奥密克戎病毒等变种的兴起凸显了治疗的必要性,以更好地保护那些对导致Covid-19的病毒免疫反应较弱的人。</blockquote></p><p> The company in August said Evusheld, also called AZD7442, showed 77% efficacy in reducing risk of symptomatic Covid-19 compared with a placebo in late-stage clinical trials testing its usefulness as a preventive treatment. In summarized preliminary findings, the company said that more than three-fourths of the 5,197 participants in the trial had comorbidities, or chronic disease, including conditions that could render vaccines less effective.</p><p><blockquote>该公司8月份表示,在测试其作为预防性治疗有效性的后期临床试验中,与安慰剂相比,Evusheld(也称为AZD7442)在降低症状性Covid-19风险方面显示出77%的疗效。该公司在总结的初步调查结果中表示,该试验的5,197名参与者中,超过四分之三患有合并症或慢性病,包括可能降低疫苗效果的疾病。</blockquote></p><p> Protection has been shown to last six months, the FDA and AstraZeneca said. Evaluation of the antibody combination is ongoing.</p><p><blockquote>FDA和阿斯利康表示,保护作用已被证明可持续六个月。抗体组合的评价正在进行中。</blockquote></p><p> Monoclonal antibody drugs are designed to mimic natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca earlier hoped the therapy could be used to treat acute Covid-19 symptoms and stem infection to keep people already exposed to the virus out of the hospital. But the drug failed in late-stage trials for that primary purpose.</p><p><blockquote>单克隆抗体药物旨在模拟免疫系统产生的天然抗体来对抗冠状病毒。阿斯利康早些时候希望该疗法可用于治疗急性Covid-19症状并阻止感染,以使已经接触该病毒的人远离医院。但该药物在这一主要目的的后期试验中失败了。</blockquote></p><p></p><p> Earlier in the pandemic, AstraZeneca received funding pledges that could exceed $700 million from the U.S. government to develop, test and potentially supply up to 700,000 doses of AZD7442 this year. The antibodies used were developed by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.</p><p><blockquote>在疫情早些时候,阿斯利康从美国政府获得了可能超过7亿美元的资金承诺,用于今年开发、测试和潜在供应多达70万剂AZD7442。使用的抗体由范德比尔特大学医学中心开发,并于2020年6月授权给阿斯利康。</blockquote></p><p> European medicines regulators are also reviewing data for potential authorization of the antibody combination.</p><p><blockquote>欧洲药品监管机构也在审查该抗体组合可能获得授权的数据。</blockquote></p><p></p>","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>AstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease<blockquote>阿斯利康Covid-19抗体被FDA授权作为预防症状性疾病的新型工具</blockquote></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: 12.5px; color: #7E829C; margin: 0;}\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\">\nAstraZeneca Covid-19 Antibody Authorized by FDA as Novel Tool to Prevent Symptomatic Disease<blockquote>阿斯利康Covid-19抗体被FDA授权作为预防症状性疾病的新型工具</blockquote>\n</h2>\n<h4 class=\"meta\">\n<p class=\"head\">\n<strong class=\"h-name small\">The Wall Street Journal</strong><span class=\"h-time small\">2021-12-09 08:17</span>\n</p>\n</h4>\n</header>\n<article>\n<p> The U.S. Food and Drug Administration authorized a preventive antibody combination from AstraZeneca AZN 0.68% PLC that has shown strong efficacy in reducing risk of symptomatic Covid-19, offering a first-of-its-kind alternative for a minority of people for whom vaccines are considered less effective.</p><p><blockquote>美国。美国食品药品监督管理局批准了阿斯利康AZN 0.68%PLC的一种预防性抗体组合,该组合在降低有症状的新冠肺炎风险方面显示出强大的功效,为少数疫苗被认为效果较差的人提供了首创的替代方案。</blockquote></p><p> The antibody cocktail, called Evusheld, is aimed primarily for use in a minority of adolescents and adults age 12 and older with moderate to severely compromised immune systems. That may be because they have cancer or another illness or take medications or undergo treatments such as chemotherapy that inhibit an immune response to Covid-19 vaccines, the FDA said in a statement.</p><p><blockquote>这种名为Evusheld的抗体鸡尾酒主要用于少数12岁及以上免疫系统中度至重度受损的青少年和成人。FDA在一份声明中表示,这可能是因为他们患有癌症或其他疾病,或者正在服用药物或接受化疗等抑制对Covid-19疫苗免疫反应的治疗。</blockquote></p><p> AstraZeneca said earlier this year that it would aim the antibody combination, called AZD7442 and delivered as two consecutive shots, at preventing Covid-19 symptoms, like a vaccine. Emergency-use authorization from the FDA offers a new preventive option in addition to widely deployed vaccines.