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; Naveen Ravichandran; 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; 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, Naveen Ravichandran, 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, COVAD Study Group

Bristol Medical School (THS)

Research output: Contribution to journal › Article (Academic Journal) › peer-review

4 Citations (Scopus)

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
Pages (from-to)	1341-1351
Number of pages	11
Journal	Rheumatology (Oxford, England)
Volume	63
Issue number	5
Early online date	28 Jul 2023
DOIs	https://doi.org/10.1093/rheumatology/kead382
Publication status	Published - 2 May 2024

Bibliographical note

Publisher Copyright:
© 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].

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Humans
Female
Pregnancy
Breast Feeding
Adult
Autoimmune Diseases
COVID-19 Vaccines/adverse effects
COVID-19/prevention & control
SARS-CoV-2/immunology
Vaccination/adverse effects

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10.1093/rheumatology/kead382

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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, A. L., Shinjo, S. K., Ziade, N., Velikova, T., Milchert, M., Gracia-Ramos, A. E., ... COVAD Study Group (2024). COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study. Rheumatology (Oxford, England), 63(5), 1341-1351. https://doi.org/10.1093/rheumatology/kead382

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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.",

keywords = "Humans, Female, Pregnancy, Breast Feeding, Adult, Autoimmune Diseases, COVID-19 Vaccines/adverse effects, COVID-19/prevention \& control, SARS-CoV-2/immunology, Vaccination/adverse effects",

author = "Laura Andreoli and Daniele Lini and Karen Schreiber and Ioannis Parodis and Parikshit Sen and Naveen Ravichandran 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 Gracia-Ramos, \{Abraham Edgar\} 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 \{De La Torre\}, \{Ignacio Garc{\'i}a\} and \{COVAD Study Group\}",

note = "Publisher Copyright: {\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 = "2024",

month = may,

day = "2",

doi = "10.1093/rheumatology/kead382",

language = "English",

volume = "63",

pages = "1341--1351",

journal = "Rheumatology (Oxford, England)",

issn = "1462-0324",

publisher = "Oxford University Press",

number = "5",

}

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 & COVAD Study Group 2024, 'COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study', Rheumatology (Oxford, England), vol. 63, no. 5, pp. 1341-1351. https://doi.org/10.1093/rheumatology/kead382

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 - 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 - COVAD Study Group

N1 - Publisher Copyright: © 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 - 2024/5/2

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.

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 (Academic Journal)

C2 - 37505460

SN - 1462-0324

VL - 63

SP - 1341

EP - 1351

JO - Rheumatology (Oxford, England)

JF - Rheumatology (Oxford, England)

IS - 5

ER -

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

Abstract

Bibliographical note

UN SDGs

Keywords

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