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COVID-19 疫苗 III 期临床试验及之后的目标产品概况分析:2021 年初展望。

Target Product Profile Analysis of COVID-19 Vaccines in Phase III Clinical Trials and Beyond: An Early 2021 Perspective.

机构信息

Department of Biomedical and Molecular Sciences, Queen's University, Kingston, ON K7L 3N6, Canada.

Scientific Research Division, Novateur Ventures Inc., Vancouver, BC V6E 3P3, Canada.

出版信息

Viruses. 2021 Mar 5;13(3):418. doi: 10.3390/v13030418.

DOI:10.3390/v13030418
PMID:33807839
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7998902/
Abstract

The coronavirus SARS-CoV-2, which causes Coronavirus disease 2019 (COVID-19), has infected more than 100 million people globally and caused over 2.5 million deaths in just over one year since its discovery in Wuhan, China in December 2019. The pandemic has evoked widespread collateral damage to societies and economies, and has destabilized mental health and well-being. Early in 2020, unprecedented efforts went into the development of vaccines that generate effective antibodies to the SARS-CoV-2 virus. Teams developing twelve candidate vaccines, based on four platforms (messenger RNA, non-replicating viral vector, protein/virus-like particle, and inactivated virus) had initiated or announced the Phase III clinical trial stage by early November 2020, with several having received emergency use authorization in less than a year. Vaccine rollout has proceeded around the globe. Previously, we and others had proposed a target product profile (TPP) for ideal/optimal and acceptable/minimal COVID-19 vaccines. How well do these candidate vaccines stack up to a harmonized TPP? Here, we perform a comparative analysis in several categories of these candidate vaccines based on the latest available trial data and highlight the early successes as well as the hurdles and barriers yet to be overcome for ending the global COVID-19 pandemic.

摘要

导致 2019 年冠状病毒病(COVID-19)的冠状病毒 SARS-CoV-2 自 2019 年 12 月在中国武汉发现以来,在短短一年多的时间里,已在全球感染了超过 1 亿人,并导致超过 250 万人死亡。大流行对社会和经济造成了广泛的附带损害,并破坏了心理健康和幸福感。早在 2020 年初,就投入了前所未有的努力来开发可产生针对 SARS-CoV-2 病毒有效抗体的疫苗。基于四个平台(信使 RNA、非复制病毒载体、蛋白/病毒样颗粒和灭活病毒)的 12 种候选疫苗的开发团队在 2020 年 11 月初已经启动或宣布了 III 期临床试验阶段,其中几个疫苗在不到一年的时间内就获得了紧急使用授权。疫苗接种已在全球范围内展开。此前,我们和其他人曾为理想/最佳和可接受/最小 COVID-19 疫苗提出了目标产品概况(TPP)。这些候选疫苗在多大程度上符合协调的 TPP?在这里,我们根据最新的可用试验数据,对这些候选疫苗的几个类别进行了比较分析,并强调了早期的成功,以及为结束全球 COVID-19 大流行而仍需克服的障碍和挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcb2/7998902/c3272cf59176/viruses-13-00418-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcb2/7998902/29ecc987ec92/viruses-13-00418-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcb2/7998902/b7c59436cf2c/viruses-13-00418-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcb2/7998902/c3272cf59176/viruses-13-00418-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcb2/7998902/29ecc987ec92/viruses-13-00418-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcb2/7998902/b7c59436cf2c/viruses-13-00418-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bcb2/7998902/c3272cf59176/viruses-13-00418-g003.jpg

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