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

Abstract

OBJECTIVES:

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 (AEs) 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.

METHODS:

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

RESULTS:

Ten thousand nine hundred respondents [median (interquartile range) age 42 (30-55) years, 74% females and 45% Caucasians] were analysed; 5867 patients (54%) with SAIDs were compared with 5033 HCs. Seventy-nine percent had minor and only 3% had major vaccine AEs requiring urgent medical attention (but not hospital admission) overall. Headache [SAIDs = 26%, HCs = 24%; odds ratio (OR) = 1.1 (95% CI: 1.03, 1.3); P = 0.014], abdominal pain [SAIDs = 2.6%, HCs = 1.4%; OR = 1.5 (95% CI: 1.1, 2.3); P = 0.011], and dizziness [SAIDs = 6%, HCs = 4%; OR = 1.3 (95% CI: 1.07, 1.6); P = 0.011], were slightly more frequent in SAIDs. Overall, major AEs [SAIDs = 4%, HCs = 2%; OR = 1.9 (95% CI: 1.6, 2.2); P < 0.001] and, specifically, throat closure [SAIDs = 0.5%, HCs = 0.3%; OR = 5.7 (95% CI: 2.9, 11); P = 0.010] were more frequent in SAIDs though absolute risk was small (0-4%). Major AEs and hospitalizations (<2%) were comparable across vaccine types in SAIDs.

CONCLUSION:

Vaccination against COVID-19 is safe in SAID patients. SAIDs were at a higher risk of major AEs than HCs, though absolute risk was small. There are small differences in minor AEs between vaccine types in SAID patients.

• Authors: Parikshit Sen, Naveen Ravichandran, 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 Saavedra, Samuel Katsuyuki Shinjo, Nelly Ziade, Johannes Knitza, Masataka Kuwana, Oliver Distler, Hector Chinoy, Vikas Agarwal, Rohit Aggarwal, Latika Gupta, COVAD Study Group
• Journal: Rheumatology (Oxford, England) (Rheumatology (Oxford)) Vol. 62 Issue 1 Pg. 65-76 (12 23 2022) ISSN: 1462-0332 [Electronic] England
• PMID: 35713499 (Publication Type: Journal Article)
• Copyright: © The Author(s) 2022. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: [email protected].

Chemical References

• COVID-19 Vaccines

Topics

• Female
• Animals
• Humans
• Adult
• Male
• COVID-19 Vaccines (adverse effects)
• COVID-19 (prevention & control)
• Cross-Sectional Studies
• Simian Acquired Immunodeficiency Syndrome (etiology)
• Vaccination (adverse effects)
• Autoimmune Diseases (epidemiology, etiology)