Pregnant or breastfeeding women with autoimmune diseases did not experience adverse events (AEs) or disease flares more frequently than healthy control patients after COVID-19 vaccination, according to study results published in Rheumatology.
To aid communication between physicians and patients on COVID-19 vaccination uptake during gestational and postpartum periods, researchers surveyed pregnant and breastfeeding women with autoimmune diseases on the occurrence of adverse events and worsening disease following vaccination.
This ongoing, international, cross-sectional, multicenter study was conducted among women in 94 countries. Self-reported data were captured from a total of 4954 patients with (Groups A-C) and 1833 without (healthy controls; Groups D-F) autoimmune diseases. The study population was divided into 6 groups, as follows:
- Nonpregnant and nonbreastfeeding women (Group A; n=4862);
- Pregnant women (Group B; n=40);
- Breastfeeding women (Group C; n=52);
- Nonpregnant and nonbreastfeeding women (Group D; n=1749);
- Pregnant women (Group E; n=31); and
- Breastfeeding Women (Group F; n=53).
All patients included in the analysis were adult women (median age, 47 [IQR, 35-58] years). Overall, 47.5% of patients were White, 19.2% were Asian, and 15.8% were Hispanic. The majority of patients had at least 1 comorbidity (55.4%), the most common of which included generalized anxiety disorder (18.5%), hypertension (17.3%), and major depressive disorder (15.6%). In addition, most patients received at least 1 COVID-19 vaccine dose (97.7%), 73.2% received 3 vaccine doses, and 2.3% were unvaccinated.
Postvaccination AEs occurred in 1837 (25.4%) patients, with minor AEs reported by 24.3%, major AEs reported by 4.3%, and injection site pain and soreness reported by 9.5%. Patients in Group B reported the highest frequency of AEs among the study population (45% vs 23.3%-28%). Patients in Group B vs Group A reported significantly higher rates of minor AEs (40% vs 25.9%; P =.03), major AEs (17.5% vs 4.6%; P <.01), and AEs overall (45% vs 26%; P =.01). In addition, AE and hospitalization frequency did not significantly differ between patients in Group B and those in Group E.
Further analysis was performed to compare postvaccination changes in disease activity between pregnant (n=40) and breastfeeding (n=50) patients with autoimmune diseases and age- and disease-matched control patients (n=262). The most common diseases among pregnant vs breastfeeding women included systemic lupus erythematosus (27.5% vs 20%), rheumatoid arthritis (10% vs 20%), and hypo- or hyperthyroidism (10% vs 22%).
Prior to vaccination, inactive disease was reported by 37.5%, 48%, and 38.5% of pregnant, breastfeeding, and control patients, respectively. Following vaccination, worsening disease status occurred at similar rates among these 3 groups (17.5%, 20%, and 18.3%, respectively).
Study limitations include the use of self-reported data, potential recall bias, and the small number of pregnant and breastfeeding patients.
“Our data may help physicians navigate discussions regarding the risk-benefit ratio of COVID-19 vaccination in women who carry high-risk pregnancies due to underlying disease,” the researchers concluded.
Disclosure: Multiple study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
This article originally appeared on Infectious Disease Advisor
Andreoli L, Lini D, Schreiber K, et al. COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study. Rheumatology (Oxford). Published online July 28, 2023. doi:10.1093/rheumatology/kead382