Objective: To compare the occurrence of sudden sensorineural hearing loss following immunization with BNT162b2 (Comirnaty®; Pfizer BioNTech) or mRNA-1273 (Spikevax®; Moderna) to the occurrence among unvaccinated individuals. Study Design: Cohort study. Setting: Nationwide Danish health care registers comprised all Danish residents living in Denmark on October 1, 2020, who were 18 years or older or turned 18 in 2021. Methods: We compared the occurrence of sudden sensorineural hearing loss following immunization with BNT162b2 (Comirnaty®; Pfizer BioNTech) or mRNA-1273 (Spikevax®; Moderna) (first, second, or third dose) against unvaccinated person time. Secondary outcomes were a first-ever hospital diagnosis of vestibular neuritis and a hearing examination, by an ear-nose-throat (ENT) specialist, followed by a prescription of moderate to high-dose prednisolone. Results: BNT162b2 or mRNA-1273 vaccine was not associated with an increased risk of receiving a discharge diagnosis of sudden sensorineural hearing loss (adjusted hazard ratio [HR]: 0.99, confidence interval [CI]: 0.59-1.64) or vestibular neuritis (adjusted HR: 0.94, CI: 0.69-1.24). We found a slightly increased risk (adjusted HR: 1.40, CI, 1.08-1.81) of initiating moderate to high-dose oral prednisolone following a visit to an ENT specialist within 21 days from receiving a messenger RNA (mRNA)-based Covid-19 vaccine. Conclusion: Our findings do not suggest an increased risk of sudden sensorineural hearing loss or vestibular neuritis following mRNA-based COVID-19 vaccination. mRNA-Covid-19 vaccination may be associated with a small excess risk of a visit to an ENT specialist visit followed by a prescription of moderate to high doses of prednisolone.
|Tidsskrift||Otolaryngology - Head and Neck Surgery (United States)|
|Status||E-pub ahead of print - 2023|
Bibliografisk noteFunding Information:
Jesper Hallas declares participation in research projects funded by Alcon, Almirall, Astellas, Astra‐Zeneca, Boehringer‐Ingelheim, Novo Nordisk, Servier, and LEO Pharma, all regulator‐mandated phase IV studies, all with funds paid to the institution where he was employed (no personal fees) and with no relation to the work reported in this paper. Jesper H. Schmidt declares research collaborations and has received research grants from Oticon, Widex‐Sivantos Audiology, and Resound GN. None of these are related to this work, no personal grants or honorary salary has been received. Lars Christian Lund declares participation in research projects funded by Menarini Pharmaceuticals and LEO Pharma, all with funds paid to the institution where he was employed (no personal fees) and with no relation to the current work. Lars Christian Lund has personally received fees for teaching epidemiological methods related to COVID‐19 research from Atrium, the Danish association of the pharmaceutical industry. Per Damkier, Brian Cleary, Louise Ladebo, and Peter B. Jensen declare no conflicts of interest.
© 2023 The Authors. Otolaryngology–Head and Neck Surgery published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngology–Head and Neck Surgery Foundation.