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2021-12-15

Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation<blockquote>赛诺菲和葛兰素史克宣布其COVID-19候选疫苗的积极初步加强数据，并根据独立监测委员会的建议继续进行3期试验</blockquote>

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Preliminary results from the VAT0002 clinical trial investigating the safety and immunogenicity of the booster showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson &amp; Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested. The booster was well tolerated, with a safety profile similar to currently approved COVID-19 vaccines. This is the most comprehensive booster trial to date to explore boosting across different vaccine technologies used for primary vaccination.<blockquote><ul><li>阳性加强剂数据显示，接受的所有初级疫苗（mRNA或腺病毒）中的中和抗体增加了9至43倍，并且对于所有测试的年龄组，具有良好的安全性和耐受性</li><li>随着世界各地的人群越来越多地暴露于新冠肺炎变种，3期试验继续增加分析所需的事件数量；预计2022年第一季度业绩</li><li>公司打算在第三阶段结果公布后向监管机构提交加强数据</li></ul>赛诺菲和葛兰素史克今天宣布，他们的重组佐剂新冠肺炎候选疫苗的单次加强剂量产生了持续强烈的免疫反应。调查加强剂安全性和免疫原性的VAT0002临床试验的初步结果显示，无论接受的初级疫苗（阿斯利康、强生、Moderna、辉瑞/BioNTech）和所有测试年龄组，中和抗体都增加了9至43倍。加强剂耐受性良好，安全性与目前批准的新冠肺炎疫苗相似。这是迄今为止最全面的加强试验，旨在探索用于初级疫苗接种的不同疫苗技术的加强。</blockquote> The ongoing global Phase 3 trial, VAT0008, includes regular reviews by an independent Data Safety Monitoring Board (DSMB). During its last review, the DSMB identified no safety concerns and recommended the trial to continue into early 2022 to accrue more data.<blockquote>正在进行的全球3期试验VAT0008包括独立数据安全监测委员会(DSMB)的定期审查。在上次审查中，DSMB没有发现任何安全问题，并建议试验继续到2022年初，以积累更多数据。</blockquote> Regulatory authorities require Phase 3 efficacy to be demonstrated in “naive” populations, i.e. participants who have never been infected by the COVID-19 virus (seronegative). The Phase 3 trial recruited most participants in Q3 2021, coinciding with a significant increase in the number of people infected by the COVID-19 virus globally due to the Delta variant. To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022.<blockquote>监管机构要求在“幼稚”人群中证明3期疗效，即从未感染过新冠肺炎病毒（血清阴性）的参与者。3期试验在2021年第三季度招募了大多数参与者，恰逢德尔塔变异毒株导致全球感染COVID-19病毒的人数大幅增加。为了向监管机构提供加强疫苗提交所需的数据，该试验将继续累积分析所需的事件数量，预计将于2022年第一季度得出结果。</blockquote> “These preliminary data show we have a strong booster candidate, whatever primary vaccine you have received.”said Thomas Triomphe, Executive Vice President, Sanofi Pasteur.“This is consistent with our efforts to provide relevantresponses to evolving public health needs. While pursuing a phase 3 trial is a challenge in a quickly shifting pandemic environment, we look forward to seeing the results to support submissions of our booster vaccine as quickly as possible.”<blockquote>“这些初步数据表明，无论您接种的是什么初级疫苗，我们都有一种强大的加强候选疫苗。”赛诺菲巴斯德执行副总裁Thomas Triomphe说道。“这与我们为不断变化的公共卫生需求提供相关响应的努力是一致的。虽然在快速变化的大流行环境中进行3期试验是一项挑战，但我们期待看到结果，以支持尽快提交我们的加强疫苗。”</blockquote> Roger Connor, President of GSK Vaccines, added: “As the pandemic threat continues with the current dominant Delta variant and Omicron rapidly gaining ground, booster vaccines will continue to be needed to help protect people over time. The initial booster data are promising, and we await the phase III results to determine the next steps on making protein-based adjuvanted COVID-19 vaccines available.\"<blockquote>葛兰素史克疫苗总裁罗杰·康纳补充道：“随着大流行威胁的持续，目前占主导地位的德尔塔变异毒株和奥密克戎迅速取得进展，随着时间的推移，将继续需要加强疫苗来帮助保护人们。最初的加强数据很有希望，我们正在等待III期结果，以确定提供基于蛋白质的佐剂COVID-19疫苗的下一步措施。”