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 (AEs) 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 AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type. Results. Ten thousand nine hundred respondents [median (interquartile range) age 42 (30–55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs ¼ 26%, HCs ¼ 24%; odds ratio (OR) ¼ 1.1 (95% CI: 1.03, 1.3); P ¼ 0.014], abdominal pain [SAIDs ¼ 2.6%, HCs ¼ 1.4%; OR ¼ 1.5 (95% CI: 1.1, 2.3); P ¼ 0.011], and dizziness [SAIDs ¼ 6%, HCs ¼ 4%; OR ¼ 1.3 (95% CI: 1.07, 1.6); P ¼ 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs ¼ 4%, HCs ¼ 2%; OR ¼ 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs ¼ 0.5%, HCs ¼ 0.3%; OR ¼ 5.7 (95% CI: 2.9, 11); P ¼ 0.010] were more frequent in SAIDs though absolute risk was small (0–4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs. Conclusion. Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.
COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study / Sen, P.; Ravichandran, N.; Nune, A.; Lilleker, J. B.; Agarwal, V.; Kardes, S.; Kim, M.; Day, J.; Milchert, M.; Gheita, T.; Salim, B.; Velikova, T.; Gracia-Ramos, A. E.; Parodis, I.; O'Callaghan, A. S.; Nikiphorou, E.; Chatterjee, T.; Tan, A. L.; Cavagna, L.; Saavedra, M. A.; Shinjo, S. K.; Ziade, N.; Knitza, J.; Kuwana, M.; Distler, O.; Chinoy, H.; Agarwal, V.; Aggarwal, R.; Gupta, L.; Joshi, M.; Barman, B.; Singh, Y. P.; Ranjan, R.; Jain, A.; Pandya, S. C.; Pilania, R. K.; Sharma, A.; Manesh Manoj, M.; Gupta, V.; Kavadichanda, C. G.; Patro, P. S.; Ajmani, S.; Phatak, S.; Goswami, R. P.; Chowdhury, A. C.; Mathew, A. J.; Shenoy, P.; Asranna, A.; Bommakanti, K. T.; Shukla, A.; Pande, A. R.; Chandwar, K.; Cansu, D. U.; Pauling, J. D.; Wincup, C.; Makol, A.; Del Papa, N.; Sambataro, G.; Fabiola, A.; Govoni, M.; Parisi, S.; Bocci, E. B.; Sebastiani, G. D.; Fusaro, E.; Sebastiani, M.; Quartuccio, L.; Franceschini, F.; Sainaghi, P. P.; Orsolini, G.; De Angelis, R.; Danielli, M. G.; Venerito, V.; Traboco, L. S.; Wibowo, S. A. K.; Serrano, J. R.; Garcia-De La Torre, I.; Tehozol, E. A. Z.; Loarce-Martos, J.; Prieto-Gonzalez, S.; Gil-Vila, A.; Gonzalez, R. A.; Yoshida, A.; Nakashima, R.; Sato, S.; Kimura, N.; Kaneko, Y.; Tomaras, S.; Gromova, M. A.; Aharonov, O.; Hmamouchi, I.; Hoff, L. S.; Giannini, M.; Maurier, F.; Campagne, J.; Meyer, A.; Nagy-Vincze, M.; Langguth, D.; Limaye, V.; Needham, M.; Srivastav, N.; Hudson, M.; Landon-Cardinal, O.; Shaharir, S. S.; Zuleta, W. G. R.; Silva, J. A. P.; Fonseca, J. E.; Zimba, O.. - In: RHEUMATOLOGY. - ISSN 1462-0324. - 62:1(2023), pp. 65-76. [10.1093/rheumatology/keac305]
COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study
Sebastiani M.;
2023-01-01
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 (AEs) 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 AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type. Results. Ten thousand nine hundred respondents [median (interquartile range) age 42 (30–55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs ¼ 26%, HCs ¼ 24%; odds ratio (OR) ¼ 1.1 (95% CI: 1.03, 1.3); P ¼ 0.014], abdominal pain [SAIDs ¼ 2.6%, HCs ¼ 1.4%; OR ¼ 1.5 (95% CI: 1.1, 2.3); P ¼ 0.011], and dizziness [SAIDs ¼ 6%, HCs ¼ 4%; OR ¼ 1.3 (95% CI: 1.07, 1.6); P ¼ 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs ¼ 4%, HCs ¼ 2%; OR ¼ 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs ¼ 0.5%, HCs ¼ 0.3%; OR ¼ 5.7 (95% CI: 2.9, 11); P ¼ 0.010] were more frequent in SAIDs though absolute risk was small (0–4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs. Conclusion. Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
