COVID-19 VACCINE SAFETY DURING PREGNANCY AND BREASTFEEDING IN WOMEN WITH AUTOIMMUNE DISEASES: RESULTS FROM THE COVAD STUDY Sanjay Gandhi Postgraduate Institute of Medical Sciences, Department of Clinical Immunology and Rheumatology, Lucknow, India.
Pontifica Universidad Javeriana, Reference Center for Osteoporosis, Rheumatology and Dermatology, Cali, Colombia.
Mahidol University, Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand.
Queen Savang Vadhana Memorial Hospital, Department of Medicine, Chonburi, Thailand.
University Hospital “St. Ivan Rilski”, Department of Rheumatology, Sofia, Bulgaria.
University of Nigeria Teaching Hospital, Ituku-Ozalla/University of Nigeria, Enugu Campus, Department of Medicine, Enugu, Nigeria.
Sofia University St. Kliment Ohridski, Medical Faculty, Sofia, Bulgaria.
Institute of Medical Research, Walter and Eliza Hall, Parkville, Australia; University of Melbourne, Department of Medical Biology, Parkville, Australia; Royal Melbourne Hospital, Department of Rheumatology, Parkville, Australia.
Byramjee Jeejeebhoy Government Medical College, Sassoon General Hospitals, Pune, India.
Faculdade de Medicina FMUSP, Universidade de Sao Paulo, Division of Rheumatology, São Paulo, Brazil.
National Medical Center “La Raza”, Instituto Mexicano del Seguro Social, Department of Internal Medicine, General Hospital, Mexico City, Mexico.
University of Pavia, Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Pavia, Italy.
Nippon Medical School Graduate School of Medicine, Department of Allergy and Rheumatology, Tokyo, Japan.
Friedrich-Alexander-Universität Erlangen-Nürnberg, Medizinische Klinik 3 - Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Erlangen, Germany.
Mayo Clinic, Division of Rheumatology, Rochester, United States of America.
Taichung Veterans General Hospital, Division of Allergy, Immunology and Rheumatology, Department of Medical Research, Taichung, Taiwan, Republic of China.
School of Biological Sciences, The University of Manchester, Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, Manchester, United Kingdom; Manchester University NHS Foundation Trust, National Institute for Health Research Manchester Biomedical Research Centre, Manchester, United Kingdom; Manchester Academic Health Science Centre, Department of Rheumatology, Salford Royal NHS Foundation Trust, Salford, United Kingdom.
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Department of Clinical Immunology and Rheumatology, Lucknow, India.
University of Pittsburgh School of Medicine, Division of Rheumatology and Clinical Immunology, Pittsburgh, United States of America.
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Department of Clinical Immunology and Rheumatology, Lucknow, India; New Cross Hospital, Royal Wolverhampton Trust, Department of Rheumatology, Wolverhampton, United Kingdom.
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2023 (English) In: Annals of the Rheumatic Diseases, ISSN 0003-4967, E-ISSN 1468-2060, Vol. 82, no Suppl. 1, p. 56-57, article id OP0082Article in journal, Meeting abstract (Other academic) Published
Abstract [en]
Background : COVID-19 vaccine hesitancy among pregnant and breastfeeding women with autoimmune diseases (AID) is often attributed to the fear of adverse events (AE) and disease flares (DF). No data are available regarding COVID-19 vaccine safety in this population.
Objectives : We aimed at describing delayed-onset (>7 days) vaccine-related AE (minor and major), DF, and related AID treatment modifications from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.
Methods : Among complete responses from 9201 participants as of June 21, 2022, 6787 (73.8%) were women. Six subgroups were identified upon diagnosis of AID vs healthy controls (HC) and their pregnancy/breastfeeding status at the time of any dose of vaccine (Figure 1).
Results : Forty pregnant and 52 breastfeeding AID patients were identified and their vaccination rates (at least one dose) was 100% and 96.2%, respectively (Table 1). Overall AE, minor AE, and major AE were reported significantly more frequently by pregnant than non-pregnant patients (45% vs. 26%, p=0.01; 40% vs. 25.9%, p=0.03; 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. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18% of age- and disease-matched control patients (n=2315). All DF in pregnant/breastfeeding patients were managed with glucocorticoids and a fifth of them required initiation or change in immunosuppressive treatment.
Conclusion : This study provides the first insights into the safety of COVID-19 vaccination during the antenatal period in women with AID. While AEs were more commonly reported by pregnant patients with AID, these were no higher than among pregnant healthy controls without AID. These observations are reassuring, likely to strengthen physician-patient communication and overcome hesitancy as the benefits for the mother and fetus by passive immunization are likely to overweigh the potential risks of AE and DF.
Reference : [1]Fazal ZZ, et al; COVAD Study Group. COVAD survey 2 long-term outcomes: unmet need and protocol. Rheumatol Int 2022; 42:2151-2158.
Place, publisher, year, edition, pages HighWire Press , 2023. Vol. 82, no Suppl. 1, p. 56-57, article id OP0082
Keywords [en]
Pregnancy and reproduction, COVID, Vaccination/Immunization
National Category
Clinical Medicine
Identifiers URN: urn:nbn:se:oru:diva-111583 DOI: 10.1136/annrheumdis-2023-eular.2935 ISI: 001107398700083 OAI: oai:DiVA.org:oru-111583 DiVA, id: diva2:1838427
Conference European Congress of Rheumatology, (EULAR 2023), Milan, Italy, May 31 - June 3, 2023
2024-02-162024-02-162025-02-18 Bibliographically approved