March_m
2021-06-15
Sounds like a good vaccine
Novavax Vs. Pfizer Vs. Moderna: How COVID-19 Vaccines Stack Up<blockquote>Novavax、辉瑞、Moderna:COVID-19 疫苗如何叠加</blockquote>
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Pfizer Vs. Moderna: How COVID-19 Vaccines Stack Up<blockquote>Novavax、辉瑞、Moderna:COVID-19 疫苗如何叠加</blockquote>","url":"https://stock-news.laohu8.com/highlight/detail?id=1167457915","media":"Benzinga Earnings","summary":"It was \"better late than never\" for Novavax, Inc.NVAX, as the biopharma finally got around to announ","content":"<p>It was \"better late than never\" for <b>Novavax, Inc.</b>NVAX, as the biopharma finally got around to announcing interim results from the U.S. and Mexico leg of the Phase 3 study of NVX-CoV2371, its vaccine candidate against the novel coronavirus.</p><p><blockquote>“迟到总比不到好”<b>诺瓦瓦克斯公司。</b>NVAX,这家生物制药公司终于宣布了其针对新型冠状病毒的候选疫苗 NVX-CoV2371 的 3 期研究在美国和墨西哥的中期结果。</blockquote></p><p> Here's a comparative perspective of the vaccine candidates from Novavax, and the frontrunners, namely<b>Pfizer Inc.</b>PFE 0.05%-<b>BioNTech SE</b>BNTXand<b>Moderna, Inc.</b>MRNA, both of which have authorized vaccines in the market.</p><p><blockquote>以下是 Novavax 候选疫苗和领先者的比较视角,即<b>辉瑞公司。</b>PFE 0.05%-<b>生物科技公司</b>BNTXand<b>现代公司。</b>MRNA,两者都有市场上的授权疫苗。</blockquote></p><p> <b>Vaccine Type:</b> Novavax's NVX-CoV2371 is a recombinant nano-particle protein-based COVID-19 vaccine that is packaged with the company's proprietary Matrix-M adjuvant.</p><p><blockquote><b>疫苗类型:</b>Novavax 的 NVX-CoV2371 是一种基于重组纳米颗粒蛋白的 COVID-19 疫苗,包装有该公司专有的 Matrix-M 佐剂。</blockquote></p><p> The Pfizer-BioNTech and Moderna products are mRNA vaccines, or modern vaccines that work by using a genetic code called mRNA that instructs our immune cells to make spike protein, which is found on the surface of the virus that causes COVID-19.</p><p><blockquote>辉瑞-BioNTech和Moderna的产品是mRNA疫苗,或现代疫苗,通过使用一种称为mRNA的遗传密码来工作,这种密码指示我们的免疫细胞制造刺突蛋白,刺突蛋白存在于导致新冠肺炎的病毒表面。</blockquote></p><p> This spike protein, though harmless, is capable of triggering our immune system to produce antibodies that offer protection against future infection.</p><p><blockquote>这种刺突蛋白虽然无害,但能够触发我们的免疫系统产生抗体,防止未来的感染。</blockquote></p><p> Novavax's vaccine is a protein adjuvant that contains the spike protein of the coronavirus itself, but formulated as a nanoparticle that cannot cause disease. The injected vaccine then stimulates the immune system to produce antibodies and T-cell immune responses.</p><p><blockquote>Novavax的疫苗是一种蛋白质佐剂,含有冠状病毒本身的刺突蛋白,但配制成不会致病的纳米颗粒。然后,注射的疫苗刺激免疫系统产生抗体和T细胞免疫反应。</blockquote></p><p> <b>The Vaccine Doses:</b> The vaccines from each of the three companies require two doses. Each dose consists of 30 mcg for Pfizer and 100 mcg for Moderna, while for Novavax, each vaccine dose consists of 5 mcg of NVX-CoV2371 and 50 mcg of Matrix-M1 adjuvant that are co-formulated.</p><p><blockquote><b>疫苗剂量:</b>这三家公司的疫苗都需要两剂。辉瑞的每剂疫苗由30微克和Moderna的100微克组成,而Novavax的每剂疫苗由5微克NVX-CoV2371和50微克Matrix-M1佐剂组成,它们是共同配制的。</blockquote></p><p> The interval between the two doses — the priming and booster dose — is 21 days each for Pfizer and Novavax and 28 days for Moderna.</p><p><blockquote>辉瑞和Novavax两种剂量(启动剂量和加强剂量)之间的间隔分别为21天,Moderna为28天。