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新型冠状病毒肺炎疫苗的疗效与安全性:随机临床试验的系统评价与荟萃分析

Efficacy and Safety of COVID-19 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

作者信息

Pormohammad Ali, Zarei Mohammad, Ghorbani Saied, Mohammadi Mehdi, Razizadeh Mohammad Hossein, Turner Diana L, Turner Raymond J

机构信息

Department of Biological Sciences, University of Calgary, Calgary, AB T2N 1N4, Canada.

John B. Little Center for Radiation Sciences, Harvard T.H. Chan School of Public Health, Boston, MA 02115, USA.

出版信息

Vaccines (Basel). 2021 May 6;9(5):467. doi: 10.3390/vaccines9050467.


DOI:10.3390/vaccines9050467
PMID:34066475
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8148145/
Abstract

The current study systematically reviewed, summarized and meta-analyzed the clinical features of the vaccines in clinical trials to provide a better estimate of their efficacy, side effects and immunogenicity. All relevant publications were systematically searched and collected from major databases up to 12 March 2021. A total of 25 RCTs (123 datasets), 58,889 cases that received the COVID-19 vaccine and 46,638 controls who received placebo were included in the meta-analysis. In total, mRNA-based and adenovirus-vectored COVID-19 vaccines had 94.6% (95% CI 0.936-0.954) and 80.2% (95% CI 0.56-0.93) efficacy in phase II/III RCTs, respectively. Efficacy of the adenovirus-vectored vaccine after the first (97.6%; 95% CI 0.939-0.997) and second (98.2%; 95% CI 0.980-0.984) doses was the highest against receptor-binding domain (RBD) antigen after 3 weeks of injections. The mRNA-based vaccines had the highest level of side effects reported except for diarrhea and arthralgia. Aluminum-adjuvanted vaccines had the lowest systemic and local side effects between vaccines' adjuvant or without adjuvant, except for injection site redness. The adenovirus-vectored and mRNA-based vaccines for COVID-19 showed the highest efficacy after first and second doses, respectively. The mRNA-based vaccines had higher side effects. Remarkably few experienced extreme adverse effects and all stimulated robust immune responses.

摘要

本研究系统回顾、总结并荟萃分析了疫苗在临床试验中的临床特征,以更好地评估其疗效、副作用和免疫原性。截至2021年3月12日,从各大数据库中系统检索并收集了所有相关出版物。荟萃分析共纳入25项随机对照试验(123个数据集),58889例接种新冠疫苗的病例和46638例接受安慰剂的对照。总体而言,在II/III期随机对照试验中,基于mRNA的新冠疫苗和腺病毒载体新冠疫苗的疗效分别为94.6%(95%CI 0.936-0.954)和80.2%(95%CI 0.56-0.93)。腺病毒载体疫苗在首次(97.6%;95%CI 0.939-0.997)和第二次(98.2%;95%CI 0.980-0.984)接种后3周,对受体结合域(RBD)抗原的疗效最高。除腹泻和关节痛外,基于mRNA的疫苗报告的副作用水平最高。在有佐剂或无佐剂的疫苗中,铝佐剂疫苗的全身和局部副作用最低,但注射部位发红除外。新冠腺病毒载体疫苗和基于mRNA的疫苗分别在首次和第二次接种后显示出最高疗效。基于mRNA的疫苗副作用更高。极少数人经历了极端不良反应,所有疫苗都激发了强烈的免疫反应。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/6bb34cd73cc0/vaccines-09-00467-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/4438545bbbf0/vaccines-09-00467-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/b5890e55f95b/vaccines-09-00467-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/e284629d5c0d/vaccines-09-00467-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/6bb34cd73cc0/vaccines-09-00467-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/4438545bbbf0/vaccines-09-00467-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/b5890e55f95b/vaccines-09-00467-g002a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/e284629d5c0d/vaccines-09-00467-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/719a/8148145/6bb34cd73cc0/vaccines-09-00467-g004.jpg

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本文引用的文献

[1]
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N Engl J Med. 2021-6-10

[2]
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Vaccines (Basel). 2021-3-5

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Deep vein thrombosis (DVT) occurring shortly after the second dose of mRNA SARS-CoV-2 vaccine.

Intern Emerg Med. 2021-4

[9]
Acute Allergic Reactions to mRNA COVID-19 Vaccines.

JAMA. 2021-4-20

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SARS-CoV-2 501Y.V2 escapes neutralization by South African COVID-19 donor plasma.

Nat Med. 2021-4

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