PMID- 36740090 OWN - NLM STAT- MEDLINE DCOM- 20230322 LR - 20230322 IS - 1873-0183 (Electronic) IS - 1568-9972 (Print) IS - 1568-9972 (Linking) VI - 22 IP - 4 DP - 2023 Apr TI - COVID-19 vaccine safety during pregnancy in women with systemic lupus erythematosus. PG - 103292 LID - S1568-9972(23)00026-5 [pii] LID - 10.1016/j.autrev.2023.103292 [doi] AB - COVID-19 vaccination has been shown to be safe in patients with systemic lupus erythematosus (SLE), but data on vaccine-associated adverse events (AEs) during the antenatal and lactation period are scarce or lacking. We investigated COVID-19 vaccination-related AEs in pregnant SLE patients from the COVAD study, a global esurvey involving 157 collaborators from 106 countries. A total of 9201 complete responses were extracted. Among 6787 (73.8%) women, we identified 70 (1.1%) who were exposed to at least one COVID-19 vaccine dose during pregnancy, 11 with SLE. Delayed onset (>7 days) vaccine-related AEs were triangulated with disease activity, treatment changes due to flare after vaccination, and COVID-19 infections in vaccinated pregnant women. Health-related quality of life and physical function was recorded using PROMIS. Age of patients ranged from 28 to 39 years; 5/11 women were of Asian origin. None of these patients reported major vaccine AEs or change in the status of their autoimmune disease. Although minor AEs were common, they did not impair daily functioning, and the symptoms resolved after a median of 3 (IQR: 2.5-5.0) days. All patients reported good to excellent health status. No adverse pregnancy outcomes were reported. Importantly, none of the patients reported thrombotic events post-vaccination, which provides reassurance in a patient population with a high risk for cardiovascular comorbidity and thrombosis, especially in the presence of antiphospholipid antibodies or the antiphospholipid syndrome, a considerable portion of SLE patients. Our findings provide reassurance and can contribute to informed decisions regarding vaccination in patients with SLE and high-risk pregnancies due to their background autoimmune disease. The risk/benefit ratio of COVID-19 vaccination appears favourable, with vaccines both providing passive immunisation to the fetus and active immunisation to the mother with no signals of exacerbation of the mother's autoimmune disease. CI - Copyright (c) 2023. Published by Elsevier B.V. FAU - Giannopoulou, Nefeli AU - Giannopoulou N AD - Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; General Hospital of Paphos, University of Nicosia, Nicosia, Cyprus. FAU - Gupta, Latika AU - Gupta L AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India; Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK; Department of Rheumatology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, Birmingham, UK; 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. FAU - Andreoli, Laura AU - Andreoli L AD - Rheumatology and Clinical Immunology Unit, Azienda Socio-Sanitaria Territoriale Spedali Civili, Brescia, Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. FAU - Lini, Daniele AU - Lini D AD - Rheumatology and Clinical Immunology Unit, Azienda Socio-Sanitaria Territoriale Spedali Civili, Brescia, Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. CN - COVAD Study Group FAU - Nikiphorou, Elena AU - Nikiphorou E AD - Centre for Rheumatic Diseases, King's College London, London, UK; Rheumatology Department, King's College Hospital, London, UK. FAU - Aggarwal, Rohit AU - Aggarwal R AD - Division of Rheumatology and Clinical Immunology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. FAU - Agarwal, Vikas AU - Agarwal V AD - Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. Electronic address: vikasagr@yahoo.com. FAU - Parodis, Ioannis AU - Parodis I AD - Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden; Department of Rheumatology, Faculty of Medicine and Health, Orebro University, Orebro, Sweden. Electronic address: ioannis.parodis@ki.se. LA - eng PT - Letter DEP - 20230203 PL - Netherlands TA - Autoimmun Rev JT - Autoimmunity reviews JID - 101128967 RN - 0 (COVID-19 Vaccines) RN - 0 (Vaccines) SB - IM MH - Humans MH - Female MH - Pregnancy MH - Adult MH - Male MH - COVID-19 Vaccines/adverse effects MH - Quality of Life MH - *COVID-19/complications/epidemiology/prevention & control MH - *Lupus Erythematosus, Systemic/diagnosis MH - Pregnancy Outcome/epidemiology MH - *Autoimmune Diseases MH - *Vaccines PMC - PMC9896878 OTO - NOTNLM OT - Adverse events OT - COVID-19 OT - Pregnancy OT - SARS-CoV-2 virus OT - Systemic lupus erythematosus OT - Vaccines COIS- Declaration of Competing Interest R.A. has a consultancy relationship with and/or has received research funding from 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 Therapeutics, Teva, Beigene, ANI Pharmaceuticals, Biogen, Nuvig, Capella Bioscience, and CabalettaBio. I.P. 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. The other authors declare that they have no conflict of interest. EDAT- 2023/02/06 06:00 MHDA- 2023/03/23 06:00 PMCR- 2023/02/03 CRDT- 2023/02/05 19:27 PHST- 2023/01/15 00:00 [received] PHST- 2023/02/01 00:00 [accepted] PHST- 2023/02/06 06:00 [pubmed] PHST- 2023/03/23 06:00 [medline] PHST- 2023/02/05 19:27 [entrez] PHST- 2023/02/03 00:00 [pmc-release] AID - S1568-9972(23)00026-5 [pii] AID - 103292 [pii] AID - 10.1016/j.autrev.2023.103292 [doi] PST - ppublish SO - Autoimmun Rev. 2023 Apr;22(4):103292. doi: 10.1016/j.autrev.2023.103292. Epub 2023 Feb 3.