<p>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; <i>p</i> = 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 ( <i>p</i> = 0.0472; OR 0.14, 95% CI 0.03–0.68), with pre-existing comorbidities (<i>p</i> = 0.0122; OR 0.04, 95% CI 0.01–0.99) and for stroke (<i>p</i> = 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.</p>

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

  • 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

摘要

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.