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.
Department of Ophthalmology, Government Medical College and Hospital, Chandigarh, India.
Ophthalmology. 2023 Feb;130(2):179-186. doi: 10.1016/j.ophtha.2022.08.027. Epub 2022 Aug 31.
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.
A retrospective study from December 11, 2020, to May 9, 2022, using the Centers for Disease Control and Prevention Vaccine Adverse Event Reporting System.
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.
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.
The estimated global crude reporting rate, observed to expected ratio of VAU in the United States, associated ocular and systemic presentations, and onset duration.
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).
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.
评估严重急性呼吸综合征冠状病毒 2 （SARS-CoV-2）疫苗接种后与疫苗相关的葡萄膜炎（VAU）的风险，并评估患者的葡萄膜炎发病间隔和临床表现。
2020 年 12 月 11 日至 2022 年 5 月 9 日，使用疾病控制和预防中心疫苗不良事件报告系统进行的回顾性研究。
在全球范围内接受 BNT162b2（辉瑞-生物科技，辉瑞公司/生物科技 SE）、mRNA-1273（莫德纳，莫德纳治疗公司）和 Ad26.COV2.S（杨森，杨森制药公司）疫苗后诊断为 VAU 的患者。
对人口统计学、临床病史和表现进行描述性分析。我们评估了 3 种疫苗之间以及连续和分类变量之间的相关性。在疫苗接种后葡萄膜炎发病间隔与年龄、剂量和疫苗类型之间进行了事后分析。最后，对疫苗接种后 30 天 VAU 发病风险进行了分析。
全球粗报告率估计、美国观察到的与预期的 VAU 比值、相关的眼部和全身表现以及发病持续时间。
从 40 个国家报告了 1094 例 VAU 病例，BNT162b2、mRNA-1273 和 Ad26.COV2.S 的估计粗报告率（每百万剂）分别为 0.57、0.44 和 0.35。VAU 的观察到的与预期的比值在 BNT162b2（0.023）、mRNA-1273（0.025）和 Ad26.COV2.S（0.027）之间相当。大多数 VAU 病例发生在接受 BNT162b2 治疗的患者中（n=853，77.97%）。VAU 患者的平均年龄为 46.24±16.93 岁，68.65%（n=751）为女性。大多数病例发生在疫苗接种后的第一剂（n=452，41.32%）和第一周内（n=591，54.02%）。VAU 的发病间隔在接受 mRNA-1273 治疗的患者中明显长于接受 BNT162b2（11.42±23.16 天）和 rAd26.COV2.S（12.69±16.02 天）疫苗的患者（P<0.0001）。事后分析显示，BNT162b2 组与 mRNA 1273 组相比，发病间隔明显缩短（P<0.0001）。30 天风险分析显示 3 种疫苗之间存在显著差异（P<0.0001）。
低粗报告率和观察到的与预期的比值表明 VAU 的安全性担忧较低。本研究提供了 SARS-CoV-2 疫苗接种后与报告的 VAU 事件之间可能存在时间关联的见解；然而，需要进一步研究来阐明相关的免疫机制。
