Article
作者: Toro Gutiérrez, Carlos Enrique ; Franceschini, Franco ; Vince, Melinda Nagy ; Cristian Vergara, M ; Madu, Nwankwo Henry ; Pimentel, Victorio ; Chowdhury, Abhra Chandra ; Calapaqui, Wendy ; Hoff, Leonardo Santos ; Zimba, Olena ; Cachafeiro-Vilar, Antonio ; Andreoli, Laura ; Meyer, Alain ; Day, Jessica ; Merayo-Chalico, Javier ; Aggarwal, Rohit ; Gupta, Vikas ; Gheita, Tamer ; Pastelin, Carlos Benito Santiago ; Sato, Shinji ; Sebastiani, Marco ; Salim, Babur ; Ravichandran, Naveen ; Chatterjee, Tulika ; Ho, Enrique Julio Giraldo ; Quartuccio, Luca ; Jagtap, Kshitij ; De La Torre, Ignacio García ; Báez, Jossiell Then ; Mohammed, Reem Hamdy A ; Schreiber, Karen ; Gono, Takahisa ; Agarwal, Vishwesh ; Sen, Parikshit ; Orsolini, Giovanni ; Prieto-González, Sergio ; Srivastav, Nilesh ; Shenoy, Padnamabha ; Hasan, A T M Tanveer ; Alonzo, Hugo ; Ordóñez, Andrea Bran ; Fathi, Hanan Mohammed ; Harifi, Ghita ; El Kibbi, Lina ; Nune, Arvind ; Saenz, Ricardo ; Vaidya, Binit ; Gasparyan, Armen Yuri ; Fusaro, Enrico ; Bohdana, Doskaliuk ; Cabriza, Karoll ; Gupta, Latika ; Baba, Zineb ; Olaosebikan, Hakeem ; Jain, Avinash ; Giollo, Alessandro ; Caballero-Uribe, Carlo V ; Cajas, Javier ; Velikova, Tsvetelina ; Cavagna, Lorenzo ; Arredondo, Gabriela ; Silva, José António Pereira ; Cansu, Döndü Üsküdar ; Barman, Bhupen ; Patel, Aarat ; Maurier, François ; Airenakho, Emorinken ; Dedeke, Ibukunoluwa ; Loarce-Martos, Jesús ; Gonzalez, Raquel Aranega ; Pilania, Rakesh Kumar ; Yoshida, Akira ; El bouchti, Imane ; Knitza, Johannes ; Kavadichanda, Chengappa G ; Fazal, Zoha Zahid ; Gracia-Ramos, Abraham Edgar ; Lini, Daniele ; Aharonov, Or ; Distler, Oliver ; Ajmani, Sajal ; Sharma, Aman ; Shukla, Anuj ; Traboco, Lisa S ; Llerena, Gil Alberto Reyes ; Shaharir, Syahrul Sazliyana ; Ima-Edomwonyi, Uyi ; Chávez, Nilmo ; Lilleker, James B ; Katchamart, Wanruchada ; Joshi, Mrudula ; Becky, A ; Fonseca, João Eurico ; Singh, Yogesh Preet ; Chandwar, Kunal ; Sainaghi, Pier Paolo ; Gromova, Margarita Aleksandrovna ; Chibuzo, Okwara Celestine ; Dey, Dzifa ; Halabi, Hussein ; Losanto, Jonathan ; Nakashima, Ran ; Mathew, Ashish Jacob ; Kaneko, Yuko ; Campagne, Julien ; Hmamouchi, Ihsane ; Pande, Arunkumar R ; Chen, Yi-Ming ; Sambataro, Gianluca ; Makol, Ashima ; Quezada, Ivonne ; Saha, Sreoshy ; Shumnalieva, Russka ; Hidalgo, Eduardo Romero ; Chinchay, Lyn ; Fabiola, Atzeni ; Colunga-Pedraza, Iris J ; Arrieta, Dina ; Idania Escalante, M ; Arbeláez, Álvaro ; Koussougbo, Oruma Devi ; Goswami, Rudra Prosad ; Colaman, Nelly ; Parisi, Simone ; Landon-Cardinal, Océane ; Wincup, Chris ; Danieli, Maria Giovanna ; Manesh Manoj, M ; Palalane, Elisa ; Tomaras, Stylianos ; Kardes, Sinan ; Fornaro, Marco ; Bautista, Generoso Guerra ; Zamora Tehozol, Erick Adrian ; Obiols, Alejandro Quiñónez ; Kuwana, Masataka ; Parodis, Ioannis ; Proft, Fabian Nikolai ; Zuleta, Wilmer Gerardo Rojas ; Govoni, Marcello ; Bommakanti, Keerthi Talari ; Serrano, Jorge Rojas ; Limaye, Vidya ; Bocci, Elena Bartoloni ; Wibowo, Suryo Anggoro Kusumo ; Nunez, Lilith Stange ; De Angelis, Rossella ; Yıldırım, Reşit ; Patro, Pradeepta Sekhar ; Sebastiani, Gian Domenico ; Pandya, Sapan C ; Tan, Ai Lyn ; Akarawatcharangura Goo, Phonpen ; Bernaola, José Proaño ; Holzer, Marie-Therese ; Needham, Merrilee ; Ranjan, Rajiv ; Venerito, Vincenzo ; Pauling, John D ; Ghodke, Akanksha ; Phatak, Sanat ; Langguth, Daman ; Ugarte-Gil, Manuel Francisco ; Hudson, Marie ; So, Ho ; Grignaschi, Silvia ; Boro, Hiya ; Iannone, Florenzo ; Milchert, Marcin ; Ziade, Nelly ; Shinjo, Samuel Katsuyuki ; Nikiphorou, Elena ; Saavedra, Miguel A ; Salinas, Rodrigo García ; Alunno, Alessia ; Sierra-Zorita, Radames ; Fuentes-Silva, Yurilís ; Giannini, Margherita ; Chinoy, Hector ; Yerima, Abubakar ; Griger, Zoltán ; Asranna, Ajay ; Kimura, Naoki ; Del Papa, Nicoletta ; Agarwal, Vikas
AbstractObjectivesWe 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.MethodsDelayed-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.ResultsAmong 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.ConclusionThis 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.