疫苗世界:COVID-19 疫苗的临床试验阶段和现状

Navya Pabbathi, Haritha Pasupulati, Soni Gaddam, Satyanarayana SV Padi
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摘要

疫苗世界改变了疫苗接种,挽救了数百万人的生命,否则这些生命可能会夺去许多人的生命,并阻碍全世界的可持续发展。事实上,2019 年冠状病毒病(COVID-19)大流行是一个公共卫生紧急事件,也是一个重要的里程碑,它揭示了疫苗是如何真正改变全世界生命的转折点。在人类的广泛努力下,COVID-19 疫苗在不到一年的时间内被发现、开发并在全球范围内获得批准,这在世界疫苗史上尚属首次。此外,世界卫生组织 "2030 年免疫议程"(IA2030)的战略目标之一是到 2030 年临床开发和批准 500 种新疫苗。发现能引起免疫反应的免疫原是优化候选疫苗以进一步进行临床前和临床试验的关键步骤或过程。临床评估分阶段(1-3)进行,是确定人体安全性和有效性的一个循序渐进的方法。疫苗审批和批量生产许可的监管要求是另一个障碍。此外,上市后安全性研究和上市后监测(第 4 阶段)对于收集获批疫苗安全性和有效性的真实世界数据至关重要。本综述简要概述了传统疫苗和 COVID-19 疫苗的开发时间表,并总结了疫苗开发的所有六个阶段。此外,还从未来批准的角度讨论了 COVID-19 疫苗的现状。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The World of Vaccines: Phases of Clinical Trials and Current Status of COVID-19 Vaccines
The world of vaccines has transformed vaccination by saving millions of lives which otherwise would have killed many people and a hurdle for sustainable development world-wide. Indeed, the coronavirus disease 2019 (COVID-19) pandemic is a public health emergency and an important milestone that revealed how vaccines are really turning point for live changing across the world. Owing to extensive human efforts, vaccines for COVID-19 are discovered and developed and approved globally in less than a year, which is the first time in the history of the world of vaccines. Furthermore, one of the strategic goals of WHO’s ‘The Immunization Agenda 2030’ (IA2030) is the clinical development and approval of 500 new vaccines by 2030. Discovery of immunogens that elicit immune responses is a key step or process by which vaccine candidates have been optimized for further preclinical and clinical trials. Clinical evaluation is carried out in Phases (1-3) and is a sequential approach of establishing safety and efficacy in humans. Regulatory requirements for vaccine approval and licensure to bulk manufacturing are another hurdle. Further, post-marketing safety studies and post-marketing surveillance (Phase 4) are essential to collect the real-world data on safety and effectiveness of the approved vaccines. This review work provides a brief outline on timeline of development of traditional and COVID-19 vaccines and summarizes all the six stages of the vaccine development. Furthermore, current status of COVID-19 vaccines is discussed in view of future approvals.
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