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

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 AT, 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 (2024)

Publication Type: Journal article

Publication year: 2024


Book Volume: 63

Pages Range: 1341-1351

Journal Issue: 5

DOI: 10.1093/rheumatology/kead382


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.

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Involved external institutions

Dansk Gigthospital DK Denmark (DK) Maulana Azad Medical College (MAMC) IN India (IN) Università degli Studi di Brescia IT Italy (IT) Hospital Universitario Dr José Eleuterio Gonzalez MX Mexico (MX) Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán MX Mexico (MX) Instituto Mexicano del Seguro Social MX Mexico (MX) University of Manchester GB United Kingdom (GB) Mayo Clinic US United States (USA) (US) Instituto Nacional de Enfermedades Respiratorias MX Mexico (MX) Hospital General de Occidente (HGO) MX Mexico (MX) University of Virginia (UVA) US United States (USA) (US) Walter and Eliza Hall Institute of Medical Research (WEHI) AU Australia (AU) Karolinska University Hospital / Karolinska Universitetssjukhuset SE Sweden (SE) Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS) IN India (IN) Byramjee Jeejeebhoy Government Medical College & Sassoon General Hospital IN India (IN) Mahatma Gandhi Mission Medical College and Hospital IN India (IN) King Edward Memorial Hospital and Seth G.S. Medical College / கிங் எட்வர்ட் நினைவு மருத்துவமனை,राजा एड्वर्ड स्मारक रुग्णालय व सेठ गोवर्धनदास सुंदरदास वैद्यकीय महाविद्यालय IN India (IN) Siriraj Hospital TH Thailand (TH) Southport and Ormskirk Hospital NHS Trust GB United Kingdom (GB) King’s College London GB United Kingdom (GB) Pontifical Xavierian University / Pontificia Universidad Javeriana CO Colombia (CO) Mymensingh Medical College / ময়মনসিংহ মেডিকেল কলেজ BD Bangladesh (BD) Universidad del Norte CO Colombia (CO) University of Illinois at Chicago US United States (USA) (US) Universitätsspital Zürich (USZ) CH Switzerland (CH) NIHR Leeds Musculoskeletal Biomedical Research Unit (LMBRU) GB United Kingdom (GB) Fauji Foundation Hospital PK Pakistan (PK) University of Pittsburgh US United States (USA) (US) Centro Medico Nacional Siglo XXI MX Mexico (MX) University of São Paulo / Universidade de São Paulo (USP) BR Brazil (BR) Université Saint-Joseph (USJ) / جامعة القديس يوسف / Սուրբ Ժոզեֆի համալսարան LB Lebanon (LB) Sofia University "St. Kliment Ohridski" / Софийски университет "Св. Климент Охридски" BG Bulgaria (BG) Pomeranian Medical University / Pomorski Uniwersytet Medyczny w Szczecinie (PMU) PL Poland (PL) Università degli Studi di Pavia IT Italy (IT) University of Bristol GB United Kingdom (GB) University College London (UCL) GB United Kingdom (GB) University of Nigeria NG Nigeria (NG) Queen Savang Vadhana Memorial Hospital / โรงพยาบาลสมเด็จพระบรมราชเทวี ณ ศรีราชา TH Thailand (TH) Aleksandrovska University Hospital / университетска болница "Александровска" BG Bulgaria (BG) Taichung Veterans General Hospital TW Taiwan (TW) Universidade Potiguar (UnP) BR Brazil (BR) King Faisal Specialist Hospital & Research Centre SA Saudi Arabia (SA) University of Malaya (UM) / Universiti Malaya MY Malaysia (MY) Enam Medical College & Hospital (EMCH) / এনাম মেডিকেল কলেজ ও হাসপাতাল BD Bangladesh (BD) University of Ghana GH Ghana (GH)

How to cite


Andreoli, L., Lini, D., Schreiber, K., Parodis, I., Sen, P., Ravichandran, N.,... Gupta, L. (2024). COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study. Rheumatology, 63(5), 1341-1351.


Andreoli, Laura, et al. "COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study." Rheumatology 63.5 (2024): 1341-1351.

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