Sudden hearing loss following vaccination against COVID-19

Abstract

Importance Spontaneous adverse reaction reports of sudden hearing loss have been observed and a population-based cohort study conducted in Israel showed an increase in the incidence of sudden sensorineural hearing loss (SSNHL) following vaccination with messenger RNA COVID-19 vaccine BNT162b2 (Pfizer-BioNTech). However, in this setting, possibility of confounding remained. Objective To assess a potential association between COVID-19 vaccinations and SSNHL. Design A register-based country-wide observational study with study period from January 1, 2019, until Apr 12, 2022. Setting Residents in Finland: 5.8 million. Participants All individuals identified from population information system alive or born during the study period except individuals having SSNHL during 2015 to 2018 according to specialized care derived diagnosis codes for SSNHL (ICD10-code H91.2) as a primary or secondary diagnosis. Exposures The a priori primary risk period was 0 to 54 days following each COVID-19 vaccine dose. The secondary risk time was 55 or more days after the vaccination. A later vaccine exposure overruled a previous one. A secondary analysis included a risk time of 0 to 54 days following a positive polymerase chain reaction (PCR) test for SARS-CoV-2. Main Outcome We compared incidences of SSNHL following COVID-19 vaccination to incidences before the COVID-19 epidemic in Finland. In our Poisson regression analysis, we adjusted for calendar time, age, sex, diabetes, cardiovascular disease, other chronic diseases, number of visits in primary health care. Results Comparison time constituted of 6.5 million person years, primary risk time of 1.7 million person years, and secondary risk time of 2.1 million person years. Before the epidemic yearly 18.7 / 100,000 people were diagnosed with SSNHL. Our data suggested no increased risk for SSNHL following any COVID-19 vaccination. In particular, adjusted incidence rate ratios, with 95 percent confidence intervals (95% CI) for the BNT162b2 vaccine's three doses were 0.8 (95% CI 0.6 to 1.0), 0.9 (95% CI 0.6 to 1.2), and 1.3 (95% CI 0.9 to 2.0). SARS-CoV-2 infection was not associated with an increased incidence of SSNHL either. Conclusions and relevance Our results show no evidence of increased SSNHL with the COVID-19 vaccinations. We accounted for previous disease and other potential confounding factors. Our results base on diagnosis codes in specialized care but still need to be verified with settings, that are capable to evaluate the degree of hearing loss.

Competing Interest Statement

I.K. none. (a board member of Finnish Association of Otorhinolaryngology Head & Neck Surgery and a board member of The Finnish Society of Ear Surgery) T.N. has received funding from Sanofi Pasteur for projects outside the current work. J.K. none (a board member of the Finnish Audiological Society) T.N., M.A., H.N., and P.H. were employed by the Finnish Institute for Health and Welfare and were thus obligated by legislation to investigate the potential post marketing harmful effects of vaccines during the conduct of the study. Other authors report no potential conflicts of interest.

Funding Statement

This study did not receive any funding from outside the institute.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Director of the department for Health security of the Finnish Insitute for Health and Welfare, prof. Mika Salminen, certifies that the research presented required no further ethical review. Surveillance including the safety of vaccines utilized in the national vaccination program is part of the Institute's (THL) duties. THL has the statutory right, notwithstanding confidentiality provisions, to access and link necessary data from the national registers. Finlex. Communicable Diseases Act. Published 2016. Accessed December 21, 2021. https://www.finlex.fi/en/laki/kaannokset/2016/en20161227

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Data Availability

By Finnish law,the authors are not permitted to share individual-level register data. The computing code is available upon request. Possible inqueries kirjaamo@thl.fi.

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