</p><p><blockquote>阿斯利康今年早些时候表示,它将把这种名为AZD7442的抗体组合作为连续两次注射的目标,像疫苗一样预防Covid-19症状。除了广泛部署的疫苗之外,FDA的紧急使用授权还提供了一种新的预防选择。</blockquote></p><p> AstraZeneca said about seven million people in the U.S. may benefit from Evusheld to reduce their risk of symptomatic Covid-19 if taken before exposure.</p><p><blockquote>阿斯利康表示,如果在接触前服用Evusheld,美国约有700万人可能会受益于Evusheld,以降低出现症状性Covid-19的风险。</blockquote></p><p> Monoclonal antibodies are the only drug treatments authorized for mild to moderate Covid-19 cases in people who aren’t sick enough to be hospitalized. The drugs, which are given by infusion or injection, provide a temporary substitute for the antibodies produced by the immune system to fight the virus after infection or vaccination.</p><p><blockquote>单克隆抗体是唯一被授权用于治疗轻中度Covid-19病例的药物治疗方法,这些患者的病情尚未严重到需要住院。这些药物通过输注或注射给药,为免疫系统在感染或接种疫苗后产生的对抗病毒抗体提供了临时替代品。</blockquote></p><p> AstraZeneca’s drug is the first to get U.S. clearance to prevent Covid-19 in people who aren’t yet infected, but the company could face competition in the coming months. Rivals including Regeneron Pharmaceuticals Inc. are also seeking authorization for drugs to temporarily defend against infection.</p><p><blockquote>阿斯利康的药物是第一个获得美国批准的用于预防尚未感染Covid-19的人的药物,但该公司可能在未来几个月面临竞争。包括再生元制药公司在内的竞争对手也在寻求暂时预防感染的药物授权。</blockquote></p><p> Regeneron said in November that its antibody drug REGEN-COV was 82% effective at preventing infection at least eight months after infusion in a study that included patients who hadn’t yet been exposed to the virus. Pfizer Inc. is also testing its antiviral pill Paxlovid to prevent infections in people recently exposed to the virus, which could provide another option for people with weakened immune systems.</p><p><blockquote>再生元(Regeneron)去年11月表示,在一项包括尚未接触过该病毒的患者的研究中,其抗体药物REGEN-COV在输注后至少八个月预防感染的有效性为82%。辉瑞公司也在测试其抗病毒药物Paxlovid,以预防最近接触过该病毒的人感染,这可能为免疫系统较弱的人提供另一种选择。</blockquote></p><p> The FDA said the authorization is for individuals not infected or recently exposed to someone infected with the virus. It said that vaccines remain “the best defense available against Covid-19.” In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that Evusheld could help reduce the risk of Covid-19 in a subset of the population with a history of adverse reactions to Covid-19 vaccines or their components or with compromised immune systems.</p><p><blockquote>FDA表示,该授权适用于未感染或最近接触过病毒感染者的个人。报告称,疫苗仍然是“针对Covid-19的最佳防御手段”。在该机构的声明中,FDA药物评估和研究中心主任Patrizia Cavazzoni表示,Evusheld可以帮助降低对Covid-19疫苗或其成分有不良反应史或免疫系统受损的部分人群的Covid-19风险。</blockquote></p><p> “Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended,” the FDA said.</p><p><blockquote>FDA表示:“对于建议接种Covid-19疫苗的个体,使用Evusheld进行暴露前预防并不能替代疫苗接种。”</blockquote></p><p> The antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford. That vaccine is one of the most broadly distributed globally, with more than 2.2 billion doses delivered, but it isn’t authorized for use in the U.S.</p><p><blockquote>这种抗体治疗与阿斯利康与牛津大学合作开发的广泛使用的Covid-19疫苗是分开的。该疫苗是全球分布最广泛的疫苗之一,已交付超过22亿剂,但尚未获准在美国使用。</blockquote></p><p> AstraZeneca said it’s testing Evusheld against the new Omicron variant. It “neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” said Mene Pangalos, the company’s executive vice president for biopharmaceuticals research and development, in a statement.</p><p><blockquote>AstraZeneca表示,正在针对新的奥密克戎变种测试Evusheld。该公司负责生物制药研发的执行副总裁Mene Pangalos在一份声明中表示,它“迄今为止中和了所有以前的新型冠状病毒病毒变种,我们正在迅速确定其对新的奥密克戎病毒变种的功效”。</blockquote></p><p> Some scientists think that Omicron may have developed in a patient whose immune response was too weak to clear the virus, allowing it time to adapt and mutate. The rise of variants like Omicron highlights the need for treatments to better protect people who mount weak immune responses to the virus causing Covid-19, scientists say.</p><p><blockquote>一些科学家认为,奥密克戎病可能是在一名免疫反应太弱而无法清除病毒的患者身上发展起来的,让病毒有时间适应和变异。科学家表示,奥密克戎病毒等变种的兴起凸显了治疗的必要性,以更好地保护那些对导致Covid-19的病毒免疫反应较弱的人。