</blockquote> In parallel, Sanofi continues its contribution to global public health needs with the manufacturing of up to half a billion doses from BioNTech/Pfizer, Moderna, and Johnson &amp; Johnson vaccines.<blockquote>与此同时，赛诺菲继续为全球公共卫生需求做出贡献，生产了多达5亿剂BioNTech/辉瑞、Moderna和强生疫苗。</blockquote> About the booster trial (VAT0002)<blockquote>关于加强试验（VAT0002）</blockquote> The VAT0002 extension trial is the most comprehensive heterologous booster trial conducted to date. In the first cohort of this trial, the four most-widely approved COVID-19 primary vaccines using mRNA and adenovirus vector technologies were boosted with the Sanofi/GSK protein-based adjuvanted vaccine candidate after full primary vaccination to assess its safety profile and immunogenicity.<blockquote>VAT0002扩展试验是迄今为止进行的最全面的异源加强试验。在该试验的第一个队列中，使用mRNA和腺病毒载体技术的四种最广泛批准的新冠肺炎初级疫苗在完全初级疫苗接种后用赛诺菲/GSK基于蛋白质的佐剂候选疫苗加强，以评估其安全性和免疫原性。</blockquote> Participants in the first cohort (n=521) had previously been vaccinated with the approved dosing schedule of an authorized COVID-19 mRNA vaccine (Moderna, Pfizer/BioNTech,) or adenovirus vector vaccine (AstraZeneca, Johnson &amp; Johnson,). This preliminary analysis includes data from trial participants who received one 5µg booster dose of the adjuvanted recombinant protein vaccine targeting the D614 parent virus, between four and ten months after a complete primary vaccination schedule.<blockquote>第一个队列（n=521）的参与者之前已经接种了授权的新冠肺炎mRNA疫苗（Moderna，辉瑞/BioNTech）或腺病毒载体疫苗（阿斯利康，强生）的批准给药方案。该初步分析包括试验参与者的数据，这些参与者在完成初级疫苗接种计划后4至10个月期间接受了一次5µg加强剂量的针对D614亲本病毒的佐剂重组蛋白疫苗。</blockquote> The trial is ongoing across sites in multiple countries, including the U.S., France, and the UK. To address the emergence of COVID-19 variants of concern, additional trial cohorts are assessing the boosting potential of monovalent and bivalent vaccine formulations also containing the Beta (B.1.351) variant. More data from this trial are expected during the first half of 2022. The Omicron variant was not circulating during the trial. Using sera from booster trial participants, testing is underway to establish the ability of the vaccine candidate to cross-neutralize against Omicron.<blockquote>该试验正在多个国家进行，包括美国、法国和英国。为了解决令人担忧的新冠肺炎变异体的出现，其他试验队列正在评估也含有β（B.1.351）变异体的单价和二价疫苗制剂的加强潜力。该试验的更多数据预计将在2022年上半年公布。奥密克戎变种在试验期间没有传播。使用加强试验参与者的血清，正在进行测试，以确定候选疫苗交叉中和奥密克戎病毒的能力。</blockquote> About the Phase 3 efficacy trial (VAT0008)<blockquote>关于3期疗效试验（VAT0008）</blockquote> The primary endpoint of this ongoing Phase 3, randomized, double-blind, placebo-controlled trial is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints of preventing severe COVID-19 disease and infection. Stage one of the trial is assessing the efficacy of a vaccine formulation containing the spike protein against the original D614 (parent) virus in more than 10,000 participants &gt;18 years of age, randomized to receive two doses of 10µg vaccine or placebo at day 1 and day 22 across sites in the US, Asia, Africa and Latin America. A second stage in the trial is evaluating a second bivalent formulation, adding the spike protein of the B.1.351 (Beta) variant.<blockquote>这项正在进行的3期、随机、双盲、安慰剂对照试验的主要终点是在新型冠状病毒初治成人中预防有症状的COVID-19，次要终点是预防严重的COVID-19疾病和感染。该试验的第一阶段正在评估含有刺突蛋白的疫苗制剂对原始D614（亲代）病毒的功效，超过10,000名年龄&gt;18岁的参与者随机接受两剂10µg疫苗或安慰剂在美国、亚洲、非洲和拉丁美洲的研究中心第1天和第22天。试验的第二阶段是评估第二种二价制剂，添加B.1.351（β）变体的刺突蛋白。</blockquote> These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002.<blockquote>这些努力得到了生物医学高级研究与发展局的联邦资金的支持，该局是美国负责准备和响应的助理部长办公室的一部分。