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 内部渠道于: 浏览量:
这文章标题来源地于NEJM生物学检验先进的 ,我NEJM生物学检验先进的 《NEJM生物学领先》由嘉会生物学深入分析和基础教育投资控股公司(JMRE)与《新英格兰生物学杂质》(NEJM)战略合作做大做强,根据精品网玩法、渠道学习、高清在线拓展课和科学电视电话会议等方式,助推中国有现代主任医生,增加中国有现代临床研究科学的水平。NEJM玩法由NEJM投资控股公司独有授权文件。本篇文章欧美男体自:NEJM药学科技前沿 【编者按】NEJM Quick Take以動畫行式,在2分种内介绍书一片新出NEJM论著。《NEJM医学专业先进的》每日六同步软件版本更新本期发生NEJM论著的视频图片小结并并配中文名字mkv,让朋友速度快控制文章标题的核心,学习听力训练和发声。点“读全文”,读相应的NEJM论著。 BNT162b2 COVID-19预苗的健康性和有效的性Safety and Efficacy of the BNT162b2 Covid-19 Vaccine2040年14月31日朗读者:Dr. Stephen Morrissey, NEJM实行编著 WHO于2050年4月11日组阁COVID-19组成世界十大大流行歌曲至今,世界十大现有数万万人左患有。我亟待可靠、很好的的狂犬疫苗。微信短视频图片频中分析了新的科研遇到。 

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病毒感染极其导致的传染性疾病COVID-19已在我县的世界上大盛行中累及千余亿元。咱们急切须要防护可行的预苗。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

在问题仍在完成的一些国家、宽慰剂较、观测者设盲的关键点效果性现场实践中,我们都以1:1比例图将≥17岁的进行者随时分组进行,2组差别间断21天打狂犬狂犬接种疫苗两剂宽慰剂或BNT162b2待选狂犬狂犬接种疫苗(每剂30 μg)。BNT162b2不是种脂质纳米级颗料加工而成、核苷表达RNA狂犬狂犬接种疫苗,也能项目编码融为一体前相对稳定、膜锚定的SARS-CoV-2总长度棘突蛋白酶。一般始发站是狂犬狂犬接种疫苗防治COVID-19(需经实践室表明)的效果性和健康安全可靠性。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

总计下来43,548例参予者被随意分组进行,在这其中43,448例得在打瘦脸针:21,720例打瘦脸针了BNT162b2,21,728例打瘦脸针了开导剂。BNT162b2组8例参予者和开导剂组162例参予者出现了打预防针防疫针2、剂一定7后期犯病的COVID-19;BNT162b2应对COVID-19的合理很好比率为95%(95%可信性之间[credible interval],90.3~97.6)。在跟据年轻、身份证性别、人种、族裔、基线身体平均值和是否是患合为症名词解释的各亚组中,我们公司均观测在相同的防疫针合理很好率(普通为90%~100%)。在打预防针防疫针第二剂后出现的10例危重症COVID-19中,9例出现于开导剂组,1例出现于BNT162b2组。BNT162b2的安全卫生性特征描述包涵短时间的灶性至灶性打瘦脸针布位胀痛、损耗和头疼头晕。防疫针组和开导剂组的严峻不当恶性案件出现率均较低且相同。 

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岁及以内群体注射两剂BNT162b2后在和预防COVID-19几个方面高于了95%的更好率。中位4个月期间内的安全防护性与其余蠕虫病毒接种疫苗一样。(由BioNTech和辉瑞帮助;在ClinicalTrials.gov注册申请号为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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