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Sci Rep
. 2025 Feb 4;15(1):4179.
doi: 10.1038/s41598-025-88837-0. Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX)
Elisabetta Pupillo 1 , Elisa Bianchi 1 , Ettore Beghi 1 , Francesco Andrea Pedrazzini 2 , Angela Giglio 2 , Edoardo Dalmato Schilke 2 , Marco Percetti 2 , Carlo Morotti Colleoni 2 , Gabriele Mainini 2 , Paolo Calabresi 3 4 , Guido Primiano 3 4 , Giovanni Frisullo 3 4 , Alessandro Padovani 5 , Viviana Cristillo 5 , Andrea Pilotto 5 , Davide Arici 5 , Stefano Gipponi 5 , Gioacchino Tedeschi 6 , Alessandro d'Ambrosio 6 , Rosario Domenico Melisi 6 , Antonio Gallo 6 , Alvino Bisecco 6 , Andrea Salmaggi 7 , Paola Basilico 7 , Chiara Scaccabarozzi 7 , Lorenzo Kiferle 8 , Raffaella Valenti 8 , Gianluca Avino 8 , Annamaria Borghi 9 , Sara Contardi 9 , Andrea Zini 9 , Carlo Ferrarese 2 10 , Simone Beretta 11 12 13
Affiliations
The COVIVAX study assessed the association between COVID-19 vaccination and the risk of common neurological disorders in a multicenter case-control design. Vaccination exposure was compared between individuals with a first diagnosis of a neurological disorder (cases) and age- and sex-matched controls. A total of 624 participants were enrolled, and after random 1:1 matching 265 cases and 265 matched controls (total 530 participants) were included in the analyses. The most frequent neurological diagnosis in cases were stroke (60.4%), multiple sclerosis (11.3%) and seizures (6.4%). The proportion of vaccinated participants was 72.1% among cases and 79.6% among controls. A protective role of vaccination on the risk of developing a new neurological disorder was detected in the unadjusted analysis (OR 0.50; 95% CI 0.29-0.86; p = 0.0114). After adjustment for confounders, the number of vaccination doses received was associated with a reduced risk of developing new neurological disorders for participants aged over 60 years ( p = 0.0472; OR 0.14, 95% CI 0.03-0.68), with pre-existing comorbidities (p = 0.0122; OR 0.04, 95% CI 0.01-0.99) and for stroke (p = 0.0232; OR 0.04, 95% CI 0.02-0.97). The COVIVAX study provided no warning sign regarding an increase in the risk of developing new neurological disorders following COVID-19 vaccination of any type or doses. A potentially protective effect of multiple doses of COVID-19 vaccines against the risk of stroke in people aged over 60 needs to be confirmed by further studies.
Keywords: Attributable risk; COVID-19; Case-control study; Epidemiology; Neurological disorders; Vaccines.
. 2025 Feb 4;15(1):4179.
doi: 10.1038/s41598-025-88837-0. Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX)
Elisabetta Pupillo 1 , Elisa Bianchi 1 , Ettore Beghi 1 , Francesco Andrea Pedrazzini 2 , Angela Giglio 2 , Edoardo Dalmato Schilke 2 , Marco Percetti 2 , Carlo Morotti Colleoni 2 , Gabriele Mainini 2 , Paolo Calabresi 3 4 , Guido Primiano 3 4 , Giovanni Frisullo 3 4 , Alessandro Padovani 5 , Viviana Cristillo 5 , Andrea Pilotto 5 , Davide Arici 5 , Stefano Gipponi 5 , Gioacchino Tedeschi 6 , Alessandro d'Ambrosio 6 , Rosario Domenico Melisi 6 , Antonio Gallo 6 , Alvino Bisecco 6 , Andrea Salmaggi 7 , Paola Basilico 7 , Chiara Scaccabarozzi 7 , Lorenzo Kiferle 8 , Raffaella Valenti 8 , Gianluca Avino 8 , Annamaria Borghi 9 , Sara Contardi 9 , Andrea Zini 9 , Carlo Ferrarese 2 10 , Simone Beretta 11 12 13
Affiliations
- PMID: 39905221
- PMCID: PMC11794632
- DOI: 10.1038/s41598-025-88837-0
The COVIVAX study assessed the association between COVID-19 vaccination and the risk of common neurological disorders in a multicenter case-control design. Vaccination exposure was compared between individuals with a first diagnosis of a neurological disorder (cases) and age- and sex-matched controls. A total of 624 participants were enrolled, and after random 1:1 matching 265 cases and 265 matched controls (total 530 participants) were included in the analyses. The most frequent neurological diagnosis in cases were stroke (60.4%), multiple sclerosis (11.3%) and seizures (6.4%). The proportion of vaccinated participants was 72.1% among cases and 79.6% among controls. A protective role of vaccination on the risk of developing a new neurological disorder was detected in the unadjusted analysis (OR 0.50; 95% CI 0.29-0.86; p = 0.0114). After adjustment for confounders, the number of vaccination doses received was associated with a reduced risk of developing new neurological disorders for participants aged over 60 years ( p = 0.0472; OR 0.14, 95% CI 0.03-0.68), with pre-existing comorbidities (p = 0.0122; OR 0.04, 95% CI 0.01-0.99) and for stroke (p = 0.0232; OR 0.04, 95% CI 0.02-0.97). The COVIVAX study provided no warning sign regarding an increase in the risk of developing new neurological disorders following COVID-19 vaccination of any type or doses. A potentially protective effect of multiple doses of COVID-19 vaccines against the risk of stroke in people aged over 60 needs to be confirmed by further studies.
Keywords: Attributable risk; COVID-19; Case-control study; Epidemiology; Neurological disorders; Vaccines.