</blockquote></p><p> <b>The Target Population:</b> The original late-stage trial of Pfizer-BioNTech evaluated the vaccine in participants ages 16 years and older. The trial enrolled 43,448 participants.</p><p><blockquote><b>目标人群:</b>辉瑞-BioNTech最初的后期试验在16岁及以上的参与者中评估了疫苗。该试验招募了43,448名参与者。</blockquote></p><p> Moderna'sPhase 3 COVE study enrolled 30,000 participants ages 18 years and up.</p><p><blockquote>Moderna的第三阶段COVE研究招募了30,000名18岁及以上的参与者。</blockquote></p><p> Since then, these two companies have obtained authorizations for their respective vaccines to be used in adolescents.</p><p><blockquote>此后,这两家公司获得了各自疫苗用于青少年的授权。</blockquote></p><p> Bothcompanieshave also initiated studies in the pediatric population.</p><p><blockquote>两家公司还启动了儿科人群的研究。</blockquote></p><p> Novavax's study enrolled 29,960 participants 18 years of age and older across 119 sites in the U.S. and Mexico. The placebo-controlled portion of PREVENT-19 continues in adolescents from 12 to less than 18 years of age and recently completed enrollment with 2,248 participants.</p><p><blockquote>Novavax 的研究招募了美国和墨西哥 119 个地点的 29,960 名 18 岁及以上的参与者。PREVENT-19的安慰剂对照部分继续在12至18岁以下的青少年中进行,最近完成了2,248名参与者的入组。</blockquote></p><p> <b>Vaccine Logistics:</b> Pfizer recently secured FDA authorization for storing undiluted, thawed vaccine vials in the refrigerator at 2°C to 8°C for up to one month.</p><p><blockquote><b>疫苗物流:</b>辉瑞最近获得了FDA的授权,可以在2°C至8°C的冰箱中储存未稀释、解冻的疫苗小瓶长达一个月。</blockquote></p><p> Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days. Moderna's vaccine can be stored refrigerated between 2° and 8°C for up to 30 days prior to first use.</p><p><blockquote>以前,解冻的未稀释的疫苗小瓶可以在冰箱中储存长达五天。在首次使用前,Moderna的疫苗可以在2°C至8°C之间冷藏储存长达30天。</blockquote></p><p> NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.</p><p><blockquote>NVX-CoV2373在2°-8°C下储存并稳定,允许使用现有的疫苗供应链渠道进行分销。它包装在10剂小瓶中的即用型液体制剂中。</blockquote></p><p> <b>Vaccine Efficacy:</b> Interim data from Pfizer-BioNTech's Phase 3 trials released in December showed the vaccine was well-tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection seven days or more after the second dose. Updated top-line results released for up to six months after the second dose confirmed efficacy at 91.3%.</p><p><blockquote><b>疫苗效力:</b>辉瑞-BioNTech 于 12 月发布的 3 期试验的中期数据显示,该疫苗耐受性良好,并在第二剂疫苗接种后 7 天或更长时间内,在先前未感染的人群中预防 COVID-19 的功效为 95%。第二次给药后长达六个月的更新顶线结果确认疗效为91.3%。</blockquote></p><p> The vaccine was found 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention, and 95.3% effective against severe COVID-19 as defined by the FDA. It was also proved effective against the U.K. strain in lab studies.</p><p><blockquote>发现该疫苗对美国疾病控制和预防中心定义的严重疾病100%有效,对FDA定义的严重新冠肺炎有效95.3%。在实验室研究中,它还被证明对英国菌株有效。</blockquote></p><p> Moderna's vaccine showed efficacy of 94.1% against COVID-19. The company announced in May initial data from its Phase 2 study showing that a single 50 mcg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351, first identified in South Africa, and P.1, first identified in Brazil.</p><p><blockquote>Moderna 的疫苗对 COVID-19 的有效率为 94.1%。该公司于 5 月份宣布了其 2 期研究的初步数据,显示单次 50 微克剂量的 mRNA-1273 或 mRNA-1273.351 作为加强剂给予先前接种疫苗的个体,可增加针对 SARS-CoV-2 和两种令人担忧的变体的中和抗体滴度反应,B.1.351 首先在南非发现,P.1 首先在巴西发现。