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, 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. U.; 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.; De Angelis, R.; Danieli, M. G.; Venerito, V.; Grignaschi, S.; Giollo, A.; Alunno, A.; Iannone, F.; Fornaro, M.; Traboco, L. S.; Wibowo, S. A. K.; Loarce-Martos, J.; Prieto-Gonzalez, S.; Gonzalez, R. A.; Yoshida, A.; Nakashima, R.; Sato, S.; Kimura, N.; Kaneko, Y.; Gono, T.; Tomaras, S.; Proft, F. N.; Holzer, M. -T.; Gromova, M. A.; Aharonov, O.; Griger, Z.; Hmamouchi, I.; El Bouchti, I.; Baba, Z.; Giannini, M.; Maurier, F.; Campagne, J.; Meyer, A.; Langguth, D.; Limaye, V.; Needham, M.; Srivastav, N.; Hudson, M.; Landon-Cardinal, O.; Zuleta, W. G. R.; Arbelaez, A.; Cajas, J.; Silva, J. A. P.; Fonseca, J. E.; Zimba, O.; Bohdana, D.; Ima-Edomwonyi, U.; Dedeke, I.; Airenakho, E.; Madu, N. H.; Yerima, A.; Olaosebikan, H.; Becky, A.; Koussougbo, O. D.; Palalane, E.; So, H.; Ugarte-Gil, M. F.; Chinchay, L.; Bernaola, J. P.; Pimentel, V.; Fathi, H. M.; Mohammed, R. H. A.; Harifi, G.; Fuentes-Silva, Y.; Cabriza, K.; Losanto, J.; Colaman, N.; Cachafeiro-Vilar, A.; Bautista, G. G.; E. J. G., Ho; Nunez, L. S.; Cristian Vergara, M.; Baez, J. T.; Alonzo, H.; Pastelin, C. B. S.; Salinas, R. G.; Obiols, A. Q.; Chavez, N.; Ordonez, A. B.; Llerena, G. A. R.; Sierra-Zorita, R.; Arrieta, D.; Hidalgo, E. R.; Saenz, R.; Idania Escalante, M.; Calapaqui, W.; Quezada, I.; Arredondo, G.

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.