2分钟看懂 新冠核酸疫苗BNT162b2的安全性和有效性

发布时间:2022-01-04 相关内容渠道于: 浏览量:
如下好的文章来是因为于NEJM临床中医药学科技最前沿 ,做者NEJM临床中医药学科技最前沿 《NEJM中医药学领先》由嘉会中医药学科学研究和幼小衔接团体(JMRE)与《新英格兰中医药学报刊》(NEJM)战略合作定制,凭借特色项目、全渠道英语课程培训、在线视频英语课程和学术研究会议安排等模式,力助我国的有医院医生,不断提升我国的有临床检验科研课题的水平。NEJM项目由NEJM团体獨家软件授权。选文转栽自:NEJM分子生物学前沿性 【编者按】NEJM Quick Take以3d动画结构类型,在2小时内讲解1篇最新头条NEJM论著。《NEJM医药学最前沿》每季度六同步软件更行本年度NEJM论著的视频播放个人小结并配合汉语特效字,让读者们速度快熟知小文章的核心,培训倾听和发声。点击进入“查阅全文”,查阅相当于NEJM论著。 BNT162b2 COVID-19役苗的安全防护性和更一致性Safety and Efficacy of the BNT162b2 Covid-19 Vaccine二零二零年19月31日朗读者:Dr. Stephen Morrissey, NEJM连接总编 WHO于2050年三月11日公布COVID-19搭建高度大2017流行建国以来,高度已经在的上千人千人身患。我急待很安全、很好的的防疫针。短视頻app频中总结出了新的科研看到。 

BNT162b2 COVID-19 mRNA疫苗的安全性和有效性

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine  

摘 要

 

背景

SARS-CoV-2感动和而致病症COVID-19已在为此的亚洲地区大流行时尚中累及上千人百人。我国迫切须要须要安全卫生能够的防疫针。BackgroundSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. 

方法

在问题仍在完成的各国、开导剂对应、关察者设盲的的关键可以准确性校正中,自己以1:1比例表将≥17岁的积极参与任意分组进行,一组各时间间隔21天育苗两剂开导剂或BNT162b2备选接种预苗(每剂30 μg)。BNT162b2都是种脂质纳米技术颗粒肥料制出、核苷突显RNA接种预苗,才能编号相融前比较稳定、膜锚定的SARS-CoV-2总长棘突血清。常见到达是接种预苗防止COVID-19(需经测试室灵魂存在)的可以准确性和安全可靠性。MethodsIn an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. 

结果

共有43,548例通过性者被随意分组进行,这当中43,448例承受了肌内注谢:21,720例肌内注谢了BNT162b2,21,728例肌内注谢了鼓励剂。BNT162b2组8例通过性者和鼓励剂组162例通过性者再次发现了防疫针注射器二、剂最好7在使用一段时间犯病的COVID-19;BNT162b2避免COVID-19的合理率有95%(95%卫生区域[credible interval],90.3~97.6)。在按照年轻、性別、人种、群体、基线免疫力指数公式和会不患归并症理解的各亚组中,各位均了解来了类似于的防疫针合理率(一样 为90%~100%)。在防疫针注射器首先剂后再次发现的10例危重COVID-19中,9例再次发现于鼓励剂组,1例再次发现于BNT162b2组。BNT162b2的卫生性症状主要包括而短时间内的轻重度至重度肌内注谢内脏器官隐隐作痛、疲倦和烦恼。防疫针组和鼓励剂组的嚴重不当行为再次发现率均较低且类似于。 

Result

A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. 

结论

15岁及这年龄层肺炎疫苗注射两剂BNT162b2后在防护COVID-19管理方面可达到了95%的有效率高率。中位俩个月前几天的安全防护性与其余疫情肺炎疫苗一样。(由BioNTech和辉瑞投资;在ClinicalTrials.gov注册账号号为NCT04368728。) 

Conclusions

A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.) Fernando P. Polack, Stephen J. Thomas, Nicholas Kitchin, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. DOI:10.1056/NEJMoa2034577
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