Autoimmune disorders reported following COVID-19 vaccination: A disproportionality analysis using the WHO database.
Adverse events
Autoimmune disorders
Coronavirus disease (COVID-19) vaccines
Pharmacovigilance
Reporting odds ratio
Journal
European journal of clinical pharmacology
ISSN: 1432-1041
Titre abrégé: Eur J Clin Pharmacol
Pays: Germany
ID NLM: 1256165
Informations de publication
Date de publication:
12 Jan 2024
12 Jan 2024
Historique:
received:
30
08
2023
accepted:
30
12
2023
medline:
12
1
2024
pubmed:
12
1
2024
entrez:
11
1
2024
Statut:
aheadofprint
Résumé
Owing to adverse event following immunization (AEFI) related to autoimmune disorders and coronavirus disease 2019 (COVID-19) vaccines sharing common biological mechanisms, identifying the risk of AEFIs associated with COVID-19 vaccines remains a critical unmet need. We aimed to assess the potential safety signals for 16 AEFIs and explore co-reported adverse events (AEs) and drugs using the global database of the World Health Organization, VigiBase. We assessed the occurrence of 16 AEFIs following COVID-19 vaccination through the Standardized MedDRA Queries group "Immune-mediated/Autoimmune Disorders" from MedDRA and performed a disproportionality analysis using reporting odds ratio (ROR) and information component (IC) with 95% confidence intervals (CIs). We identified 25,219 events associated with COVID-19 vaccines in VigiBase. Although rare, we detected four potential safety signals related to autoimmune disorders following COVID-19 vaccination, including ankylosing spondylitis or psoriatic arthritis (ROR 1.86; 95% CI 1.53-2.27), inflammatory bowel disease (ROR 1.77; 95% CI 1.60-1.96), polymyalgia rheumatica (ROR 1.42; 95% CI 1.30-1.55), and thyroiditis (ROR 1.40; 95% CI 1.30-1.50), with positive IC In addressing the imperative to comprehend AEFI related to autoimmune disorders following COVID-19 vaccination, our study identified four potential safety signals. Thus, our research underscores the importance of proactive safety monitoring for the identification of the four AEFIs following COVID-19 vaccination, considering the associated advantages.
Identifiants
pubmed: 38212538
doi: 10.1007/s00228-023-03618-w
pii: 10.1007/s00228-023-03618-w
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : the Ministry of Food and Drug Safety of South Korea
ID : 21153MFDS607, 22183MFDS433
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Michot JM et al (2019) Haematological immune-related adverse events with immune checkpoint inhibitors, how to manage? Eur J Cancer 122:72–90
doi: 10.1016/j.ejca.2019.07.014
pubmed: 31634647
Garrido I et al (2021) Autoimmune hepatitis after COVID-19 vaccine - more than a coincidence. J Autoimmun 125:102741
doi: 10.1016/j.jaut.2021.102741
pubmed: 34717185
pmcid: 8547941
Grana C et al (2022) Efficacy and safety of COVID-19 vaccines. Cochrane Database Syst Rev 12(12):CD015477
Pavord S et al (2021) Clinical features of vaccine-induced immune thrombocytopenia and thrombosis. N Engl J Med 385(18):1680–1689
doi: 10.1056/NEJMoa2109908
pubmed: 34379914
Pang E et al (2022) Cerebral arterial and venous thrombosis due to COVID-19 vaccine-induced immune thrombotic thrombocytopenia. BMJ Case Rep 15(1)
Rizk JG et al (2021) Clinical characteristics and pharmacological management of COVID-19 vaccine-induced immune thrombotic thrombocytopenia with cerebral venous sinus thrombosis: a review. JAMA Cardiol 6(12):1451–1460
doi: 10.1001/jamacardio.2021.3444
pubmed: 34374713
Ishay Y et al (2021) Autoimmune phenomena following SARS-CoV-2 vaccination. Int Immunopharmacol 99
Safary A et al (2022) Autoimmune inflammatory rheumatic diseases post-COVID-19 vaccination. Int Immunopharmacol 110
Bril F et al (2021) Autoimmune hepatitis developing after coronavirus disease 2019 (COVID-19) vaccine: causality or casualty? J Hepatol 75(1):222–224
doi: 10.1016/j.jhep.2021.04.003
pubmed: 33862041
pmcid: 8056822
Hippisley-Cox J et al (2021) Risk of thrombocytopenia and thromboembolism after COVID-19 vaccination and SARS-CoV-2 positive testing: self-controlled case series study. BMJ 374:n1931
doi: 10.1136/bmj.n1931
pubmed: 34446426
Ostrowski SR et al (2021) Inflammation and platelet activation after COVID-19 vaccines - possible mechanisms behind vaccine-induced immune thrombocytopenia and thrombosis. Front Immunol 12:779453. https://doi.org/10.3389/fimmu.2021.779453
Abara WE et al (2023) Reports of Guillain-Barré syndrome after COVID-19 vaccination in the United States. JAMA Netw Open 6(2):e2253845. https://doi.org/10.1001/jamanetworkopen.2022.53845
Hanson KE et al (2022) Incidence of Guillain-Barré syndrome after COVID-19 vaccination in the vaccine safety datalink. JAMA Netw Open 5(4):e228879. https://doi.org/10.1001/jamanetworkopen.2022.8879
