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COVID-19 疫苗的安全性和有效性:对照和随机临床试验的系统评价和荟萃分析。

Safety and efficacy of COVID-19 vaccines: A systematic review and meta-analysis of controlled and randomized clinical trials.

机构信息

Department of Pharmacology, L. M. College of Pharmacy, Ahmedabad, Gujarat, India.

Department of Pharmaceutical Chemistry, L. M. College of Pharmacy, Ahmedabad, Gujarat, India.

出版信息

Rev Med Virol. 2024 Jan;34(1):e2507. doi: 10.1002/rmv.2507.


DOI:10.1002/rmv.2507
PMID:38282394
Abstract

Vaccines against coronavirus disease 2019 (COVID-19) have been discovered within a very small duration of time as compared to the traditional way for the development of vaccines, which raised the question about the safety and efficacy of the approved vaccines. The purpose of this study is to look at the effectiveness and safety of vaccine platforms against the incidence of COVID-19. The literature search was performed on PubMed/Medline, Cochrane, and clinical trials.gov databases for studies published between 1 January 2020 and 19 February 2022. Preferred Reporting Items for Systemic Review and Meta-Analysis Statement guidelines were followed. Among 284 articles received by keywords, a total of 11 studies were eligible according to the inclusion and exclusion criteria (studies in special populations, e.g., pregnant women, paediatric patients, editorials, case reports, review articles, preclinical and in vitro studies) of the study. A total of 247,186 participants were considered for randomisation at baseline, among them, 129,572 (52.42%) were provided with vaccine (Intervention group) and 117,614 (47.58%) with the placebo (Control group). A pooled fold change estimation of 0.19 (95% CI: 0.12-0.31, p < 0.0001) showed significant protection against the incidence of COVID-19 in the vaccines received group versus the placebo group. mRNA based, inactivated vaccines and non-replicating viral vector-based vaccines showed significantly protection against the incidence of COVID-19 compared to placebo with pooled fold change estimation was 0.08 (95% CI: 0.06-0.10), 0.20 (95% CI: 0.14-0.29) and 0.36 (95% CI: 0.28-0.46), respectively. Injection site discomfort and fatigue were the most common side effect observed in mRNA, non-replicating viral vector, inactivated, and protein subunit-based vaccines. All the approved vaccines were found safe and efficacious but mRNA-based vaccines were found to be more efficacious against SARS-CoV-2 than other platforms.

摘要

针对 2019 年冠状病毒病(COVID-19)的疫苗在相对传统疫苗开发方法非常短的时间内被发现,这引发了对已批准疫苗的安全性和有效性的质疑。本研究旨在研究针对 COVID-19 发病率的疫苗平台的有效性和安全性。文献检索在 PubMed/Medline、Cochrane 和 clinicaltrials.gov 数据库中进行,检索了 2020 年 1 月 1 日至 2022 年 2 月 19 日期间发表的研究。遵循系统评价和荟萃分析报告的首选报告项目声明指南。通过关键词共收到 284 篇文章,根据研究的纳入和排除标准(例如孕妇、儿科患者、社论、病例报告、综述文章、临床前和体外研究等特殊人群的研究),共有 11 项研究符合条件。在基线时共有 247186 名参与者被随机分配,其中 129572 名(52.42%)接受疫苗(干预组),117614 名(47.58%)接受安慰剂(对照组)。疫苗组与安慰剂组 COVID-19 发病率的汇总折叠变化估计值为 0.19(95%CI:0.12-0.31,p<0.0001),表明疫苗接种显著保护 COVID-19 发病率。基于 mRNA 的、灭活疫苗和非复制病毒载体疫苗与安慰剂相比,对 COVID-19 的发病率有显著保护作用,汇总折叠变化估计值分别为 0.08(95%CI:0.06-0.10)、0.20(95%CI:0.14-0.29)和 0.36(95%CI:0.28-0.46)。在基于 mRNA、非复制病毒载体、灭活和蛋白亚单位的疫苗中,最常见的不良反应是注射部位不适和疲劳。所有批准的疫苗均被发现安全有效,但与其他平台相比,基于 mRNA 的疫苗对 SARS-CoV-2 更有效。

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[4]
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[5]
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[6]
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[7]
The Effectiveness and Influence of COVID-19 Vaccination on Perinatal Individuals and Their Newborns: An Updated Meta-Analysis.

Can J Infect Dis Med Microbiol. 2025-6-24

[8]
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[9]
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