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新型冠状病毒疫苗在老年人中的疗效和安全性。

Efficacy and safety of COVID-19 vaccines in older people.

机构信息

NHS Grampian, Aberdeen Royal Infirmary, Aberdeen, UK.

Ageing Clinical & Experimental Research Group, University of Aberdeen, UK.

出版信息

Age Ageing. 2021 Feb 26;50(2):279-283. doi: 10.1093/ageing/afaa274.

Abstract

Several vaccines against coronavirus disease 2019 (COVID-19) are on the cusp of regulatory approval. Their safety and efficacy in older people is critical to their success. Even though care home residents and older people are likely to be amongst the first to be vaccinated, these patient groups are usually excluded from clinical trials. Data from several Phase II trials have given cause for optimism, with strong antibody responses and reassuring safety profiles but, with the exception of AstraZeneca's vaccine, recruited few older people. Overall, the sparse data from Phase II trials suggest a reduction in both antibody responses and mild to moderate adverse events in well older people compared to younger participants. Many of the Phase III trials have made a conscious effort to recruit older people, and interim analyses of the Pfizer and Moderna vaccine have led to press releases announcing high degrees of efficacy. However, older people with co-morbidities and frailty have once again been largely excluded and there are no published data on safety and efficacy in this group. Although the speed and impact of the pandemic on older people with frailty justify an approach where they are offered vaccination first, patients and their carers and supervising health care professionals alike will need to make a decision on accepting vaccination based on limited evidence. Here we review the main candidate vaccines that may become available, with a focus on the evidence of safety and efficacy in older people.

摘要

几种针对 2019 年冠状病毒病(COVID-19)的疫苗即将获得监管部门的批准。它们在老年人中的安全性和有效性对其成功至关重要。尽管养老院居民和老年人可能是首批接种疫苗的人群之一,但这些患者群体通常被排除在临床试验之外。几项 II 期试验的数据令人乐观,这些数据显示出强烈的抗体反应和令人放心的安全性特征,但除了阿斯利康的疫苗外,很少有老年人参与。总体而言,II 期试验的稀疏数据表明,与年轻参与者相比,身体较好的老年人的抗体反应和轻度至中度不良事件均有所减少。许多 III 期试验都有意识地努力招募老年人,辉瑞和 Moderna 疫苗的中期分析导致发布了公告,宣布了高功效。然而,患有合并症和虚弱的老年人再次被排除在外,而且在这一人群中没有安全性和有效性的已发表数据。尽管 COVID-19 大流行对患有虚弱症的老年人的速度和影响证明了首先为他们提供疫苗接种的方法是合理的,但患者及其护理人员和监督医疗保健专业人员都需要根据有限的证据就接受疫苗接种做出决定。在这里,我们回顾了可能获得的主要候选疫苗,重点关注老年人安全性和有效性的证据。

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