</blockquote></p><p> The company in August said Evusheld, also called AZD7442, showed 77% efficacy in reducing risk of symptomatic Covid-19 compared with a placebo in late-stage clinical trials testing its usefulness as a preventive treatment. In summarized preliminary findings, the company said that more than three-fourths of the 5,197 participants in the trial had comorbidities, or chronic disease, including conditions that could render vaccines less effective.</p><p><blockquote>该公司8月份表示,在测试其作为预防性治疗有效性的后期临床试验中,与安慰剂相比,Evusheld(也称为AZD7442)在降低症状性Covid-19风险方面显示出77%的疗效。该公司在总结的初步调查结果中表示,该试验的5,197名参与者中,超过四分之三患有合并症或慢性病,包括可能降低疫苗效果的疾病。</blockquote></p><p> Protection has been shown to last six months, the FDA and AstraZeneca said. Evaluation of the antibody combination is ongoing.</p><p><blockquote>FDA和阿斯利康表示,保护作用已被证明可持续六个月。抗体组合的评价正在进行中。</blockquote></p><p> Monoclonal antibody drugs are designed to mimic natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca earlier hoped the therapy could be used to treat acute Covid-19 symptoms and stem infection to keep people already exposed to the virus out of the hospital. But the drug failed in late-stage trials for that primary purpose.</p><p><blockquote>单克隆抗体药物旨在模拟免疫系统产生的天然抗体来对抗冠状病毒。阿斯利康早些时候希望该疗法可用于治疗急性Covid-19症状并阻止感染,以使已经接触该病毒的人远离医院。但该药物在这一主要目的的后期试验中失败了。</blockquote></p><p></p><p> Earlier in the pandemic, AstraZeneca received funding pledges that could exceed $700 million from the U.S. government to develop, test and potentially supply up to 700,000 doses of AZD7442 this year. The antibodies used were developed by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.</p><p><blockquote>在疫情早些时候,阿斯利康从美国政府获得了可能超过7亿美元的资金承诺,用于今年开发、测试和潜在供应多达70万剂AZD7442。使用的抗体由范德比尔特大学医学中心开发,并于2020年6月授权给阿斯利康。</blockquote></p><p> European medicines regulators are also reviewing data for potential authorization of the antibody combination.</p><p><blockquote>欧洲药品监管机构也在审查该抗体组合可能获得授权的数据。</blockquote></p><p></p>\n<div class=\"bt-text\">\n\n\n<p> 来源:<a href=\"https://www.wsj.com/articles/astrazeneca-covid-19-antibody-authorized-by-fda-as-novel-tool-to-prevent-symptomatic-disease-11639005991?mod=hp_lista_pos4\">The Wall Street Journal</a></p>\n<p>为提升您的阅读体验,我们对本页面进行了排版优化</p>\n\n\n</div>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"AZN":"阿斯利康"},"source_url":"https://www.wsj.com/articles/astrazeneca-covid-19-antibody-authorized-by-fda-as-novel-tool-to-prevent-symptomatic-disease-11639005991?mod=hp_lista_pos4","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1141494008","content_text":"The U.S. Food and Drug Administration authorized a preventive antibody combination from AstraZeneca AZN 0.68% PLC that has shown strong efficacy in reducing risk of symptomatic Covid-19, offering a first-of-its-kind alternative for a minority of people for whom vaccines are considered less effective.\n\nThe antibody cocktail, called Evusheld, is aimed primarily for use in a minority of adolescents and adults age 12 and older with moderate to severely compromised immune systems. That may be because they have cancer or another illness or take medications or undergo treatments such as chemotherapy that inhibit an immune response to Covid-19 vaccines, the FDA said in a statement.\n\nAstraZeneca said earlier this year that it would aim the antibody combination, called AZD7442 and delivered as two consecutive shots, at preventing Covid-19 symptoms, like a vaccine. Emergency-use authorization from the FDA offers a new preventive option in addition to widely deployed vaccines.\n\nAstraZeneca said about seven million people in the U.S. may benefit from Evusheld to reduce their risk of symptomatic Covid-19 if taken before exposure.\n\nMonoclonal antibodies are the only drug treatments authorized for mild to moderate Covid-19 cases in people who aren’t sick enough to be hospitalized. The drugs, which are given by infusion or injection, provide a temporary substitute for the antibodies produced by the immune system to fight the virus after infection or vaccination.