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COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study
Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, India.
Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Southport and Ormskirk Hospital NHS Trust, Southport, UK.
Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre,The University of Manchester, Manchester, UK; Neurology Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK.
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2022 (English)In: Rheumatology, ISSN 1462-0324, E-ISSN 1462-0332, Vol. 62, no 1, p. 65-76Article in journal (Refereed) Published
Abstract [en]

OBJECTIVES: COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination related adverse events (ADEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey.

METHODS: The survey was circulated in early 2021 by > 110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details, and 7-day vaccine ADEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type.

RESULTS: 10900 respondents [42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 5,867 patients (54%) with SAIDs were compared with 5033 HCs.79% had minor and only 3% had major vaccine ADEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs=26%, HCs=24%; OR = 1.1 (1.03-1.3); p = 0.014], abdominal pain [SAIDs=2.6%, HCs=1.4%; OR = 1.5 (1.1-2.3); p = 0.011], and dizziness [SAIDs=6%, HCs=4%; OR = 1.3 (1.07-1.6); p = 0.011], were slightly more frequent in SAIDs. Overall, major ADEs [SAIDs=4%, HCs=2%; OR = 1.9 (1.6-2.2); p < 0.001] and, specifically, throat closure [SAIDs=0.5%, HCs=0.3%; OR = 5.7 (2.9-11); p = 0.010] were more frequent in SAIDs though absolute risk was small (0-4%). Major ADEs and hospitalizations (less than 2%) were comparable across vaccine types in SAIDs.

CONCLUSION: Vaccination against COVID-19 is relatively safe in SAID patients. SAIDs were at a higher risk of major ADEs than HCs, though absolute risk was small. There are small differences in minor ADEs between vaccine types in SAID patients.

Place, publisher, year, edition, pages
Oxford University Press, 2022. Vol. 62, no 1, p. 65-76
Keywords [en]
COVID-19, adverse reaction, autoimmune disease, rheumatic disease, vaccine
National Category
Rheumatology and Autoimmunity Social and Clinical Pharmacy
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URN: urn:nbn:se:oru:diva-99646DOI: 10.1093/rheumatology/keac305ISI: 000833562000001PubMedID: 35713499Scopus ID: 2-s2.0-8514021865OAI: oai:DiVA.org:oru-99646DiVA, id: diva2:1673007
Available from: 2022-06-20 Created: 2022-06-20 Last updated: 2023-01-19Bibliographically approved

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