Adverse events were significantly more frequently reported by pregnant patients when compared with non-pregnant patients. However, no differences were observed when comparing pregnant patients with autoimmune disease and healthy controls.
During the prenatal period, receiving the COVID-19 vaccination in pregnant women with autoimmune diseases was demonstrated to be safe, according to data presented at the European Congress of Rheumatology (EULAR) 2023.1 While adverse events (AEs) were more common in pregnant patients, rates were not higher between patients with autoimmune disease and healthy controls.
Investigators believe that these results can help to overcome vaccine hesitancy and strengthen communication between the physician and patient, as any risks of AE and disease flare did not outweigh the benefits for both mother and fetus by passive immunization.
The findings are also encouraging as a recent study noted that mid-trimester maternal COVID-19 infection had the potential to infect the placenta and fetal brain, triggering inflammatory events in both the fetus and placenta.2 This in turn was linked to critical brain injury and progressive neurological sequelae.
“COVID-19 vaccine hesitancy among pregnant and breastfeeding women with autoimmune diseases is often attributed to the fear of AEs and disease flares,” wrote lead investigator Laura Andreoli, PhD, associate professor of rheumatology, University of Brescia and consultant physician, Rheumatology and Clinical Immunology Unit of Spedali Civili, Brescia, and colleagues. “No data are available regarding COVID-19 vaccine safety in this population.”
Investigators analyzed delayed-onset, defined as >7 days, vaccine-related AE (both minor and major), disease flare, and autoimmune disease treatment modifications utilizing data from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.
As of June 21, 2022, a total of 9201 participants completed responses, of which most (73.8%, n = 6786) were female. Subsequently, 6 subgroups were categorized based on pregnancy and breastfeeding status at the time of vaccination as well as autoimmune disease diagnosis. Of the female respondents, 5954 had an autoimmune disease diagnosis and 1833 were placed in the healthy control group.
The subgroups included: non-pregnant, non-breastfeeding patients with autoimmune disease (n = 4862); pregnant patients with autoimmune disease (n = 40); breastfeeding patients with autoimmune disease (n = 52); non-pregnant, non-breastfeeding healthy controls (n = 1749); pregnant healthy controls (n = 31); and breastfeeding healthy controls (n = 53).
The median age of all female patients was 47 years, approximately half (47.5%, n = 3225) were White, and 97.7% (n = 6632) had received at least 1 dose of the COVID-19 vaccination. Patients with autoimmune disease who were either pregnant or breastfeeding reported vaccination rates of 100% and 96.2%, respectively.
Major AE was reported in 4.3% (n = 285) of the total women observed and hospitalization was reported in 1.1% (n = 74). Overall AE, minor AE, and major AE were significantly more frequently reported by pregnant patients when compared with non-pregnant patients (45% vs 26%, P =0.01; 40% vs 25.9%, P =0.03; 17.5% vs 4.6%, P <.01, respectively). However, no differences were observed when comparing pregnant patients with autoimmune disease and healthy controls. Further, no differences were observed between breastfeeding patients and healthy controls.
Disease flare post-vaccination were reported by 20% of breastfeeding patients, 17.5% of pregnant patients, and 18% of age- and disease-matched controls (n = 2315). All disease flares in the pregnant and breastfeeding cohorts were managed with glucocorticoids and approximately 1 out of 5 patients required changing or initiating immunosuppressive treatment.