Discussion
uveitis, COVID-19 illness
SARS-COV-2 INFECTION, DISEASE, UVEITIS, ADVERSE EFFECTS, SECONDARY
This open-label, randomized clinical trial showed that recommendation for early non-mRNA COVID-19 vaccination to patients with inactive uveitis led to earlier self-reported symptomatic uveitis worsening than the recommendation for deferred vaccination. We found no evidence that uveitis activity and visual acuity at 3 months differed substantially according to recommendation type.This trial extends prior observations linking COVID-19 vaccination with an increased risk of newly active or worsening uveitisAs a subjective measure, the primary outcome could at least partially reflect subjective feelings about the disease condition and certain levels of quality of life. However, participants were aware of their vaccination status, and those concerned about vaccination could have an exacerbated experience of their symptoms. Our trial detected the significant effects of recommending early COVID-19 vaccination on patient’s symptoms. However, the between-group mean difference (7.4% [95% CI, 1.2%-13.6%]) in incidence of symptomatic uveitis worsening was subtle, and it would be possible to have reporting bias from people who received COVID-19 vaccines as large as that would negate the currently reported significant difference in the primary outcome. More importantly, no adverse effects were observed in disease and visual prognosis at 3 months. The inconsistency between the primary and secondary outcomes also suggested the possibility of reporting bias incurred by psychological factors related to subjective assessment of the primary outcome. These findings highlight that, in clinical practice, more psychological reassurance should be provided to patients before or after COVID-19 vaccination, especially those worried about the adverse effects of COVID-19 vaccine. The timing choices for COVID-19 vaccination in inactive uveitis may be primarily based on the individual risk of SARS-CoV-2 infection and severe COVID-19 illness as well as patient’s expectations and preferences rather than on anticipated differences in the disease and visual prognosis of uveitis.