COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study
- Author(s)
- Sen, P; R, N; Nune, A; Lilleker, JB; Agarwal, V; Kardes, S; Kim, M; Day, J; Milchert, M; Gheita, T; Salim, B; Velikova, T; Gracia-Ramos, AE; Parodis, I; O'Callaghan, AS; Nikiphorou, E; Chatterjee, T; Tan, AL; Cavagna, L; Saavedra, MA; Shinjo, SK; Ziade, N; Knitza, J; Kuwana, M; Distler, O; Chinoy, H; Agarwal, V; Aggarwal, R; Gupta, L;
- Journal Title
- Rheumatology
- Publication Type
- epub ahead of print
- Abstract
- 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.
- Keywords
- Covid-19; adverse reaction; autoimmune disease; rheumatic disease; vaccine
- Research Division(s)
- Inflammation
- PubMed ID
- 35713499
- Link To PubMed Central Version
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9214139/
- Publisher's Version
- https://doi.org/10.1093/rheumatology/keac305
- Terms of Use/Rights Notice
- Refer to copyright notice on published article.
Creation Date: 2022-06-21 11:06:42
Last Modified: 2022-06-24 10:57:04