. 2023 Sep;43(9):1651-1664.

doi: 10.1007/s00296-023-05345-y. Epub 2023 Jun 23.

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

Bohdana Doskaliuk¹, Naveen Ravichandran², Parikshit Sen³, Jessica Day^{4

5

6}, Mrudula Joshi⁷, Arvind Nune⁸, Elena Nikiphorou^{9

10}, Sreoshy Saha¹¹, Ai Lyn Tan^{12

13}, Samuel Katsuyuki Shinjo¹⁴, Nelly Ziade^{15

16}, Tsvetelina Velikova¹⁷, Marcin Milchert¹⁸, Kshitij Jagtap¹⁹, Ioannis Parodis^{20

21}, Abraham Edgar Gracia-Ramos²², Lorenzo Cavagna²³, Masataka Kuwana²⁴, Johannes Knitza²⁵, Yi Ming Chen^{26

27}, Ashima Makol²⁸, Vishwesh Agarwal²⁹, Aarat Patel³⁰, John D Pauling^{31

32}, Chris Wincup^{33

34}, Bhupen Barman³⁵, Erick Adrian Zamora Tehozol³⁶, Jorge Rojas Serrano³⁷, Ignacio García-De La Torre³⁸, Iris J Colunga-Pedraza³⁹, Javier Merayo-Chalico⁴⁰, Okwara Celestine Chibuzo⁴¹, Wanruchada Katchamart⁴², Phonpen Akarawatcharangura Goo⁴³, Russka Shumnalieva⁴⁴, Leonardo Santos Hoff⁴⁵, Lina El Kibbi⁴⁶, Hussein Halabi⁴⁷, Binit Vaidya⁴⁸, Syahrul Sazliyana Shaharir⁴⁹, A T M Tanveer Hasan⁵⁰, Dzifa Dey⁵¹, Carlos Enrique Toro Gutiérrez⁵², Carlo V Caballero-Uribe⁵³, James B Lilleker^{54

55}, Babur Salim⁵⁶, Tamer Gheita⁵⁷, Tulika Chatterjee⁵⁸, Oliver Distler⁵⁹, Miguel A Saavedra⁶⁰; COVAD study group; Hector Chinoy^{54

61

62}, Vikas Agarwal², Rohit Aggarwal^#⁶³, Latika Gupta^#^{64

65

66}

Collaborators, Affiliations

Collaborators

COVAD study group:
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 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 Pande, Kunal Chandwar, Akanksha Ghodke, Hiya Boro, Zoha Zahid Fazal, Döndü Üsküdar Cansu, Reşit Yıldırım, Armen Yuri Gasparyan Nicoletta Gianluca Del PapaSambataro, Atzeni Fabiola, Marcello Govoni Simone Parisi, Elena Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco Sebastiani Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi Giovanni Orsolini, Rossella Maria Giovanna Danielli Vincenzo De AngelisVenerito, Silvia Grignaschi, Alessandro Giollo, Alessia Alluno, Florenzo Ioannone, Marco Fornaro, Lisa S Traboco, Suryo Anggoro Kusumo Wibowo, Jesús Loarce-Martos, Sergio Prieto-González, Raquel Aranega Gonzalez, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Takahisa Gono, Stylianos Tomaras, Fabian Nikolai Proft, Marie-Therese Holzer, Margarita Aleksandrovna Gromova, 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 Océane Landon-Cardinal, Wilmer Gerardo Rojas Zuleta, Álvaro Arbeláez Javier Cajas, José António Pereira Silva, João Eurico Fonseca, Olena Zimba Doskaliuk Bohdana, Uyi Ima-Edomwonyi, Ibukunoluwa Dedeke, Emorinken Airenakho, Nwankwo Henry Madu, Abubakar Yerima, Hakeem Olaosebikan, Becky A, Oruma Devi Koussougbo, Elisa Palalane, Ho So, Manuel Francisco Ugarte-Gil, Lyn Chinchay, José Proaño Bernaola, Victorio Pimentel, Hanan Mohammed Fathi, Reem Hamdy A Mohammed, Ghita Harifi, Yurilís Fuentes-Silva Karoll Cabriza, Jonathan Losanto, Nelly Colaman, Antonio Cachafeiro-Vilar, Generoso Guerra Bautista, Enrique Julio Giraldo Ho, Lilith Stange Nunez, Cristian Vergara M, Jossiell Then Báez, Hugo Alonzo, Carlos Benito Santiago Pastelin, Rodrigo García Salinas, Alejandro Quiñónez Obiols, Nilmo Chávez, Andrea Bran Ordóñez, Gil Alberto Reyes Llerena, Radames Sierra-Zorita, Dina Arrieta, Eduardo Romero Hidalgo, Ricardo Saenz, Idania Escalante M, Wendy Calapaqui, Ivonne Quezada, Gabriela Arredondo