</blockquote></p><p> Novavax's investigational vaccine demonstrated 100% protection against moderate and severe disease not involving variants of concern or variants of interest.</p><p><blockquote>Novavax的研究性疫苗证明了对不涉及关注变异或感兴趣变异的中度和重度疾病的100%保护。</blockquote></p><p> Against variants of concern and variants of interest, the efficacy was 93.2% and in high-risk populations, defined as over 65 or under 65 years with certain comorbidities or having circumstances with frequent COVID-19 exposure, the efficacy was 91%.</p><p><blockquote>针对关注变异和关注变异,疗效为93.2%,在高危人群(定义为65岁以上或65岁以下患有某些合并症或频繁接触新冠肺炎的情况)中,疗效为91%。</blockquote></p><p> Overall efficacy was 90.4%, meeting the primary endpoint.</p><p><blockquote>总有效率为90.4%,符合主要终点。</blockquote></p><p></p><p> <b>Cantor Fitzgerald On Novavax's Vaccine:</b>A differentiating factor for NVX-2373 is that it showed vaccine efficacy of 93.2% against VoC/VoI, which demonstrates protection across a broad range of SARS-CoV-2 strains, Cantor Fitzgerald analyst Charles Duncan said in a Monday morning note.</p><p><blockquote><b>Cantor Fitzgerald 谈 Novavax 疫苗:</b>Cantor Fitzgerald 分析师 Charles Duncan 在周一上午的一份报告中表示,NVX-2373 的一个与众不同的因素是,它对 VoC/VoI 的疫苗效力为 93.2%,这证明了对多种 SARS-CoV-2 毒株的保护作用。</blockquote></p><p> \"Overall, these results enhance our conviction for a differentiated clinical and logistics profile from the SARS-CoV-2 vaccine candidate ‘2373,\" the analyst said.</p><p><blockquote>“总的来说,这些结果增强了我们对新型冠状病毒候选疫苗‘2373’不同临床和后勤特征的信念,”这位分析师说。</blockquote></p><p> Showing efficacy against new strains in two Phase 3 clinical trials, rather than extrapolating potential efficacy from a neutralizing antibody assay conducted in a petri dish, differentiates NVX-CoV2373 from other vaccines that have emergency use authorization, he said.</p><p><blockquote>他说,在两项 3 期临床试验中显示对新毒株的功效,而不是从培养皿中进行的中和抗体测定中推断潜在功效,这将 NVX-CoV2373 与其他获得紧急使用授权的疫苗区分开来。</blockquote></p><p> This profile, according to Cantor reduces regulatory/ commercial risk for the ‘2373 SARS-CoV-2 prophylactic vaccine candidate and, with positive Phase 3 data for NanoFlu reported in March 2020, should raise the profile for Novavax's platform as a whole.</p><p><blockquote>根据Cantor的说法,这一概况降低了2373新型冠状病毒预防性候选疫苗的监管/商业风险,并且随着2020年3月报告的NanoFlu的积极3期数据,应该会提高Novavax平台的整体形象。</blockquote></p><p> <b>Vaccine Safety Data:</b>Pfizer-BioNTech's vaccine showed a favorable tolerability and safety profile, with the most common adverse events from BNT162b2 being transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days.</p><p><blockquote><b>疫苗安全性数据:</b>辉瑞-BioNTech的疫苗显示出良好的耐受性和安全性,BNT162b2最常见的不良事件是短暂的,注射部位轻度至中度疼痛、疲劳和头痛,这些通常在两天内消失。</blockquote></p><p> For Moderna, the most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.</p><p><blockquote>对于Moderna,最常见的不良反应包括注射部位疼痛、疲劳、肌痛、关节痛、头痛和注射部位红斑/发红。在第二次给药后,mRNA-1273组中征集的不良反应的频率和严重程度增加。</blockquote></p><p> Preliminary safety data from Novavax's trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.</p><p><blockquote>Novavax试验的初步安全性数据显示,该疫苗通常具有良好的耐受性。严重和严重不良事件数量较少,疫苗组和安慰剂组之间保持平衡。</blockquote></p><p> In assessing reactogenicity seven days after dose one and dose two, injection site pain and tenderness, generally mild to moderate in severity, were the most common local symptoms, lasting less than three days. Fatigue, headache and muscle pain were the most common systemic symptoms, lasting less than two days.