{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T23:02:54Z","timestamp":1773788574073,"version":"3.50.1"},"reference-count":27,"publisher":"Springer Science and Business Media LLC","issue":"9","license":[{"start":{"date-parts":[[2023,6,23]],"date-time":"2023-06-23T00:00:00Z","timestamp":1687478400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,6,23]],"date-time":"2023-06-23T00:00:00Z","timestamp":1687478400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Rheumatol Int"],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb\u2013June 2022. We collected data on demographics, comorbidities, IIM\/SAID details, COVID-19 history, and vaccination details. Delayed-onset (&gt;\u20097\u00a0day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35\u201358) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (<jats:italic>n<\/jats:italic>\u2009=\u200910) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2\u20137.0, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford\/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period.<\/jats:p>","DOI":"10.1007\/s00296-023-05345-y","type":"journal-article","created":{"date-parts":[[2023,6,23]],"date-time":"2023-06-23T18:36:05Z","timestamp":1687545365000},"page":"1651-1664","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD 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EN has received speaker honoraria\/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from Pfizer and Lilly. HC has received grant support from Eli Lilly and UCB, consulting fees from Novartis, Eli Lilly, Orphazyme, Astra Zeneca, speaker for UCB, and Biogen. IP has received research funding and\/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG. JBL has received speaker honoraria\/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript. JD has received research funding from CSL Limited. JDP has undertaken consultancy work and\/or received speaker honoraria from Astra Zenaca, Boehringer Ingelgheim, Sojournix Pharma, Permeatus Inc, Janssen and IsoMab Pharmacueticals. MK has received speaker honoraria\/participated in advisory boards for Abbvie, Asahi-Kasei, Astellas, AstraZeneca, Boehringer-Ingelheim, Chugai, Corbus, Eisai, GSK, Horizon, Kissei, BML, Mochida, Nippon Shinyaku, Ono Pharmaceuticals, Tanabe-Mitsubishi. NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre; none are related to this manuscript. OD has\/had consultancy relationship with and\/or has received research funding from and\/or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last 3 calendar years: 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi and Topadur. Patent issued \u201cmir-29 for the treatment of systemic sclerosis\u201d (US8247389, EP2331143). RA has a consultancy relationship with and\/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio. TV has received speaker honoraria from Pfizer and AstraZeneca, non-related to the current manuscript. Rest of the authors have no conflict of interest relevant to this manuscript.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflicts of interest"}},{"value":"Ethical approval was obtained from the Institutional Ethics Committee of the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Raebareli Road, Lucknow, 226014. 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