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一种灭活SARS-CoV-2疫苗的预防效果
Effectiveness of an Inactivated SARS-CoV-2 Vaccine


Annelies Wilder-Smith ... 传染病 呼吸系统疾病 • 2021.09.02
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• 一种灭活SARS-CoV-2疫苗在智利发挥的预防效果

全世界需要更多可预防COVID-19致病病毒SARS-CoV-2的疫苗,从而减轻此次全球疫情对健康和社会造成的灾难性后果。即使是预防效果较低的疫苗也可能对公共卫生产生实质性影响。目前有六种COVID-19疫苗已进入世界卫生组织(WHO)的紧急使用清单(Emergency Use Listing)。每种疫苗有不同的属性和优缺点,而且指导政策决策时需考虑多种因素。3期试验确定的疫苗预防效力的点估计值(置信区间通常相对较宽且互相重叠)在不同疫苗之间有很大差异。但这些点估计值不能直接比较,因为预防效力试验是在不同的流行病学背景下开展,而且使用了不同的病例定义、临床终点和终点确认方案。

北京科兴中维生物技术有限公司开发的克尔来福疫苗是在全球部署的首批疫苗之一。迄今,40多个国家已接种超过7.5亿剂克尔来福疫苗。该疫苗是含氢氧化铝佐剂的灭活全病毒疫苗。疫苗可在2~8℃的冷藏温度下运输和储存。在来自中国(WHO评估可否列入紧急使用清单时,已分发3,580万剂疫苗)以及巴西、印度尼西亚和智利(约2,000万剂)的批准后被动监测数据中,安全性数据表明未出现非预期的安全信号1。目前已在巴西、印度尼西亚和土耳其开展了三项随机、安慰剂对照的3期临床试验。根据期中分析结果,在中位2个月的观察时间,该疫苗对有症状疾病的预防效力的点估计值各不相同,巴西为50.65%,印度尼西亚为65.30%,土耳其为83.50%1。疫苗对住院和死亡的预防效力显著较高,接近100%,但置信区间较宽。临床试验中60岁以上参与者的人数不足以确定疫苗在该年龄人群中的预防效力。此外,上述试验是在高关注变异株尚未出现时开展。因此,为了填补尚存的知识缺口,我们需要开展上市后的疫苗预防效果研究。





作者信息

Annelies Wilder-Smith, M.D., Ph.D., and Kim Mulholland, M.B., B.S., M.D.
From the Institute of Social and Preventive Medicine, University of Bern, Switzerland (A.W.-S.); Murdoch Children’s Research Institute, Melbourne, VIC, Australia (K.M.); and the London School of Hygiene and Tropical Medicine, London (K.M.).

 

参考文献

1. Recommendation for an emergency use listing of Covid-19 vaccine (Vero cell), inactivated — submitted by Sinovac. Geneva: World Health Organization. June 28, 2021 (https://extranet.who.int/pqweb/sites/default/files/documents/SINOVAC_TAG_PEG_REPORT_EUL-Final28june2021.pdf).

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