</p><p><blockquote>在第1次和第2次给药后7天评估反应原性时,注射部位疼痛和压痛(严重程度通常为轻度至中度)是最常见的局部症状,持续时间少于3天。疲劳、头痛和肌肉疼痛是最常见的全身症状,持续不到两天。</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>Novavax Vs. Pfizer Vs. Moderna: How COVID-19 Vaccines Stack Up<blockquote>Novavax、辉瑞、Moderna:COVID-19 疫苗如何叠加</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\">\nNovavax Vs. Pfizer Vs. Moderna: How COVID-19 Vaccines Stack Up<blockquote>Novavax、辉瑞、Moderna:COVID-19 疫苗如何叠加</blockquote>\n</h2>\n<h4 class=\"meta\">\n<div class=\"head\" \">\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/d08bf7808052c0ca9deb4e944cae32aa);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Benzinga Earnings </p>\n<p class=\"h-time smaller\">2021-06-15 17:52</p>\n</div>\n</div>\n</h4>\n</header>\n<article>\n<p>It was \"better late than never\" for <b>Novavax, Inc.</b>NVAX, as the biopharma finally got around to announcing interim results from the U.S. and Mexico leg of the Phase 3 study of NVX-CoV2371, its vaccine candidate against the novel coronavirus.</p><p><blockquote>“迟到总比不到好”<b>诺瓦瓦克斯公司。</b>NVAX,这家生物制药公司终于宣布了其针对新型冠状病毒的候选疫苗 NVX-CoV2371 的 3 期研究在美国和墨西哥的中期结果。</blockquote></p><p> Here's a comparative perspective of the vaccine candidates from Novavax, and the frontrunners, namely<b>Pfizer Inc.</b>PFE 0.05%-<b>BioNTech SE</b>BNTXand<b>Moderna, Inc.</b>MRNA, both of which have authorized vaccines in the market.</p><p><blockquote>以下是 Novavax 候选疫苗和领先者的比较视角,即<b>辉瑞公司。</b>PFE 0.05%-<b>生物科技公司</b>BNTXand<b>现代公司。</b>MRNA,两者都有市场上的授权疫苗。</blockquote></p><p> <b>Vaccine Type:</b> Novavax's NVX-CoV2371 is a recombinant nano-particle protein-based COVID-19 vaccine that is packaged with the company's proprietary Matrix-M adjuvant.</p><p><blockquote><b>疫苗类型:</b>Novavax 的 NVX-CoV2371 是一种基于重组纳米颗粒蛋白的 COVID-19 疫苗,包装有该公司专有的 Matrix-M 佐剂。</blockquote></p><p> The Pfizer-BioNTech and Moderna products are mRNA vaccines, or modern vaccines that work by using a genetic code called mRNA that instructs our immune cells to make spike protein, which is found on the surface of the virus that causes COVID-19.</p><p><blockquote>辉瑞-BioNTech和Moderna的产品是mRNA疫苗,或现代疫苗,通过使用一种称为mRNA的遗传密码来工作,这种密码指示我们的免疫细胞制造刺突蛋白,刺突蛋白存在于导致新冠肺炎的病毒表面。</blockquote></p><p> This spike protein, though harmless, is capable of triggering our immune system to produce antibodies that offer protection against future infection.</p><p><blockquote>这种刺突蛋白虽然无害,但能够触发我们的免疫系统产生抗体,防止未来的感染。</blockquote></p><p> Novavax's vaccine is a protein adjuvant that contains the spike protein of the coronavirus itself, but formulated as a nanoparticle that cannot cause disease. The injected vaccine then stimulates the immune system to produce antibodies and T-cell immune responses.</p><p><blockquote>Novavax的疫苗是一种蛋白质佐剂,含有冠状病毒本身的刺突蛋白,但配制成不会致病的纳米颗粒。然后,注射的疫苗刺激免疫系统产生抗体和T细胞免疫反应。</blockquote></p><p> <b>The Vaccine Doses:</b> The vaccines from each of the three companies require two doses. Each dose consists of 30 mcg for Pfizer and 100 mcg for Moderna, while for Novavax, each vaccine dose consists of 5 mcg of NVX-CoV2371 and 50 mcg of Matrix-M1 adjuvant that are co-formulated.</p><p><blockquote><b>疫苗剂量:</b>这三家公司的疫苗都需要两剂。辉瑞的每剂疫苗由30微克和Moderna的100微克组成,而Novavax的每剂疫苗由5微克NVX-CoV2371和50微克Matrix-M1佐剂组成,它们是共同配制的。