卫生与公众服务部与美国合作。国防部化学、生物、辐射和核防御联合计划执行办公室，合同号为W15QKN-16-9-1002。</blockquote> About the Sanofi and GSK collaboration<blockquote>关于赛诺菲与葛兰素史克合作</blockquote> In the collaboration between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.<blockquote>在两家公司的合作中，赛诺菲提供其重组抗原，葛兰素史克提供其大流行佐剂，这两个已建立的疫苗平台已被证明在对抗流感方面是成功的。</blockquote> About GSK<blockquote>关于GSK</blockquote> GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally.<blockquote>葛兰素史克是一家以科学为主导的全球医疗保健公司，有着特殊的目标：帮助人们做得更多，感觉更好，活得更长。葛兰素史克是全球领先的疫苗制造商。</blockquote> About Sanofi<blockquote>关于赛诺菲</blockquote> Sanofi is dedicated to supporting people through their health challenges. It is a global biopharmaceutical company focused on human health. It prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. It stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.<blockquote>赛诺菲致力于支持人们应对健康挑战。是一家专注于人类健康的全球性生物制药公司。它通过疫苗预防疾病，提供创新的治疗方法来对抗疼痛和减轻痛苦。它支持少数患有罕见疾病的人和数百万患有长期慢性病的人。</blockquote> With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.<blockquote>赛诺菲在100个国家拥有超过100,000名员工，正在将科学创新转化为全球医疗保健解决方案。</blockquote>","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>Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation<blockquote>赛诺菲和葛兰素史克宣布其COVID-19候选疫苗的积极初步加强数据，并根据独立监测委员会的建议继续进行3期试验</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; 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}\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\">\nSanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation<blockquote>赛诺菲和葛兰素史克宣布其COVID-19候选疫苗的积极初步加强数据，并根据独立监测委员会的建议继续进行3期试验</blockquote>\n</h2>\n<h4 class=\"meta\">\n<a class=\"head\" href=\"https://laohu8.com/wemedia/1079075236\">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/8274c5b9d4c2852bfb1c4d6ce16c68ba);background-size:cover;\"></div>\n\n<div class=\"h-content\">\nTiger Newspress \n2021-12-15 15:14\n</div>\n</a>\n</h4>\n</header>\n<article>\nSanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation<blockquote>赛诺菲和葛兰素史克宣布其COVID-19候选疫苗的积极初步加强数据，并根据独立监测委员会的建议继续进行3期试验</blockquote> <ul> <li>Positive booster data show that neutralizing antibodies increased across all primary vaccines received (mRNA or adenovirus) in a 9- to 43-fold range and for all age groups tested, with a good safety and tolerability profile</li> <li>Phase 3 trial continues to accrue number of events needed for analysis as populations around the world are increasingly exposed to COVID-19 variants; results expected in Q1, 2022</li> <li>Companies intend to file booster data with regulatory authorities following the Phase 3 results</li> </ul> Sanofi and GSK announced today that a single booster dose of their recombinant adjuvanted COVID-19 vaccine candidate delivered consistently strong immune responses. Preliminary results from the VAT0002 clinical trial investigating the safety and immunogenicity of the booster showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson &amp; Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested. The booster was well tolerated, with a safety profile similar to currently approved COVID-19 vaccines. This is the most comprehensive booster trial to date to explore boosting across different vaccine technologies used for primary vaccination.<blockquote><ul><li>阳性加强剂数据显示，接受的所有初级疫苗（mRNA或腺病毒）中的中和抗体增加了9至43倍，并且对于所有测试的年龄组，具有良好的安全性和耐受性</li><li>随着世界各地的人群越来越多地暴露于新冠肺炎变种，3期试验继续增加分析所需的事件数量；预计2022年第一季度业绩</li><li>公司打算在第三阶段结果公布后向监管机构提交加强数据</li></ul>赛诺菲和葛兰素史克今天宣布，他们的重组佐剂新冠肺炎候选疫苗的单次加强剂量产生了持续强烈的免疫反应。