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

Laura Andreoli; Daniele Lini; Karen Schreiber; Ioannis Parodis; Parikshit Sen; R Naveen; Jessica Day; Mrudula Joshi; Kshitij Jagtap; Arvind Nune; Elena Nikiphorou; Vishwesh Agarwal; Sreoshy Saha; Ai Lyn Tan; Samuel Katsuyuki Shinjo; Nelly Ziade; Tsvetelina Velikova; Marcin Milchert; Abraham Edgar Gracia-Ramos; Lorenzo Cavagna; Masataka Kuwana; Johannes Knitza; Ashima Makol; Aarat Patel; John D Pauling; Chris Wincup; Bhupen Barman; Erick Adrian Zamora Tehozol; Jorge Rojas Serrano; Ignacio García-De La Torre; Iris J Colunga-Pedraza; Javier Merayo-Chalico; Okwara Celestine Chibuzo; Wanruchada Katchamart; Phonpen Akarawatcharangura Goo; Russka Shumnalieva; Yi-Ming Chen; Leonardo Santos Hoff; Lina El Kibbi; Hussein Halabi; Binit Vaidya; Syahrul Sazliyana Shaharir; A T M Tanveer Hasan; Dzifa Dey; Carlos Enrique Toro Gutiérrez; Carlo V Caballero-Uribe; James B Lilleker; Babur Salim; Tamer Gheita; Tulika Chatterjee; COVAD Study Group

doi:10.1093/rheumatology/kead382

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

Laura Andreoli, Daniele Lini, Karen Schreiber, Ioannis Parodis, Parikshit Sen, R Naveen, Jessica Day, Mrudula Joshi, Kshitij Jagtap, Arvind Nune, Elena Nikiphorou, Vishwesh Agarwal, Sreoshy Saha, Ai Lyn Tan, Samuel Katsuyuki Shinjo, Nelly Ziade, Tsvetelina Velikova, Marcin Milchert, Abraham Edgar Gracia-Ramos, Lorenzo CavagnaMasataka Kuwana, Johannes Knitza, Ashima Makol, Aarat Patel, John D Pauling, Chris Wincup, Bhupen Barman, Erick Adrian Zamora Tehozol, Jorge Rojas Serrano, Ignacio García-De La Torre, Iris J Colunga-Pedraza, Javier Merayo-Chalico, Okwara Celestine Chibuzo, Wanruchada Katchamart, Phonpen Akarawatcharangura Goo, Russka Shumnalieva, Yi-Ming Chen, Leonardo Santos Hoff, Lina El Kibbi, Hussein Halabi, Binit Vaidya, Syahrul Sazliyana Shaharir, A T M Tanveer Hasan, Dzifa Dey, Carlos Enrique Toro Gutiérrez, Carlo V Caballero-Uribe, James B Lilleker, Babur Salim, Tamer Gheita, Tulika Chatterjee, COVAD Study Group

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.

Original language	English
Journal	Rheumatology (Oxford, England)
ISSN	1462-0324
DOIs	https://doi.org/10.1093/rheumatology/kead382
Publication status	E-pub ahead of print - 28 Jul 2023
Externally published	Yes

Access to Document

10.1093/rheumatology/kead382

Cite this

Andreoli, L., Lini, D., Schreiber, K., Parodis, I., Sen, P., Naveen, R., Day, J., Joshi, M., Jagtap, K., Nune, A., Nikiphorou, E., Agarwal, V., Saha, S., Tan, A. L., Shinjo, S. K., Ziade, N., Velikova, T., Milchert, M., Edgar Gracia-Ramos, A., ... COVAD Study Group (2023). COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study. Rheumatology (Oxford, England). Advance online publication. https://doi.org/10.1093/rheumatology/kead382

Andreoli, L, Lini, D, Schreiber, K, Parodis, I, Sen, P, Naveen, R, Day, J, Joshi, M, Jagtap, K, Nune, A, Nikiphorou, E, Agarwal, V, Saha, S, Tan, AL, Shinjo, SK, Ziade, N, Velikova, T, Milchert, M, Edgar Gracia-Ramos, A, Cavagna, L, Kuwana, M, Knitza, J, Makol, A, Patel, A, Pauling, JD, Wincup, C, Barman, B, Zamora Tehozol, EA, Serrano, JR, García-De La Torre, I, Colunga-Pedraza, IJ, Merayo-Chalico, J, Chibuzo, OC, Katchamart, W, Akarawatcharangura Goo, P, Shumnalieva, R, Chen, Y-M, Hoff, LS, El Kibbi, L, Halabi, H, Vaidya, B, Sazliyana Shaharir, S, Hasan, ATMT, Dey, D, Gutiérrez, CET, Caballero-Uribe, CV, Lilleker, JB, Salim, B, Gheita, T, Chatterjee, T & COVAD Study Group 2023, 'COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study', Rheumatology (Oxford, England). https://doi.org/10.1093/rheumatology/kead382

@article{8a774ce3681a4b75868ce0425f4de67e,

title = "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 = "Laura Andreoli and Daniele Lini and Karen Schreiber and Ioannis Parodis and Parikshit Sen and R Naveen and Jessica Day and Mrudula Joshi and Kshitij Jagtap and Arvind Nune and Elena Nikiphorou and Vishwesh Agarwal and Sreoshy Saha and Tan, {Ai Lyn} and Shinjo, {Samuel Katsuyuki} and Nelly Ziade and Tsvetelina Velikova and Marcin Milchert and {Edgar Gracia-Ramos}, Abraham and Lorenzo Cavagna and Masataka Kuwana and Johannes Knitza and Ashima Makol and Aarat Patel and Pauling, {John D} and Chris Wincup and Bhupen Barman and {Zamora Tehozol}, {Erick Adrian} and Serrano, {Jorge Rojas} and {Garc{\'i}a-De La Torre}, Ignacio and Colunga-Pedraza, {Iris J} and Javier Merayo-Chalico and Chibuzo, {Okwara Celestine} and Wanruchada Katchamart and {Akarawatcharangura Goo}, Phonpen and Russka Shumnalieva and Yi-Ming Chen and Hoff, {Leonardo Santos} and {El Kibbi}, Lina and Hussein Halabi and Binit Vaidya and {Sazliyana Shaharir}, Syahrul and Hasan, {A T M Tanveer} and Dzifa Dey and Guti{\'e}rrez, {Carlos Enrique Toro} and Caballero-Uribe, {Carlo V} and Lilleker, {James B} and Babur Salim and Tamer Gheita and Tulika Chatterjee and {COVAD Study Group}",

note = "{\textcopyright} 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].",

year = "2023",

month = jul,

day = "28",

doi = "10.1093/rheumatology/kead382",

language = "English",

journal = "Rheumatology (Oxford, England)",

issn = "1462-0324",

publisher = "Oxford University Press",

}

TY - JOUR

T1 - COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases

T2 - 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 - COVAD Study Group

PY - 2023/7/28

Y1 - 2023/7/28

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.

UR - http://www.scopus.com/inward/record.url?scp=85186949878&partnerID=8YFLogxK

U2 - 10.1093/rheumatology/kead382

DO - 10.1093/rheumatology/kead382

M3 - Journal article

C2 - 37505460

SN - 1462-0324

JO - Rheumatology (Oxford, England)

JF - Rheumatology (Oxford, England)

ER -

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

Abstract

Access to Document

Other files and links

Fingerprint

Cite this