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

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 (&gt;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 &lt; 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.