Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine.

文献信息

DOI	10.1056/NEJMoa2035389
PMID	33378609
期刊	The New England journal of medicine
影响因子	78.5
JCR 分区	Q1
发表年份	2021
被引次数	5937
关键词	mRNA-1273疫苗, 新冠病毒, 疫苗有效性, 安全性, 临床试验
文献类型	Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H., Extramural
ISSN	0028-4793
页码	403-416
期号	384(5)
作者	Lindsey R Baden, Hana M El Sahly, Brandon Essink, Karen Kotloff, Sharon Frey, Rick Novak, David Diemert, Stephen A Spector, Nadine Rouphael, C Buddy Creech, John McGettigan, Shishir Khetan, Nathan Segall, Joel Solis, Adam Brosz, Carlos Fierro, Howard Schwartz, Kathleen Neuzil, Larry Corey, Peter Gilbert, Holly Janes, Dean Follmann, Mary Marovich, John Mascola, Laura Polakowski, Julie Ledgerwood, Barney S Graham, Hamilton Bennett, Rolando Pajon, Conor Knightly, Brett Leav, Weiping Deng, Honghong Zhou, Shu Han, Melanie Ivarsson, Jacqueline Miller, Tal Zaks

一句话小结

本研究评估了mRNA-1273疫苗在预防Covid-19方面的有效性，结果显示该疫苗在高风险人群中具有94.1%的有效性，显著降低了症状性Covid-19的发生率。该研究的发现为Covid-19疫苗的广泛应用提供了有力支持，并确认了其安全性和有效性，尤其是在高风险群体中。

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mRNA-1273疫苗 · 新冠病毒 · 疫苗有效性 · 安全性 · 临床试验

摘要

背景
疫苗的需求是为了预防2019冠状病毒病（Covid-19），并保护那些面临并发症高风险的人群。mRNA-1273疫苗是一种脂质纳米颗粒包裹的mRNA疫苗，编码严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）的预融合稳定全长刺突蛋白，该病毒是导致Covid-19的病因。

方法
本研究是一项第三阶段随机、观察者盲法、安慰剂对照试验，在美国的99个中心进行。高风险人群被随机分配，以1:1的比例接受两次肌肉注射mRNA-1273（100微克）或安慰剂，间隔28天。主要终点是预防Covid-19疾病的发生，要求在第二次注射后至少14天内，参与者之前未感染过SARS-CoV-2。

结果
试验共招募了30,420名志愿者，随机分配到接种疫苗或安慰剂组（每组15,210名参与者）。超过96%的参与者接受了两次注射，2.2%的人在基线时有SARS-CoV-2感染的证据（血清学、病毒学或两者）。安慰剂组有185名参与者确诊为有症状的Covid-19（每千人年56.5例；95%置信区间[CI]，48.7至65.3），而mRNA-1273组有11名参与者（每千人年3.3例；95% CI，1.7至6.0）；疫苗有效性为94.1%（95% CI，89.3至96.8%；P<0.001）。在关键的次要分析中，疫苗有效性保持一致，包括第一次接种后14天的评估、基线时有SARS-CoV-2感染证据的参与者的分析，以及65岁及以上参与者的分析。30名参与者发生了严重Covid-19，其中一例死亡；这30名均在安慰剂组。mRNA-1273组的疫苗接种后出现中等程度、短暂的反应性不良事件的频率较高。严重不良事件较为罕见，两组的发生率相似。

结论
mRNA-1273疫苗在预防Covid-19疾病（包括严重疾病）方面显示出94.1%的有效性。除了短暂的局部和全身反应外，没有发现安全性问题。（由生物医学先进研究与发展局和国家过敏与传染病研究所资助；COVE临床试验注册号，NCT04470427。）

英文摘要

BACKGROUND Vaccines are needed to prevent coronavirus disease 2019 (Covid-19) and to protect persons who are at high risk for complications. The mRNA-1273 vaccine is a lipid nanoparticle-encapsulated mRNA-based vaccine that encodes the prefusion stabilized full-length spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes Covid-19.

