COVID-19 vaccine safety during the antenatal period in women with idiopathic inflammatory myopathies.

Abstract

DEAR EDITOR, Patients with idiopathic inflammatory myopathies (IIMs) represent a high-risk group for adverse pregnancy outcomes (APOs), and post COVID-19 vaccination disease flares have been speculated. However, data on vaccine-associated adverse events (ADEs) in the antenatal period and APOs in this vulnerable group are virtually non-existent, limiting physicians’ ability to make informed choices [1–3].

We analysed the long-term (>7 days) vaccine-related ADEs, post-vaccination disease flares, COVID-19 infections, current health status and patient-reported outcomes in six fully vaccinated pregnant/lactating women with IIMs, in a descriptive subanalysis of the ongoing multicentre second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study (involving 157 collaborators, 106 countries) [4].

We extracted 9201 total complete responses on 20 June 2022, which included responses from 6787 (73.8%) women, among whom 70 (1.1%) and 99 (1.5%) were pregnant and breastfeeding at the time of vaccination, respectively (Supplementary Fig. S1, available at Rheumatology online). Relevant data on the aforementioned outcome measures, baseline features, and treatment history of these patients were extracted (Supplementary Data S1, available at Rheumatology online). All data are expressed as medians and ranges.