Musha Chen, Yue Yuan, Yiguo Zhou, Zhaomin Deng, Jin Zhao, Fengling Feng, Huachun Zou, Caijun Sun
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引用次数: 95
摘要
背景:基于不同平台和免疫程序的多种新型冠状病毒病(COVID-19)疫苗已在全球范围内陆续获批上市。迫切需要对评估新冠肺炎疫苗安全性的临床试验进行全面审查,以便对大规模疫苗接种做出准确判断。本文通过系统评价和荟萃分析来确定随机对照试验(rct)中COVID-19候选疫苗的安全性。在PubMed、Embase、Cochrane library、Scopus、Web of Science和MedRxiv中进行数据检索。纳入的文章仅限于关于COVID-19疫苗的随机对照试验。共纳入14篇文章的73,633名受试者,比较接种不同COVID-19疫苗后免疫不良事件(AEFI)的风险。灭活疫苗、病毒载体疫苗和mRNA疫苗的总AEFI合并风险比(RR)为1.34[95%可信区间(CI) 1.11-1.61, P]。结论:目前的COVID-19候选疫苗用于大规模接种的安全性和耐受性是可以接受的,其中COVID-19候选灭活疫苗报告的AEFI最低。需要对疫苗安全性进行长期监测,特别是对有基础疾病的老年人。
Safety of SARS-CoV-2 vaccines: a systematic review and meta-analysis of randomized controlled trials.
Background: Various modalities of vaccines against coronavirus disease 2019 (COVID-19), based on different platforms and immunization procedures, have been successively approved for marketing worldwide. A comprehensive review for clinical trials assessing the safety of COVID-19 vaccines is urgently needed to make an accurate judgment for mass vaccination.
Main text: A systematic review and meta-analysis was conducted to determine the safety of COVID-19 vaccine candidates in randomized controlled trials (RCTs). Data search was performed in PubMed, Embase, Cochrane library, Scopus, Web of Science, and MedRxiv. Included articles were limited to RCTs on COVID-19 vaccines. A total of 73,633 subjects from 14 articles were included to compare the risks of adverse events following immunization (AEFI) after vaccinating different COVID-19 vaccines. Pooled risk ratios (RR) of total AEFI for inactivated vaccine, viral-vectored vaccine, and mRNA vaccine were 1.34 [95% confidence interval (CI) 1.11-1.61, P < 0.001], 1.65 (95% CI 1.31-2.07, P < 0.001), and 2.01 (95% CI 1.78-2.26, P < 0.001), respectively. No significant differences on local and systemic AEFI were found between the first dose and second dose. In addition, people aged ≤ 55 years were at significantly higher risk of AEFI than people aged ≥ 56 years, with a pooled RR of 1.25 (95% CI 1.15-1.35, P < 0.001).
Conclusions: The safety and tolerance of current COVID-19 vaccine candidates are acceptable for mass vaccination, with inactivated COVID-19 vaccines candidates having the lowest reported AEFI. Long-term surveillance of vaccine safety is required, especially among elderly people with underlying medical conditions.
期刊介绍:
Infectious Diseases of Poverty is a peer-reviewed, open access journal that focuses on essential public health questions related to infectious diseases of poverty. It covers a wide range of topics and methods, including the biology of pathogens and vectors, diagnosis and detection, treatment and case management, epidemiology and modeling, zoonotic hosts and animal reservoirs, control strategies and implementation, new technologies, and their application.
The journal also explores the impact of transdisciplinary or multisectoral approaches on health systems, ecohealth, environmental management, and innovative technologies. It aims to provide a platform for the exchange of research and ideas that can contribute to the improvement of public health in resource-limited settings.
In summary, Infectious Diseases of Poverty aims to address the urgent challenges posed by infectious diseases in impoverished populations. By publishing high-quality research in various areas, the journal seeks to advance our understanding of these diseases and contribute to the development of effective strategies for prevention, diagnosis, and treatment.