COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study

TY - JOUR

T1 - COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study

AU - Andreoli, Laura

AU - Lini, Daniele

AU - Schreiber, Karen

AU - Parodis, Ioannis

AU - Sen, Parikshit

AU - Naveen, R

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 - Edgar Gracia-Ramos, Abraham

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 - García-De La Torre, Ignacio

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 - Sazliyana Shaharir, Syahrul

AU - Hasan, A T M Tanveer

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

AU - Saavedra, Miguel A

AU - Distler, Oliver

AU - Chinoy, Gabriela Arredondo Hector

AU - Agarwal, Vikas

AU - Aggarwal, Rohit

AU - Gupta, Latika

AU - COVAD Study Group

AU - Holzer, Marie-Therese

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: journals.permissions@oup.com.

PY - 2024/5/2

Y1 - 2024/5/2

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.

U2 - 10.1093/rheumatology/kead382

DO - 10.1093/rheumatology/kead382

M3 - SCORING: Journal article

C2 - 37505460

VL - 63

SP - 1341

EP - 1351

JO - RHEUMATOLOGY

JF - RHEUMATOLOGY

SN - 1462-0324

IS - 5

ER -