Affiliations

¹ Department of Pathophysiology, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine.
² Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
³ Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India.
⁴ Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia.
⁵ Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, 3052, Australia.
⁶ Department of Medical Biology, University of Melbourne, Parkville, VIC, 3052, Australia.
⁷ Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
⁸ Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK.
⁹ Centre for Rheumatic Diseases, King's College London, London, UK.
¹⁰ Rheumatology Department, King's College Hospital, London, UK.
¹¹ Mymensingh Medical College, Mymensingh, Bangladesh.
¹² NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK.
¹³ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
¹⁴ Division of RheumatologyFaculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
¹⁵ Rheumatology Department, Saint-Joseph University, Beirut, Lebanon.
¹⁶ Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.
¹⁷ Medical Faculty, Sofia University St. Kliment Ohridski, 1 Kozyak Str, 1407, Sofia, Bulgaria.
¹⁸ Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Ul Unii Lubelskiej 1, 71-252, Szczecin, Poland.
¹⁹ Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India.
²⁰ Division of RheumatologyDepartment of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
²¹ Department of RheumatologyFaculty of Medicine and Health, Örebro University, Örebro, Sweden.
²² Department of Internal Medicine, General Hospital, National Medical Center "La Raza", Instituto Mexicano del Seguro Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P. 02990, Mexico City, Mexico.
²³ Rheumatology UnitDipartimento Di Medicine Interna E Terapia Medica, Università Degli Studi Di Pavia, Pavia, Lombardy, Italy.
²⁴ Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, 113-8602, Japan.
²⁵ Medizinische Klinik 3-Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Deutschland.
²⁶ Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City, Taiwan.
²⁷ Department of Medical Research, Taichung Veterans General Hospital, Taichung, Taiwan.
²⁸ Division of Rheumatology, Mayo Clinic, Rochester, MN, USA.
²⁹ Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
³⁰ Bon Secours Rheumatology Center and Division of Pediatric RheumatologyDepartment of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA.
³¹ Bristol Medical School Translational Health Sciences, University of Bristol, Bristol, UK.
³² Department of Rheumatology, North Bristol NHS Trust, Bristol, UK.
³³ Division of Medicine, Rayne InstituteDepartment of Rheumatology, University College London, London, UK.
³⁴ Centre for Adolescent Rheumatology Versus Arthritis at UCL, UCLH, GOSH, London, UK.
³⁵ Department of General Medicine, All India Institute of Medical Sciences (AIIMS), Guwahati, India.
³⁶ Rheumatology, Medical Care & Research, Centro Medico Pensiones Hospital, Instituto Mexicano del Seguro Social Delegación Yucatán, Yucatán, Mexico.
³⁷ Rheumatologist and Clinical InvestigatorInterstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.
³⁸ Departamento de Inmunología Y Reumatología, Hospital General de Occidente and Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.
³⁹ Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, Mexico.
⁴⁰ Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.
⁴¹ Department of Medicine, University of Nigeria Teaching Hospital, Ituku-Ozalla/University of Nigeria, Enugu Campus, Enugu, Nigeria.
⁴² Division of RheumatologyDepartment of MedicineFaculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
⁴³ Department of Medicine, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand.
⁴⁴ Department of RheumatologyClinic of Rheumatology, University Hospital "St. Ivan Rilski", Medical University-Sofia, Sofia, Bulgaria.
⁴⁵ School of Medicine, Universidade Potiguar (UnP), Natal, Brazil.
⁴⁶ Internal Medicine Department, Rheumatology Unit, Specialized Medical Center, Riyadh, Saudi Arabia.
⁴⁷ Department of Internal MedicineSection of Rheumatology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia.
⁴⁸ National Center for Rheumatic Diseases (NCRD), Ratopul, Kathmandu, Nepal.
⁴⁹ Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Cheras, Kuala Lumpur, Malaysia.
⁵⁰ Department of Rheumatology, Enam Medical College & Hospital, Dhaka, Bangladesh.
⁵¹ Department of Medicine and Therapeutics, Rheumatology Unit, University of Ghana Medical SchoolCollege of Health Sciences, Korle-Bu, Accra, Ghana.
⁵² Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali, Cali, Colombia.
⁵³ Department of Medicine, Hospital Universidad del Norte, Barranquilla, Atlantico, Colombia.
⁵⁴ Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
⁵⁵ Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford, UK.
⁵⁶ Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
⁵⁷ Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
⁵⁸ Department of Internal Medicine, University of Illinois College of Medicine at Peoria, Peoria, IL, USA.
⁵⁹ Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
⁶⁰ Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.
⁶¹ National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, The University of Manchester, Manchester, UK.
⁶² Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
⁶³ Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁶⁴ Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK. drlatikagupta@gmail.com.
⁶⁵ Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK. drlatikagupta@gmail.com.
⁶⁶ City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK. drlatikagupta@gmail.com.