</blockquote></p><p> The interval between the two doses — the priming and booster dose — is 21 days each for Pfizer and Novavax and 28 days for Moderna.</p><p><blockquote>辉瑞和Novavax两种剂量(启动剂量和加强剂量)之间的间隔分别为21天,Moderna为28天。</blockquote></p><p> <b>The Target Population:</b> The original late-stage trial of Pfizer-BioNTech evaluated the vaccine in participants ages 16 years and older. The trial enrolled 43,448 participants.</p><p><blockquote><b>目标人群:</b>辉瑞-BioNTech最初的后期试验在16岁及以上的参与者中评估了疫苗。该试验招募了43,448名参与者。</blockquote></p><p> Moderna'sPhase 3 COVE study enrolled 30,000 participants ages 18 years and up.</p><p><blockquote>Moderna的第三阶段COVE研究招募了30,000名18岁及以上的参与者。</blockquote></p><p> Since then, these two companies have obtained authorizations for their respective vaccines to be used in adolescents.</p><p><blockquote>此后,这两家公司获得了各自疫苗用于青少年的授权。</blockquote></p><p> Bothcompanieshave also initiated studies in the pediatric population.</p><p><blockquote>两家公司还启动了儿科人群的研究。</blockquote></p><p> Novavax's study enrolled 29,960 participants 18 years of age and older across 119 sites in the U.S. and Mexico. The placebo-controlled portion of PREVENT-19 continues in adolescents from 12 to less than 18 years of age and recently completed enrollment with 2,248 participants.</p><p><blockquote>Novavax 的研究招募了美国和墨西哥 119 个地点的 29,960 名 18 岁及以上的参与者。PREVENT-19的安慰剂对照部分继续在12至18岁以下的青少年中进行,最近完成了2,248名参与者的入组。</blockquote></p><p> <b>Vaccine Logistics:</b> Pfizer recently secured FDA authorization for storing undiluted, thawed vaccine vials in the refrigerator at 2°C to 8°C for up to one month.</p><p><blockquote><b>疫苗物流:</b>辉瑞最近获得了FDA的授权,可以在2°C至8°C的冰箱中储存未稀释、解冻的疫苗小瓶长达一个月。</blockquote></p><p> Previously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days. Moderna's vaccine can be stored refrigerated between 2° and 8°C for up to 30 days prior to first use.</p><p><blockquote>以前,解冻的未稀释的疫苗小瓶可以在冰箱中储存长达五天。在首次使用前,Moderna的疫苗可以在2°C至8°C之间冷藏储存长达30天。</blockquote></p><p> NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.</p><p><blockquote>NVX-CoV2373在2°-8°C下储存并稳定,允许使用现有的疫苗供应链渠道进行分销。它包装在10剂小瓶中的即用型液体制剂中。</blockquote></p><p> <b>Vaccine Efficacy:</b> Interim data from Pfizer-BioNTech's Phase 3 trials released in December showed the vaccine was well-tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection seven days or more after the second dose. Updated top-line results released for up to six months after the second dose confirmed efficacy at 91.3%.</p><p><blockquote><b>疫苗效力:</b>辉瑞-BioNTech 于 12 月发布的 3 期试验的中期数据显示,该疫苗耐受性良好,并在第二剂疫苗接种后 7 天或更长时间内,在先前未感染的人群中预防 COVID-19 的功效为 95%。第二次给药后长达六个月的更新顶线结果确认疗效为91.3%。</blockquote></p><p> The vaccine was found 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention, and 95.3% effective against severe COVID-19 as defined by the FDA. It was also proved effective against the U.K. strain in lab studies.</p><p><blockquote>发现该疫苗对美国疾病控制和预防中心定义的严重疾病100%有效,对FDA定义的严重新冠肺炎有效95.3%。在实验室研究中,它还被证明对英国菌株有效。</blockquote></p><p> Moderna's vaccine showed efficacy of 94.1% against COVID-19. The company announced in May initial data from its Phase 2 study showing that a single 50 mcg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351, first identified in South Africa, and P.1, first identified in Brazil.</p><p><blockquote>Moderna 的疫苗对 COVID-19 的有效率为 94.1%。