\n\nAstraZeneca’s drug is the first to get U.S. clearance to prevent Covid-19 in people who aren’t yet infected, but the company could face competition in the coming months. Rivals including Regeneron Pharmaceuticals Inc. are also seeking authorization for drugs to temporarily defend against infection.\n\nRegeneron said in November that its antibody drug REGEN-COV was 82% effective at preventing infection at least eight months after infusion in a study that included patients who hadn’t yet been exposed to the virus. Pfizer Inc. is also testing its antiviral pill Paxlovid to prevent infections in people recently exposed to the virus, which could provide another option for people with weakened immune systems.\n\n\nThe FDA said the authorization is for individuals not infected or recently exposed to someone infected with the virus. It said that vaccines remain “the best defense available against Covid-19.” In the agency’s statement, Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said that Evusheld could help reduce the risk of Covid-19 in a subset of the population with a history of adverse reactions to Covid-19 vaccines or their components or with compromised immune systems.\n\n“Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom Covid-19 vaccination is recommended,” the FDA said.\n\nThe antibody treatment is separate from AstraZeneca’s widely used Covid-19 vaccine developed in partnership with the University of Oxford. That vaccine is one of the most broadly distributed globally, with more than 2.2 billion doses delivered, but it isn’t authorized for use in the U.S.\n\nAstraZeneca said it’s testing Evusheld against the new Omicron variant. It “neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” said Mene Pangalos, the company’s executive vice president for biopharmaceuticals research and development, in a statement.\n\nSome scientists think that Omicron may have developed in a patient whose immune response was too weak to clear the virus, allowing it time to adapt and mutate. The rise of variants like Omicron highlights the need for treatments to better protect people who mount weak immune responses to the virus causing Covid-19, scientists say.\n\nThe company in August said Evusheld, also called AZD7442, showed 77% efficacy in reducing risk of symptomatic Covid-19 compared with a placebo in late-stage clinical trials testing its usefulness as a preventive treatment. In summarized preliminary findings, the company said that more than three-fourths of the 5,197 participants in the trial had comorbidities, or chronic disease, including conditions that could render vaccines less effective.\n\nProtection has been shown to last six months, the FDA and AstraZeneca said. Evaluation of the antibody combination is ongoing.\n\nMonoclonal antibody drugs are designed to mimic natural antibodies produced by the immune system to fight the coronavirus. AstraZeneca earlier hoped the therapy could be used to treat acute Covid-19 symptoms and stem infection to keep people already exposed to the virus out of the hospital. But the drug failed in late-stage trials for that primary purpose.\n\n\nEarlier in the pandemic, AstraZeneca received funding pledges that could exceed $700 million from the U.S. government to develop, test and potentially supply up to 700,000 doses of AZD7442 this year. The antibodies used were developed by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020.\n\nEuropean medicines regulators are also reviewing data for potential authorization of the antibody combination.","news_type":1,"symbols_score_info":{"AZN":0.9}},"isVote":1,"tweetType":1,"viewCount":684,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":2,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/602847732"}
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