^# Contributed equally.

PMID: 37351634
PMCID: PMC10348925
DOI: 10.1007/s00296-023-05345-y

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

Bohdana Doskaliuk et al. Rheumatol Int. 2023 Sep.

. 2023 Sep;43(9):1651-1664.

doi: 10.1007/s00296-023-05345-y. Epub 2023 Jun 23.

Authors

Collaborators

COVAD study group:
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 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 Pande, Kunal Chandwar, Akanksha Ghodke, Hiya Boro, Zoha Zahid Fazal, Döndü Üsküdar Cansu, Reşit Yıldırım, Armen Yuri Gasparyan Nicoletta Gianluca Del PapaSambataro, Atzeni Fabiola, Marcello Govoni Simone Parisi, Elena Bartoloni Bocci, Gian Domenico Sebastiani, Enrico Fusaro, Marco Sebastiani Luca Quartuccio, Franco Franceschini, Pier Paolo Sainaghi Giovanni Orsolini, Rossella Maria Giovanna Danielli Vincenzo De AngelisVenerito, Silvia Grignaschi, Alessandro Giollo, Alessia Alluno, Florenzo Ioannone, Marco Fornaro, Lisa S Traboco, Suryo Anggoro Kusumo Wibowo, Jesús Loarce-Martos, Sergio Prieto-González, Raquel Aranega Gonzalez, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Takahisa Gono, Stylianos Tomaras, Fabian Nikolai Proft, Marie-Therese Holzer, Margarita Aleksandrovna Gromova, 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 Océane Landon-Cardinal, Wilmer Gerardo Rojas Zuleta, Álvaro Arbeláez Javier Cajas, José António Pereira Silva, João Eurico Fonseca, Olena Zimba Doskaliuk Bohdana, Uyi Ima-Edomwonyi, Ibukunoluwa Dedeke, Emorinken Airenakho, Nwankwo Henry Madu, Abubakar Yerima, Hakeem Olaosebikan, Becky A, Oruma Devi Koussougbo, Elisa Palalane, Ho So, Manuel Francisco Ugarte-Gil, Lyn Chinchay, José Proaño Bernaola, Victorio Pimentel, Hanan Mohammed Fathi, Reem Hamdy A Mohammed, Ghita Harifi, Yurilís Fuentes-Silva Karoll Cabriza, Jonathan Losanto, Nelly Colaman, Antonio Cachafeiro-Vilar, Generoso Guerra Bautista, Enrique Julio Giraldo Ho, Lilith Stange Nunez, Cristian Vergara M, Jossiell Then Báez, Hugo Alonzo, Carlos Benito Santiago Pastelin, Rodrigo García Salinas, Alejandro Quiñónez Obiols, Nilmo Chávez, Andrea Bran Ordóñez, Gil Alberto Reyes Llerena, Radames Sierra-Zorita, Dina Arrieta, Eduardo Romero Hidalgo, Ricardo Saenz, Idania Escalante M, Wendy Calapaqui, Ivonne Quezada, Gabriela Arredondo

