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LO-027 COVID-19 vaccine safety during pregnancy in women with systemic lupus erythematosus
  1. Nefeli Giannopoulou1,
  2. Latika Gupta2,3,4,
  3. Laura Andreoli5,6,
  4. Daniele Lini5,6,
  5. Elena Nikiphorou7,8,
  6. Rohit Aggarwal2,
  7. Vikas Agarwal9 and
  8. Ioannis Parodis10,11
  1. 1General Hospital of Paphos, University of Nicosia, Cyprus
  2. 2Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, India
  3. 3Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust, UK
  4. 4Department of Rheumatology, City Hospital, Sandwell and West Birmingham Hospitals NHS Trust, UK
  5. 5Rheumatology and Clinical Immunology Unit, Azienda Socio-Sanitaria Territoriale Spedali Civili, Italy
  6. 6Department of Clinical and Experimental Sciences, University of Brescia, Italy
  7. 7Centre for Rheumatic Diseases, King’s College London, UK
  8. 8Rheumatology Department, King’s College Hospital, UK
  9. 9Department of Medicine, University of Pittsburgh School of Medicine, USA
  10. 10Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital, Sweden
  11. 11Department of Rheumatology, Örebro University, Sweden


Background While COVID-19 vaccination has been shown to be safe in patients with systemic lupus erythematosus (SLE), data on vaccine-associated adverse events (AEs) during the antenatal and lactation period are scarce, justifying the present investigation.

Methods A total of 9201 complete responses were extracted from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) database, a global e-survey involving 157 collaborators from 106 countries. Among respondents, 6787 (73.8%) were women. We identified 70 (1.1%) women who were exposed to at least one COVID-19 vaccine dose during pregnancy, among those 11 with SLE.

Results The age of patients ranged from 28 to 39 years; 5/11 women were of Asian origin. None of these patients reported major vaccine AEs, change in the status of their autoimmune disease, hospitalisation, or special treatment requirement. Six women experienced minor vaccine AEs; two of them had active disease prior to vaccination. Four patients reported COVID-19 infection; two of them while they were pregnant and post-vaccination and two prior to pregnancy and vaccination. All four patients experienced symptoms of their disease, but no overt SLE flare was reported. All patients reported their general health to be good/excellent. Importantly, no adverse pregnancy outcomes were reported. No post-vaccination thrombotic events were recorded. Although minor AEs were common, they did not impair daily functioning, and the symptoms resolved in all patients after a median of 3 (IQR: 2.5–5.0) days.

Conclusions Our report adds evidence concerning the sensitive issue of COVID-19 vaccine AEs and flares in SLE patients during the antenatal and lactation period. Based on the present data, 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.

  • systemic lupus erythematosus
  • pregnancy

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