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Vol. 24. Núm. 3.
Páginas 258-259 (Julio - Septiembre 2023)
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Vol. 24. Núm. 3.
Páginas 258-259 (Julio - Septiembre 2023)
Letter to the editor
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Incidence of sudden sensorineural hearing loss associated with BNT162b2 COVID-19 vaccine: Pooled results from register-based nationwide studies
Incidencia de la hipoacusia sensorineural súbita asociada a la vacuna BNT162b2 contra la COVID-19: resultados agrupados de los estudios nacionales basados en registros
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Paulo Ricardo Martins-Filho
Autor para correspondencia
prmartinsfh@gmail.com

Corresponding author.
Investigative Pathology Laboratory, Federal University of Sergipe, Aracaju, SE, Brazil
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Table 1. Incidence rate of sudden sensorineural hearing loss following BNT162b2 COVID-19 vaccine.
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Este artículo forma parte de:
Efectos secundarios de las vacunas contra el COVID-19 - Side effects of COVID-19 vaccines

Editado por: Dra. Núria Torner CIBER Epidemiologia y Salud Publica CIBERESP Unitat de Medicina Preventiva i Salut Pública Departament de Medicina, Universitat de Barcelona

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Dear Editor,

Studies have evaluated the incidence rate of adverse events following vaccination with the mRNA COVID-19 vaccine BNT162b2 (Pfizer-BioNTech) due to the potential mechanisms of autoimmunogenicity associated with the mRNA payload and the lipid nanoparticle delivery vehicle.1 Recently, there has been increased concern about the risk of sudden sensorineural hearing loss (SSNHL) after receiving the BNT162b2 vaccine. A nationwide cohort study using data from the Finnish Institute for Health and Welfare published by Nieminen et al.2 showed crude incidences of SSNHL during the first 54 days following the first, second, and third COVID-19 vaccine doses with BNT162b2 of 21.2 (95% CI 17.5–25.6), 19.4 (15.8–23.5), and 25.2 (19.9–31.4), respectively, per 100,000 person-years. These findings were compared to the incidences prior to the COVID-19 epidemic, and no evidence of an increased risk of SSNHL following COVID-19 vaccination was found.

This study inspired us to pool the incidence rates of SSNHL following BNT162b2 vaccine from register-based nationwide studies through January 2, 2023. The overall incidence rate of SSNHL per 100,000 person-years was calculated using the Freeman-Tukey double-arcsine transformation with an inverse-variance random-effects model. The meta-analysis was conducted in RStudio (version 0.98.1083) following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline.3

We found three studies2,4,5 that met the eligibility criteria through a systematic search on PubMed, Embase, and Scopus using the keywords “COVID-19”, “vaccine”, “hearing loss”, and related terms. The studies were conducted in the United States,4 Israel,5 and Finland2 by using data from the Centers for Disease Control and Prevention Vaccine Adverse Events Reporting System (VAERS), Clalit Health Services (CHS), and Finnish Institute for Health and Welfare (THL), respectively. A total of 768 SSNHL cases were registered, and the pooled incidence was 24.3 (7.7–50.2) per 100,000 person-years (Table 1).

Table 1.

Incidence rate of sudden sensorineural hearing loss following BNT162b2 COVID-19 vaccine.

Author  Country  Period  Vaccine doses  Outcome  Source  SSNHL cases  Incidence per 100,000 person-years (95% CI) 
NieminenFinlandMarch 2020 to April 20221st dose  SSNHL within 8 weeks of COVID-19 vaccinationFinnish Institute for Health and Welfare (THL)111  21.2 (17.5–25.6) 
2nd dose  104  19.4 (15.8–23.5) 
3rd dose  78  25.2 (19.9–31.4) 
YanirIsraelDecember 2020 to April 20211st dose  SSNHL within 3 weeks of COVID-19 vaccinationClalit Health Services (CHS)91  60.8 (48.3–73.3) 
2nd dose  79  56.2 (43.8–68.6) 
Formeister  USA  December 2020 to July 2021  1st dose  SSNHL within 3 weeks of COVID-19 vaccination  Vaccine Adverse Events Reporting System (VAERS)  305  0.16 (NR) 
Pooled results (random effects model)      768  24.3 (7.7–50.2)* 

CI, confidence interval. NR, not reported. *I2 = 99.7%.

Although a meta-analysis of the risk of SSNHL was not performed due to the heterogeneity in the description of individual results, the observed incidence of SSNHL after the BNT162b2 vaccine does not appear to exceed the incidence of this event in pre-pandemic periods. Based on historical data used by the included studies, the expected number of SSNHL cases per 100,000 person-years in the United States, Israel, and Finland are 27 (confidence interval not reported), 44.5 (40.9–48.1), and 18.7 (17.7–19.8), respectively. Furthermore, in a recent retrospective cohort study using electronic patient records at a secondary hospital in the Israeli city of Ashdod, it was shown that the incidence of audiometry-confirmed SSNHL was lower in vaccine recipients than in pre-pandemic unvaccinated patients.6

Our results need to be evaluated in light of common limitations in registry-based research, including reporting bias and confounding. In addition, temporality and the strength with which an observed event is associated with an intervention are important factors in establishing causality. The available evidence from register-based nationwide studies showed a low incidence of SSNHL following the BNT162b2 COVID-19 vaccine. However, further evidence synthesis based on large cohort studies should be able to measure the strength of association between SSNHL and BNT162b2 vaccine.

Funding

None.

References
[1.]
D. Tsilingiris, N.G. Vallianou, I. Karampela, J. Liu, M. Dalamaga.
Potential implications of lipid nanoparticles in the pathogenesis of myocarditis associated with the use of mRNA vaccines against SARS-CoV-2.
[2.]
T.A. Nieminen, I. Kivekäs, M. Artama, H. Nohynek, J. Kujansivu, P. Hovi.
Sudden hearing loss following vaccination against COVID-19.
JAMA Otolaryngol Neck Surg, (2022),
[3.]
M.J. Page, J.E. McKenzie, P.M. Bossuyt, I. Boutron, T.C. Hoffmann, C.D. Mulrow, et al.
The PRISMA 2020 statement: an updated guideline for reporting systematic reviews.
[4.]
E.J. Formeister, M.J. Wu, D.A. Chari, R. Meek, S.D. Rauch, A.K. Remenschneider, et al.
Assessment of sudden sensorineural hearing loss after COVID-19 vaccination.
JAMA Otolaryngol Neck Surg, 148 (2022), pp. 307
[5.]
Y. Yanir, I. Doweck, R. Shibli, R. Najjar-Debbiny, W. Saliba.
Association between the BNT162b2 messenger RNA COVID-19 vaccine and the risk of sudden sensorineural hearing loss.
JAMA Otolaryngol Neck Surg, 148 (2022), pp. 299
[6.]
O. Cohen Michael, S.O. Tamir, N. O'Rourke, T. Marom.
Audiometry-confirmed sudden sensorineural hearing loss incidence among COVID-19 Patients and BNT162b2 vaccine recipients.
Otol Neurotol, 44 (2023), pp. e68-e72
Copyright © 2023. Elsevier España, S.L.U.. All rights reserved
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