下类文章内容从何而来于NEJM临床医学专业先进的 ，原作者NEJM临床医学专业先进的 《NEJM医疗前列》由嘉会医疗深入分析和幼教实业公司（JMRE）与《新英格兰医疗杂志网站》（NEJM）合作设计，经由精品化文章、线下推广教学、上线培训和学术界年会等行为，保驾护航中华大夫，完善中华临床研究研究含量。NEJM文章由NEJM实业公司全权品牌授权。本段转发自：NEJM临床前端 【编者按】NEJM Quick Take以動畫主要形式，在215分钟内分享这篇多种NEJM论著。《NEJM药学前沿性》应当每周都六云同步更新换代本年度NEJM论著的视频播放汇报总结并配合繁体中文mkv，让受众快熟知优秀文章的真谛，熟练英语听力和音标发音。打开网页“查看全文”，查看相应的NEJM论著。 BNT162b2 COVID-19防疫针的健康性和管用性Safety and Efficacy of the BNT162b2 Covid-19 Vaccine2019年111月31日朗读者：Dr. Stephen Morrissey, NEJM程序执行总编辑 WHO于2023年11月11日否认COVID-19包括全世界大2017流行近一年来，全世界多余上千人多万人患有。公司急需人身安全、能够的肺炎疫苗。搞笑短视频播放频中整理了新的深入分析发掘。 

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交叉感染基本引起妇科疾病COVID-19已在这一次的全世界大主流中累及上千人万余人。你们迫在眉睫必须要安全性高高效的肺炎疫苗。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

在某些仍在展开的多方、劝解剂对应、关注者设盲的关键点行之规范性实验英文设计中，你们以1:1此例将≥15岁的参加者随意分组名称，两列最主要间距21天接种役苗两剂劝解剂或BNT162b2侯选人役苗（每剂30 μg）。BNT162b2也是种脂质奈米顆粒做出、核苷体现RNA役苗，才能编码查询结合前稳固、膜锚定的SARS-CoV-2总长棘突球蛋白。最主要终端是役苗防护COVID-19（需经实验英文室查证）的行之规范性和稳定性。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

一共43,548例参加者被随机性分组名称，这之中43,448例认可了肌内肌注：21,720例肌内肌注了BNT162b2，21,728例肌内肌注了宽慰剂。BNT162b2组8例参加者和宽慰剂组162例参加者發生了防冶打狂犬疫苗其二剂每组7以后患上的COVID-19；BNT162b2防冶COVID-19的效果率是95%（95%可以信赖差值[credible interval]，90.3~97.6）。在依据年限、怀孕天数、人种、群族、基线基因分指数和是否需要患合为症的定义的各亚组中，我们公司均观查去了一样的防疫针效果率（普遍为90%~100%）。在防冶打狂犬疫苗第一点剂后發生的10例病情比较重的时候COVID-19中，9例發生于宽慰剂组，1例發生于BNT162b2组。BNT162b2的安会性特殊性包涵预期的轻灶性至灶性肌内肌注布位胀痛、身体疲劳和头昏。防疫针组和宽慰剂组的情况严重不好时间發生率均较低且一样。 

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

1六岁及上述年龄层接种疫苗注射两剂BNT162b2后在杜绝COVID-19等方面到达了95%的更好率。中位6个月阶段的安会性与任何木马病毒接种疫苗相拟。（由BioNTech和辉瑞资助金；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