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J. Med. Virol., Apr 2024, 96 (4) | https://doi.org/10.1002/jmv.29591 Global burden of vaccine-associated multiple sclerosis, 1967-2022: A comprehensive analysis of the international pharmacovigilance database

Ho Geol Woo ¹, Hyeon Jin Kim^2,3, Jaeyu Park^2,3, Jinseok Lee ⁴, Hayeon Lee ^2,4, Min Seo Kim ⁵, Ai Koyanagi ⁶, Lee Smith ⁷, Masoud Rahmati ^8,9,10, Seung Geun Yeo ¹¹, Dong Keon Yon ^2,3,12

¹Department of Neurology, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.

²Center for Digital Health, Medical Science Research Institute, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.

³Department of Regulatory Science, Kyung Hee University, Seoul, South Korea.

⁴Department of Biomedical Engineering, Kyung Hee University, Yongin, South Korea.

⁵Medical and Population Genetics and Cardiovascular Disease Initiative, Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA.

⁶Research and Development Unit, Parc Sanitari Sant Joan de Deu, Barcelona, Spain.

⁷Centre for Health, Performance and Wellbeing, Anglia Ruskin University, Cambridge, UK.

⁸CEReSS-Health Service Research and Quality of Life Center, Assistance Publique-Hôpitaux de Marseille (APHM), Aix-Marseille University, Marseille, France.

⁹Department of Physical Education and Sport Sciences, Faculty of Literature and Human Sciences, Lorestan University, Khoramabad, Iran.

¹⁰Department of Physical Education and Sport Sciences, Faculty of Literature and Humanities, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.

¹¹Department of Otolaryngology-Head & Neck Surgery, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.

¹²Department of Pediatrics, Kyung Hee University Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea.

Ho Geol Woo, Hyeon Jin Kim, and Jaeyu Park contributed equally to this study.

CORRESPONDING AUTHORS : Ho Geol Woo, Seung Geun Yeo, Dong Keon Yon

Abstract

Vaccine-associated multiple sclerosis (MS) is rare, with insufficient evidence from case reports. Given the scarcity of large-scale data investigating the association between vaccine administration and adverse events, we investigated the global burden of vaccine-associated MS and potential related vaccines from 1967 to 2022. Reports on vaccine-associated MS between 1967 and 2022 were obtained from the World Health Organization International Pharmacovigilance Database (total number of reports = 120 715 116). We evaluated global reports, reporting odds ratio (ROR), and information components (IC) to investigate associations between 19 vaccines and vaccine-associated MS across 156 countries and territories. We identified 8288 reports of vaccine-associated MS among 132 980 cases of all-cause MS. The cumulative number of reports on vaccine-associated MS gradually increased over time, with a substantial increase after 2020, owing to COVID-19 mRNA vaccine-associated MS. Vaccine-associated MS develops more frequently in males and adolescents. Nine vaccines were significantly associated with higher MS reporting, and the highest disproportional associations were observed for hepatitis B vaccines (ROR 19.82; IC ₀₂₅ 4.18), followed by encephalitis (ROR 7.42; IC ₀₂₅ 2.59), hepatitis A (ROR 4.46; IC ₀₂₅ 1.95), and papillomavirus vaccines (ROR 4.45; IC ₀₂₅ 2.01). Additionally, MS showed a significantly disproportionate signal for COVID-19 mRNA vaccines (ROR 1.55; IC ₀₂₅ 0.52). Fatal clinical outcomes were reported in only 0.3% (21/8288) of all cases of vaccine-associated MS. Although various vaccines are potentially associated with increased risk of MS, we should be cautious about the increased risk of MS following vaccination, particularly hepatitis B and COVID-19 mRNA vaccines, and should consider the risk factors associated with vaccine-associated MS.

논문정보

형식Research article
게재일2024년 04월 (BRIC 등록일 2024-04-05)
연구진국내(교신)+국외 연구진
분야 바이오·의료융합 > 다학제 융합/복합

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