COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study
Issued Date
2024-05-02
Resource Type
eISSN
14620332
Scopus ID
2-s2.0-85186949878
Pubmed ID
37505460
Journal Title
Rheumatology (Oxford, England)
Volume
63
Issue
5
Start Page
1341
End Page
1351
Rights Holder(s)
SCOPUS
Bibliographic Citation
Rheumatology (Oxford, England) Vol.63 No.5 (2024) , 1341-1351
Suggested 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 A.L., Shinjo S.K., Ziade N., Velikova T., Milchert M., Gracia-Ramos A.E., Cavagna L., Kuwana M., Knitza J., Makol A., Patel A., Pauling J.D., Wincup C., Barman B., Zamora Tehozol E.A., Serrano J.R., De La Torre I.G., Colunga-Pedraza I.J., Merayo-Chalico J., Chibuzo O.C., Katchamart W., Akarawatcharangura Goo P., Shumnalieva R., Chen Y.M., Hoff L.S., El Kibbi L., Halabi H., Vaidya B., Shaharir S.S., Hasan A.T.M.T., Dey D., Toro Gutierrez C.E., Caballero-Uribe C.V., Lilleker J.B., Salim B., Gheita T., Chatterjee T., Saavedra M.A., Distler O., Chinoy H., Agarwal V., Aggarwal R., Gupta L., Griger Z., Kardes S., Vince M.N., Singh Y.P., Ranjan R., Jain A., Pandya S.C., Pilania R.K., Sharma A., Manesh Manoj M., Gupta V., Kavadichanda C.G., Patro P.S., Ajmani S., Phatak S., Goswami R.P., Chowdhury A.C., Mathew A.J., Shenoy P., Asranna A., Bommakanti K.T., Shukla A., Pande A.R., Chandwar K., Ghodke A., Boro H., Fazal Z.Z., Vaidya B., Cansu D.Ü., Ylldlrlm R., Gasparyan A.Y., Del Papa N., Sambataro G., Fabiola A., Govoni M., Parisi S., Bocci E.B., Sebastiani G.D., Fusaro E., Sebastiani M., Quartuccio L., Franceschini F., Sainaghi P.P., Orsolini G. 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 (2024) , 1341-1351. 1351. doi:10.1093/rheumatology/kead382 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/98288
Title
COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study
Author(s)
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.
Cavagna L.
Kuwana M.
Knitza J.
Makol A.
Patel A.
Pauling J.D.
Wincup C.
Barman B.
Zamora Tehozol E.A.
Serrano J.R.
De La Torre I.G.
Colunga-Pedraza I.J.
Merayo-Chalico J.
Chibuzo O.C.
Katchamart W.
Akarawatcharangura Goo P.
Shumnalieva R.
Chen Y.M.
Hoff L.S.
El Kibbi L.
Halabi H.
Vaidya B.
Shaharir S.S.
Hasan A.T.M.T.
Dey D.
Toro Gutierrez C.E.
Caballero-Uribe C.V.
Lilleker J.B.
Salim B.
Gheita T.
Chatterjee T.
Saavedra M.A.
Distler O.
Chinoy H.
Agarwal V.
Aggarwal R.
Gupta L.
Griger Z.
Kardes S.
Vince M.N.
Singh Y.P.
Ranjan R.
Jain A.
Pandya S.C.
Pilania R.K.
Sharma A.
Manesh Manoj M.
Gupta V.
Kavadichanda C.G.
Patro P.S.
Ajmani S.
Phatak S.
Goswami R.P.
Chowdhury A.C.
Mathew A.J.
Shenoy P.
Asranna A.
Bommakanti K.T.
Shukla A.
Pande A.R.
Chandwar K.
Ghodke A.
Boro H.
Fazal Z.Z.
Vaidya B.
Cansu D.Ü.
Ylldlrlm R.
Gasparyan A.Y.
Del Papa N.
Sambataro G.
Fabiola A.
Govoni M.
Parisi S.
Bocci E.B.
Sebastiani G.D.
Fusaro E.
Sebastiani M.
Quartuccio L.
Franceschini F.
Sainaghi P.P.
Orsolini G.
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.
Cavagna L.
Kuwana M.
Knitza J.
Makol A.
Patel A.
Pauling J.D.
Wincup C.
Barman B.
Zamora Tehozol E.A.
Serrano J.R.
De La Torre I.G.
Colunga-Pedraza I.J.
Merayo-Chalico J.
Chibuzo O.C.
Katchamart W.
Akarawatcharangura Goo P.
Shumnalieva R.
Chen Y.M.
Hoff L.S.
El Kibbi L.
Halabi H.
Vaidya B.
Shaharir S.S.
Hasan A.T.M.T.
Dey D.
Toro Gutierrez C.E.
Caballero-Uribe C.V.
Lilleker J.B.
Salim B.
Gheita T.
Chatterjee T.
Saavedra M.A.
Distler O.
Chinoy H.
Agarwal V.
Aggarwal R.
Gupta L.
Griger Z.
Kardes S.
Vince M.N.
Singh Y.P.
Ranjan R.
Jain A.
Pandya S.C.
Pilania R.K.
Sharma A.
Manesh Manoj M.
Gupta V.
Kavadichanda C.G.
