Long-term safety of COVID vaccination in individuals with idiopathic inflammatory myopathies: results from the COVAD study
Authors: Doskaliuk Bohdana , Ravichandran Naveen , Sen Parikshit , Day Jessica , Joshi Mrudula , Nune Arvind , Nikiphorou Elena , Saha Sreoshy , Tan Ai Lyn , Shinjo Samuel Katsuyuki , Ziade Nelly , Velikova Tsvetelina , Milchert Marcin , Jagtap Kshitij , Parodis Ioannis , Gracia-Ramos Abraham Edgar , Cavagna Lorenzo , Kuwana Masataka , Knitza Johannes , Chen Yi Ming , Makol Ashima , Agarwal Vishwesh , Patel Aarat , Pauling John D. , Wincup Chris , Barman Bhupen , Tehozol Erick Adrian Zamora , Serrano Jorge Rojas , La Torre Ignacio García-De , Colunga-Pedraza Iris J. , Merayo-Chalico Javier , Chibuzo Okwara Celestine , Katchamart Wanruchada , Goo Phonpen Akarawatcharangura , Shumnalieva Russka , Hoff Leonardo Santos , Kibbi Lina El , Halabi Hussein , Vaidya Binit , Shaharir Syahrul Sazliyana , Hasan A. T. M. Tanveer , Dey Dzifa , Gutiérrez Carlos Enrique Toro , Caballero-Uribe Carlo V. , Lilleker James B. , Salim Babur , Gheita Tamer , Chatterjee Tulika , Distler Oliver , Saavedra Miguel A. ,   COVAD study group, Kardes Sinan , Andreoli Laura , Lini Daniele , Schreiber Karen , Vince Melinda Nagy , Singh Yogesh Preet , Ranjan Rajiv , Jain Avinash , Pandya Sapan C. , Pilania Rakesh Kumar , Sharma Aman , M Manesh Manoj , Gupta Vikas , Kavadichanda Chengappa G. , Patro Pradeepta Sekhar , Ajmani Sajal , Phatak Sanat , Goswami Rudra Prosad , Chowdhury Abhra Chandra , Mathew Ashish Jacob , Shenoy Padnamabha , Asranna Ajay , Bommakanti Keerthi Talari , Shukla Anuj , Pande Arunkumar R. , Chandwar Kunal , Ghodke Akanksha , Boro Hiya , Fazal Zoha Zahid , Cansu Döndü Üsküdar , Yıldırım Reşit , Del PapaSambataro Armen Yuri Gasparyan Nicoletta Gian , Fabiola Atzeni , Parisi Marcello Govoni Simone , Bocci Elena Bartoloni , Sebastiani Gian Domenico , Fusaro Enrico , Quartuccio Marco Sebastiani Luca , Franceschini Franco , Orsolini Pier Paolo Sainaghi Giovanni , De AngelisVenerito Rossella Maria Giovanna Danielli Vi , Grignaschi Silvia , Giollo Alessandro , Alluno Alessia , Ioannone Florenzo , Fornaro Marco , Traboco Lisa S. , Wibowo Suryo Anggoro Kusumo , Loarce-Martos Jesús , Prieto-González Sergio , Gonzalez Raquel Aranega , Yoshida Akira , Nakashima Ran , Sato Shinji , Kimura Naoki , Kaneko Yuko , Gono Takahisa , Tomaras Stylianos , Proft Fabian Nikolai , Holzer Marie-Therese , Gromova Margarita Aleksandrovna , Aharonov Or , Griger Zoltán , Hmamouchi Ihsane , bouchti Imane El , Baba Zineb , Giannini Margherita , Maurier François , Campagne Julien , Meyer Alain , Langguth Daman , Limaye Vidya , Needham Merrilee , Srivastav Nilesh , Landon-Cardinal Marie Hudson Océane , Zuleta Wilmer Gerardo Rojas , Cajas Álvaro Arbeláez Javier , Silva José António Pereira , Fonseca João Eurico , Bohdana Olena Zimba Doskaliuk , Ima-Edomwonyi Uyi , Dedeke Ibukunoluwa , Airenakho Emorinken , Madu Nwankwo Henry , Yerima Abubakar , Olaosebikan Hakeem , A. Becky , Koussougbo Oruma Devi , Palalane Elisa , So Ho , Ugarte-Gil Manuel Francisco , Chinchay Lyn , Bernaola José Proaño , Pimentel Victorio , Fathi Hanan Mohammed , Mohammed Reem Hamdy A. , Harifi Ghita , Cabriza Yurilís Fuentes-Silva Karoll , Losanto Jonathan , Colaman Nelly , Cachafeiro-Vilar Antonio , Bautista Generoso Guerra , Ho Enrique Julio Giraldo , Nunez Lilith Stange , M Cristian Vergara , Báez Jossiell Then , Alonzo Hugo , Pastelin Carlos Benito Santiago , Salinas Rodrigo García , Obiols Alejandro Quiñónez , Chávez Nilmo , Ordóñez Andrea Bran , Llerena Gil Alberto Reyes , Sierra-Zorita Radames , Arrieta Dina , Hidalgo Eduardo Romero , Saenz Ricardo , M Idania Escalante , Calapaqui Wendy , Quezada Ivonne , Arredondo Gabriela , Chinoy Hector , Agarwal Vikas , Aggarwal Rohit , Gupta Latika 
Published: June 2023

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