Department of Otolaryngology-Head and Neck Surgery, Lady Davis Carmel Medical Center, Haifa, Israel.
Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.
JAMA Otolaryngol Head Neck Surg. 2022 Apr 1;148(4):299-306. doi: 10.1001/jamaoto.2021.4278.
Identification of adverse events after vaccination increases awareness of vaccine-associated complications, leading to early diagnosis and treatment. Evidence remains scarce on the association between the BNT162b2 messenger RNA (mRNA) COVID-19 vaccine (Pfizer-BioNTech) and sudden sensorineural hearing loss (SSNHL).
To assess the association between the BNT162b2 mRNA COVID-19 vaccine and SSNHL.
DESIGN, SETTING, AND PARTICIPANTS: This retrospective, population-based cohort study was performed from December 20, 2020, to May 31, 2021, using data from the largest health care organization in Israel. Patients 16 years or older who received the first vaccine dose between December 20, 2020, and April 30, 2021, and the second vaccine dose between January 10, 2021, and April 30, 2021, were included.
Receipt of first and second BNT162b2 mRNA COVID-19 vaccine doses.
The main outcome was SSNHL based on International Classification of Diseases, Ninth Revision (ICD-9) codes in conjunction with concurrent prednisone dispensing. Observed cases of SSNHL, occurring within 21 days after each of the first and second vaccine doses, were compared with the expected cases based on the experience of the population in 2018 and 2019. Standardized incidence ratios (SIRs) and attributable risks were computed.
Overall, 2 602 557 patients (mean [SD] age, 46.8 [19.6] years; 51.5% female) received the first dose of BNT162b2 mRNA COVID-19 vaccine, with 91 cases of SSNHL reported. Of these patients, 2 441 719 (93.8%) received the second vaccine dose, with 79 cases of SSNHL reported. The age- and sex-weighted SIRs were 1.35 (95% CI, 1.09-1.65) after the first vaccine dose and 1.23 (95% CI, 0.98-1.53) after the second vaccine dose. After the first vaccine dose, the estimated SIRs were more pronounced in female patients aged 16 to 44 years (SIR, 1.92; 95% CI, 0.98-3.43) and female patients 65 years or older (SIR, 1.68; 95% CI, 1.15-2.37). After the second vaccine dose, the highest estimated SIR was observed in male patients 16 to 44 years (SIR, 2.45; 95% CI, 1.36-4.07). The attributable risks were generally small, and the results were similar when 2019 was used as a reference to estimate the expected number of SSNHL cases.
This study suggests that the BNT162b2 mRNA COVID-19 vaccine might be associated with increased risk of SSNHL; however, the effect size is very small. Further studies are warranted to establish this possible association.
重要性：识别疫苗接种后的不良反应可提高对疫苗相关并发症的认识，从而实现早期诊断和治疗。目前关于 BNT162b2 信使 RNA（mRNA）COVID-19 疫苗（辉瑞-生物技术）与突发性聋（SSNHL）之间关联的证据仍然很少。
目的：评估 BNT162b2 mRNA COVID-19 疫苗与 SSNHL 之间的关联。
设计、环境和参与者：这是一项回顾性、基于人群的队列研究，于 2020 年 12 月 20 日至 2021 年 5 月 31 日期间，使用以色列最大的医疗保健组织的数据进行。纳入年龄在 16 岁及以上、在 2020 年 12 月 20 日至 2021 年 4 月 30 日期间接受第一剂疫苗、在 2021 年 1 月 10 日至 2021 年 4 月 30 日期间接受第二剂疫苗的患者。
暴露：接受第一剂和第二剂 BNT162b2 mRNA COVID-19 疫苗。
主要结果和措施：主要结局是根据国际疾病分类第 9 版（ICD-9）代码和同时开具的泼尼松龙处方判断的 SSNHL。将第一剂和第二剂疫苗后 21 天内发生的 SSNHL 观察病例与 2018 年和 2019 年人群经验的预期病例进行比较。计算标准化发病率比（SIR）和归因风险。
结果：共有 2602557 名（平均[标准差]年龄，46.8[19.6]岁；51.5%为女性）患者接受了第一剂 BNT162b2 mRNA COVID-19 疫苗，其中有 91 例 SSNHL 报告病例。这些患者中有 2441719 人（93.8%）接受了第二剂疫苗，其中有 79 例 SSNHL 报告病例。第一剂疫苗后和第二剂疫苗后的年龄和性别加权 SIR 分别为 1.35（95%CI，1.09-1.65）和 1.23（95%CI，0.98-1.53）。第一剂疫苗后，16 至 44 岁的女性患者（SIR，1.92；95%CI，0.98-3.43）和 65 岁及以上的女性患者（SIR，1.68；95%CI，1.15-2.37）的估计 SIR 更为明显。第二剂疫苗后，16 至 44 岁的男性患者的估计 SIR 最高（SIR，2.45；95%CI，1.36-4.07）。归因风险通常较小，当使用 2019 年作为参考来估计 SSNHL 病例的预期数量时，结果也相似。
结论和相关性：本研究表明，BNT162b2 mRNA COVID-19 疫苗可能与 SSNHL 风险增加相关；然而，效应大小非常小。需要进一步的研究来确定这种可能的关联。
