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全球批准的新冠病毒疫苗:一项系统综述。

Globally approved vaccines for COVID-19: a systematic review.

作者信息

Magalhães Brenda de Almeida Perret, Medeiros Minasi Jéssica, Lobato Rubens Caurio, Lemos Luiza Curi, de Britto Laryssa Saez, Barros Rhaysa Madruga, de Martínez Ana Maria Barral, da Hora Vanusa Pousada

机构信息

Interdisciplinary Group of Virology and Immunology, Faculty of Medicine, Federal University of Rio Grande (FURG), Rio Grande, RS, Brazil.

Post-Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Rio Grande (FURG), Rio Grande, RS, Brazil.

出版信息

Braz J Microbiol. 2025 Mar;56(1):511-527. doi: 10.1007/s42770-024-01600-x. Epub 2025 Jan 9.

Abstract

COVID-19 caused a public health emergency, which instituted a global effort to develop vaccines using different platforms, such as basic types and new-generation vaccines. Considering the importance of vaccination in preventing the severity of infectious diseases and the success in developing and approving vaccines against COVID-19 in record time, it is essential to learn about the characteristics of these vaccines. This study aimed to conduct a structured, systematic review following the PRISMA guideline, to analyze the general characteristics of vaccines approved globally for use against COVID-19. We used the list of approved vaccines available by the WHO as guidance to search for studies in the literature. We searched the terms "SARS-CoV-2 and vaccine and safety and efficacy" in the MEDLINE via PUBMED and Web of Science databases. We conducted the research on both bases, including complete articles published from January 2020 to June 2023. The selection of files occurred between May/2021 and June/2023. Therefore, the paper did not consider articles published after this period or vaccines approved after this moment. This study only included approved vaccines; phase three studies published in English. We found 11 published articles from phase three that met the established criteria. The vaccines included in this study were: Cominarty, mRNA-1273 or Spikevax, Vaxzevria or AZD1222 or Covishield, CoronaVac or PicoVacc, and Ad26.COV2.S, SputnikV or Gam-Covid-Vac, Covaxin, NVX-CoV2373 or Covovax or Nuvaxovid, WIV04 and HB02, CoVLP or Covifenz and Convidecia or Ad5-nCoV. We summarized the main findings of each vaccine, considering the vaccine composition, number of doses, efficacy analyses, and main adverse effects. In general, the vaccines had high efficacy rates and few adverse effects. Efficacy values are important for vaccine approval, but they will not necessarily reflect the real-world impact of vaccination. It was seen that the effectiveness of COV2.S, CoronaVac/PicoVacc, Cominarty, and Covaxin vaccines was lower than the efficacy, whereas, for AZD1222/Vaxzevria/Covishield, the two parameters remained at similar rates. All vaccines evaluated have different compositions, dosages, populations, and study designs. All are effective in at least preventing symptomatic COVID-19, causing mild or moderate adverse effects when present.

摘要

新冠疫情引发了一场公共卫生突发事件,促使全球努力利用不同平台研发疫苗,比如基础型和新一代疫苗。鉴于疫苗接种对于预防传染病严重程度的重要性,以及在创纪录的时间内成功研发并批准新冠疫苗,了解这些疫苗的特性至关重要。本研究旨在遵循PRISMA指南进行结构化、系统性综述,以分析全球批准使用的针对新冠病毒的疫苗的一般特性。我们以世界卫生组织提供的批准疫苗清单为指导,在文献中搜索相关研究。我们在通过PUBMED接入的MEDLINE数据库以及科学网数据库中搜索了“SARS-CoV-2、疫苗、安全性和有效性”等关键词。我们在这两个数据库上进行检索,纳入2020年1月至2023年6月发表的完整文章。文献筛选工作于2021年5月至2023年6月期间进行。因此,本文未考虑在此期间之后发表的文章或在此时间点之后批准的疫苗。本研究仅纳入已批准的疫苗;以英文发表的三期研究。我们找到了11篇符合既定标准的三期发表文章。本研究纳入的疫苗有:辉瑞新冠疫苗(Cominarty)、mRNA-1273或莫德纳新冠疫苗(Spikevax)、阿斯利康新冠疫苗(Vaxzevria或AZD1222或Covishield)、科兴新冠疫苗(CoronaVac或PicoVacc)、杨森新冠疫苗(Ad26.COV2.S)、卫星V新冠疫苗(SputnikV或Gam-Covid-Vac)、印度巴拉特生物新冠疫苗(Covaxin)、诺瓦瓦克斯新冠疫苗(NVX-CoV2373或Covovax或Nuvaxovid)、WIV04和HB02、重组蛋白新冠疫苗(CoVLP或Covifenz)以及康希诺新冠疫苗(Convidecia或Ad5-nCoV)。我们总结了每种疫苗的主要研究结果,包括疫苗成分、剂量数、疗效分析和主要不良反应。总体而言,这些疫苗具有较高的有效率且不良反应较少。疗效数值对于疫苗获批很重要,但它们不一定能反映疫苗接种在现实世界中的影响。可以看出,杨森新冠疫苗、科兴新冠疫苗/克尔来福、辉瑞新冠疫苗和印度巴拉特生物新冠疫苗的实际效果低于其疗效,而对于阿斯利康新冠疫苗(AZD1222/Vaxzevria/Covishield),这两个参数保持相似水平。所有评估的疫苗在成分、剂量、适用人群和研究设计方面均有所不同。所有疫苗至少在预防有症状的新冠方面是有效的,出现不良反应时多为轻度或中度。

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