Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX)
Year: 2025
Type: article
Study design: Observational Study
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.
Source: Scientific Reports
Authors: Elisabetta Pupillo, Elisa Bianchi, Ettore Beghi, Francesco Andrea Pedrazzini, Angela Giglio, Edoardo Dalmato Schilke, Marco Percetti, Carlo Morotti Colleoni, Gabriele Mainini, Paolo Calabresi, Guido Primiano, Giovanni Frisullo, Alessandro Padovani, Viviana Cristillo, Andrea Pilotto, Davide Arici, Stefano Gipponi, Gioacchino Tedeschi, Alessandro d’Ambrosio, Rosario Domenico Melisi, Antonio Gallo, Alvino Bisecco, Andrea Salmaggi, Paola Basilico, Chiara Scaccabarozzi, Lorenzo Kiferle, Raffaella Valenti, Gianluca Avino, Annamaria Borghi, Sara Contardi, Andrea Zini, Carlo Ferrarese, Simone Beretta
Institutions: Mario Negri Institute for Pharmacological Research, University of Milano-Bicocca, Università Cattolica del Sacro Cuore, Agostino Gemelli University Polyclinic, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Campania "Luigi Vanvitelli", Aziende Socio Sanitarie Territoriali di Lecco, Ospedale di Prato Santo Stefano, Azienda Usl Toscana Centro, Hospital of Prato, Ospedale Maggiore Carlo Alberto Pizzardi, Istituto delle Scienze Neurologiche di Bologna
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,690
Funder: Dipartimenti di Eccellenza
Award: G1303340219
OpenAlex ID: W4407146461