Patro P.S.
Ajmani S.
Phatak S.
Goswami R.P.
Chowdhury A.C.
Mathew A.J.
Shenoy P.
Asranna A.
Bommakanti K.T.
Shukla A.
Pande A.R.
Chandwar K.
Ghodke A.
Boro H.
Fazal Z.Z.
Vaidya B.
Cansu D.Ü.
Ylldlrlm R.
Gasparyan A.Y.
Del Papa N.
Sambataro G.
Fabiola A.
Govoni M.
Parisi S.
Bocci E.B.
Sebastiani G.D.
Fusaro E.
Sebastiani M.
Quartuccio L.
Franceschini F.
Sainaghi P.P.
Orsolini G.
Author's Affiliation
Faculty of Medicine and Health
Siriraj Hospital
UCL Division of Medicine
Graduate School of Medicine
Faculty of Biology, Medicine and Health
Bristol Medical School
NIHR Leeds Biomedical Research Centre
Southport and Ormskirk Hospital NHS Trust
Pontificia Universidad Javeriana, Cali
Seth GS Medical College and KEM Hospital
Fauji Foundation Hospital
Hospital General de Occidente
Hôtel-Dieu de France Hospital
Université Saint-Joseph de Beyrouth
Universidad del Norte
Ministry of Health and Family Welfare
University of Virginia School of Medicine
Universitätsklinikum Erlangen
Universidade Potiguar
North Bristol NHS Trust
Walter and Eliza Hall Institute of Medical Research
University of Melbourne
University of Nigeria
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Faculty of Medicine
University of Leeds, School of Medicine
University of Illinois College of Medicine
University College London
Mymensingh Medical College
King's College Hospital
Sofia University St. Kliment Ohridski
UniversitatsSpital Zurich
Karolinska Universitetssjukhuset
UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI
Pomeranian Medical University in Szczecin
Syddansk Universitet
Hospital Universitario Dr. Jose Eleuterio Gonzalez
University of Ghana
King Faisal Specialist Hospital and Research Centre
Università degli Studi di Brescia
Università degli Studi di Pavia
University Hospital Alexandrovska
King's College London
Maulana Azad Medical College
Instituto Nacional de la Nutrición Salvador Zubiran
Salford Royal NHS Foundation Trust
Instituto Mexicano del Seguro Social
Instituto Nacional de Enfermedades Respiratorias
Universidade de São Paulo
Birmingham City Hospital
The Royal Wolverhampton NHS Trust
Veterans General Hospital-Taichung Taiwan
Mayo Clinic
Guy's and St Thomas' NHS Foundation Trust
Royal Melbourne Hospital
Salford Royal Hospital
University of Pittsburgh School of Medicine
Faculty of Medicine, UKM
Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals
Danish Hospital for Rheumatic Diseases
National Center for Rheumatic Diseases
Specialized Medical Center
Enam Medical College and Hospital
Queen Savang Vadhana Memorial Hospital
Mahatma Gandhi Mission Medical College
Siriraj Hospital
UCL Division of Medicine
Graduate School of Medicine
Faculty of Biology, Medicine and Health
Bristol Medical School
NIHR Leeds Biomedical Research Centre
Southport and Ormskirk Hospital NHS Trust
Pontificia Universidad Javeriana, Cali
Seth GS Medical College and KEM Hospital
Fauji Foundation Hospital
Hospital General de Occidente
Hôtel-Dieu de France Hospital
Université Saint-Joseph de Beyrouth
Universidad del Norte
Ministry of Health and Family Welfare
University of Virginia School of Medicine
Universitätsklinikum Erlangen
Universidade Potiguar
North Bristol NHS Trust
Walter and Eliza Hall Institute of Medical Research
University of Melbourne
University of Nigeria
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Faculty of Medicine
University of Leeds, School of Medicine
University of Illinois College of Medicine
University College London
Mymensingh Medical College
King's College Hospital
Sofia University St. Kliment Ohridski
UniversitatsSpital Zurich
Karolinska Universitetssjukhuset
UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI
Pomeranian Medical University in Szczecin
Syddansk Universitet
Hospital Universitario Dr. Jose Eleuterio Gonzalez
University of Ghana
King Faisal Specialist Hospital and Research Centre
Università degli Studi di Brescia
Università degli Studi di Pavia
University Hospital Alexandrovska
King's College London
Maulana Azad Medical College
Instituto Nacional de la Nutrición Salvador Zubiran
Salford Royal NHS Foundation Trust
Instituto Mexicano del Seguro Social
Instituto Nacional de Enfermedades Respiratorias
Universidade de São Paulo
Birmingham City Hospital
The Royal Wolverhampton NHS Trust
Veterans General Hospital-Taichung Taiwan
Mayo Clinic
Guy's and St Thomas' NHS Foundation Trust
Royal Melbourne Hospital
Salford Royal Hospital
University of Pittsburgh School of Medicine
Faculty of Medicine, UKM
Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals
Danish Hospital for Rheumatic Diseases
National Center for Rheumatic Diseases
Specialized Medical Center
Enam Medical College and Hospital
Queen Savang Vadhana Memorial Hospital
Mahatma Gandhi Mission Medical College
Corresponding Author(s)
Other Contributor(s)
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.