Oliver SE et al (2022) Use of the Janssen (Johnson & Johnson) COVID-19 vaccine: updated interim recommendations from the Advisory Committee on Immunization Practices - United States, December 2021. MMWR Morb Mortal Wkly Rep 71(3):90–95
doi: 10.15585/mmwr.mm7103a4
pubmed: 35051137
pmcid: 8774160
Noseda R et al (2021) Adverse event reporting with immune checkpoint inhibitors in older patients: age subgroup disproportionality analysis in VigiBase. Cancers (Basel) 13(5)
Sen, Parikshit et al (2022) COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study. Rheumatology (Oxford, England)62(1):65–76. https://doi.org/10.1093/rheumatology/keac305
Yoon, Dongwon et al (2021) Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study. BMJ (Clinical research ed.) 372:m4931. https://doi.org/10.1136/bmj.m4931
Standardised MedDRA Queries | MedDRA. https://www.meddra.org/standardised-meddra-queries
van Puijenbroek EP et al (2002) A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf 11(1):3–10
doi: 10.1002/pds.668
pubmed: 11998548
Lumini A, Nanni L (2018) Convolutional neural networks for ATC classification. Curr Pharm Des 24(34):4007–4012
doi: 10.2174/1381612824666181112113438
pubmed: 30417778
Patone M et al (2021) Neurological complications after first dose of COVID-19 vaccines and SARS-CoV-2 infection. Nat Med 27(12):2144-+
Xing E et al (2022) Sex bias and autoimmune diseases. J Invest Dermatol 142(3):857–866. https://doi.org/10.1016/j.jid.2021.06.008
Sellner J et al (2011) The increasing incidence and prevalence of female multiple sclerosis--a critical analysis of potential environmental factors. Autoimmun Rev 10(8):495–502. https://doi.org/10.1016/j.autrev.2011.02.006
Li X et al (2022) Lack of inflammatory bowel disease flare-up following two-dose BNT162b2 vaccine: a population-based cohort study. Gut 71(12):2608–2611
doi: 10.1136/gutjnl-2021-326860
pubmed: 35135842
Weaver KN et al (2022) Impact of SARS-CoV-2 vaccination on inflammatory bowel disease activity and development of vaccine-related adverse events: results from PREVENT-COVID. Inflamm Bowel Dis 28(10):14971505. https://doi.org/10.1093/ibd/izab302
Masuta Y et al (2022) A case of ulcerative colitis relapse characterized by systemic type i interferon responses after COVID-19 vaccination. Inflamm Bowel Dis 28(8):e110-e111. https://doi.org/10.1093/ibd/izac031
Mettler C et al (2022) Risk of giant cell arteritis and polymyalgia rheumatica following COVID-19 vaccination: a global pharmacovigilance study. Rheumatology (Oxford) 61(2):865–867
doi: 10.1093/rheumatology/keab756
pubmed: 34626105
Rider LG et al (2022) Baseline factors associated with self-reported disease flares following COVID-19 vaccination among adults with systemic rheumatic disease: results from the COVID-19 global rheumatology alliance vaccine survey. Rheumatology (Oxford) 61(SI2):SI143-SI150
McGonagle D, De Marco G, Bridgewood C (2021) Mechanisms of immunothrombosis in vaccine-induced thrombotic thrombocytopenia (VITT) compared to natural SARS-CoV-2 infection. J Autoimmun 121
Teijaro JR, Farber DL (2021) COVID-19 vaccines: modes of immune activation and future challenges. Nat Rev Immunol 21(4):195–197
doi: 10.1038/s41577-021-00526-x
pubmed: 33674759
pmcid: 7934118
Reikine S, Nguyen JB, Modis Y (2014) Pattern recognition and signaling mechanisms of RIG-I and MDA5. Front Immunol 5
Frontera JA et al (2022) Neurological events reported after COVID-19 vaccines: an analysis of VAERS. Ann Neurol 91(6):756–771
doi: 10.1002/ana.26339
pubmed: 35233819
pmcid: 9082459
Weschawalit S et al (2023) Cutaneous adverse events after COVID-19 vaccination. Clin Cosmet Investig Dermatol 16:1473–1484. https://doi.org/10.2147/CCID.S410690
Ursini F et al (2022) Spectrum of short-term inflammatory musculoskeletal manifestations after COVID-19 vaccine administration: a report of 66 cases. Ann Rheum Dis 81(3):440–441
doi: 10.1136/annrheumdis-2021-221587
pubmed: 34836886
Ritchlin CT, Colbert RA, Gladman DD (2017) Psoriatic arthritis. N Engl J Med 376(10):957–970
doi: 10.1056/NEJMra1505557
pubmed: 28273019
Polack FP et al (2020) Safety and efficacy of the BNT162b2 mRNA COVID-19 vaccine. N Engl J Med 383(27):2603–2615
doi: 10.1056/NEJMoa2034577
pubmed: 33301246
Ozonoff Al et al (2021) Bell’s palsy and SARS-CoV-2 vaccines. The Lancet. Infect Dis 21(4):450–452. https://doi.org/10.1016/S1473-3099(21)00076-1
Arnold J, Winthrop K, Emery P (2021) COVID-19 vaccination and antirheumatic therapy. Rheumatology (Oxford) 60(8):3496–3502
doi: 10.1093/rheumatology/keab223
pubmed: 33710296
Mohseni Afshar Z et al (2022) Coronavirus disease 2019 (COVID-19) vaccination recommendations in special populations and patients with existing comorbidities. Rev Med Virol 32(3):e2309
doi: 10.1002/rmv.2309
pubmed: 34677889
Rosenthal S, Chen R (1995) The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 85:1706–1709
doi: 10.2105/AJPH.85.12.1706
pubmed: 7503351
pmcid: 1615747