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

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

Producción científica: Contribución a una revistaArtículorevisión exhaustiva

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Resumen

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.

Idioma originalInglés
Páginas (desde-hasta)1341-1351
Número de páginas11
PublicaciónRheumatology (United Kingdom)
Volumen63
N.º5
DOI
EstadoPublicada - 1 may. 2024

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