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.
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