Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.
Instituto de Ensino, Pesquisa e Inovação, Liga Contra o Câncer, Natal, Rio Grande do Norte, Brazil.
BMJ Open. 2022 Feb 24;12(2):e050278. doi: 10.1136/bmjopen-2021-050278.
SARS-CoV-2 is responsible for a large number of global COVID-19 cases. Strategies such as social isolation, personal hygiene and frequent hand washing have been implemented; however, a protective vaccine is required to achieve sufficient herd immunity to SARS-CoV-2 infection to ultimately control the COVID-19 pandemic. To meet the urgent need for a vaccine, a reduction in the development schedule has been proposed from 10-15 years to 1-2 years. For this reason, this systematic review and meta-analysis protocol aims to compare the side effects, safety and toxicity of COVID-19 vaccines available globally, including their combinations.
We will select randomised controlled trial-type studies that evaluate the side effects of the COVID-19 vaccine. PubMed, Web of Science, Embase, CINAHL, PsycINFO, LILACS, SCOPUS, ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), medRxiv.org, biorxiv.org, preprints.org and the Cochrane Library will be searched for eligible studies until December 2021. Three reviewers will independently screen and select studies, assess methodological quality and extract data. A meta-analysis will be performed, if possible, and the Grading of Recommendations, Assessment, Development and Evaluations summary of findings will be presented.
This study will review published data, and thus it is unnecessary to obtain ethical approval. The findings of this systematic review will be published in a peer-reviewed journal.
CRD42021231101.
SARS-CoV-2 是导致全球大量 COVID-19 病例的罪魁祸首。已经实施了社交隔离、个人卫生和经常洗手等策略；然而，需要一种保护性疫苗来实现对 SARS-CoV-2 感染的足够群体免疫，以最终控制 COVID-19 大流行。为了满足对疫苗的迫切需求，已经提出将开发时间表从 10-15 年缩短至 1-2 年。出于这个原因，本系统评价和荟萃分析方案旨在比较全球可用的 COVID-19 疫苗（包括其组合）的副作用、安全性和毒性。
我们将选择评估 COVID-19 疫苗副作用的随机对照试验型研究。将检索 PubMed、Web of Science、Embase、CINAHL、PsycINFO、LILACS、SCOPUS、ClinicalTrials.gov、国际临床试验注册平台（ICTRP）、medRxiv.org、biorxiv.org、预印本.org 和 Cochrane 图书馆，直到 2021 年 12 月，以查找合格的研究。三名评审员将独立筛选和选择研究、评估方法学质量并提取数据。如果可能，将进行荟萃分析，并呈现推荐、评估、制定和评估总结发现的分级。
本研究将审查已发表的数据，因此无需获得伦理批准。本系统评价的研究结果将发表在同行评议的期刊上。
PROSPERO 注册号：CRD42021231101。
