一些文章标题的来是因为NEJM医学界专业前端 ，创作者NEJM医学界专业前端 《NEJM中医药学先进的》由嘉会中医药学研究分析和教肓投资投资集团（JMRE）与《新英格兰中医药学报纸》（NEJM）携手构造，实现佳品资源、地推培训课、再线培训课和学术交流年会等习惯，转向我国咨询师，提高了我国临床护理科学研究含量。NEJM资源由NEJM投资投资集团独特权限。我们网易博客自：NEJM药学前列 【编者按】NEJM Quick Take以动画作品方法，在2小时内价绍一篇新闻最近NEJM论著。《NEJM医学研究最前沿》应当每周都六同部升级贷方NEJM论著的视频播放汇报总结并搭配英文版特效字，让意林少年版急剧熟悉本文的精要，训练方法听力测试和字母发音。单击“读书看答案”，读书相匹配NEJM论著。 BNT162b2 COVID-19防疫针的可靠性和合理规范性Safety and Efficacy of the BNT162b2 Covid-19 Vaccine去年111月31日朗读者：Dr. Stephen Morrissey, NEJM来执行总编辑 WHO于2023年9月11日发出COVID-19产生环球最大大流行趋势来说，环球最大某个上千人数万病。我门亟须人身安全、效果的役苗。短视頻频中归纳总结了新的设计察觉到。 

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影响举例造成急病COVID-19已在报好名的的环球大最火中累及千余两万人。当我们迫切须得须得安全的可以有效的预防针。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

在各项仍在实行的几国、关心的话剂较、观查者设盲的重点行之合理有效实验报告设计中，我们大家以1:1配比将≥17岁的参与活动者随时分组名，几组对应距离21天预苗接种两剂关心的话剂或BNT162b2得票数预苗（每剂30 μg）。BNT162b2是一种种脂质nm顆粒而成、核苷呈现RNA预苗，可代码融成前可靠、膜锚定的SARS-CoV-2起点始发站棘突蛋清。大部分始发站是预苗防治COVID-19（需经实验报告室印证）的行之合理有效和可靠性性。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

共要43,548例发起人者被随机函数分组进行，这之中43,448例吸收了填充：21,720例填充了BNT162b2，21,728例填充了劝解剂。BNT162b2组8例发起人者和劝解剂组162例发起人者时有造成了肺炎预防针打针第二点剂必须7之后的犯病的COVID-19；BNT162b2杜绝COVID-19的能够比率为95%（95%信得过区段[credible interval]，90.3~97.6）。在只能根据年龄段、性別、人种、族裔、基线身体体质平均值和能否患合并为症定意的各亚组中，大家均检查直到相类似的肺炎预防针能够率（普遍为90%~100%）。在肺炎预防针打针1、剂后时有造成的10例病情比较重的时候COVID-19中，9例时有造成于劝解剂组，1例时有造成于BNT162b2组。BNT162b2的人身安全与否特证具有远期的轻微至轻中度填充部位零件阵疼、疲劳度和头晕头疼。肺炎预防针组和劝解剂组的严峻不好的的事件时有造成率均较低且相类似。 

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岁及以内大学生消费群体接种疫苗接种两剂BNT162b2后在防范COVID-19上提高了95%的合理有率。中位多个月前一天的安全的性与的电脑病毒接种疫苗是类似的。（由BioNTech和辉瑞国家助学金；在ClinicalTrials.gov注冊号为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