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.
Pupillo, E., Bianchi, E., Beghi, E., Pedrazzini, F. A., Giglio, A., Schilke, E. D., Percetti, M., Colleoni, C. M., Mainini, G., Calabresi, P., Primiano, G. A., Frisullo, G., Padovani, A., Cristillo, V., Pilotto, A., Arici, D., Gipponi, S., Tedeschi, G., D'Ambrosio, A., Melisi, R. D., Gallo, A., Bisecco, A., Salmaggi, A., Basilico, P., Scaccabarozzi, C., Kiferle, L., Valenti, R., Avino, G., Borghi, A., Contardi, S., Zini, A., Ferrarese, C., Beretta, S., Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX), <<SCIENTIFIC REPORTS>>, 2025; 15 (1): N/A-N/A. [doi:10.1038/s41598-025-88837-0] [https://hdl.handle.net/10807/312881]
Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX)
Calabresi, Paolo;Primiano, Guido Alessandro;Frisullo, Giovanni;
2025
Abstract
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.
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