COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases : results from the COVAD study
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.
Author
Andreoli, Laura
Lini, Daniele
Schreiber, Karen
Parodis, Ioannis
Sen, Parikshit
Ravichandran, Naveen
Day, Jessica
Joshi, Mrudula
Jagtap, Kshitij
Nune, Arvind
Nikiphorou, Elena
Agarwal, Vishwesh
Saha, Sreoshy
Tan, Ai Lyn
Shinjo, Samuel Katsuyuki
Ziade, Nelly
Velikova, Tsvetelina
Milchert, Marcin
Gracia-Ramos, Abraham Edgar
Cavagna, Lorenzo
Kuwana, Masataka
Knitza, Johannes
Makol, Ashima
Patel, Aarat
Pauling, John D
Wincup, Chris
Barman, Bhupen
Zamora Tehozol, Erick Adrian
Serrano, Jorge Rojas
De La Torre, Ignacio García
Colunga-Pedraza, Iris J
Merayo-Chalico, Javier
Chibuzo, Okwara Celestine
Katchamart, Wanruchada
Akarawatcharangura Goo, Phonpen
Shumnalieva, Russka
Chen, Yi-Ming
Hoff, Leonardo Santos
El Kibbi, Lina
Halabi, Hussein
Vaidya, Binit
Shaharir, Syahrul Sazliyana
Hasan, A T M Tanveer
Dey, Dzifa
Toro Gutiérrez, Carlos Enrique
Caballero-Uribe, Carlo V
Lilleker, James B
Salim, Babur
Gheita, Tamer
Chatterjee, Tulika
Saavedra, Miguel A
Distler, Oliver
Chinoy, Hector
Agarwal, Vikas
Aggarwal, Rohit
Gupta, Latika
Lini, Daniele
Schreiber, Karen
Parodis, Ioannis
Sen, Parikshit
Ravichandran, Naveen
Day, Jessica
Joshi, Mrudula
Jagtap, Kshitij
Nune, Arvind
Nikiphorou, Elena
Agarwal, Vishwesh
Saha, Sreoshy
Tan, Ai Lyn
Shinjo, Samuel Katsuyuki
Ziade, Nelly
Velikova, Tsvetelina
Milchert, Marcin
Gracia-Ramos, Abraham Edgar
Cavagna, Lorenzo
Kuwana, Masataka
Knitza, Johannes
Makol, Ashima
Patel, Aarat
Pauling, John D
Wincup, Chris
Barman, Bhupen
Zamora Tehozol, Erick Adrian
Serrano, Jorge Rojas
De La Torre, Ignacio García
Colunga-Pedraza, Iris J
Merayo-Chalico, Javier
Chibuzo, Okwara Celestine
Katchamart, Wanruchada
Akarawatcharangura Goo, Phonpen
Shumnalieva, Russka
Chen, Yi-Ming
Hoff, Leonardo Santos
El Kibbi, Lina
Halabi, Hussein
Vaidya, Binit
Shaharir, Syahrul Sazliyana
Hasan, A T M Tanveer
Dey, Dzifa
Toro Gutiérrez, Carlos Enrique
Caballero-Uribe, Carlo V
Lilleker, James B
Salim, Babur
Gheita, Tamer
Chatterjee, Tulika
Saavedra, Miguel A
Distler, Oliver
Chinoy, Hector
Agarwal, Vikas
Aggarwal, Rohit
Gupta, Latika
Citations
Altmetric:
Date
2024-05
Type
Article
Subject
Rheumatology, Obstetrics. Midwifery
Collections
Citation
Andreoli L, Lini D, Schreiber K, Parodis I, Sen P, Ravichandran N, Day J, Joshi M, Jagtap K, Nune A, Nikiphorou E, Agarwal V, Saha S, Tan AL, Shinjo SK, Ziade N, Velikova T, Milchert M, Gracia-Ramos AE, Cavagna L, Kuwana M, Knitza J, Makol A, Patel A, Pauling JD, Wincup C, Barman B, Zamora Tehozol EA, Serrano JR, De La Torre IG, Colunga-Pedraza IJ, Merayo-Chalico J, Chibuzo OC, Katchamart W, Akarawatcharangura Goo P, Shumnalieva R, Chen YM, Hoff LS, El Kibbi L, Halabi H, Vaidya B, Shaharir SS, Hasan ATMT, Dey D, Toro Gutiérrez CE, Caballero-Uribe CV, Lilleker JB, Salim B, Gheita T, Chatterjee T, Saavedra MA, Distler O, Chinoy H, Agarwal V, Aggarwal R, Gupta L; COVAD Study Group. COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study. Rheumatology (Oxford). 2024 May 2;63(5):1341-1351. doi: 10.1093/rheumatology/kead382
Journal / Source Title
Rheumatology
DOI
10.1093/rheumatology/kead382
PMID
37505460
Publisher
Oxford University Press