COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study.


Journal

Rheumatology (Oxford, England)
ISSN: 1462-0332
Titre abrégé: Rheumatology (Oxford)
Pays: England
ID NLM: 100883501

Informations de publication

Date de publication:
23 12 2022
Historique:
received: 14 01 2022
revised: 14 04 2022
pubmed: 18 6 2022
medline: 28 12 2022
entrez: 17 6 2022
Statut: ppublish

Résumé

COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination-related adverse events (AEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey. The survey was circulated in early 2021 by >110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details and 7-day vaccine AEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type. Ten thousand nine hundred respondents [median (interquartile range) age 42 (30-55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 0.010] were more frequent in SAIDs though absolute risk was small (0-4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs. Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.

Identifiants

pubmed: 35713499
pii: 6609762
doi: 10.1093/rheumatology/keac305
pmc: PMC9214139
doi:

Substances chimiques

COVID-19 Vaccines 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

65-76

Subventions

Organisme : Versus Arthritis
ID : 21992
Pays : United Kingdom

Investigateurs

Mrudula Joshi (M)
Bhupen Barman (B)
Yogesh Preet Singh (YP)
Rajiv Ranjan (R)
Avinash Jain (A)
Sapan C Pandya (SC)
Rakesh Kumar Pilania (RK)
Aman Sharma (A)
M Manesh Manoj (M)
Vikas Gupta (V)
Chengappa G Kavadichanda (CG)
Pradeepta Sekhar Patro (PS)
Sajal Ajmani (S)
Sanat Phatak (S)
Rudra Prosad Goswami (RP)
Abhra Chandra Chowdhury (AC)
Ashish Jacob Mathew (AJ)
Padnamabha Shenoy (P)
Ajay Asranna (A)
Keerthi Talari Bommakanti (KT)
Anuj Shukla (A)
ArunKumar R Pandey (AR)
Kunal Chandwar (K)
Döndü Üsküdar Cansu (DÜ)
John D Pauling (JD)
Chris Wincup (C)
Ashima Makol (A)
Nicoletta Del Papa (N)
Gianluca Sambataro (G)
Atzeni Fabiola (A)
Marcello Govoni (M)
Simone Parisi (S)
Elena Bartoloni Bocci (EB)
Gian Domenico Sebastiani (GD)
Enrico Fusaro (E)
Marco Sebastiani (M)
Luca Quartuccio (L)
Franco Franceschini (F)
Pier Paolo Sainaghi (PP)
Giovanni Orsolini (G)
Rossella De Angelis (R)
Maria Giovanna Danielli (MG)
Vincenzo Venerito (V)
Lisa S Traboco (LS)
Suryo Anggoro Kusumo Wibowo (SAK)
Jorge Rojas Serrano (JR)
Ignacio García-De La Torre (I)
Erick Adrian Zamora Tehozol Jesús Loarce-Martos (EAZTJ)
Sergio Prieto-González (S)
Albert Gil-Vila (A)
Raquel Aranega (R)
Ran Nakashima (R)
Shinji Sato (S)
Naoki Kimura (N)
Yuko Kaneko (Y)
Stylianos Tomaras (S)
Margarita Aleksandrovna Gromova (MA)
Or Aharonov (O)
Ihsane Hmamouchi (I)
Leonardo Santos Hoff (LS)
Margherita Giannini (M)
François Maurier (F)
Julien Campagne (J)
Alain Meyer (A)
Melinda Nagy-Vincze (M)
Daman Langguth (D)
Vidya Limaye (V)
Merrilee Needham (M)
Nilesh Srivastav (N)
Marie Hudson (M)
Océane Landon-Cardinal (O)
Syahrul Sazliyana Shaharir (SS)
Wilmer Gerardo Rojas Zuleta (WGR)
José António Pereira Silva (JAP)
João Eurico Fonseca (JE)
Olena Zimba (O)

Informations de copyright

© The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Auteurs

Parikshit Sen (P)

Maulana Azad Medical College, New Delhi.

Naveen Ravichandran (N)

Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.

Arvind Nune (A)

Southport and Ormskirk Hospital NHS Trust, Southport.

James B Lilleker (JB)

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.
Neurology, Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, UK.

Vishwesh Agarwal (V)

Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India.

Sinan Kardes (S)

Department of Medical Ecology and Hydroclimatology, Istanbul Faculty of Medicine, Istanbul University, Istanbul, Turkey.

Minchul Kim (M)

Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, IL, USA.

Jessica Day (J)

Department of Rheumatology, Royal Melbourne Hospital.
Walter and Eliza Hall Institute of Medical Research.
Department of Medical Biology, University of Melbourne, Parkville, Victoria, Australia.

Marcin Milchert (M)

Department of Internal Medicine, Rheumatology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Szczecin, Poland.

Tamer Gheita (T)

Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt.

Babur Salim (B)

Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan.

Tsvetelina Velikova (T)

Department of Clinical Immunology, Medical Faculty, University Hospital 'Lozenetz', Sofia University St. Kliment Ohridski, Sofia, Bulgaria.

Abraham Edgar Gracia-Ramos (AE)

Department of Internal Medicine, General Hospital, National Medical Center 'La Raza', Instituto Mexicano del Seguro Social, Mexico City, Mexico.

Ioannis Parodis (I)

Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm.
Department of Rheumatology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.

Albert Selva O'Callaghan (A)

Internal Medicine Department, Vall D'hebron General Hospital, Universitat Autonoma de Barcelona, Barcelona, Spain.

Elena Nikiphorou (E)

Centre for Rheumatic Diseases, King's College London.
Rheumatology Department, King's College Hospital, London.

Tulika Chatterjee (T)

Center for Outcomes Research, Department of Internal Medicine, University of Illinois College of Medicine Peoria, IL, USA.

Ai Lyn Tan (AL)

NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust.
Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Leeds, UK.

Lorenzo Cavagna (L)

Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli studi di Pavia, Pavia, Italy.

Miguel A Saavedra (MA)

Departamento de Reumatología, Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico.

Samuel Katsuyuki Shinjo (SK)

Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, São Paulo, Brazil.

Nelly Ziade (N)

Rheumatology Department, Saint-Joseph University.
Rheumatology Department, Hotel-Dieu de France Hospital, Beirut, Lebanon.

Johannes Knitza (J)

Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.

Masataka Kuwana (M)

Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.

Oliver Distler (O)

Department of Rheumatology, University Hospital Zürich, University of Zürich, Zürich, Switzerland.

Hector Chinoy (H)

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.
National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, The University of Manchester, Manchester.
Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.

Vikas Agarwal (V)

Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.

Rohit Aggarwal (R)

Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.

Latika Gupta (L)

Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India.
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.
Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.

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