2分钟看懂 新冠核酸疫苗BNT162b2的安全性和有效性

发布时间:2021-01-04 文章体现了: 浏览量:
一下句子起来自于NEJM医学界研究研究 ,原作者NEJM医学界研究研究 《NEJM临床研究医美科技研究最前沿》由嘉会临床研究医美科技研究科技研究和育儿教育集团网站网站(JMRE)与《新英格兰临床研究医美科技研究报刊》(NEJM)联袂塑造,采用珍品的相关内容、线上训练、线上课程相关内容和科技研究商务会议等的方法,促动我国专家,的提升我国临床研究科技研究平均水平。NEJM的相关内容由NEJM集团网站网站全权授权证书。文中引用自:NEJM医学研究前列 【编者按】NEJM Quick Take以h动画结构类型,在21分钟内讲解篇最薪NEJM论著。《NEJM中医学前列》每日六同时进行刷新本年度NEJM论著的短视频汇报并配上中文名音轨,让阅览者不断掌控文章内容的核心思想,学习倾听和拼读。点击进入“阅览原稿”,阅览相匹配的NEJM论著。 BNT162b2 COVID-19预防针的安全管理性和更好性Safety and Efficacy of the BNT162b2 Covid-19 Vaccine明年16月31日朗读者:Dr. Stephen Morrissey, NEJM执行程序编著 WHO于20212月11日即日起COVID-19组合而成亚洲地区最大大潮流十八大以来,亚洲地区最大现有千余全民起病。自己急待安全保障、高效的预防针。短抖音视频频中分析了新的探究表明。 

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妇科感染及而致问题COVID-19已在这回的全世界大时尚中累及数万万余人。我们的迫切可以可以人身安全行之有效的防疫针。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

在一笔仍在来的几国、安抚剂比、观察分析者设盲的根本效果性做研究的时候中,.我以1:1基数将≥15岁的通过者随机数分组名称,三组各自隔21天育苗两剂安抚剂或BNT162b2待选防疫针(每剂30 μg)。BNT162b2是种脂质nm颗粒肥料制造而成、核苷体现RNA防疫针,可能商品编码要融合前稳定可靠、膜锚定的SARS-CoV-2起点终点站棘突球蛋白。最主要的终点站是防疫针防控COVID-19(需经研究室声明)的效果性和安全防护性。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

共得43,548例参与活动的者被随机的排序,之中43,448例认同了肌内滴注:21,720例肌内滴注了BNT162b2,21,728例肌内滴注了鼓励的话语剂。BNT162b2组8例参与活动的者和鼓励的话语剂组162例参与活动的者出现了育苗2.剂少于7在使用一段时间犯病的COVID-19;BNT162b2怎样预防COVID-19的很好的率是95%(95%有可信度范围内[credible interval],90.3~97.6)。在选择多少岁、姓别、人种、族裔、基线免疫力指数值和能否患合在一起症构成的各亚组中,我门均观擦在差不多的预防针很好的率(通常情况下为90%~100%)。在育苗首要剂后出现的10例危重COVID-19中,9例出现于鼓励的话语剂组,1例出现于BNT162b2组。BNT162b2的很安全问题表现分为一年期的轻中重度至中重度肌内滴注位置剧痛着、疲劳值和头疼头晕。预防针组和鼓励的话语剂组的较为严重较差事件处理出现率均较低且差不多。 

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

17岁及上面的大学生消费群体注射两剂BNT162b2后在預防COVID-19等方面做到了95%的有效地率。中位6个月其间的的安全等级与某个宏病毒防疫针差不多。(由BioNTech和辉瑞国家助学金;在ClinicalTrials.gov报名号为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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