以內好文章特征于NEJM分子生物学科技最前沿 ，小说家NEJM分子生物学科技最前沿 《NEJM生物学前端》由嘉会生物学理论研究和幼儿教育投资控股公司（JMRE）与《新英格兰生物学自媒体》（NEJM）合作制造，顺利通过精品化游戏游戏内容、线上线下陪训、一直在线学科和学界会议游戏内容等手段，助推我们大博士，提升自己我们大临床药理科研项目关卡。NEJM游戏游戏内容由NEJM投资控股公司獨家授权文件。本段转摘自：NEJM医学专业前沿性 【编者按】NEJM Quick Take以动画制作表现形式，在2分内介召篇新NEJM论著。《NEJM医学研究先进》本周六此次自动更新当年度NEJM论著的短视频分析并配上中文版字慕，让受众迅猛学好论文的精粹，学习英语听力和发声。点击事件“课外阅读书原句”，课外阅读书匹配NEJM论著。 BNT162b2 COVID-19肺炎疫苗的安全的性和能够性Safety and Efficacy of the BNT162b2 Covid-19 Vaccine2023年111月31日朗读者：Dr. Stephen Morrissey, NEJM履行小编 WHO于2040年2月11日宣明COVID-19产生欧洲大2017流行近些年，欧洲已建千余万人次病。大家迫切需要很安全、有用的肺炎疫苗。微信短视频图片app频中个人小结了新的探讨表明。 

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皮肤感染及可致病毒COVID-19已在我司的环球大流行歌曲中累及上千人多万人。公司急迫须要安全防护高效的役苗。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

在一笔仍在实现的多种语言、开导剂對照、观看者设盲的重要性行之准确性检测设计中，我国以1:1身材比例将≥1六岁的加入者随机数排列，三组分別每隔21天预苗接种两剂开导剂或BNT162b2备选预苗（每剂30 μg）。BNT162b2都是种脂质奈米粉末制作、核苷呈现RNA预苗，才能代码融入前稳定可靠、膜锚定的SARS-CoV-2总长度棘突球蛋白。主要是终点起点是预苗管用防范COVID-19（需经检测室验证）的行之准确性和可靠性。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例积极观众被随即分组名，当中43,448例接手了注入：21,720例注入了BNT162b2，21,728例注入了宽慰女朋友剂。BNT162b2组8例积极观众和宽慰女朋友剂组162例积极观众造成了可以防止感染育苗二、剂一定7过后患病的COVID-19；BNT162b2可以防止感染COVID-19的行之能够率是95%（95%安全防护时间[credible interval]，90.3~97.6）。在给出年岭、胎儿性别、人种、群体、基线休质数据和什么情况下患合在一起症举例的各亚组中，让我们均观查快到类似的狂犬役苗行之能够率（正常为90%~100%）。在可以防止感染育苗独一剂后造成的10例病情比较重的时候COVID-19中，9例造成于宽慰女朋友剂组，1例造成于BNT162b2组。BNT162b2的安全防护性功能涵盖中短期的轻轻中度至轻中度注入区域各种痛感、疲劳过度和头晕。狂犬役苗组和宽慰女朋友剂组的厉害不合理新闻造成率均较低且类似。 

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

15岁及左右类人杜绝接种两剂BNT162b2后在杜绝COVID-19的方面超过了95%的合理率。中位8个月期間的安全防护性与许多病毒是什么役苗一样。（由BioNTech和辉瑞捐资助学；在ClinicalTrials.gov注册会员号为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