该公司于 5 月份宣布了其 2 期研究的初步数据,显示单次 50 微克剂量的 mRNA-1273 或 mRNA-1273.351 作为加强剂给予先前接种疫苗的个体,可增加针对 SARS-CoV-2 和两种令人担忧的变体的中和抗体滴度反应,B.1.351 首先在南非发现,P.1 首先在巴西发现。</blockquote></p><p> Novavax's investigational vaccine demonstrated 100% protection against moderate and severe disease not involving variants of concern or variants of interest.</p><p><blockquote>Novavax的研究性疫苗证明了对不涉及关注变异或感兴趣变异的中度和重度疾病的100%保护。</blockquote></p><p> Against variants of concern and variants of interest, the efficacy was 93.2% and in high-risk populations, defined as over 65 or under 65 years with certain comorbidities or having circumstances with frequent COVID-19 exposure, the efficacy was 91%.</p><p><blockquote>针对关注变异和关注变异,疗效为93.2%,在高危人群(定义为65岁以上或65岁以下患有某些合并症或频繁接触新冠肺炎的情况)中,疗效为91%。</blockquote></p><p> Overall efficacy was 90.4%, meeting the primary endpoint.</p><p><blockquote>总有效率为90.4%,符合主要终点。</blockquote></p><p></p><p> <b>Cantor Fitzgerald On Novavax's Vaccine:</b>A differentiating factor for NVX-2373 is that it showed vaccine efficacy of 93.2% against VoC/VoI, which demonstrates protection across a broad range of SARS-CoV-2 strains, Cantor Fitzgerald analyst Charles Duncan said in a Monday morning note.</p><p><blockquote><b>Cantor Fitzgerald 谈 Novavax 疫苗:</b>Cantor Fitzgerald 分析师 Charles Duncan 在周一上午的一份报告中表示,NVX-2373 的一个与众不同的因素是,它对 VoC/VoI 的疫苗效力为 93.2%,这证明了对多种 SARS-CoV-2 毒株的保护作用。</blockquote></p><p> \"Overall, these results enhance our conviction for a differentiated clinical and logistics profile from the SARS-CoV-2 vaccine candidate ‘2373,\" the analyst said.</p><p><blockquote>“总的来说,这些结果增强了我们对新型冠状病毒候选疫苗‘2373’不同临床和后勤特征的信念,”这位分析师说。</blockquote></p><p> Showing efficacy against new strains in two Phase 3 clinical trials, rather than extrapolating potential efficacy from a neutralizing antibody assay conducted in a petri dish, differentiates NVX-CoV2373 from other vaccines that have emergency use authorization, he said.</p><p><blockquote>他说,在两项 3 期临床试验中显示对新毒株的功效,而不是从培养皿中进行的中和抗体测定中推断潜在功效,这将 NVX-CoV2373 与其他获得紧急使用授权的疫苗区分开来。</blockquote></p><p> This profile, according to Cantor reduces regulatory/ commercial risk for the ‘2373 SARS-CoV-2 prophylactic vaccine candidate and, with positive Phase 3 data for NanoFlu reported in March 2020, should raise the profile for Novavax's platform as a whole.</p><p><blockquote>根据Cantor的说法,这一概况降低了2373新型冠状病毒预防性候选疫苗的监管/商业风险,并且随着2020年3月报告的NanoFlu的积极3期数据,应该会提高Novavax平台的整体形象。</blockquote></p><p> <b>Vaccine Safety Data:</b>Pfizer-BioNTech's vaccine showed a favorable tolerability and safety profile, with the most common adverse events from BNT162b2 being transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days.</p><p><blockquote><b>疫苗安全性数据:</b>辉瑞-BioNTech的疫苗显示出良好的耐受性和安全性,BNT162b2最常见的不良事件是短暂的,注射部位轻度至中度疼痛、疲劳和头痛,这些通常在两天内消失。</blockquote></p><p> For Moderna, the most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.</p><p><blockquote>对于Moderna,最常见的不良反应包括注射部位疼痛、疲劳、肌痛、关节痛、头痛和注射部位红斑/发红。在第二次给药后,mRNA-1273组中征集的不良反应的频率和严重程度增加。</blockquote></p><p> Preliminary safety data from Novavax's trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.</p><p><blockquote>Novavax试验的初步安全性数据显示,该疫苗通常具有良好的耐受性。严重和严重不良事件数量较少,疫苗组和安慰剂组之间保持平衡。