Journal
VACCINE
Volume 40, Issue 15, Pages 2324-2330Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2022.02.064
Keywords
GeroCovid Vax; COVID-19 vaccine; Nursing homes (NH); Long term care (LTC); Frailty syndrome; Elderly; Safety
Categories
Funding
- Italian Medicines Agency (AIFA)
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The COVID-19 pandemic has significantly impacted routine care for older individuals, particularly those living in long term care facilities. The vaccination of older adults in LTC facilities against COVID-19 is crucial in protecting them from infection and death. The GeroCovid Vax study in Italy aims to investigate the safety and efficacy of anti-SARS-CoV-2 vaccines in this population.
The COVID-19 pandemic has changed routine care practice for older persons, especially in those with frailty living in long term care (LTC) facilities. Due to the high mortality rates of Nursing home (NH) residents during the first wave of the COVID-19 pandemic, priority for COVID-19 vaccinations was given to this vulnerable population. However, the safety and efficacy of such vaccines in older frail elders remains questionable due to the fact that initial randomized clinical trials (RCTs) for such vaccines did not include this population. This type of discrimination in patient participation in RCTs continues and has been recognized in the literature. Nevertheless, in the context of a worldwide emergency, COVID-19 vaccination in older persons living in LTC facilities may provide a solid basis to protect against negative outcomes, such as COVID-19 infection and death. In this report, we present the protocol of the GeroCovid Vax study, an Italian study that began in February 2021 which is aimed at investigating the safety and efficacy of the anti-SARS-CoV-2 vaccinations in older persons living in LTCs. This protocol specially aims to continuously and closely monitor events related to- and following- the anti-SARS-CoV-2 vaccination in elderly living in LTC facilities. In this report, we will provide information related to the study protocol and describe baseline characteristics of the sample. (C) 2022 Elsevier Ltd. All rights reserved.
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