调查加强剂安全性和免疫原性的VAT0002临床试验的初步结果显示，无论接受的初级疫苗（阿斯利康、强生、Moderna、辉瑞/BioNTech）和所有测试年龄组，中和抗体都增加了9至43倍。加强剂耐受性良好，安全性与目前批准的新冠肺炎疫苗相似。这是迄今为止最全面的加强试验，旨在探索用于初级疫苗接种的不同疫苗技术的加强。</blockquote> The ongoing global Phase 3 trial, VAT0008, includes regular reviews by an independent Data Safety Monitoring Board (DSMB). During its last review, the DSMB identified no safety concerns and recommended the trial to continue into early 2022 to accrue more data.<blockquote>正在进行的全球3期试验VAT0008包括独立数据安全监测委员会(DSMB)的定期审查。在上次审查中，DSMB没有发现任何安全问题，并建议试验继续到2022年初，以积累更多数据。</blockquote> Regulatory authorities require Phase 3 efficacy to be demonstrated in “naive” populations, i.e. participants who have never been infected by the COVID-19 virus (seronegative). The Phase 3 trial recruited most participants in Q3 2021, coinciding with a significant increase in the number of people infected by the COVID-19 virus globally due to the Delta variant. To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022.<blockquote>监管机构要求在“幼稚”人群中证明3期疗效，即从未感染过新冠肺炎病毒（血清阴性）的参与者。3期试验在2021年第三季度招募了大多数参与者，恰逢德尔塔变异毒株导致全球感染COVID-19病毒的人数大幅增加。为了向监管机构提供加强疫苗提交所需的数据，该试验将继续累积分析所需的事件数量，预计将于2022年第一季度得出结果。</blockquote> “These preliminary data show we have a strong booster candidate, whatever primary vaccine you have received.”said Thomas Triomphe, Executive Vice President, Sanofi Pasteur.“This is consistent with our efforts to provide relevantresponses to evolving public health needs. While pursuing a phase 3 trial is a challenge in a quickly shifting pandemic environment, we look forward to seeing the results to support submissions of our booster vaccine as quickly as possible.”<blockquote>“这些初步数据表明，无论您接种的是什么初级疫苗，我们都有一种强大的加强候选疫苗。”赛诺菲巴斯德执行副总裁Thomas Triomphe说道。“这与我们为不断变化的公共卫生需求提供相关响应的努力是一致的。虽然在快速变化的大流行环境中进行3期试验是一项挑战，但我们期待看到结果，以支持尽快提交我们的加强疫苗。”</blockquote> Roger Connor, President of GSK Vaccines, added: “As the pandemic threat continues with the current dominant Delta variant and Omicron rapidly gaining ground, booster vaccines will continue to be needed to help protect people over time. The initial booster data are promising, and we await the phase III results to determine the next steps on making protein-based adjuvanted COVID-19 vaccines available.\"<blockquote>葛兰素史克疫苗总裁罗杰·康纳补充道：“随着大流行威胁的持续，目前占主导地位的德尔塔变异毒株和奥密克戎迅速取得进展，随着时间的推移，将继续需要加强疫苗来帮助保护人们。最初的加强数据很有希望，我们正在等待III期结果，以确定提供基于蛋白质的佐剂COVID-19疫苗的下一步措施。”</blockquote> In parallel, Sanofi continues its contribution to global public health needs with the manufacturing of up to half a billion doses from BioNTech/Pfizer, Moderna, and Johnson &amp; Johnson vaccines.<blockquote>与此同时，赛诺菲继续为全球公共卫生需求做出贡献，生产了多达5亿剂BioNTech/辉瑞、Moderna和强生疫苗。</blockquote> About the booster trial (VAT0002)<blockquote>关于加强试验（VAT0002）</blockquote> The VAT0002 extension trial is the most comprehensive heterologous booster trial conducted to date. In the first cohort of this trial, the four most-widely approved COVID-19 primary vaccines using mRNA and adenovirus vector technologies were boosted with the Sanofi/GSK protein-based adjuvanted vaccine candidate after full primary vaccination to assess its safety profile and immunogenicity.<blockquote>VAT0002扩展试验是迄今为止进行的最全面的异源加强试验。在该试验的第一个队列中，使用mRNA和腺病毒载体技术的四种最广泛批准的新冠肺炎初级疫苗在完全初级疫苗接种后用赛诺菲/GSK基于蛋白质的佐剂候选疫苗加强，以评估其安全性和免疫原性。