Department of Pharmacy, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.
J Clin Pharm Ther. 2022 Nov;47(11):1789-1795. doi: 10.1111/jcpt.13767. Epub 2022 Sep 11.
Evidence on whether the coronavirus disease 2019 (COVID-19) vaccination could cause hearing-related adverse events is still conflicting. This study aims to access the association between COVID-19 vaccine and hearing disorder.
The Vaccine Adverse Event Reporting System (VAERS) was queried between January 2020 to November 2021. The disproportionality pattern for hearing impairment of COVID-19 vaccine was accessed by calculating the reporting odds ratio (ROR) and proportional reporting ratio (PRR). A further subgroup analysis based on the type of COVID-19 vaccine and the doses administered was performed. In addition, the disproportionalities for hearing dysfunction between COVID-19 and influenza vaccines were compared.
A total of 14,956 reports of hearing-related adverse events were identified with COVID-19 vaccination and 151 with influenza vaccine during the analytic period in VAERS. The incidence of hearing disorder following COVID-19 vaccination was 6.66 per 100,000. The results of disproportionality analysis revealed that the adverse events of hearing impairment, after administration of COVID-19 vaccine, was significantly highly reported (ROR 2.38, 95% confidence interval [CI] 2.20-2.56; PRR: 2.35, χ 537.58), for both mRNA (ROR 2.37, 95% CI 2.20-2.55; PRR 2.34, χ 529.75) and virus vector vaccines (ROR 2.50, 95% CI 2.28-2.73; PRR 2.56, χ 418.57). While the disproportional level for hearing dysfunction was quite lower in influenza vaccine (ROR 0.36, 95% CI 0.30-0.42; PRR 0.36, χ 172.24).
This study identified increased risk for hearing disorder following administration of both mRNA and virus vector COVID-19 vaccines compared to influenza vaccination in real-world settings.
关于新型冠状病毒病 2019（COVID-19）疫苗接种是否会引起与听力相关的不良事件的证据仍存在争议。本研究旨在评估 COVID-19 疫苗与听力障碍之间的关联。
本研究通过计算报告比值比（ROR）和比例报告比（PRR），于 2020 年 1 月至 2021 年 11 月期间在疫苗不良事件报告系统（VAERS）中检索 COVID-19 疫苗与听力障碍相关的不良反应报告。根据 COVID-19 疫苗的类型和接种剂量进行了进一步的亚组分析。此外，还比较了 COVID-19 疫苗和流感疫苗之间听力障碍的不良反应比例。
在 VAERS 中，分析期间共发现 14956 例与 COVID-19 疫苗接种相关的听力不良事件报告和 151 例流感疫苗接种报告。COVID-19 疫苗接种后听力障碍的发生率为每 100000 人 6.66 例。比例失衡分析结果表明，COVID-19 疫苗接种后听力损伤的不良反应报告显著增高（ROR 2.38，95%置信区间[CI]2.20-2.56；PRR：2.35，χ 537.58），包括 mRNA（ROR 2.37，95%CI 2.20-2.55；PRR 2.34，χ 529.75）和病毒载体疫苗（ROR 2.50，95%CI 2.28-2.73；PRR 2.56，χ 418.57）。而流感疫苗的听力障碍比例失衡程度较低（ROR 0.36，95%CI 0.30-0.42；PRR 0.36，χ 172.24）。
本研究在真实环境中发现，与流感疫苗接种相比，接种 mRNA 和病毒载体 COVID-19 疫苗后发生听力障碍的风险增加。
