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Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis.
Ophthalmology. 2023 Feb; 130(2):179-186.O

Abstract

PURPOSE

To assess the risk of vaccine-associated uveitis (VAU) after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and evaluate uveitis onset interval and clinical presentations in the patients.

DESIGN

A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention Vaccine Adverse Event Reporting System.

PARTICIPANTS

Patients diagnosed with VAU after administration of BNT162b2 (Pfizer-BioNTech, Pfizer Inc/BioNTech SE), mRNA-1273 (Moderna, Moderna Therapeutics Inc), and Ad26.COV2.S (Janssen, Janssen Pharmaceuticals) vaccine worldwide.

METHODS

A descriptive analysis of the demographics, clinical history, and presentation was performed. We evaluated the correlation among the 3 vaccines and continuous and categorical variables. A post hoc analysis was performed between uveitis onset interval after vaccination and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset postvaccination was performed.

MAIN OUTCOME MEASURES

The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.

RESULTS

A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n = 853, 77.97%). The mean age of patients with VAU was 46.24 ± 16.93 years, and 68.65% (n = 751) were women. Most cases were reported after the first dose (n = 452, 41.32%) and within the first week (n = 591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22 ± 42.74 days) compared with BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (P < 0.0001). The post hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared with the mRNA 1273 vaccine (P < 0.0001). The 30-day risk analysis showed a significant difference among the 3 vaccines (P < 0.0001).

CONCLUSIONS

The low crude reporting rate and observed to expected ratio suggest a low safety concern for VAU. This study provides insights into a possible temporal association between reported VAU events and SARS-CoV-2 vaccines; however, further investigations are required to delineate the associated immunological mechanisms.

Links

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Authors+Show Affiliations

Singh RB
Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts; Department of Ophthalmology, Leiden University Medical Center, Leiden, the Netherlands; Discipline of Ophthalmology and Visual Sciences, Faculty of Health and Medical Sciences, Adelaide Medical School, University of Adelaide, Adelaide, Australia.
Parmar UPS
Department of Ophthalmology, Government Medical College and Hospital, Chandigarh, India.
Kahale F
Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.
Agarwal A
Eye Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates; Department of Ophthalmology, University of Maastricht, Maastricht, the Netherlands. Electronic address: aniruddha9@gmail.com.
Tsui E
Stein Eye Institute, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California. Electronic address: ETsui@mednet.ucla.edu.

MeSH

AdultFemaleHumansMaleMiddle Aged2019-nCoV Vaccine mRNA-1273Ad26COVS1BNT162 VaccineCOVID-19COVID-19 VaccinesRetrospective StudiesSARS-CoV-2UveitisVaccinationVaccines

Pub Type(s)

Journal Article

Language

eng

PubMed ID

36055601

Citation

Singh, Rohan Bir, et al. "Vaccine-Associated Uveitis After COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis." Ophthalmology, vol. 130, no. 2, 2023, pp. 179-186.
Singh RB, Parmar UPS, Kahale F, et al. Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. Ophthalmology. 2023;130(2):179-186.
Singh, R. B., Parmar, U. P. S., Kahale, F., Agarwal, A., & Tsui, E. (2023). Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. Ophthalmology, 130(2), 179-186. https://doi.org/10.1016/j.ophtha.2022.08.027
Singh RB, et al. Vaccine-Associated Uveitis After COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. Ophthalmology. 2023;130(2):179-186. PubMed PMID: 36055601.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Vaccine-Associated Uveitis after COVID-19 Vaccination: Vaccine Adverse Event Reporting System Database Analysis. AU - Singh,Rohan Bir, AU - Parmar,Uday Pratap Singh, AU - Kahale,Francesca, AU - Agarwal,Aniruddha, AU - Tsui,Edmund, Y1 - 2022/08/31/ PY - 2022/07/01/received PY - 2022/08/11/revised PY - 2022/08/24/accepted PY - 2022/9/3/pubmed PY - 2023/1/25/medline PY - 2022/9/2/entrez KW - COVID-19 KW - SARS-CoV-2 vaccine KW - Uveitis KW - VAERS KW - Vaccine adverse events KW - Vaccine-associated uveitis SP - 179 EP - 186 JF - Ophthalmology JO - Ophthalmology VL - 130 IS - 2 N2 - PURPOSE: To assess the risk of vaccine-associated uveitis (VAU) after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination and evaluate uveitis onset interval and clinical presentations in the patients. DESIGN: A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention Vaccine Adverse Event Reporting System. PARTICIPANTS: Patients diagnosed with VAU after administration of BNT162b2 (Pfizer-BioNTech, Pfizer Inc/BioNTech SE), mRNA-1273 (Moderna, Moderna Therapeutics Inc), and Ad26.COV2.S (Janssen, Janssen Pharmaceuticals) vaccine worldwide. METHODS: A descriptive analysis of the demographics, clinical history, and presentation was performed. We evaluated the correlation among the 3 vaccines and continuous and categorical variables. A post hoc analysis was performed between uveitis onset interval after vaccination and age, dose, and vaccine type. Finally, a 30-day risk analysis for VAU onset postvaccination was performed. MAIN OUTCOME MEASURES: The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration. RESULTS: A total of 1094 cases of VAU were reported from 40 countries with an estimated crude reporting rate (per million doses) of 0.57, 0.44, and 0.35 for BNT162b2, mRNA-1273, and Ad26.COV2.S, respectively. The observed to expected ratio of VAU was comparable for BNT162b2 (0.023), mRNA-1273 (0.025), and Ad26.COV2.S (0.027). Most cases of VAU were reported in patients who received BNT162b2 (n = 853, 77.97%). The mean age of patients with VAU was 46.24 ± 16.93 years, and 68.65% (n = 751) were women. Most cases were reported after the first dose (n = 452, 41.32%) and within the first week (n = 591, 54.02%) of the vaccination. The onset interval for VAU was significantly longer in patients who received mRNA-1273 (21.22 ± 42.74 days) compared with BNT162b2 (11.42 ± 23.16 days) and rAd26.COV2.S (12.69 ± 16.02 days) vaccines (P < 0.0001). The post hoc analysis revealed a significantly shorter interval of onset for the BNT162b2 compared with the mRNA 1273 vaccine (P < 0.0001). The 30-day risk analysis showed a significant difference among the 3 vaccines (P < 0.0001). CONCLUSIONS: The low crude reporting rate and observed to expected ratio suggest a low safety concern for VAU. This study provides insights into a possible temporal association between reported VAU events and SARS-CoV-2 vaccines; however, further investigations are required to delineate the associated immunological mechanisms. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/36055601/Vaccine_Associated_Uveitis_after_COVID_19_Vaccination:_Vaccine_Adverse_Event_Reporting_System_Database_Analysis_ DB - PRIME DP - Unbound Medicine ER -