</blockquote> Participants in the first cohort (n=521) had previously been vaccinated with the approved dosing schedule of an authorized COVID-19 mRNA vaccine (Moderna, Pfizer/BioNTech,) or adenovirus vector vaccine (AstraZeneca, Johnson &amp; Johnson,). This preliminary analysis includes data from trial participants who received one 5µg booster dose of the adjuvanted recombinant protein vaccine targeting the D614 parent virus, between four and ten months after a complete primary vaccination schedule.<blockquote>第一个队列（n=521）的参与者之前已经接种了授权的新冠肺炎mRNA疫苗（Moderna，辉瑞/BioNTech）或腺病毒载体疫苗（阿斯利康，强生）的批准给药方案。该初步分析包括试验参与者的数据，这些参与者在完成初级疫苗接种计划后4至10个月期间接受了一次5µg加强剂量的针对D614亲本病毒的佐剂重组蛋白疫苗。</blockquote> The trial is ongoing across sites in multiple countries, including the U.S., France, and the UK. To address the emergence of COVID-19 variants of concern, additional trial cohorts are assessing the boosting potential of monovalent and bivalent vaccine formulations also containing the Beta (B.1.351) variant. More data from this trial are expected during the first half of 2022. The Omicron variant was not circulating during the trial. Using sera from booster trial participants, testing is underway to establish the ability of the vaccine candidate to cross-neutralize against Omicron.<blockquote>该试验正在多个国家进行，包括美国、法国和英国。为了解决令人担忧的新冠肺炎变异体的出现，其他试验队列正在评估也含有β（B.1.351）变异体的单价和二价疫苗制剂的加强潜力。该试验的更多数据预计将在2022年上半年公布。奥密克戎变种在试验期间没有传播。使用加强试验参与者的血清，正在进行测试，以确定候选疫苗交叉中和奥密克戎病毒的能力。</blockquote> About the Phase 3 efficacy trial (VAT0008)<blockquote>关于3期疗效试验（VAT0008）</blockquote> The primary endpoint of this ongoing Phase 3, randomized, double-blind, placebo-controlled trial is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints of preventing severe COVID-19 disease and infection. Stage one of the trial is assessing the efficacy of a vaccine formulation containing the spike protein against the original D614 (parent) virus in more than 10,000 participants &gt;18 years of age, randomized to receive two doses of 10µg vaccine or placebo at day 1 and day 22 across sites in the US, Asia, Africa and Latin America. A second stage in the trial is evaluating a second bivalent formulation, adding the spike protein of the B.1.351 (Beta) variant.<blockquote>这项正在进行的3期、随机、双盲、安慰剂对照试验的主要终点是在新型冠状病毒初治成人中预防有症状的COVID-19，次要终点是预防严重的COVID-19疾病和感染。该试验的第一阶段正在评估含有刺突蛋白的疫苗制剂对原始D614（亲代）病毒的功效，超过10,000名年龄&gt;18岁的参与者随机接受两剂10µg疫苗或安慰剂在美国、亚洲、非洲和拉丁美洲的研究中心第1天和第22天。试验的第二阶段是评估第二种二价制剂，添加B.1.351（β）变体的刺突蛋白。</blockquote> These efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002.<blockquote>这些努力得到了生物医学高级研究与发展局的联邦资金的支持，该局是美国负责准备和响应的助理部长办公室的一部分。卫生与公众服务部与美国合作。国防部化学、生物、辐射和核防御联合计划执行办公室，合同号为W15QKN-16-9-1002。</blockquote> About the Sanofi and GSK collaboration<blockquote>关于赛诺菲与葛兰素史克合作</blockquote> In the collaboration between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.<blockquote>在两家公司的合作中，赛诺菲提供其重组抗原，葛兰素史克提供其大流行佐剂，这两个已建立的疫苗平台已被证明在对抗流感方面是成功的。</blockquote> About GSK<blockquote>关于GSK</blockquote> GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally.<blockquote>葛兰素史克是一家以科学为主导的全球医疗保健公司，有着特殊的目标：帮助人们做得更多，感觉更好，活得更长。葛兰素史克是全球领先的疫苗制造商。</blockquote> About Sanofi<blockquote>关于赛诺菲</blockquote> Sanofi is dedicated to supporting people through their health challenges. It is a global biopharmaceutical company focused on human health. It prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. It stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.<blockquote>赛诺菲致力于支持人们应对健康挑战。是一家专注于人类健康的全球性生物制药公司。它通过疫苗预防疾病，提供创新的治疗方法来对抗疼痛和减轻痛苦。它支持少数患有罕见疾病的人和数百万患有长期慢性病的人。