. 2023 Jul;43(7):1265-1275.

doi: 10.1007/s00296-023-05310-9. Epub 2023 Mar 31.

Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey

R Naveen¹, Darpan R Thakare¹, Masataka Kuwana², John D Pauling^{3

4}, Jessica Day^{5

6

7}, Mrudula Joshi⁸, Ioannis Parodis^{9

10}, Parikshit Sen¹¹, Kshitij Jagtap¹², Elena Nikiphorou^{13

14}, Sreoshy Saha¹⁵, Vishwesh Agarwal¹⁶, Tulika Chatterjee¹⁷, James B Lilleker^{18

19}, Sinan Kardes²⁰, Marcin Milchert²¹, Tamer Gheita²², Babur Salim²³, Tsvetelina Velikova²⁴, Abraham Edgar Gracia-Ramos²⁵, Ai Lyn Tan^{26

27}, Arvind Nune²⁸, Lorenzo Cavagna^{29

30}, Miguel A Saavedra³¹, Samuel Katsuyuki Shinjo³², Nelly Ziade^{33

34}, Johannes Knitza³⁵, Oliver Distler³⁶, Hector Chinoy^{18

37

38}; COVAD Study Group; Rohit Aggarwal³⁹, Latika Gupta^{18

40}, Vikas Agarwal^#¹, Ashima Makol^#⁴¹

Collaborators, Affiliations

Collaborators

COVAD Study Group:
Bhupen Barman, 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, Döndü Üsküdar Cansu, John D Pauling, Chris Wincup, Ashima Makol, Nicoletta Del Papa, Gianluca Sambataro, 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 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, Raquel Aranega Gonzalez, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Stylianos Tomaras, Margarita Aleksandrovna Gromova, Or Aharonov, Ihsane Hmamouchi, Leonardo Santos Hoff, Margherita Giannini, François Maurier, Julien Campagne, Alain Meyer, Melinda Nagy-Vincze, Daman Langguth, Vidya Limaye, Merrilee Needham, Nilesh Srivastav, Marie Hudson, Océane Landon-Cardinal, Syahrul Sazliyana Shaharir, Wilmer Gerardo Rojas Zuleta, José António Pereira Silva, João Eurico Fonseca, Olena Zimba

Affiliations

¹ Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
² Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
³ Bristol Medical School Translational Health Sciences, University of Bristol, Bristol, UK.
⁴ Department of Rheumatology, North Bristol NHS Trust, Bristol, UK.
⁵ Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia.
⁶ Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, 3052, Australia.
⁷ Department of Medical Biology, University of Melbourne, Parkville, VIC, 3052, Australia.
⁸ Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
⁹ Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
¹⁰ Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
¹¹ Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India.
¹² Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India.
¹³ Centre for Rheumatic Diseases, King's College London, London, UK.
¹⁴ Rheumatology Department, King's College Hospital, London, UK.
¹⁵ Mymensingh Medical College, Mymensingh, Bangladesh.
¹⁶ Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
¹⁷ Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Peoria, IL, USA.
¹⁸ Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
¹⁹ Neurology, Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK.
²⁰ Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Capa-Fatih, 34093, Istanbul, Turkey.
²¹ Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Ul Unii Lubelskiej 1, 71-252, Szczecin, Poland.
²² Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
²³ Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
²⁴ Department of Clinical Immunology, Medical Faculty, University Hospital "Lozenetz", Sofia University St. Kliment Ohridski, 1 Kozyak Str, 1407, Sofia, Bulgaria.
²⁵ 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.
²⁶ NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK.
²⁷ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
²⁸ Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK.
²⁹ Department of Rheumatology, Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.
³⁰ Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli Studi di Pavia, Pavia, Lombardy, Italy.
³¹ Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.
³² Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
³³ Rheumatology Department, Saint-Joseph University, Beirut, Lebanon.
³⁴ Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.
³⁵ Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Deutschland.
³⁶ Department of Rheumatology, University Hospital Zürich, University of Zürich, Zurich, Switzerland.
³⁷ National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, The University of Manchester, Manchester, UK.
³⁸ Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
³⁹ Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁴⁰ Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.
⁴¹ Division of Rheumatology, Mayo Clinic, 200 1st St. SW, Rochester, MN, 55905, USA. Makol.ashima@mayo.edu.

^# Contributed equally.

PMID: 37000295
PMCID: PMC10064600
DOI: 10.1007/s00296-023-05310-9

Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey

R Naveen et al. Rheumatol Int. 2023 Jul.

. 2023 Jul;43(7):1265-1275.

doi: 10.1007/s00296-023-05310-9. Epub 2023 Mar 31.

