TY - JOUR
T1 - COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases
T2 - results from the COVAD study
AU - 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 - Zamora Tehozol, Erick Adrian
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 - Akarawatcharangura Goo, Phonpen
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 - Hasan, A T M Tanveer
AU - Dey, Dzifa
AU - Toro Gutiérrez, Carlos Enrique
AU - Caballero-Uribe, Carlo V
AU - Lilleker, James B
AU - Salim, Babur
AU - Gheita, Tamer
AU - Chatterjee, Tulika
AU - Saavedra, Miguel A
AU - Distler, Oliver
AU - Chinoy, Hector
AU - Agarwal, Vikas
AU - Aggarwal, Rohit
AU - Gupta, Latika
N1 - © The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: [email protected].
PY - 2024/5
Y1 - 2024/5
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 - Humans
KW - Female
KW - Pregnancy
KW - Breast Feeding
KW - Adult
KW - Autoimmune Diseases
KW - COVID-19 Vaccines/adverse effects
KW - COVID-19/prevention & control
KW - SARS-CoV-2/immunology
KW - Vaccination/adverse effects
U2 - 10.1093/rheumatology/kead382
DO - 10.1093/rheumatology/kead382
M3 - Article
C2 - 37505460
SN - 1462-0324
VL - 63
SP - 1341
EP - 1351
JO - Rheumatology (Oxford, England)
JF - Rheumatology (Oxford, England)
IS - 5
ER -
