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Multicenter Study
. 2023 Sep;36(7):2013-2022.
doi: 10.1007/s40620-023-01708-7. Epub 2023 Jul 25.

Safety and efficacy of COVID-19 vaccines in patients on dialysis: a multicentre cohort study in Italy

Francesca Menniti-Ippolito  1 , Alfonso Mele  1 , Roberto Da Cas  1 , Salvatore De Masi  2 , Flavia Chiarotti  1 , Massimo Fabiani  1 , Giovanni Baglio  3 , Giuseppe Traversa  1 , Francesca Colavita  4 , Concetta Castilletti  5 , Mario Salomone  6 , Carmine Zoccali  7   8   9 , Piergiorgio Messa  10 ; COVIDVaxDia Study Group
Collaborators, Affiliations
Multicenter Study

Safety and efficacy of COVID-19 vaccines in patients on dialysis: a multicentre cohort study in Italy

Francesca Menniti-Ippolito et al. J Nephrol. 2023 Sep.

Erratum in

Abstract

Background: The aim of this study was to evaluate the efficacy and safety of COVID-19 vaccines in patients undergoing haemodialysis in Italy compared to the general population.

Methods: In this cohort study, 118 dialysis centres from 18 Italian Regions participated. Individuals older than 16 years on dialysis treatment for at least 3 months, who provided informed consent were included. We collected demographic and clinical information, as well as data on vaccination status, hospitalisations, access to intensive care units and adverse events. We calculated the incidence, hospitalisation, mortality, and fatality rates in the vaccinated dialysis cohort, adjusted for several covariates. The incidence rates of infection in the dialysis cohort and the general population were compared through Standardised Incidence Rate Ratio.

Results: The study included 6555 patients vaccinated against SARS-CoV-2 infection according to the schedule recommended in Italy. Between March 2021 and May 2022, there were 1096 cases of SARS-CoV-2 infection, with an incidence rate after completion of the three-dose vaccination cycle of 37.7 cases per 100 person-years. Compared to the general population, we observed a 14% reduction in the risk of infection for patients who received three vaccine doses (Standardised Incidence Rate Ratio: 0.86; 95% Confidence Interval: 0.81-0.91), whereas no statistically significant differences were found for COVID-19-related hospitalisations, intensive care unit admissions or death. No safety signals emerged from the reported adverse events.

Conclusions: The vaccination program against SARS-CoV-2 in the haemodialysis population showed an effectiveness and safety profile comparable to that seen in the general population.

Keywords: COVID vaccines; Cohort study; Dialysis; Effectiveness; Safety.

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