COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study.
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Andreoli L, Lini D, Schreiber K, Parodis I, Sen P, Naveen R, Day J, Joshi M, Jagtap K, Nune A, Nikiphorou E, Agarwal V, Saha S, Tan AL, Shinjo SK, Ziade N, Velikova T, Milchert M, Edgar Gracia-Ramos A, Cavagna L, Kuwana M, Knitza J, Makol A, Patel A, Pauling JD, Wincup C, Barman B, Zamora Tehozol EA, Serrano JR, García-De La Torre I, Colunga-Pedraza IJ, Merayo-Chalico J, Chibuzo OC, Katchamart W, Akarawatcharangura Goo P, Shumnalieva R, Chen Y, Hoff LS, El Kibbi L, Halabi H, Vaidya B, Sazliyana Shaharir S, Hasan ATMT, Dey D, Gutiérrez CET, Caballero-Uribe CV, Lilleker JB, Salim B, Gheita T, Chatterjee T, Saavedra MA, Distler O, group Cs, , , Chinoy GAH, Agarwal V, Aggarwal R, Gupta L
Rheumatology (Oxford) - (-) - [2023-07-28; online 2023-07-28]
We investigated COVID-19 vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares (DF), and AID-related treatment modifications were analyzed upon diagnosis of AID versus healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine. Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, p= 0.01; minor AE 40% vs 25.9%, p= 0.03; major AE 17.5% vs 4.6%, p< 0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC with respect to AE. Post-vaccination DF were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18.3% of age- and disease-matched non-pregnant and non-breastfeeding patients (n = 262). All pregnant/breastfeeding patients who experienced a DF were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively. This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods, helping overcome hesitant attitudes, as the benefits for the mother and the fetus by passive immunization appear to outweigh potential risks.
PubMed 37505460
DOI 10.1093/rheumatology/kead382
Crossref 10.1093/rheumatology/kead382
pii: 7233066