COVID-19 vaccination-related adverse events among autoimmune disease patients: results from the COVAD study

Parikshit Sen, Naveen R, Arvind Nune, James B Lilleker, Vishwesh Agarwal, Sinan Kardes, Minchul Kim, Jessica Day, Marcin Milchert, Tamer Gheita, Babur Salim, Tsvetelina Velikova, Abraham Edgar Gracia-ramos, Ioannis Parodis, Albert Selva O’callaghan, Elena Nikiphorou, Tulika Chatterjee, Ai Lyn Tan, Lorenzo Cavagna, Miguel A SaavedraSamuel Katsuyuki Shinjo, Nelly Ziade, Johannes Knitza, Masataka Kuwana, Oliver Distler, Hector Chinoy, Vikas Agarwal, Rohit Aggarwal, Latika Gupta

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COVID-19 vaccines have been proven to be safe in the healthy population. However, gaps remain in the evidence of their safety in patients with systemic autoimmune and inflammatory disorders (SAIDs). COVID-19 vaccination related adverse events (ADEs) in patients with SAIDs and healthy controls (HC) seven days post-vaccination were assessed in the COVAD study, a patient self-reported cross-sectional survey.

The survey was circulated in early 2021 by > 110 collaborators (94 countries) to collect SAID details, COVID-19 vaccination details, and 7-day vaccine ADEs, irrespective of respondent vaccination status. Analysis was performed based on data distribution and variable type.

10900 respondents [42 (30-55) years, 74% females and 45% Caucasians] were analyzed. 5,867 patients (54%) with SAIDs were compared with 5033 HCs.

79% had minor and only 3% had major vaccine ADEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs=26%, HCs=24%; OR = 1.1 (1.03-1.3); p = 0.014], abdominal pain [SAIDs=2.6%, HCs=1.4%; OR = 1.5 (1.1-2.3); p = 0.011], and dizziness [SAIDs=6%, HCs=4%; OR = 1.3 (1.07-1.6); p = 0.011], were slightly more frequent in SAIDs. Overall, major ADEs [SAIDs=4%, HCs=2%; OR = 1.9 (1.6-2.2); p < 0.001] and, specifically, throat closure [SAIDs=0.5%, HCs=0.3%; OR = 5.7 (2.9-11); p = 0.010] were more frequent in SAIDs though absolute risk was small (0-4%). Major ADEs and hospitalizations (less than 2%) were comparable across vaccine types in SAIDs.

Vaccination against COVID-19 is relatively safe in SAID patients. SAIDs were at a higher risk of major ADEs than HCs, though absolute risk was small. There are small differences in minor ADEs between vaccine types in SAID patients.
Original languageEnglish
Early online date17 Jun 2022
Publication statusPublished - 17 Jun 2022


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