Sudden Sensorineural Hearing Loss Following Immunization With BNT162b2 or mRNA‐1273: A Danish Population‐Based Cohort Study

Abstract 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.