Affiliations

¹ Department of Pathophysiology, Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Ukraine.
² Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
³ Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India.
⁴ Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia.
⁵ Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, 3052, Australia.
⁶ Department of Medical Biology, University of Melbourne, Parkville, VIC, 3052, Australia.
⁷ Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
⁸ Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK.
⁹ Centre for Rheumatic Diseases, King's College London, London, UK.
¹⁰ Rheumatology Department, King's College Hospital, London, UK.
¹¹ Mymensingh Medical College, Mymensingh, Bangladesh.
¹² NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK.
¹³ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
¹⁴ Division of RheumatologyFaculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil.
¹⁵ Rheumatology Department, Saint-Joseph University, Beirut, Lebanon.
¹⁶ Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.
¹⁷ Medical Faculty, Sofia University St. Kliment Ohridski, 1 Kozyak Str, 1407, Sofia, Bulgaria.
¹⁸ Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Ul Unii Lubelskiej 1, 71-252, Szczecin, Poland.
¹⁹ Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India.
²⁰ Division of RheumatologyDepartment of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
²¹ Department of RheumatologyFaculty of Medicine and Health, Örebro University, Örebro, Sweden.
²² Department of Internal Medicine, General Hospital, National Medical Center "La Raza", Instituto Mexicano del Seguro Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P. 02990, Mexico City, Mexico.
²³ Rheumatology UnitDipartimento Di Medicine Interna E Terapia Medica, Università Degli Studi Di Pavia, Pavia, Lombardy, Italy.
²⁴ Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-Ku, Tokyo, 113-8602, Japan.
²⁵ Medizinische Klinik 3-Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Deutschland.
²⁶ Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City, Taiwan.
²⁷ Department of Medical Research, Taichung Veterans General Hospital, Taichung, Taiwan.
²⁸ Division of Rheumatology, Mayo Clinic, Rochester, MN, USA.
²⁹ Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
³⁰ Bon Secours Rheumatology Center and Division of Pediatric RheumatologyDepartment of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA.
³¹ Bristol Medical School Translational Health Sciences, University of Bristol, Bristol, UK.
³² Department of Rheumatology, North Bristol NHS Trust, Bristol, UK.
³³ Division of Medicine, Rayne InstituteDepartment of Rheumatology, University College London, London, UK.
³⁴ Centre for Adolescent Rheumatology Versus Arthritis at UCL, UCLH, GOSH, London, UK.
³⁵ Department of General Medicine, All India Institute of Medical Sciences (AIIMS), Guwahati, India.
³⁶ Rheumatology, Medical Care & Research, Centro Medico Pensiones Hospital, Instituto Mexicano del Seguro Social Delegación Yucatán, Yucatán, Mexico.
³⁷ Rheumatologist and Clinical InvestigatorInterstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico.
³⁸ Departamento de Inmunología Y Reumatología, Hospital General de Occidente and Universidad de Guadalajara, Guadalajara, Jalisco, Mexico.
³⁹ Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, Mexico.
⁴⁰ Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, Mexico City, Mexico.
⁴¹ Department of Medicine, University of Nigeria Teaching Hospital, Ituku-Ozalla/University of Nigeria, Enugu Campus, Enugu, Nigeria.
⁴² Division of RheumatologyDepartment of MedicineFaculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
⁴³ Department of Medicine, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand.
⁴⁴ Department of RheumatologyClinic of Rheumatology, University Hospital "St. Ivan Rilski", Medical University-Sofia, Sofia, Bulgaria.
⁴⁵ School of Medicine, Universidade Potiguar (UnP), Natal, Brazil.
⁴⁶ Internal Medicine Department, Rheumatology Unit, Specialized Medical Center, Riyadh, Saudi Arabia.
⁴⁷ Department of Internal MedicineSection of Rheumatology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia.
⁴⁸ National Center for Rheumatic Diseases (NCRD), Ratopul, Kathmandu, Nepal.
⁴⁹ Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Cheras, Kuala Lumpur, Malaysia.
⁵⁰ Department of Rheumatology, Enam Medical College & Hospital, Dhaka, Bangladesh.
⁵¹ Department of Medicine and Therapeutics, Rheumatology Unit, University of Ghana Medical SchoolCollege of Health Sciences, Korle-Bu, Accra, Ghana.
⁵² Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali, Cali, Colombia.
⁵³ Department of Medicine, Hospital Universidad del Norte, Barranquilla, Atlantico, Colombia.
⁵⁴ Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
⁵⁵ Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford, UK.
⁵⁶ Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
⁵⁷ Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
⁵⁸ Department of Internal Medicine, University of Illinois College of Medicine at Peoria, Peoria, IL, USA.
⁵⁹ Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
⁶⁰ Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.
⁶¹ National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, The University of Manchester, Manchester, UK.
⁶² Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
⁶³ Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁶⁴ Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK. drlatikagupta@gmail.com.
⁶⁵ Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK. drlatikagupta@gmail.com.
⁶⁶ City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK. drlatikagupta@gmail.com.

^# Contributed equally.

PMID: 37351634
PMCID: PMC10348925
DOI: 10.1007/s00296-023-05345-y

Abstract

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.

Keywords: Adverse event; Autoimmunity; COVID-19; Myositis; Surveys and questionnaires; Vaccination.

