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

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

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 an...

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Hauptverfasser: Andreoli, L, Lini, D, Schreiber, K, Parodis, I, Sen, P, Ravichandran, N, Jagtap, K, Nune, A, Agarwal, V, Saha, S, Tan, A.L, Milchert, M, Cavagna, L, Makol, A, Wincup, C, Barman, B, Tehozol, E.A.Z, Serrano, J.R, Colunga-Pedraza, I.J, Merayo-Chalico, J, Chibuzo, O.C, Goo, P.A, Chen, Y.-M, Hoff, L.S, Kibbi, L.E, Shaharir, S.S, Lilleker, J.B, Salim, B, Gheita, T, Saavedra, M.A, Distler, O, Aggarwal, R, Griger, Z, Singh, Y.P, Jain, A, Sharma, A, Patro, P.S, Ajmani, S, Goswami, R.P, Shenoy, P, Bommakanti, K.T, Shukla, A, Pande, A.R, Chandwar, K, Ghodke, A, Fazal, Z.Z, Yıldırım, R, Del Papa, N, Bocci, E.B, Fusaro, E, Franceschini, F, Orsolini, G, De Angelis, R, Danieli, M.G, Alunno, A, Iannone, F, Fornaro, M, Loarce-Martos, J, Prieto-González, S, Gonzalez, R.A, Yoshida, A, Nakashima, R, Sato, S, Kimura, N, Kaneko, Y, Gono, T, Tomaras, S, Gromova, M.A, Hmamouchi, I, bouchti, I.E, Baba, Z, Giannini, M, Meyer, A, Limaye, V, Needham, M, Srivastav, N, Cajas, J, Zimba, O, Bohdana, D, Dedeke, I, Olaosebikan, H, Becky, A, Koussougbo, O.D, Palalane, E, Ugarte-Gil, M.F, Pimentel, V, Harifi, G, Cabriza, K, Losanto, J, Ho, E.J.G, Nunez, L.S, Vergara, M.C, Obiols, A.Q, Chávez, N, Ordóñez, A.B, Sierra-Zorita, R, Escalante, M.I, Calapaqui, W, Quezada, I, Arredondo, G
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Zusammenfassung: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 
DOI:10.1093/rheumatology/kead382