COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study
Parikshit Sen, Naveen Ravichandran, Arvind Nune, James B Lilleker, Vishwesh Agarwal, Sinan Kardeş, Min‐Chul Kim, Jessica Day, Marcin Milchert, Tamer A. Gheita, Babur Salim, Tsvetelina Velikova, Abraham Edgar Gracia‐Ramos, Ioannis Parodis, Albert Selva-O’Callaghan, Elena Nikiphorou, Tulika Chatterjee, Ai Lyn Tan, Lorenzo Cavagna, Miguel Ángel Saavedra, Samuel Katsuyuki Shinjo, Nelly Ziadé, Johannes Knitza, Masataka Kuwana, Oliver Distler, Hector Chinoy, Vikas Agarwal, Rohit Aggarwal, Latika Gupta, COVAD Study Group, Mrudula Joshi, Bhupen Barman, Yogesh Preet Singh, Rajiv Ranjan, Avinash Jain, Sapan C Pandya, Rakesh Kumar Pilania, Aman Sharma, Manesh Manoj, Vikas Gupta, Chengappa Kavadichanda, Pradeepta Sekhar Patro, Sajal Ajmani, Sanat Phatak, Rudra Prosad Goswami, Abhra Chandra Chowdhury, Ashish Jacob Mathew, Padnamabha Shenoy, Ajay Asranna, Keerthi Talari Bommakanti, Anuj Shukla, ArunKumar R Pandey, Kunal Chandwar, Döndü Üsküdar Cansu, John D Pauling, Chris Wincup, Ashima Makol, Nicoletta Del Papa, Gianluca Sambataro, Fabiola Atzeni, Marcello Govoni, Simone Parisi, Elena Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco Sebastiani, Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi, Giovanni Orsolini, Rossella De Angelis, Maria Giovanna Danielli, Vincenzo Venerito, Lisa S Traboco, Suryo Anggoro Kusumo Wibowo, Jorge Rojas‐Serrano, Ignacio García‐De La Torre, Erick Adrian Zamora Tehozol; Jesús Loarce-Martos, Sergio Prieto‐González, Albert Gil‐Vila, Raquel Aránega, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Stylianos Tomaras, Margarita Aleksandrovna Gromova, Or Aharonov, Ihsane Hmamouchi, Leonardo Santos Hoff, Margherita Giannini, F. Maurier, Julien Campagne, Alain Meyer, Melinda Nagy‐Vincze, Daman Langguth, Vidya Limaye, Merrilee Needham, Nilesh Srivastav, Marie Hudson
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.