</blockquote></p><p> In assessing reactogenicity seven days after dose one and dose two, injection site pain and tenderness, generally mild to moderate in severity, were the most common local symptoms, lasting less than three days. Fatigue, headache and muscle pain were the most common systemic symptoms, lasting less than two days.</p><p><blockquote>在第1次和第2次给药后7天评估反应原性时,注射部位疼痛和压痛(严重程度通常为轻度至中度)是最常见的局部症状,持续时间少于3天。疲劳、头痛和肌肉疼痛是最常见的全身症状,持续不到两天。</blockquote></p><p></p>\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"MRNA":"Moderna, Inc.","NVAX":"诺瓦瓦克斯医药","PFE":"辉瑞"},"is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1167457915","content_text":"It was \"better late than never\" for Novavax, Inc.NVAX, as the biopharma finally got around to announcing interim results from the U.S. and Mexico leg of the Phase 3 study of NVX-CoV2371, its vaccine candidate against the novel coronavirus.\nHere's a comparative perspective of the vaccine candidates from Novavax, and the frontrunners, namelyPfizer Inc.PFE 0.05%-BioNTech SEBNTXandModerna, Inc.MRNA, both of which have authorized vaccines in the market.\nVaccine Type: Novavax's NVX-CoV2371 is a recombinant nano-particle protein-based COVID-19 vaccine that is packaged with the company's proprietary Matrix-M adjuvant.\nThe Pfizer-BioNTech and Moderna products are mRNA vaccines, or modern vaccines that work by using a genetic code called mRNA that instructs our immune cells to make spike protein, which is found on the surface of the virus that causes COVID-19.\nThis spike protein, though harmless, is capable of triggering our immune system to produce antibodies that offer protection against future infection.\nNovavax's vaccine is a protein adjuvant that contains the spike protein of the coronavirus itself, but formulated as a nanoparticle that cannot cause disease. The injected vaccine then stimulates the immune system to produce antibodies and T-cell immune responses.\nThe Vaccine Doses: The vaccines from each of the three companies require two doses. Each dose consists of 30 mcg for Pfizer and 100 mcg for Moderna, while for Novavax, each vaccine dose consists of 5 mcg of NVX-CoV2371 and 50 mcg of Matrix-M1 adjuvant that are co-formulated.\nThe interval between the two doses — the priming and booster dose — is 21 days each for Pfizer and Novavax and 28 days for Moderna.\nThe Target Population: The original late-stage trial of Pfizer-BioNTech evaluated the vaccine in participants ages 16 years and older. The trial enrolled 43,448 participants.\nModerna'sPhase 3 COVE study enrolled 30,000 participants ages 18 years and up.\nSince then, these two companies have obtained authorizations for their respective vaccines to be used in adolescents.\nBothcompanieshave also initiated studies in the pediatric population.\nNovavax's study enrolled 29,960 participants 18 years of age and older across 119 sites in the U.S. and Mexico. The placebo-controlled portion of PREVENT-19 continues in adolescents from 12 to less than 18 years of age and recently completed enrollment with 2,248 participants.\nVaccine Logistics: Pfizer recently secured FDA authorization for storing undiluted, thawed vaccine vials in the refrigerator at 2°C to 8°C for up to one month.