Authors

Collaborators

COVAD Study Group:
Bhupen Barman, 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, Döndü Üsküdar Cansu, John D Pauling, Chris Wincup, Ashima Makol, Nicoletta Del Papa, Gianluca Sambataro, 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 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, Raquel Aranega Gonzalez, Akira Yoshida, Ran Nakashima, Shinji Sato, Naoki Kimura, Yuko Kaneko, Stylianos Tomaras, Margarita Aleksandrovna Gromova, Or Aharonov, Ihsane Hmamouchi, Leonardo Santos Hoff, Margherita Giannini, François Maurier, Julien Campagne, Alain Meyer, Melinda Nagy-Vincze, Daman Langguth, Vidya Limaye, Merrilee Needham, Nilesh Srivastav, Marie Hudson, Océane Landon-Cardinal, Syahrul Sazliyana Shaharir, Wilmer Gerardo Rojas Zuleta, José António Pereira Silva, João Eurico Fonseca, Olena Zimba

Affiliations

¹ Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
² Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Tokyo, Japan.
³ Bristol Medical School Translational Health Sciences, University of Bristol, Bristol, UK.
⁴ Department of Rheumatology, North Bristol NHS Trust, Bristol, UK.
⁵ Department of Rheumatology, Royal Melbourne Hospital, Parkville, VIC, 3050, Australia.
⁶ Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, 3052, Australia.
⁷ Department of Medical Biology, University of Melbourne, Parkville, VIC, 3052, Australia.
⁸ Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India.
⁹ Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden.
¹⁰ Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
¹¹ Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India.
¹² Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India.
¹³ Centre for Rheumatic Diseases, King's College London, London, UK.
¹⁴ Rheumatology Department, King's College Hospital, London, UK.
¹⁵ Mymensingh Medical College, Mymensingh, Bangladesh.
¹⁶ Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.
¹⁷ Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, Peoria, IL, USA.
¹⁸ Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK.
¹⁹ Neurology, Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK.
²⁰ Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Capa-Fatih, 34093, Istanbul, Turkey.
²¹ Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Ul Unii Lubelskiej 1, 71-252, Szczecin, Poland.
²² Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.
²³ Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.
²⁴ Department of Clinical Immunology, Medical Faculty, University Hospital "Lozenetz", Sofia University St. Kliment Ohridski, 1 Kozyak Str, 1407, Sofia, Bulgaria.
²⁵ 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.
²⁶ NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK.
²⁷ Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.
²⁸ Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK.
²⁹ Department of Rheumatology, Fondazione I.R.C.C.S. Policlinico San Matteo, Pavia, Italy.
³⁰ Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli Studi di Pavia, Pavia, Lombardy, Italy.
³¹ Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.
³² Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, Brazil.
³³ Rheumatology Department, Saint-Joseph University, Beirut, Lebanon.
³⁴ Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.
³⁵ Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, 91054, Erlangen, Deutschland.
³⁶ Department of Rheumatology, University Hospital Zürich, University of Zürich, Zurich, Switzerland.
³⁷ National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, The University of Manchester, Manchester, UK.
³⁸ Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.
³⁹ Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
⁴⁰ Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.
⁴¹ Division of Rheumatology, Mayo Clinic, 200 1st St. SW, Rochester, MN, 55905, USA. Makol.ashima@mayo.edu.

^# Contributed equally.

PMID: 37000295
PMCID: PMC10064600
DOI: 10.1007/s00296-023-05310-9

Abstract

The safety profile of COVID-19 vaccines is understudied in patients with systemic sclerosis (SSc). We compared short-term adverse events (AEs) 7 days following vaccination in patients with SSc vs other rheumatic (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs). The COVID-19 Vaccination in autoimmune diseases (COVAD) self-reporting e-survey was circulated by a group of > 110 collaborators in 94 countries from March to December 2021. AEs were analyzed between different groups using regression models. Of 10,679 complete respondents [73.8% females, mean age 43 years, 53% Caucasians], 478 had SSc. 83% had completed two vaccine doses, Pfizer-BioNTech (BNT162b2) (51%) was the most common. Minor and major AEs were reported by 81.2% and 3.3% SSc patients, respectively, and did not differ significantly with disease activity or different vaccine types, though with minor symptom differences. Frequencies of AEs were not affected by background immunosuppression, though SSc patients receiving hydroxychloroquine experienced fatigue less commonly (OR 0.4; 95% CI 0.2-0.8). Frequency of AEs and hospitalisations were similar to other AIRDs, nrAIDs, and HC except a higher risk of chills (OR 1.3; 95% CI 1.0-1.7) and fatigue (OR 1.3; 95% CI 1.0-1.6) compared to other AIRDs. COVID-19 vaccines were largely safe and well tolerated in SSc patients in the short term. Background immunosuppression and disease activity did not influence the vaccination-related short-term AEs.

Keywords: Adverse events; Autoimmune diseases; COVID-19; Systemic sclerosis; 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. 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 three 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. Rest of the authors have no conflict of interest relevant to this manuscript.

Figures

**Fig. 1**
Flow diagram of patients enrolled in the study

See this image and copyright information in PMC

References

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Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey

Collaborators

Affiliations

Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey

Authors

Collaborators

Affiliations

Abstract

Conflict of interest statement

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References

MeSH terms

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Grants and funding

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Medical