Safety and tolerance of vaccines against SARS-CoV-2 infection in systemic lupus erythematosus: results from the COVAD study
Authors: Naveen R , Nikiphorou Elena , Joshi Mrudula , Sen Parikshit , Lindblom Julius , Agarwal Vishwesh , Lilleker James B , Tan Ai Lyn , Salim Babur , Ziade Nelly , Velikova Tsvetelina , Gracia-Ramos Abraham Edgar , Kuwana Masataka , Day Jessica , Makol Ashima , Distler Oliver , Chinoy Hector , Traboco Lisa S , Wibowo Suryo Anggoro Kusumo , Tehozol Erick Adrian Zamora , Serrano Jorge Rojas , García-De La Torre Ignacio ,   COVAD Study Group, Barman Bhupen , 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 , Pandey Arun Kumar R , Chandwar Kunal , Kardeş Sinan , Cansu Döndü Üsküdar , Kim Minchul , Makol Ashima , Chatterjee Tulika , Pauling John D , Wincup Chris , Cavagna Lorenzo , 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 , Danielli Maria Giovanna , Venerito Vincenzo , Milchert Marcin , Traboco Lisa S , Wibowo Suryo Anggoro Kusumo , Tehozol Erick Adrian Zamora , Serrano Jorge Rojas , García-De La Torre Ignacio , Loarce-Martos Jesús , Prieto-González Sergio , Gil-Vila Albert , Gonzalez Raquel Aranega , Kuwana Masataka , Yoshida Akira , Nakashima Ran , Sato Shinji , Kimura Naoki , Kaneko Yuko , Knitza Johannes , Tomaras Stylianos , Gromova Margarita Aleksandrovna , Aharonov Or , Gheita Tamer A , Hmamouchi Ihsane , Hoff Leonardo Santos , Giannini Margherita , Maurier François , Campagne Julien , Meyer Alain , Nagy-Vincze Melinda , Langguth Daman , Limaye Vidya , Needham Merrilee , Srivastav Nilesh , Hudson Marie , Landon-Cardinal Océane , Shaharir Syahrul Sazliyana , Zuleta Wilmer Gerardo Rojas , Silva José António Pereira , Fonseca João Eurico , Zimba Olena , Aggarwal Rohit , Gupta Latika , Agarwal Vikas , Parodis Ioannis 
Published: November 2022

Abstract

Objective
To determine COVID-19 vaccine-related adverse events (AEs) in the seven-day post-vaccination period in patients with SLE vs autoimmune rheumatic diseases (AIRDs), non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HC).

Methods
Data were captured through the COVID-19 Vaccination in Autoimmune Diseases (COVAD) questionnaire (March–December 2021). Multivariable regression models accounted for age, gender, ethnicity, vaccine type and background treatment.

Results
Among 9462 complete respondents, 583 (6.2%) were SLE patients (mean age: 40.1 years; 94.5% females; 40.5% Asian; 42.9% Pfizer-recipients). Minor AEs were reported by 83.0% of SLE patients, major by 2.6%, hospitalization by 0.2%. AE and hospitalization frequencies were similar between patients with active and inactive SLE. Rashes were more frequent in SLE patients vs HC (OR; 95% CI: 1.2; 1.0, 1.5), chills less frequent in SLE vs AIRDs (0.6; 0.4, 0.8) and nrAIDs (0.5; 0.3, 0.8), and fatigue less frequent in SLE vs nrAIDs (0.6; 0.4, 0.9). Pfizer-recipients reported higher overall AE (2.2; 1.1, 4.2) and injection site pain (2.9; 1.6, 5.0) frequencies than recipients of other vaccines, Oxford/AstraZeneca-recipients more body ache, fever, chills (OR: 2.5, 3.0), Moderna-recipients more body ache, fever, chills, rashes (OR: 2.6, 4.3). Hospitalization frequencies were similar across vaccine types. AE frequencies were similar across treatment groups, although chills were less frequent in antimalarial users vs non-users (0.5; 0.3, 0.9).

Conclusion
While COVID-19 vaccination-related AEs were reported by four-fifths of SLE patients, those were mostly minor and comparable to AEs reported by healthy individuals, providing reassurance regarding COVID-19 vaccination safety in SLE.