METHODS This phase 3 randomized, observer-blinded, placebo-controlled trial was conducted at 99 centers across the United States. Persons at high risk for SARS-CoV-2 infection or its complications were randomly assigned in a 1:1 ratio to receive two intramuscular injections of mRNA-1273 (100 μg) or placebo 28 days apart. The primary end point was prevention of Covid-19 illness with onset at least 14 days after the second injection in participants who had not previously been infected with SARS-CoV-2.

RESULTS The trial enrolled 30,420 volunteers who were randomly assigned in a 1:1 ratio to receive either vaccine or placebo (15,210 participants in each group). More than 96% of participants received both injections, and 2.2% had evidence (serologic, virologic, or both) of SARS-CoV-2 infection at baseline. Symptomatic Covid-19 illness was confirmed in 185 participants in the placebo group (56.5 per 1000 person-years; 95% confidence interval [CI], 48.7 to 65.3) and in 11 participants in the mRNA-1273 group (3.3 per 1000 person-years; 95% CI, 1.7 to 6.0); vaccine efficacy was 94.1% (95% CI, 89.3 to 96.8%; P<0.001). Efficacy was similar across key secondary analyses, including assessment 14 days after the first dose, analyses that included participants who had evidence of SARS-CoV-2 infection at baseline, and analyses in participants 65 years of age or older. Severe Covid-19 occurred in 30 participants, with one fatality; all 30 were in the placebo group. Moderate, transient reactogenicity after vaccination occurred more frequently in the mRNA-1273 group. Serious adverse events were rare, and the incidence was similar in the two groups.

CONCLUSIONS The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified. (Funded by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.).

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主要研究问题

核心洞察

研究背景和目的

新冠疫情自2019年12月爆发以来，对全球造成了严重影响。为了预防COVID-19及其并发症，急需有效的疫苗。mRNA-1273疫苗是一种基于脂质纳米颗粒的mRNA疫苗，编码SARS-CoV-2的稳定化全长刺突蛋白。该研究旨在评估mRNA-1273疫苗的安全性和有效性。

主要方法/材料/实验设计

本研究为一项3期随机、观察者盲法、安慰剂对照试验，涉及美国99个中心。参与者为高风险人群，随机分为接种mRNA-1273疫苗（100μg）或安慰剂组，接种间隔28天。主要终点为在第二剂接种后至少14天内预防COVID-19的发病。

关键结果和发现

试验共招募30,420名志愿者，96%以上完成两剂接种。结果显示，安慰剂组中185名参与者确诊COVID-19（每千人年56.5例），而mRNA-1273组仅11例（每千人年3.3例），疫苗有效性为94.1%（95% CI, 89.3-96.8；P<0.001）。所有严重COVID-19病例均在安慰剂组，疫苗在预防重症方面有效性达100%。

主要结论/意义/创新性

mRNA-1273疫苗在预防COVID-19方面显示出94.1%的有效性，且安全性良好，主要不良反应为短暂的局部和全身反应。该研究为COVID-19疫苗的开发提供了重要的临床证据，表明mRNA疫苗平台在应对疫情中的有效性和潜力。

研究局限性和未来方向

研究的局限性包括随访时间较短，尚未确定保护相关性。尽管初步结果表明疫苗对预防COVID-19有效，但对于无症状感染的影响尚未充分评估。未来的研究应关注长期有效性和安全性，特别是在不同人群（如孕妇和儿童）中的应用。

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... (5927 更多篇文献)

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. ​

文献信息 ​

一句话小结 ​

在麦伴科研 (maltsci.com) 搜索更多文献 ​

摘要 ​

英文摘要 ​

麦伴智能科研服务 ​

主要研究问题 ​

核心洞察 ​

研究背景和目的 ​

主要方法/材料/实验设计 ​

关键结果和发现 ​

主要结论/意义/创新性 ​

研究局限性和未来方向 ​

参考文献 ​

引用本文的文献 ​