COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study
Articolo
Data di Pubblicazione:
2022
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 = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 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.
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 = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 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.
Tipologia CRIS:
1.1 Articolo in rivista
Keywords:
COVID-19; adverse reaction; autoimmune disease; rheumatic disease; vaccine.
Elenco autori:
Sen, Parikshit; Ravichandran, Naveen; Nune, Arvind; B Lilleker, James; Agarwal, Vishwesh; Kardes, Sinan; Kim, Minchul; Day, Jessica; Milchert, Marcin; Gheita, Tamer; Salim, Babur; Velikova, Tsvetelina; Edgar Gracia-Ramos, Abraham; Parodis, Ioannis; Selva O’Callaghan, Albert; Nikiphorou, Elena; Chatterjee, Tulika; Lyn Tan, Ai; Cavagna, Lorenzo; A Saavedra, Miguel; Katsuyuki Shinjo, Samuel; Ziade, Nelly; Knitza, Johannes; Kuwana, Masataka; Distler, Oliver; Chinoy, Hector; Agarwal, Vikas; Aggarwal, Rohit; Gupta, Latika; Joshi, Mrudula; Barman, Bhupen; Preet Singh, Yogesh; Ranjan, Rajiv; Jain, Avinash; Pandya, Sapan C.; Kumar Pilania, Rakesh; Sharma, Aman; M., Manesh Manoj; Gupta, Vikas; Kavadichanda, Chengappa G.; Sekhar Patro, Pradeepta; Ajmani, Sajal; Phatak, Sanat; Prosad Goswami, Rudra; Chandra Chowdhury, Abhra; Jacob Mathew, Ashish; Shenoy, Padnamabha; Asranna, Ajay; Talari Bommakanti, Keerthi; Shukla, Anuj; Pande, Arunkumar R.; Chandwar, Kunal; Üsküdar Cansu, Döndü; Pauling, John D.; Wincup, Chris; Makol, Ashima; Del Papa, Nicoletta; Sambataro, Gianluca; Fabiola, Atzeni; Govoni, Marcello; Parisi, Simone; Bartoloni Bocci, Elena; Domenico Sebastiani, Gian; Fusaro, Enrico; Sebastiani, Marco; Quartuccio, Luca; Franceschini, Franco; Paolo Sainaghi, Pier; Orsolini, Giovanni; De Angelis, Rossella; Giovanna Danielli, Maria; Venerito, Vincenzo; Traboco, Lisa S.; Anggoro Kusumo Wibowo, Suryo; Rojas Serrano, Jorge; García-De La Torre, Ignacio; Adrian Zamora Tehozol, Erick; Loarce-Martos, Jesús; Prieto-González, Sergio; Gil-Vila, Albert; Aranega Gonzalez, Raquel; Yoshida, Akira; Nakashima, Ran; Sato, Shinji; Kimura, Naoki; Kaneko, Yuko; Tomaras, Stylianos; Aleksandrovna Gromova, Margarita; Aharonov, Or; Hmamouchi, Ihsane; Santos Hoff, Leonardo; Giannini, Margherita; Maurier, François; Campagne, Julien; Meyer, Alain; Nagy-Vincze, Melinda; Langguth, Daman; Limaye, Vidya; Needham, Merrilee; Srivastav, Nilesh; Hudson, Marie; Landon-Cardinal, Océane; Sazliyana Shaharir, Syahrul; Gerardo Rojas Zuleta, Wilmer; António Pereira Silva, José; Eurico Fonseca, João; Zimba., Olena
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