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Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study
Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
Centre for Rheumatic Diseases, King's College London, London, UK; Rheumatology Department, King's College Hospital, London, UK.
Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, India.
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2023 (English)In: Rheumatology, ISSN 1462-0324, E-ISSN 1462-0332, Vol. 62, no 7, p. 2453-2463Article in journal (Refereed) Published
Abstract [en]

OBJECTIVE: To determine COVID-19 vaccine-related adverse events (AEs) in the seven-day post-vaccination period in patients with SLE versus autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HC).

METHODS: Data were captured through the COVID-19 Vaccination in Autoimmune Diseases (COVAD) questionnaire (March-December 2021). Multivariable regression models accounted for age, gender, ethnicity, vaccine type, and background treatment.

RESULTS: Among 9462 complete respondents, 583 (6.2%) were SLE patients (mean age: 40.1 years; 94.5% females; 40.5% Asian; 42.9% Pfizer-recipients). Minor AEs were reported by 83.0% of SLE patients, major by 2.6%, hospitalisation by 0.2%.AE and hospitalisation frequencies were similar between patients with active and inactive SLE. Rashes were more frequent in SLE patients versus HC (OR; 95% CI: 1.2; 1.0-1.5), chills less frequent in SLE versus AIRDs (0.6; 0.4-0.8) and nrAIDs (0.5; 0.3-0.8), and fatigue less frequent in SLE versus nrAIDs (0.6; 0.4-0.9). Pfizer-recipients reported higher overall AE (2.2; 1.1-4.2) and injection site pain (2.9; 1.6-5.0) frequencies than recipients of other vaccines, Oxford/AstraZeneca-recipients more body ache, fever, chills (OR: 2.5-3.0), Moderna-recipients more body ache, fever, chills, rashes (OR: 2.6-4.3). Hospitalisation frequencies were similar across vaccine types. AE frequencies were similar across treatment groups, although chills were less frequent in antimalarial users versus non-users (0.5; 0.3-0.9).

CONCLUSION: While COVID-19 vaccination-related AEs were reported by four-fifths of SLE patients, those were mostly minor and comparable to AEs reported by healthy individuals, providing reassurance regarding COVID-19 vaccination safety in SLE.

Place, publisher, year, edition, pages
Oxford University Press, 2023. Vol. 62, no 7, p. 2453-2463
Keywords [en]
COVID-19, adverse events, systemic lupus erythematosus, vaccine
National Category
Rheumatology and Autoimmunity
Identifiers
URN: urn:nbn:se:oru:diva-102373DOI: 10.1093/rheumatology/keac661ISI: 000912486900001PubMedID: 36413073Scopus ID: 2-s2.0-85166438135OAI: oai:DiVA.org:oru-102373DiVA, id: diva2:1713221
Funder
Swedish Rheumatism Association, R-941095King Gustaf V Jubilee Fund, FAI-2020-0741Swedish Society of Medicine, SLS-974449Region Stockholm, FoUI-955483Karolinska Institute
Note

Funding agencies:

Professor Nanna Svartz Foundation 2020-00368

Ulla and Roland Gustafsson Foundation

Available from: 2022-11-24 Created: 2022-11-24 Last updated: 2023-12-08Bibliographically approved

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