COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study

Andreoli L 1 , Lini D 1 , Schreiber K 2 , Parodis I 3 , Sen P 4 , Naveen R 5 Show all authors , Day J 6 , Joshi M 7 , Jagtap K 8 , Nune A 9 , Nikiphorou E 10 , Agarwal V 11 , Saha S 12 , Tan AL 13 , Shinjo SK 14 , Ziade N 15 , Velikova T 16 , Milchert M 17 , Edgar Gracia-Ramos A 18 , Cavagna L 19 , Kuwana M 20 , Knitza J 21 , Makol A 22 , Patel A 23 , Pauling JD 24 , Wincup C 25 , Barman B 26 , Zamora Tehozol EA 27 , Serrano JR 28 , García-De La Torre I 29 , Colunga-Pedraza IJ 30 , Merayo-Chalico J 31 , Chibuzo OC 32 , Katchamart W 33 , Akarawatcharangura Goo P 34 , Shumnalieva R 35 , Chen YM 36 , Hoff LS 37 , El Kibbi L 38 , Halabi H 39 , Vaidya B 40 , Sazliyana Shaharir S 41 , Hasan ATMT 42 , Dey D 43 , Gutiérrez CET 44 , Caballero-Uribe CV 45 , Lilleker JB 46 , Salim B 47 , Gheita T 48 , Chatterjee T 49 , Saavedra MA 50 , Distler O 51 , COVAD study group , Chinoy GAH 46 , Agarwal V 52 , Aggarwal R 53 , Gupta L 46

Affiliations 

  • 1 Rheumatology and Clinical Immunology Unit, ASST Spedali Civili Brescia; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, 25123, Italy
  • 2 Danish Hospital for Rheumatic Diseases, Sønderborg, 6400, Denmark
  • 3 Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden
  • 4 Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi, 110002, India
  • 5 Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India
  • 6 Walter and Eliza Hall Institute of Medical Research, Parkville, VIC, 3052, Australia
  • 7 Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India
  • 8 Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital, Mumbai, Maharashtra, India
  • 9 Southport and Ormskirk Hospital NHS Trust, Southport, PR8 6PN, UK
  • 10 Centre for Rheumatic Diseases, King's College London, London, UK
  • 11 Mahatma Gandhi Mission Medical College, Navi Mumbai, Maharashtra, India
  • 12 Mymensingh Medical College, Mymensingh, Bangladesh
  • 13 NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust, Leeds, UK
  • 14 Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Sao Paulo, SP, Brazil
  • 15 Rheumatology Department, Saint-Joseph University, Beirut, Lebanon
  • 16 Medical Faculty, Sofia University St. Kliment Ohridski, 1 Kozyak Str., 1407, Sofia, Bulgaria
  • 17 Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, ul Unii Lubelskiej 1, 71-252, Szczecin, Poland
  • 18 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
  • 19 Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli studi di Pavia, Pavia, Lombardy, Italy
  • 20 Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine, 1-1-5 Sendagi, Bunkyo-ku, 113-8602, Japan, Tokyo
  • 21 Medizinische Klinik 3-Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Ulmenweg 18, Erlangen, 91054, Deutschland
  • 22 Division of Rheumatology, Mayo Clinic, Rochester, Minnesota, USA
  • 23 Bon Secours Rheumatology Center and Division of Pediatric Rheumatology, Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA
  • 24 Bristol Medical School Translational Health Sciences, University of Bristol, UK
  • 25 Department of Rheumatology, Division of Medicine, Rayne Institute, University College London, UK
  • 26 Department of General Medicine, All India Institute of Medical Sciences (AIIMS), Guwahati, India
  • 27 Rheumatology, Medical Care & Research, Centro Medico Pensiones Hospital, Instituto Mexicano del Seguro Social Delegación Yucatán, Yucatán, Mexcio
  • 28 Rheumatologist and Clinical Investigator, Interstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias, Mexico City, Mexico
  • 29 Departamento de Inmunología y Reumatología, Hospital General de Occidente and Universidad de Guadalajara, Guadalajara, Jalisco, Mexico
  • 30 Rheumatology, Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, Mexico
  • 31 Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico
  • 32 Department of Medicine, University of Nigeria Teaching, Hospital, Ituku-Ozalla/University of Nigeria, Enugu Campus, Enugu, Nigeria
  • 33 Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • 34 Department of Medicine, Queen Savang Vadhana Memorial Hospital, Chonburi, Thailand
  • 35 Department of Rheumatology, Clinic of Rheumatology, University Hospital "St. Ivan Rilski", Medical University-Sofia, Bulgaria
  • 36 Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City, Taiwan
  • 37 School of Medicine, Universidade Potiguar (UnP), Brazil
  • 38 Rheumatology Unit, Internal Medicine Department, Specialized Medical Center, Riyadh, Saudi Arabia
  • 39 Department of Internal Medicine, Section of rheumatology, King Faisal Specialist Hospital and Research Center, Jeddah, Saudi Arabia
  • 40 National Center for Rheumatic Diseases (NCRD), Ratopul, Kathmandu, Nepal
  • 41 Faculty of Medicine, Universiti Kebangsaan Malaysia, 56000, Cheras, Kuala Lumpur
  • 42 Department of Rheumatology, Enam Medical College & Hospital, Dhaka, Bangladesh
  • 43 Rheumatology Unit, Department of Medicine and Therapeutics, University of Ghana Medical School, College of Health Sciences, Korle-Bu, Accra, Ghana
  • 44 General Director, Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali, Colombia
  • 45 Department of Medicine, Hospital Universidad del Norte, Barranquilla, Atlantico, Colombia
  • 46 Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre The University of Manchester, Manchester, UK
  • 47 Rheumatology Department, Fauji Foundation Hospital, Rawalpindi, Pakistan
  • 48 Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt
  • 49 Department of Internal Medicine, University of Illinois College of Medicine at Peoria, Illinois
  • 50 Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret, Centro Médico Nacional La Raza, IMSS, Mexico City, Mexico
  • 51 Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland
  • 52 Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
  • 53 Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania
Rheumatology (Oxford), 2023 Jul 28.
PMID: 37505460 DOI: 10.1093/rheumatology/kead382

Abstract

OBJECTIVES: We investigated COVID-19 vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.

METHODS: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares (DF), and AID-related treatment modifications were analyzed upon diagnosis of AID versus healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine.

RESULTS: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, p= 0.01; minor AE 40% vs 25.9%, p= 0.03; major AE 17.5% vs 4.6%, p< 0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC with respect to AE. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18.3% of age- and disease-matched non-pregnant and non-breastfeeding patients (n = 262). All pregnant/breastfeeding patients who experienced a DF were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively.

CONCLUSION: This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods, helping overcome hesitant attitudes, as the benefits for the mother and the fetus by passive immunization appear to outweigh potential risks.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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