"Introduction
... While previous studies have suggested an association between mRNA vaccines and several systemic autoimmune diseases, there are limited studies demonstrating the development of AI-CTDs [autoimmune connective tissue diseases] following mRNA vaccination in large populations over a period of > 1 year, despite the low incidence and slow development of AI-CTDs. These uncertainties and adverse effects of mRNA vaccines have heightened public scepticism regarding vaccination and necessitated a risk-benefit analysis of vaccination.
In this study, we aim to determine whether the incidence of AI-CTDs is associated with mRNA vaccination against SARS-CoV2.
Results
Study Population
The primary cohort was established by combining the National Health Insurance Service (NHIS) and Korea Disease Control and Prevention Agency (KDCA) databases, which comprised the healthcare data of > 99% of the entire Korean population and their COVID-19 diagnosis and vaccination profiles. In total, 9,258,803 individuals who had received at least one dose of the mRNA-based COVID-19 vaccine were included...
Autoimmune connective tissue diseases following mRNA vaccination
... Individuals who had the mRNA COVID-19 vaccine did not incur higher risks of developing most AI-CTDs... However, individuals in the mRNA vaccination cohort were at considerably higher risk of developing systemic lupus erythematosus (SLE) (aHR, 1.16; 99% CI, 1.02–1.32) than those in the historical control cohort...
Validation of the results using positive and negative control outcomes
To validate these findings, we evaluated the risks of positive and negative control outcomes associated with mRNA vaccination. For the positive control outcomes, the risk of myocarditis (aHR, 7.20; 99% CI, 4.37–11.86), pericarditis (aHR, 2.75; 99% CI, 1.95–3.88), and Guillain–Barre syndrome (aHR, 1.62; 99% CI, 1.16–2.25) were considerably higher in the vaccination cohort than in the historical control cohort."
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