Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX)

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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Publication Details

Journal
Scientific Reports
Published
2025-02-04
DOI
https://doi.org/10.1038/s41598-025-88837-0
Primary Topic
Long-Term Effects of COVID-19
Type
article
Field-Weighted Citation Impact
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article

Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX)

Giovanni Frisullo, Gabriele Mainini, Andrea Zini, Alvino Bisecco et al.
Scientific Reports
Long-Term Effects of COVID-19
article

Multicentre case-control study on the association between COVID-19 vaccines and neurological disorders (COVIVAX)

Giovanni Frisullo, Gabriele Mainini, Andrea Zini, Alvino Bisecco, Andrea Pilotto, Carlo Ferrarese, Davide Arici, Paola Basilico, Marco Percetti, Simone Beretta, Edoardo Dalmato Schilke, Elisabetta Pupillo, Guido Primiano, F. Pedrazzini, Lorenzo Kiferle, Sara Contardi, Carlo Morotti Colleoni, Viviana Cristillo, Andrea Salmaggi, Alessandro d’Ambrosio, Gioacchino Tedeschi, Stefano Gipponi, Gianluca Avino, Ettore Beghi, Annamaria Borghi, Elisa Bianchi, Antonio Gallo, Raffaella Valenti, Paolo Calabresi, Chiara Scaccabarozzi, Alessandro Padovani, Rosario Domenico Melisi, Angela Giglio
article en

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.

Scientific ReportsVol. 15(1)
Università Cattolica del Sacro Cuore (IT), Mario Negri Institute for Pharmacological Research (IT), University of Campania "Luigi Vanvitelli" (IT), Agostino Gemelli University Polyclinic (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Azienda Ospedaliera San Gerardo (IT), Istituto delle Scienze Neurologiche di Bologna (IT), Bracco (Italy) (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Azienda Usl Toscana Centro (IT), University of Milano-Bicocca (IT)
Dipartimenti di Eccellenza
Good health and well-being
Openalex Percentile: Top 96%
Long-Term Effects of COVID-19
DOIOpen Access PDFOpenAlex
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