Citations 1
COVID-19 vaccine safety during pregnancy and breastfeeding in women with autoimmune diseases: results from the COVAD study
Andréoli, Laura , Lini, Daniele , Schreiber, Karen , Parodis, Ioannis , Sen, Parikshit , Ravichandran, Naveen , Day, Jessica , Joshi, Mrudula , Jagtap, Kshitij , Nune, Arvind , Nikiphorou, Elena , Tan, Ai Lyn , Velikova, Tsvetelina , Milchert, Marcin , Gracia‐Ramos, Abraham Edgar , Kuwana, Masataka , Patel, Aarat , Pauling, John D , Wincup, Chris , Tehozol, Erick Adrian Zamora , Colunga-Pedraza, I. J. , Chibuzo, Okwara Celestine , Katchamart, Wanruchada , Goo, Phonpen Akarawatcharangura , Shumnalieva, Russka , Kibbi, Lina El , Vaidya, Binit , Shaharir, Syahrul Sazliyana , Hasan, A T M Tanveer , Dey, Dzifa , Gutiérrez, Carlos Enrique Toro , Caballero‐Uribe, Carlo V. , Salim, Babur , Gheita, Tamer A. , Chinoy, Hector , Agarwal, Vikas , Gupta, Latika, Group, COVAD Study, Kardeş, Sinan , Vince, Melinda Nagy, Singh, Yogesh Preet , Ranjan, Rajiv , Jain, Avinash , Pandya, Sapan C , Sharma, Aman , Manoj, Manesh , Gupta, Vikas , Patro, Pradeepta Sekhar , Ajmani, Sajal , Chowdhury, Abhra Chandra , Shenoy, Padnamabha, Bommakanti, Keerthi Talari, Shukla, Anuj , Ghodke, Akanksha, Fazal, Zoha Zahid , Yıldırım, Reşit, Sambataro, Gianluca , Atzeni, Fabiola , Parisi, Simone , Bocci, Elena Bartoloni, Sainaghi, Pier Paolo , Orsolini, Giovanni , Angelis, Rossella De , Danieli, Maria Giovanna , Giollo, Alessandro, Loarce‐Martos, Jesus , Prieto‐González, Sergio , Nakashima, Ran , Sato, Shinji, Kaneko, Yuko , Tomaras, Stylianos, Aharonov, Or, bouchti, Imane El, Baba, Zineb, Maurier, François, Meyer, Alain, Limaye, Vidya, Hudson, Marie , Landon‐Cardinal, Océane , Zuleta, Wilmer Gerardo Rojas, Cajas, Javier, Silva, José António Pereira, Doskaliuk, Bohdana , Ima-Edomwonyi, Uyi, Dedeke, Ibukunoluwa, Madu, Nwankwo Henry, Yerima, Abubakar , Olaosebikan, Hakeem , Becky, A, Koussougbo, Oruma Devi, Palalane, Elisa, Chinchay, Lyn , Bernaola, José Proaño, Pimentel, Victorio, Fathi, Hanan Mohammed, Harifi, Ghita , Fuentes-Silva, Yurilís , Cabriza, Karoll, Losanto, Jonathan, Colaman, Nelly, Cachafeiro-Vilar, Antonio , Bautista, Generoso Guerra , Ho, Enrique Julio Giraldo, Nunez, Lilith Stange, Vergara, M Cristian, Báez, Jossiell Then , Alonzo, Hugo, Pastelin, Carlos Benito Santiago, Obiols, Alejandro Quiñónez, Chávez, Nilmo , Ordóñez, Andrea Bran , Llerena, Gil Alberto Reyes, Sierra-Zorita, Radames, Arrieta, Dina , Hidalgo, Eduardo Romero, Saénz, Ricardo, Escalante, M Idania, Calapaqui, Wendy, Quezada, Ivonne, Arredondo, Gabriela, Giollo, Alessandro , Gupta, Latika , Agarwal, Vishwesh , Saha, Sreoshy , Tan, Ai Lyn , Shinjo, Samuel Katsuyuki , Ziade, Nelly , Velikova, Tsvetelina , Milchert, Marcin , Gracia-Ramos, Abraham Edgar , Cavagna, Lorenzo , Kuwana, Masataka , Knitza, Johannes , Makol, Ashima , Pauling, John D , Wincup, Chris , Zamora Tehozol, Erick Adrian , Rojas Serrano, Jorge , García-De La Torre, Ignacio , Colunga-Pedraza, Iris J , Merayo-Chalico, Javier , Katchamart, Wanruchada , Shumnalieva, Russka , Chen, Yi-Ming , Hoff, Leonardo Santos , El Kibbi, Lina , Halabi, Hussein , Vaidya, Binit , Sazliyana Shaharir, Syahrul , Hasan, A T M Tanveer , Gutiérrez, Carlos Enrique Toro , Lilleker, James B , Salim, Babur , Gheita, Tamer , Chatterjee, Tulika , Saavedra, Miguel A , Distler, Oliver , Chinoy, Hector , Agarwal, Vikas , Aggarwal, Rohit , Gupta, Latika , Joshi, Mrudula , Day, Jessica , Parodis, Ioannis , Nune, Arvind , Naveen, R , Agarwal, Vikas , Dey, Dzifa , Caballero-Uribe, Carlo Vinicio , Sen, Parikshit , Andreoli, Laura , Jagtap, Kshitij , De Angelis, Rossella , Singh, Yogesh Preet , Agarwal, Vishwesh , Saha, Sreoshy , Shinjo, Samuel Katsuyuki , Ziadé, Nelly , Makol, Ashima , Barman, Bhupen , Torre, Ignacio García‐De La , Goo, Phonpen Akawatcharangura , Chen, Yi‐Ming , Halabi, Hussein , Chatterjee, Tulika , Distler, Oliver , Aggarwal, Rohit , Group, COVAD Study, Griger, Zoltán , Pilania, Rakesh Kumar , Kavadichanda, Chengappa G. , Phatak, Sanat B. , Goswami, Rudra P , Mathew, Ashish Jacob , Asranna, Ajay , Pande, Arun K. , Chandwar, Kunal , Boro, Hiya , Cansu, Döndü Üsküdar , Gasparyan, Armen Yuri , Papa, Nicoletta Del , Govoni, Marcello , Bocci, Elena Bartoloni, Sebastiani, Gian Domenico , Fusaro, Enrico , Sebastiani, Marco , Quartuccio, Luca , Franceschini, Franco , Venerito, Vincenzo , Grignaschi, Silvia , Alunno, Alessia , Iannone, Florenzo , Fornaro, Marco , Traboco, Lisa S , Wibowo, Suryo Anggoro Kusumo , Gonzalez, Raquel Aranega, Yoshida, Akira, Kimura, Naoki, Gono, Takahisa , Tomaras, Stylianos , Proft, Fabian Nikolai , Holzer, Marie‐Therese , Gromova, Margarita Aleksandrovna , Hmamouchi, Ihsane , Giannini, Margherita , Maurier, F. , Campagne, Julien , Meyer, Alain , Langguth, Daman , Limaye, Vidya , Needham, Merrilee , Srivastav, Nilesh , Arbeláez-Cortés, Álvaro , Silva, José António Pereira, Fonseca, João Eurico , Zimba, Olena , Ima-Edomwonyi, Uyi, Emorinken, Airenakho , So, Ho , Ugarte‐Gil, Manuel F. , Mohammed, Reem Hamdy A , Salinas, Rodrigo Nicolás Garcia
Rheumatology | July 25, 2023 | Volume: 63 | Issue: 5 | Pages: 1341-1351
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.