</blockquote> With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.<blockquote>赛诺菲在100个国家拥有超过100,000名员工，正在将科学创新转化为全球医疗保健解决方案。</blockquote>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"SNY":"赛诺菲安万特","GSK":"葛兰素史克"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1107549050","content_text":"Sanofi and GSK announce positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial per independent Monitoring Board recommendation\n\nPositive booster data show that neutralizing antibodies increased across all primary vaccines received (mRNA or adenovirus) in a 9- to 43-fold range and for all age groups tested, with a good safety and tolerability profile\nPhase 3 trial continues to accrue number of events needed for analysis as populations around the world are increasingly exposed to COVID-19 variants; results expected in Q1, 2022\nCompanies intend to file booster data with regulatory authorities following the Phase 3 results\n\nSanofi and GSK announced today that a single booster dose of their recombinant adjuvanted COVID-19 vaccine candidate delivered consistently strong immune responses. Preliminary results from the VAT0002 clinical trial investigating the safety and immunogenicity of the booster showed neutralizing antibodies increased 9- to 43-fold regardless of the primary vaccine received (AstraZeneca, Johnson & Johnson, Moderna, Pfizer/BioNTech) and for all age groups tested. The booster was well tolerated, with a safety profile similar to currently approved COVID-19 vaccines. This is the most comprehensive booster trial to date to explore boosting across different vaccine technologies used for primary vaccination.\nThe ongoing global Phase 3 trial, VAT0008, includes regular reviews by an independent Data Safety Monitoring Board (DSMB). During its last review, the DSMB identified no safety concerns and recommended the trial to continue into early 2022 to accrue more data.\nRegulatory authorities require Phase 3 efficacy to be demonstrated in “naive” populations, i.e. participants who have never been infected by the COVID-19 virus (seronegative). The Phase 3 trial recruited most participants in Q3 2021, coinciding with a significant increase in the number of people infected by the COVID-19 virus globally due to the Delta variant. To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022.\n“These preliminary data show we have a strong booster candidate, whatever primary vaccine you have received.”said Thomas Triomphe, Executive Vice President, Sanofi Pasteur.“This is consistent with our efforts to provide relevantresponses to evolving public health needs. While pursuing a phase 3 trial is a challenge in a quickly shifting pandemic environment, we look forward to seeing the results to support submissions of our booster vaccine as quickly as possible.”\nRoger Connor, President of GSK Vaccines, added: “As the pandemic threat continues with the current dominant Delta variant and Omicron rapidly gaining ground, booster vaccines will continue to be needed to help protect people over time. The initial booster data are promising, and we await the phase III results to determine the next steps on making protein-based adjuvanted COVID-19 vaccines available.\"\nIn parallel, Sanofi continues its contribution to global public health needs with the manufacturing of up to half a billion doses from BioNTech/Pfizer, Moderna, and Johnson & Johnson vaccines.