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COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study.
- Source :
-
Rheumatology . May2024, Vol. 63 Issue 5, p1341-1351. 11p. - Publication Year :
- 2024
-
Abstract
- Objectives We investigated coronavirus disease 2019 (COVID-19) vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. Methods Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares and AID-related treatment modifications were analysed upon diagnosis of AID vs healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine. Results 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 disease flares 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 disease flare were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively. Conclusion 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 for the fetus by passive immunization appear to outweigh potential risks. [ABSTRACT FROM AUTHOR]
- Subjects :
- *BREASTFEEDING
*PATIENT safety
*IMMUNOSUPPRESSIVE agents
*RESEARCH funding
*VACCINE effectiveness
*PUERPERIUM
*VACCINATION
*COVID-19 vaccines
*PREGNANT women
*DESCRIPTIVE statistics
*BREAKTHROUGH infections
*SURVEYS
*VACCINATION coverage
*ATTITUDE (Psychology)
*AUTOIMMUNE diseases
*GESTATIONAL age
*VACCINE hesitancy
*COMPARATIVE studies
*COVID-19
*GLUCOCORTICOIDS
*PREGNANCY
Subjects
Details
- Language :
- English
- ISSN :
- 14620324
- Volume :
- 63
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- Rheumatology
- Publication Type :
- Academic Journal
- Accession number :
- 177017012
- Full Text :
- https://doi.org/10.1093/rheumatology/kead382