What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2.
What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2.
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什么是有效的COVID-19疫苗？评估SARS-CoV-2疫苗临床有效性的挑战综述
DOI：
10.1016/s1473-3099(20)30773-8
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发表时间：
2021-03
期刊：
影响因子：
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通讯作者：
Pollard AJ
中科院分区：
文献类型：
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作者：
Hodgson SH;Mansatta K;Mallett G;Harris V;Emary KRW;Pollard AJ
新的冠状病毒，严重急性呼吸综合征冠状病毒2(SARS-CoV-2)，在大流行的前6个月已造成100多万人死亡，并在国际上造成了巨大的经济和社会动荡。一种有效的疫苗对于防止进一步的发病率和死亡率至关重要。尽管一些国家部署新冠肺炎疫苗可能仅仅是因为安全性和免疫原性数据，但疫苗开发的目标是获得直接证据，证明疫苗在保护人类免受SARS-CoV-2感染和新冠肺炎感染方面的有效性，以便选择性地升级有效疫苗的生产。针对SARS-CoV-2的候选疫苗可能对感染、疾病或传播起作用，而能够减少这些因素中的任何一种的疫苗可能有助于疾病控制。然而，最重要的疗效终点，即对严重疾病和死亡的保护，在第三阶段临床试验中很难评估。在这篇综述中，我们探索了评估候选SARS-CoV-2疫苗有效性的挑战，讨论了解释已报道的疗效终点所需的注意事项，并提供了对回答看似简单的问题的洞察力：“这种新冠肺炎疫苗有效吗？”
The novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has caused more than 1 million deaths in the first 6 months of the pandemic and huge economic and social upheaval internationally. An efficacious vaccine is essential to prevent further morbidity and mortality. Although some countries might deploy COVID-19 vaccines on the strength of safety and immunogenicity data alone, the goal of vaccine development is to gain direct evidence of vaccine efficacy in protecting humans against SARS-CoV-2 infection and COVID-19 so that manufacture of efficacious vaccines can be selectively upscaled. A candidate vaccine against SARS-CoV-2 might act against infection, disease, or transmission, and a vaccine capable of reducing any of these elements could contribute to disease control. However, the most important efficacy endpoint, protection against severe disease and death, is difficult to assess in phase 3 clinical trials. In this Review, we explore the challenges in assessing the efficacy of candidate SARS-CoV-2 vaccines, discuss the caveats needed to interpret reported efficacy endpoints, and provide insight into answering the seemingly simple question, “Does this COVID-19 vaccine work?”