Department of Internal Medicine and Geriatrics, University of Palermo, Palermo, Italy.
Section of Geriatrics, Department of Internal Medicine and Paediatrics, Ghent University, Ghent, Belgium.
Ageing Res Rev. 2021 Nov;71:101455. doi: 10.1016/j.arr.2021.101455. Epub 2021 Sep 3.
During the COVID-19 pandemic older subjects have been disproportionately affected by the disease. Vaccination is a fundamental intervention to prevent the negative consequences of COVID-19, but it is not known if the needs and vulnerabilities of older people are adequately addressed by their inclusion in randomized clinical trials (RCTs) evaluating the efficacy of vaccines for COVID-19. Given this background, we aimed to evaluate if current and ongoing phase II-III RCTs evaluating the efficacy of COVID-19 vaccines included a representative sample of older people. A systematic literature search in PubMed and Clinicaltrials.gov was performed until May 01st, 2021. Among 474 abstracts initially retrieved, 20 RCTs (ten already published, ten ongoing) were included. In the ten studies already published, the mean age of participants was 45.2 ± 11.9 years and only 9.83% of the participants were more than 65 years, 1.66% more than 75 years and less than 1% (0.55%) more than 85 years. In the ten ongoing RCTs, many of the studies aimed at including participants older than 18 years, with one study including participants between 18 and 84 years, and two between 21 and 100 years. In conclusion, our systematic review demonstrates that in published and ongoing phase II-III randomized clinical trials evaluating the efficacy of COVID-19 vaccines only a tiny fraction of the most vulnerable group of older people was included, although they clearly were the first population that had to be vaccinated.
在 COVID-19 大流行期间，老年人受到该疾病的影响不成比例。接种疫苗是预防 COVID-19 负面后果的一项基本干预措施，但尚不清楚在评估 COVID-19 疫苗疗效的随机临床试验 (RCT) 中，老年人的需求和脆弱性是否得到充分考虑。有鉴于此，我们旨在评估目前和正在进行的评估 COVID-19 疫苗疗效的 II 期-III 期 RCT 是否纳入了有代表性的老年人样本。我们在 PubMed 和 Clinicaltrials.gov 上进行了系统的文献检索，直到 2021 年 5 月 1 日。在最初检索到的 474 篇摘要中，纳入了 20 项 RCT（10 项已发表，10 项正在进行）。在已发表的 10 项研究中，参与者的平均年龄为 45.2±11.9 岁，只有 9.83%的参与者超过 65 岁，1.66%超过 75 岁，不到 1%（0.55%）超过 85 岁。在正在进行的 10 项 RCT 中，许多研究旨在纳入 18 岁以上的参与者，其中一项研究纳入了 18 至 84 岁的参与者，两项研究纳入了 21 至 100 岁的参与者。总之，我们的系统评价表明，在已发表和正在进行的评估 COVID-19 疫苗疗效的 II 期-III 期随机临床试验中，只有一小部分最脆弱的老年人群体被纳入，尽管他们显然是第一批需要接种疫苗的人群。
