TY - JOUR
T1 - COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases
T2 - Results from the COVAD study
AU - behalf of COVAD Study Group
AU - Andreoli, Laura
AU - Lini, Daniele
AU - Schreiber, Karen
AU - Parodis, Ioannis
AU - Sen, Parikshit
AU - Ravichandran, Naveen
AU - Day, Jessica
AU - Joshi, Mrudula
AU - Jagtap, Kshitij
AU - Nune, Arvind
AU - Nikiphorou, Elena
AU - Agarwal, Vishwesh
AU - Saha, Sreoshy
AU - Tan, Ai Lyn
AU - Shinjo, Samuel Katsuyuki
AU - Ziade, Nelly
AU - Velikova, Tsvetelina
AU - Milchert, Marcin
AU - Gracia-Ramos, Abraham Edgar
AU - Cavagna, Lorenzo
AU - Kuwana, Masataka
AU - Knitza, Johannes
AU - Makol, Ashima
AU - Patel, Aarat
AU - Pauling, John D.
AU - Wincup, Chris
AU - Barman, Bhupen
AU - Tehozol, Erick Adrian Zamora
AU - Serrano, Jorge Rojas
AU - De La Torre, Ignacio García
AU - Colunga-Pedraza, Iris J.
AU - Merayo-Chalico, Javier
AU - Chibuzo, Okwara Celestine
AU - Katchamart, Wanruchada
AU - Goo, Phonpen Akarawatcharangura
AU - Shumnalieva, Russka
AU - Chen, Yi Ming
AU - Hoff, Leonardo Santos
AU - El Kibbi, Lina
AU - Halabi, Hussein
AU - Vaidya, Binit
AU - Shaharir, Syahrul Sazliyana
AU - Tanveer Hasan, A. T.M.
AU - Dey, Dzifa
AU - Gutiérrez, Carlos Enrique Toro
AU - Caballero-Uribe, Carlo V.
AU - Lilleker, James B.
AU - Salim, Babur
AU - Gheita, Tamer
AU - Chatterjee, Tulika
N1 - Publisher Copyright:
© 2023 The Author(s).
PY - 2024/5/1
Y1 - 2024/5/1
N2 - 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.
AB - 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.
KW - COVID-19 vaccination
KW - adverse events
KW - autoimmune diseases
KW - breastfeeding
KW - disease flare
KW - pregnancy
KW - treatment
UR - https://www.scopus.com/pages/publications/85186949878
U2 - 10.1093/rheumatology/kead382
DO - 10.1093/rheumatology/kead382
M3 - Article
C2 - 37505460
AN - SCOPUS:85186949878
SN - 1462-0324
VL - 63
SP - 1341
EP - 1351
JO - Rheumatology
JF - Rheumatology
IS - 5
ER -
SDG 3 Good Health and Well-being