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

Autor: Menniti-Ippolito F; Italian National Institute of Health, Rome, Italy., Mele A; Italian National Institute of Health, Rome, Italy., Da Cas R; Italian National Institute of Health, Rome, Italy., De Masi S; Clinical Trial Centre, Careggi Hospital, Florence, Italy. demasis@aou-careggi.toscana.it., Chiarotti F; Italian National Institute of Health, Rome, Italy., Fabiani M; Italian National Institute of Health, Rome, Italy., Baglio G; Italian National Agency for Regional Healthcare Services, Rome, Italy., Traversa G; Italian National Institute of Health, Rome, Italy., Colavita F; Laboratory of Virology, National Institute for Infectious Diseases Lazzaro Spallanzani, IRCCS, Rome, Italy., Castilletti C; Department of Infectious, Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy., Salomone M; Unit of Nephrology and Dialysis, Chieri and Moncalieri Hospitals, Turin, Italy., Zoccali C; Renal Research Institute, New York, USA.; Istituto di Biologia e Genetica Molecolare (BIOGEM), Ariano Irpino, Italy.; Associazione Ipertensione, Nefrologia e Trapianto Renale (IPNET) c/o Nefrologia, Grande Ospedale Metropolitano, Reggio Calabria, Italy., Messa P; Unit of Nephrology, Dialysis, and Renal Transplant, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Jazyk: angličtina
Zdroj: Journal of nephrology [J Nephrol] 2023 Sep; Vol. 36 (7), pp. 2013-2022. Date of Electronic Publication: 2023 Jul 25.
DOI: 10.1007/s40620-023-01708-7
Abstrakt: 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.
(© 2023. The Author(s) under exclusive licence to Italian Society of Nephrology.)
Databáze: MEDLINE
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