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Is there an association between the BNT162b2 messenger RNA (mRNA) COVID-19 vaccine and sudden sensorineural hearing loss (SSNHL)?
In this cohort study of 2 602 557 patients in Israel, an association was found between the BNT162b2 mRNA COVID-19 vaccine and SSNHL as reflected by the high ratio of observed to expected SSNHL cases; however, the effect size was very small.
Considering the small effect size of this association and the good prognosis for patients with SSNHL, the potential influence of this condition on public health appears to be relatively minor.
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.
Main Outcomes and Measures
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.
Conclusions and Relevance
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.
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CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.
Accepted for Publication: December 17, 2021.
Published Online: February 24, 2022. doi:10.1001/jamaoto.2021.4278
Corresponding Author: Yoav Yanir, MD, Department of Otolaryngology–Head and Neck Surgery, Lady Davis Carmel Medical Center, 7 Michal St, Haifa 34362, Israel (firstname.lastname@example.org).
Author Contributions: Dr Saliba had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Drs Yanir and Doweck contributed equally to this work.
Concept and design: All authors.
Acquisition, analysis, or interpretation of data: Yanir, Doweck, Shibli, Saliba.
Drafting of the manuscript: Yanir, Doweck, Saliba.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Doweck, Saliba.
Supervision: Najjar-Debbiny, Saliba.
Conflict of Interest Disclosures: None reported.
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