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Study data suggest the observed to expected ratio of VAU for the United States cases reports was comparable for all 3 approved vaccines.
A low crude reporting rate and observed-expected ratio suggested a low safety concern for vaccine-associated uveitis (VAU) following SARS-CoV-2 vaccination, according to new findings.
The analysis of the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Events Reporting System (VAERS) reported that the three approved vaccines (BNT162b2, mRNA-1273, and Ad26.COV2.S) rarely cause VAU.
Study investigators noted that most diagnosed with VAU were reported as having anterior uveitis and received the BNT162b2 vaccine.
“The data reported in this study only suggest a temporal relationship between uveitis onset and SARS-CoV-2 vaccination and does not demonstrate a causal relationship and further investigations are required to establish a causal relationship,” wrote study author Edmund Tsui, MD, Assistant Professor of Ophthalmology, Stein Eye Institute, David Geffen School of Medicine, University of California Los Angeles.
By June 2022, uveitis was one of the most commonly reported ophthalmic adverse events following SARS-CoV-2 vaccinations. Using the VAERS database, investigators in the retrospective study analyzed the largest cohort of VAU cases to determine the potential association with each authorized vaccine.
They determined the global crude reporting rate and the observed-expected ratio of uveitis and reported the clinical characteristics in those diagnosed with VAU, as well as the association between demographics and duration of uveitis onset after vaccination.
The study population consisted of patients diagnosed with VAU between December 2020 and May 2022 from 40 countries and 40 states in the United States. Crude reporting rates were estimated using the number of VAU reports by vaccine type per million COVID-19 vaccine doses.
Investigators assessed the association between the onset interval of uveitis and vaccine type, age, sex, and dosage and performed a 30-day risk analysis for VAU onset post-vaccination.
A total of 1,250,310 (0.06% of all doses) adverse events following vaccination were recorded in CDC VAERS, including 1094 reports of VAU. Demographic data show the mean age of patients with VAU was 46.24 years old and 68.65% (n=751) were women.
The estimated crude reporting rate (per million doses) for BNT162b2, mRNA-1273, and Ad26.COV2.S were 0.57, 0.44, and 0.35, respectively.
Meanwhile, the observed to expected ratio of VAU in the United States were comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most of the patients with VAU were reported in patients who received BNT162b2 (n = 853, 77.9%).
The investigators noted most VAU cases were reported following the first dose (n = 452, 41.32%) and within the first week of receiving the vaccine (n = 591, 54.02%).
Onset intervals for VAU were significantly longer in patients who received mRNA-1273 (12.22 days), compared to BNT162b2 (11.42 days) and rAd26.COV2.S (12.69 days) vaccines (P < .0001).
In the post-hoc analysis, investigators found a significantly shorter interval of onset for the BNT162b2 compared to the mRNA 1273 vaccine (P <.0001). The 30-day risk analysis revealed significant differences between the vaccines (P <.0001).
“The benefits of vaccination outweigh the risk of VAU, but physicians should be aware that there is a possibility of VAU and seek prompt referral to an ophthalmologist if there is a suspicion for uveitis following vaccination,” the study authors concluded.
The study, “Vaccine-associated uveitis following SARS-CoV-2 vaccination: A CDC-VAERS database analysis,” was published in Ophthalmology.