\nAbout the booster trial (VAT0002)\nThe VAT0002 extension trial is the most comprehensive heterologous booster trial conducted to date. In the first cohort of this trial, the four most-widely approved COVID-19 primary vaccines using mRNA and adenovirus vector technologies were boosted with the Sanofi/GSK protein-based adjuvanted vaccine candidate after full primary vaccination to assess its safety profile and immunogenicity.\nParticipants in the first cohort (n=521) had previously been vaccinated with the approved dosing schedule of an authorized COVID-19 mRNA vaccine (Moderna, Pfizer/BioNTech,) or adenovirus vector vaccine (AstraZeneca, Johnson & Johnson,). This preliminary analysis includes data from trial participants who received one 5µg booster dose of the adjuvanted recombinant protein vaccine targeting the D614 parent virus, between four and ten months after a complete primary vaccination schedule.\nThe trial is ongoing across sites in multiple countries, including the U.S., France, and the UK. To address the emergence of COVID-19 variants of concern, additional trial cohorts are assessing the boosting potential of monovalent and bivalent vaccine formulations also containing the Beta (B.1.351) variant. More data from this trial are expected during the first half of 2022. The Omicron variant was not circulating during the trial. Using sera from booster trial participants, testing is underway to establish the ability of the vaccine candidate to cross-neutralize against Omicron.\nAbout the Phase 3 efficacy trial (VAT0008)\nThe primary endpoint of this ongoing Phase 3, randomized, double-blind, placebo-controlled trial is the prevention of symptomatic COVID-19 in SARS-CoV-2 naïve adults, with secondary endpoints of preventing severe COVID-19 disease and infection. Stage one of the trial is assessing the efficacy of a vaccine formulation containing the spike protein against the original D614 (parent) virus in more than 10,000 participants >18 years of age, randomized to receive two doses of 10µg vaccine or placebo at day 1 and day 22 across sites in the US, Asia, Africa and Latin America. A second stage in the trial is evaluating a second bivalent formulation, adding the spike protein of the B.1.351 (Beta) variant.\nThese efforts are supported by federal funds from the Biomedical Advanced Research and Development Authority, part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense under Contract # W15QKN-16-9-1002.\nAbout the Sanofi and GSK collaboration\nIn the collaboration between the two companies, Sanofi provides its recombinant antigen and GSK contributes its pandemic adjuvant, both established vaccine platforms that have proven successful against influenza.\nAbout GSK\nGSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally.\nAbout Sanofi\nSanofi is dedicated to supporting people through their health challenges. It is a global biopharmaceutical company focused on human health. It prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. It stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.\nWith more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.","news_type":1,"symbols_score_info":{"SNY":0.9,"GSK":0.9}},"isVote":1,"tweetType":1,"viewCount":801,"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":4,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"isCommentEnd":true,"isTiger":false,"isWeiXinMini":false,"url":"/m/post/607593319"}