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. 2021 Nov:71:101455.
doi: 10.1016/j.arr.2021.101455. Epub 2021 Sep 3.

Underrepresentation of older adults in clinical trials on COVID-19 vaccines: A systematic review

Nicola Veronese  1 , Mirko Petrovic  2 , Athanase Benetos  3 , Michael Denkinger  4 , Adalsteinn Gudmundsson  5 , Wilma Knol  6 , Christine Marking  7 , George Soulis  8 , Stefania Maggi  9 , Antonio Cherubini  10 ; special interest group in Systematic Reviews and Meta-analyses and the task force on Pharmaceutical strategy of the European Geriatric Medicine Society (EuGMS)
Affiliations

Underrepresentation of older adults in clinical trials on COVID-19 vaccines: A systematic review

Nicola Veronese et al. Ageing Res Rev. 2021 Nov.

Abstract

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.

Keywords: COVID-19; Older adults; Vaccination.

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Figures

Fig. 1
Fig. 1
PRISMA flow-chart.
Fig. 2
Fig. 2
Graphical representation of age distribution in the randomized controlled trials included. The Blue area represents people between 45.2 years (calculated mean) and 65 years; the yellow area participants between 65 and 75 years; the orange area those between 75 and 85 years; the white area participants with more than 85 years. (For interpretation of the references to color in this figure legend, the reader is referred to the web version of this article.)
See this image and copyright information in PMC

Comment in

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