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

Naveen R, Thakare D, Kuwana M, Pauling J, Day J, Joshi M, Parodis I, Sen P, Jagtap K, Nikiphorou E, Saha S, Agarwal V, Chatterjee T, Lilleker J, Kardes S, Milchert M, Gheita T, Salim B, Velikova T, Gracia-Ramos AE, Tan AL, Nune A, Cavagna L, Saavedra M, Shinjo SK, Ziade N, Knitza J, Distler O, Chinoy H, Covid Study Grp L, Aggarwal R, Gupta L, Agarwal V, Makol A (2023)

Publication Type: Journal article

Publication year: 2023


DOI: 10.1007/s00296-023-05310-9


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.

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Involved external institutions

Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) IN India (IN) Nippon Medical School JP Japan (JP) University of Bristol GB United Kingdom (GB) Royal Melbourne Hospital (RMH) AU Australia (AU) Karolinska Institute SE Sweden (SE) King’s College London GB United Kingdom (GB) Mymensingh Medical College / ময়মনসিংহ মেডিকেল কলেজ BD Bangladesh (BD) Mahatma Gandhi Mission Institute of Health Sciences (MGMIHS) IN India (IN) University of Manchester GB United Kingdom (GB) Istanbul University / İstanbul Üniversitesi TR Turkey (TR) Fauji Foundation Hospital PK Pakistan (PK) Instituto Mexicano del Seguro Social MX Mexico (MX) Byramjee Jeejeebhoy Government Medical College & Sassoon General Hospital IN India (IN) Maulana Azad Medical College (MAMC) IN India (IN) King Edward Memorial Hospital and Seth G.S. Medical College / கிங் எட்வர்ட் நினைவு மருத்துவமனை,राजा एड्वर्ड स्मारक रुग्णालय व सेठ गोवर्धनदास सुंदरदास वैद्यकीय महाविद्यालय IN India (IN) University of Illinois at Urbana-Champaign US United States (USA) (US) Pomeranian Medical University / Pomorski Uniwersytet Medyczny w Szczecinie (PMU) PL Poland (PL) Cairo University EG Egypt (EG) Hl. Kliment Ochridski-Universität Sofia BG Bulgaria (BG) Leeds Teaching Hospitals NHS Trust GB United Kingdom (GB) Southport and Ormskirk Hospital NHS Trust GB United Kingdom (GB) Policlinico San Matteo Pavia Fondazione IRCCS IT Italy (IT) Hospital de Especialidades “Dr. Antonio Fraga Mouret” MX Mexico (MX) University of São Paulo / Universidade de São Paulo (USP) BR Brazil (BR) University of Zurich / Universität Zürich (UZH) CH Switzerland (CH) Université Saint-Joseph (USJ) / جامعة القديس يوسف / Սուրբ Ժոզեֆի համալսարան LB Lebanon (LB) Mayo Clinic US United States (USA) (US) University of Pittsburgh US United States (USA) (US)

How to cite


Naveen, R., Thakare, D., Kuwana, M., Pauling, J., Day, J., Joshi, M.,... Makol, A. (2023). Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey. Rheumatology International.


Naveen, R., et al. "Systemic sclerosis and COVID-19 vaccine safety: short-term insights from the global COVID-19 vaccination in autoimmune disease (COVAD) survey." Rheumatology International (2023).

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