Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study

• DOI: 10.1007/s00296-023-05345-y
• Publication Date: 2023-06-23T18:36:05Z
• Authors: Bohdana Doskaliuk; Naveen Ravichandran; Parikshit Sen; Jessica Day; Mrudula Joshi; Arvind Nune; Elena Nikiphorou; Sreoshy Saha; Ai Lyn Tan; Samuel Katsuyuki ...; Nelly Ziade; Tsvetelina Velikova; Marcin Milchert; Kshitij Jagtap; Ioannis Parodis; Abraham Edgar Gra...; Lorenzo Cavagna; Masataka Kuwana; Johannes Knitza; Yi Ming Chen; Ashima Makol; Vishwesh Agarwal; Aarat Patel; John D. Pauling; Chris Wincup; Bhupen Barman; Erick Adrian Zamo...; Jorge Rojas Serrano; Ignacio García-De...; Iris J. Colunga-P...; Javier Merayo-Cha...; Okwara Celestine ...; Wanruchada Katcha...; Phonpen Akarawatc...; Russka Shumnalieva; Leonardo Santos Hoff; Lina El Kibbi; Hussein Halabi; Binit Vaidya; Syahrul Sazliyana...; A. T. M. Tanveer ...; Dzifa Dey; Carlos Enrique To...; Carlo V. Caballer...; James B. Lilleker; Babur Salim; Tamer Gheita; Tulika Chatterjee; Oliver Distler; Miguel A. Saavedra; ; Sinan Kardes; Laura Andreoli; Daniele Lini; Karen Schreiber; Melinda Nagy Vince; Yogesh Preet Singh; Rajiv Ranjan; Avinash Jain; Sapan C. Pandya; Rakesh Kumar Pilania; Aman Sharma; Manesh Manoj M; Vikas Gupta; Chengappa G. Kava...; Pradeepta Sekhar ...; Sajal Ajmani; Sanat Phatak; Rudra Prosad Goswami; Abhra Chandra Cho...; Ashish Jacob Mathew; Padnamabha Shenoy; Ajay Asranna; Keerthi Talari Bo...; Anuj Shukla; Arunkumar R. Pande; Kunal Chandwar; Akanksha Ghodke; Hiya Boro; Zoha Zahid Fazal; Döndü Üsküdar Cansu; Reşit Yıldırım; Armen Yuri Gaspar...; Atzeni Fabiola; Marcello Govoni S...; Elena Bartoloni B...; Gian Domenico Seb...; Enrico Fusaro; Marco Sebastiani ...; Franco Franceschini; Pier Paolo Sainag...; Rossella Maria Gi...; Silvia Grignaschi; Alessandro Giollo; Alessia Alluno; Florenzo Ioannone; Marco Fornaro; Lisa S. Traboco; Suryo Anggoro Kus...; Jesús Loarce-Martos; Sergio Prieto-Gon...; Raquel Aranega Go...; Akira Yoshida; Ran Nakashima; Shinji Sato; Naoki Kimura; Yuko Kaneko; Takahisa Gono; Stylianos Tomaras; Fabian Nikolai Proft; Marie-Therese Holzer; Margarita Aleksan...; Or Aharonov; Zoltán Griger; Ihsane Hmamouchi; Imane El bouchti; Zineb Baba; Margherita Giannini; François Maurier; Julien Campagne; Alain Meyer; Daman Langguth; Vidya Limaye; Merrilee Needham; Nilesh Srivastav; Marie Hudson Océa...; Wilmer Gerardo Ro...; Álvaro Arbeláez J...; José António Pere...; João Eurico Fonseca; Olena Zimba Doska...; Uyi Ima-Edomwonyi; Ibukunoluwa Dedeke; Emorinken Airenakho; Nwankwo Henry Madu; Abubakar Yerima; Hakeem Olaosebikan; Becky A.; Oruma Devi Kousso...; Elisa Palalane; Ho So; Manuel Francisco ...; Lyn Chinchay; José Proaño Bernaola; Victorio Pimentel; Hanan Mohammed Fathi; Reem Hamdy A. Moh...; Ghita Harifi; Yurilís Fuentes-S...; Jonathan Losanto; Nelly Colaman; Antonio Cachafeir...; Generoso Guerra B...; Enrique Julio Gir...; Lilith Stange Nunez; Cristian Vergara M; Jossiell Then Báez; Hugo Alonzo; Carlos Benito San...; Rodrigo García Sa...; Alejandro Quiñóne...; Nilmo Chávez; Andrea Bran Ordóñez; Gil Alberto Reyes...; Radames Sierra-Zo...; Dina Arrieta; Eduardo Romero Hi...; Ricardo Saenz; Idania Escalante M; Wendy Calapaqui; Ivonne Quezada; Gabriela Arredondo; Hector Chinoy; Vikas Agarwal; Rohit Aggarwal; Latika Gupta
• Keywords: Demographics

Abstract Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute hesitancy. We studied delayed-onset adverse events (AEs) IIMs, other systemic autoimmune and disorders (SAIDs), healthy controls (HCs), using data from the second Vaccination Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by COVAD study group (157 collaborators, 106 countries) Feb–June 2022. collected demographics, comorbidities, IIM/SAID details, history, vaccination details. Delayed-onset (> 7 day) AEs were analyzed regression models. total of 15165 respondents undertook survey, whom 8759 responses vaccinated individuals [median age 46 (35–58) years, 74.4% females, 45.4% Caucasians] analyzed. Of these, 1390 (15.9%) had 50.6% SAIDs, 33.5% HCs. Among 16.3% 10.2% reported minor major AEs, respectively, 0.72% ( n = 10) required hospitalization. Notably IIMs experienced fewer than though rashes expectedly more HCs [OR 4.0; 95% CI 2.2–7.0, p < 0.001]. IIM active disease, overlap myositis, ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients often, while those inclusion body BNT162b2 (Pfizer) AEs. is reassuringly safe hospitalizations comparable largely limited multimorbidity disease. These observations may inform guidelines identify high-risk warranting close monitoring post-vaccination period.