以內优秀文章来历于NEJM医美前端 ，原作者NEJM医美前端 《NEJM诊疗检验先进》由嘉会诊疗检验学习和学校实业（JMRE）与《新英格兰诊疗检验期刊》（NEJM）强强联合着力打造，经过爆款商品内部、线上陪训、同屏在线教学信息和学术交流电视电话会议等方式英文，助推器我国的牙医，的提升我国的诊疗成果转化关卡。NEJM内部由NEJM实业全权品牌授权。本文作者转裁自：NEJM医学检验先进 【编者按】NEJM Quick Take以3d动画类型，在2分钟左右内说明一编新型NEJM论著。《NEJM生物学领先》每周7天六此次系统更新当年度NEJM论著的短视频总结范文并搭配中文名文字幕，让大学生群体在短时间内知道内容的哲学体系，训练听写和音标发音。打开网页“看课外阅读答案”，看各自NEJM论著。 BNT162b2 COVID-19预苗的卫生性和有郊性Safety and Efficacy of the BNT162b2 Covid-19 Vaccine2021年1二月31日朗读者：Dr. Stephen Morrissey, NEJM运行总编辑 WHO于2021年6月11日宣告COVID-19组成部分国内大受欢迎一来，国内有数万全民病发。当我们迫切需要安全可靠、更好的肺炎疫苗。急功近利频中小结了新的研究探讨发展。 

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传染及所导致的肠道疾病COVID-19已在我县的世界上大流行时尚中累及上千人上千人。我门急迫所需健康可以有效的防疫针。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

在每项仍在实施的多种语言、劝解剂对比、分析者设盲的根本合理性疲劳试验中，我国以1:1比例表将≥15岁的进行者js随机数分成小组，两两各分为连续21天接种狂犬防疫针两剂劝解剂或BNT162b2得票数狂犬防疫针（每剂30 μg）。BNT162b2一种脂质微米颗粒剂制得、核苷突显RNA狂犬防疫针，可代码相结合前平衡、膜锚定的SARS-CoV-2长约棘突蛋白质。一般站点是狂犬防疫针和预防COVID-19（需经研究室表明）的合理性和一致性性。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

总计43,548例陆续操作方被随机性分类，在当中43,448例进行了注谢：21,720例注谢了BNT162b2，21,728例注谢了劝慰剂。BNT162b2组8例陆续操作方和劝慰剂组162例陆续操作方發生了了滴注二、剂必须7今后有这种情况的COVID-19；BNT162b2防护COVID-19的很好率是95%（95%信得过区段[credible interval]，90.3~97.6）。在利用时间、性取向、人种、族源、基线肤质数据和什么情况下患归并症确定的各亚组中，我们公司均考察快到同类的预防针很好率（一样为90%~100%）。在滴注1剂之后生了的10例危重症COVID-19中，9例發生了于劝慰剂组，1例發生了于BNT162b2组。BNT162b2的稳定性特征英文包扩短期计划的重度至灶性注谢器官痛点、强度和后脑勺疼。预防针组和劝慰剂组的造成 黑心事故發生了率均较低且同类。 

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岁及之上群体预苗接种两剂BNT162b2后在防治COVID-19领域以达到了95%的有效的率。中位1个月这段时间的卫生性与某个蠕虫病毒预苗同类。（由BioNTech和辉瑞国家助学金；在ClinicalTrials.gov祖册号为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