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Conflict of interest statement

ALT has received honoraria for advisory boards and speaking for Abbvie, Gilead, Janssen, Lilly, Novartis, Pfizer, and UCB. EN has received speaker honoraria/participated in advisory boards for Celltrion, Pfizer, Sanofi, Gilead, Galapagos, AbbVie, and Lilly, and holds research grants from Pfizer and Lilly. HC has received grant support from Eli Lilly and UCB, consulting fees from Novartis, Eli Lilly, Orphazyme, Astra Zeneca, speaker for UCB, and Biogen. IP has received research funding and/or honoraria from Amgen, AstraZeneca, Aurinia Pharmaceuticals, Elli Lilly and Company, Gilead Sciences, GlaxoSmithKline, Janssen Pharmaceuticals, Novartis and F. Hoffmann-La Roche AG. JBL has received speaker honoraria/participated in advisory boards for Sanofi Genzyme, Roche, and Biogen. None is related to this manuscript. JD has received research funding from CSL Limited. JDP has undertaken consultancy work and/or received speaker honoraria from Astra Zenaca, Boehringer Ingelgheim, Sojournix Pharma, Permeatus Inc, Janssen and IsoMab Pharmacueticals. MK has received speaker honoraria/participated in advisory boards for Abbvie, Asahi-Kasei, Astellas, AstraZeneca, Boehringer-Ingelheim, Chugai, Corbus, Eisai, GSK, Horizon, Kissei, BML, Mochida, Nippon Shinyaku, Ono Pharmaceuticals, Tanabe-Mitsubishi. NZ has received speaker fees, advisory board fees, and research grants from Pfizer, Roche, Abbvie, Eli Lilly, NewBridge, Sanofi-Aventis, Boehringer Ingelheim, Janssen, and Pierre Fabre; none are related to this manuscript. OD has/had consultancy relationship with and/or has received research funding from and/or has served as a speaker for the following companies in the area of potential treatments for systemic sclerosis and its complications in the last 3 calendar years: 4P-Pharma, Abbvie, Acceleron, Alcimed, Altavant, Amgen, AnaMar, Arxx, AstraZeneca, Baecon, Blade, Bayer, Boehringer Ingelheim, Corbus, CSL Behring, Galderma, Galapagos, Glenmark, Gossamer, iQvia, Horizon, Inventiva, Janssen, Kymera, Lupin, Medscape, Merck, Miltenyi Biotec, Mitsubishi Tanabe, Novartis, Prometheus, Redxpharma, Roivant, Sanofi and Topadur. Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143). RA has a consultancy relationship with and/or has received research funding from the following companies: Bristol Myers-Squibb, Pfizer, Genentech, Octapharma, CSL Behring, Mallinckrodt, AstraZeneca, Corbus, Kezar, Abbvie, Janssen, Kyverna Alexion, Argenx, Q32, EMD-Serono, Boehringer Ingelheim, Roivant, Merck, Galapagos, Actigraph, Scipher, Horizon Therepeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio. TV has received speaker honoraria from Pfizer and AstraZeneca, non-related to the current manuscript. Rest of the authors have no conflict of interest relevant to this manuscript.

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References

1. Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness (Revised March 2022). Joint Statement from the International Coalition of Medicines Regulatory Authorities and World Health Organization. Accessed August 24, 2022. https://www.who.int/news/item/17-05-2022-statement-for-healthcare-profes...
1. Doroftei B, Ciobica A, Ilie O-D, Maftei R, Ilea C. Mini-review discussing the reliability and efficiency of COVID-19 vaccines. Diagnostics. 2021;11(4):579. doi: 10.3390/diagnostics11040579. - DOI - PMC - PubMed
1. Li X, Gao L, Tong X, Chan VKY, Chui CSL, Lai FTT, et al. Autoimmune conditions following mRNA (BNT162b2) and inactivated (CoronaVac) COVID-19 vaccination: a descriptive cohort study among 1.1 million vaccinated people in Hong Kong. J Autoimmun. 2022;130:102830. doi: 10.1016/j.jaut.2022.102830. - DOI - PMC - PubMed
1. Kim JH, Kim JH, Woo CG. Clinicopathological characteristics of inflammatory myositis induced by COVID-19 vaccine (Pfizer-BioNTech BNT162b2): a case report. J Korean Med Sci. 2022;37(11):e91. doi: 10.3346/jkms.2022.37.e91. - DOI - PMC - PubMed
1. Al-Rasbi S, Al-Maqbali JS, Al-Farsi R, Al Shukaili MA, Al-Riyami MH, Al Falahi Z, et al. Myocarditis, pulmonary hemorrhage, and extensive myositis with rhabdomyolysis 12 days after first dose of pfizer-BioNTech BNT162b2 mRNA COVID-19 vaccine: a case report. Am J Case Rep. 2022;23:e934399. doi: 10.12659/AJCR.934399. - DOI - PMC - PubMed

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

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

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