疫苗与COVID-19疫苗:开发和试验设计的机动时间表

Soni Gaddam, Haritha Pasupulati, S. Padi
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引用次数: 1

摘要

最近的2019冠状病毒病(COVID-19)大流行对公共卫生构成严重威胁,并成为全球负担,数百万人面临死亡风险。当时,没有批准的COVID-19抗病毒药物和疫苗,但很少有药物被重新利用,效果有限。在不到一年的时间里,已有几种COVID-19疫苗获得批准,数百种疫苗正在进行临床评估。本综述的重点是疫苗需求、疫苗接种的益处、世界卫生组织发起的新的全球战略“2030年免疫议程”、发展阶段和时间表以及传统疫苗的临床评价。我们总结了大流行前传统疫苗与常规药物的临床评价比较。本综述简要讨论了大流行时期COVID-19疫苗的优先方法、加快临床评估时间表以及无缝和免疫桥接临床试验设计。我们彻底检索了有关该主题的最新文献和数据,并总结了目前的进展、监管修订以及疫苗开发和批准的未来前景。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
VACCINES VERSUS COVID-19 VACCINES: MANEUVER TIMELINE OF DEVELOPMENT AND TRIAL DESIGNS
Recent pandemic of coronavirus disease 2019 (COVID-19) has made a serious threat to public health and became a global burden with millions of people at risk of death. At that time, there were no approved antiviral drugs and vaccines for COVID-19, but few drugs are repurposed with limited benefit. In less than a year, several COVID-19 vaccines have already been approved and hundreds of vaccines are undergoing clinical evaluation. This review focuses on need for vaccines, benefits of vaccination, the World Health Organization initiated new global strategy ‘the Immunization Agenda 2030’ (IA2030), stages and timeline of development, and clinical evaluation of traditional vaccines. We have summarized comparison of clinical evaluation between traditional vaccines and conventional drugs in the pre-pandemic era. The review briefly discusses the prioritized approaches, accelerated timeline of clinical evaluation, and seamless and immunobridging clinical trial designs of COVID-19 vaccines in the pandemic period. We have thoroughly searched recent literature and data on this topic and made a summary of current advances, regulatory amendments, and future perspectives of development and approval of vaccines.
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