\nPreviously, thawed, undiluted vaccine vials could be stored in the refrigerator for up to five days. Moderna's vaccine can be stored refrigerated between 2° and 8°C for up to 30 days prior to first use.\nNVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.\nVaccine Efficacy: Interim data from Pfizer-BioNTech's Phase 3 trials released in December showed the vaccine was well-tolerated and demonstrated 95% efficacy in preventing COVID-19 in those without prior infection seven days or more after the second dose. Updated top-line results released for up to six months after the second dose confirmed efficacy at 91.3%.\nThe vaccine was found 100% effective against severe disease as defined by the U.S. Centers for Disease Control and Prevention, and 95.3% effective against severe COVID-19 as defined by the FDA. It was also proved effective against the U.K. strain in lab studies.\nModerna's vaccine showed efficacy of 94.1% against COVID-19. The company announced in May initial data from its Phase 2 study showing that a single 50 mcg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351, first identified in South Africa, and P.1, first identified in Brazil.\nNovavax's investigational vaccine demonstrated 100% protection against moderate and severe disease not involving variants of concern or variants of interest.\nAgainst variants of concern and variants of interest, the efficacy was 93.2% and in high-risk populations, defined as over 65 or under 65 years with certain comorbidities or having circumstances with frequent COVID-19 exposure, the efficacy was 91%.\nOverall efficacy was 90.4%, meeting the primary endpoint.\nCantor Fitzgerald On Novavax's Vaccine:A differentiating factor for NVX-2373 is that it showed vaccine efficacy of 93.2% against VoC/VoI, which demonstrates protection across a broad range of SARS-CoV-2 strains, Cantor Fitzgerald analyst Charles Duncan said in a Monday morning note.\n\"Overall, these results enhance our conviction for a differentiated clinical and logistics profile from the SARS-CoV-2 vaccine candidate ‘2373,\" the analyst said.\nShowing efficacy against new strains in two Phase 3 clinical trials, rather than extrapolating potential efficacy from a neutralizing antibody assay conducted in a petri dish, differentiates NVX-CoV2373 from other vaccines that have emergency use authorization, he said.\nThis profile, according to Cantor reduces regulatory/ commercial risk for the ‘2373 SARS-CoV-2 prophylactic vaccine candidate and, with positive Phase 3 data for NanoFlu reported in March 2020, should raise the profile for Novavax's platform as a whole.\nVaccine Safety Data:Pfizer-BioNTech's vaccine showed a favorable tolerability and safety profile, with the most common adverse events from BNT162b2 being transient, mild to moderate pain at the injection site, fatigue and headache, and these generally resolved within two days.\nFor Moderna, the most common adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.\nPreliminary safety data from Novavax's trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.\nIn assessing reactogenicity seven days after dose one and dose two, injection site pain and tenderness, generally mild to moderate in severity, were the most common local symptoms, lasting less than three days. 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