引爆全球市场的疫苗究竟是什么？能终结疫情吗？_老虎社区_美港股上老虎

引爆全球市场的疫苗究竟是什么？能终结疫情吗？

华尔街见闻2020-11-09

作者：于旭东有效率高到惊人的“新款”新冠疫苗，令今夜的资本市场疯狂——道指、标普500指数开盘后创下历史新高，航空、邮轮、石油股集体飙升，而居家概念股则大幅下跌。辉瑞和BioNTech，给全球经济复苏注入了一针强心剂。目前，海外有多种路径的新冠疫苗已经进入三期临床试验阶段（ph3），其中：Moderna的mRNA疫苗已于2020年7月底在美国启动ph3，计划入组3万人；BioNTech、 ...

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钱币
·2020-11-10
如果真的那是褔音。
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尤丿
·2020-11-09
明年九月？
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敏敏猪__
·2020-11-09
是不是还有血必净[开心]
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媛媛08
·2020-11-09
老贼的莲花清瘟应该卖的差不多了吧？
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棠伯虎
·2020-11-09
我觉得应该是虚的。😂
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  2020-11-09
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LZP
·2020-11-09
板蓝根在此，尔等休得无礼！
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Seamus2015
·2020-11-09
把我大连花清瘟没有放眼里吧？哼！不服气啊院士
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Can we end the epidemic?","themeId":"d1c53a2c4a8a41a080443eef474092c2","isJumpTheme":false,"ttsUrl":"https://static.tigerbbs.com/953920f3b6f5e6db3430467bc51583bf","symbols_score_info":{"BNTX":0.9,"PFE":0.9},"content_text":"作者： 于旭东有效率高到惊人的“新款”新冠疫苗，令今夜的资本市场疯狂——道指、标普500指数开盘后创下历史新高，航空、邮轮、石油股集体飙升，而居家概念股则大幅下跌。辉瑞和BioNTech，给全球经济复苏注入了一针强心剂。目前，海外有多种路径的新冠疫苗已经进入三期临床试验阶段（ph3），其中：Moderna的mRNA疫苗已于2020年7月底在美国启动ph3，计划入组3万人；BioNTech、 Pfizer合作研发的mRNA疫苗已于2020年7月底在美国启动ph3，计划入组3.2万人；牛津大学、阿斯利康合作研发的腺病毒载体疫苗已于2020年5月底在英国启动ph3，计划入组1万人，预计将于8月启动美国ph3。作为mRNA路径的候选疫苗，此前人类并没有研发成功的先例，但在此次新冠疫情中，Moderna、辉瑞和BioNTech等明星企业都加入了角逐。mRNA疫苗的优点此次在三期临床试验中表现优异的疫苗，采用mRNA技术路径，综合来看有以下三个优点：在安全性上，mRNA并不会感染或者整合进基因组，因此不会带来感染或突变的风险。在有效性上，有多种修饰方式能够使mRNA更佳稳定，翻译效率更高；同时递送方式的发展能够使mRNA快速递送到细胞内从而发挥功能。最后，在生产的便捷性上，现在的体外转录技术能够非常快速、廉价地大规模生产RNA疫苗，相较于传统疫苗5-6个月的生产周期，mRNA疫苗有望在40天内完成疫苗样品的生产制备，因此有望更好地应对突发的传染病疫情。三期临床试验为何这么重要？三期临床试验，也叫验证性、随机对照临床试验，通常在几千至几万人的目标人群中进行，通常需要几个月至几年时间。该实验的目的是验证疫苗按给定剂量及程序接种后的有效性、安全性、免疫原性，主要研究终点为疫苗有效性，通常需要在病原体暴露环境中进行；如果不具备客观条件，也可能与已上市同类疫苗进行有效性或免疫原性的非劣效比较。目前，全球已经有超过15个候选疫苗进入临床试验阶段，大多采用1/2期合并设计，并与三期无缝衔接。此前国内外多个新冠疫苗已于2020年7月启动三期临床试验。但由于部分区域感染率爬升较快，国信证券认为三期临床试验完成时点会早于此前预期（6-12个月）。如果三期临床试验的有效性被证明，疫苗便可以进入正式上市进程。BNT162的成功之路在此次mRNA疫苗的设计中，BioNTech设计了多种形式的RNA候选疫苗BNT162系列：BNT162a1：编码S1-RBD（受体结合域）的uRNA（含尿苷的RNA）；BNT162b1：编码S1-RBD的modRNA（核苷修饰的RNA）；BNT162b2：编码S-2P（带2P突变的全长spike）的modRNA；BNT162c2：编码S-2P的saRNA（自扩增RNA）。在一期、二期临床试验中，体液免疫上BNT162第29天的中和性抗体滴度几何均值（GMT）高于康复患者血清，美国一期临床试验临床试验也有相似的初步结果，细胞免疫上CD8+、 CD4+ T细胞都对RBD有特异性反应，这使得该疫苗得以脱颖而出，进入三期临床试验。综合疫苗安全性、免疫原性和有效性，辉瑞和BioNTech最终选择BNT162b2（而非b1）进入三期临床试验，该系列采用BioNTech经验积累最丰富、相对优势最大的modRNA结构，在免疫力差异性较大的老年人群中也能提供潜在更加一致的保护力。值得注意的是，复星医药获得了BNT162大中华区的开发和商业化权利，合作范围涵盖了BNT162的各种形式（包括b1、b2）。目前BNT162b1已经在国内启动一期临床试验，BNT162b2也将启动，据国信证券推断，该系列疫苗在国内的安全性、免疫原性上，以及海外三期临床有效性试验上能够满足国内注册申报要求。值得一提的是，市场原本预期辉瑞在大选前一周公布结果，但辉瑞制药CEO Albert 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