The benefits of COVID-19 vaccine ‘outweigh its potential link’ with sudden hearing loss
The benefits of COVID-19 vaccine ‘outweigh its potential link’ with sudden hearing loss

The benefits of COVID-19 vaccine ‘outweigh its potential link’ with sudden hearing loss

February 24, 2022

4 min read


Information: Formeister, Ulrich and Yanir do not report any relevant financial information. Please see the surveys and editorial staff for all other authors’ relevant financial information.


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A recent study conducted in Israel identified a potential association between COVID-19 vaccination and sudden sensorineural hearing loss, while a similar study conducted in the United States found no significant association.

The results of both studies were published in JAMA Otolaryngology-Head and Neck Surgery.


Yanir Y, et al. JAMA Otolaryngol Head Neck Surg. 2022; doi: 10.1001 / jamaoto.2021.4278.

“I would like to emphasize that this is not something that should encourage people not to be vaccinated,” Yoav Yanir, MD, a physician in the Department of Otolaryngology Head and Neck Surgery at Lady Davis Carmel Medical Center in Israel, Healio said. “We want to raise awareness about sudden sensorineural hearing loss (SSNHL), and we want doctors to know that there is a link, but the numbers are very small.”

Pfizer vaccine and SSNHL

In a retrospective, population-based cohort study in Israel, Yanir and colleagues evaluated the association between the Pfizer-BioNTech COVID-19 vaccine and SSNHL in individuals aged 16 years or older who received one or two doses of the vaccine. Yanir and colleagues compared cases of SSNHL that occurred within 21 days after each vaccine dose with cases that occurred in the general population in 2018 and 2019 to determine standardized incidence rates (SIR), attributable risk fractions, and attributable risk.

In total, 2,602,557 people received their first dose of the Pfizer COVID-19 vaccine between December 20, 2020 and April 30, 2021. Their mean age was 46.8 years and 51.5% were women. Of these individuals, 2,441,719 received their second vaccine dose between January 10, 2021 and April 30, 2021.

Yanir and colleagues reported that SSNHL occurred within 21 days in 91 patients after the first vaccine dose, corresponding to a 21-day cumulative incidence of 3.5 per 100,000 individuals. SSNHL also occurred in 79 patients after the second dose of vaccine, corresponding to a 21-day cumulative incidence of 3.24 per 100,000 individuals.

During the study period, the researchers observed an increase in the incidence of SSNHL. Specifically, the prevalence of SSNHL was 60.77 (95% CI, 48.29-73.26) per 100,000 persons after the first vaccine dose and 56.24 (95% CI, 43.83-68.64) per 100,000 personal doses after the second vaccine dose, according to the researchers. Previously similar prevalence of SSNHL in Israel was 41.5 (95% CI, 37.98-45.01) per capita. 100,000 persons in 2018 and 44.46 (95% CI, 40.85-48.07) per. 100-1 years for 200,000 people.

Taking into account the prevalence of the general population in 2018, the prevalence of SSNHL among participants after the first vaccine dose tended to be higher among women and girls aged 16 to 44 years (SIR = 1.92; 95% CI, 0.98-3.43) and among adults aged 65 years or older (SIR = 1.68; 95% CI, 1.15-2.37). After the second vaccine dose, the incidence was higher in men and boys aged 16 to 44 years (SIR = 2.45; 95% CI, 1.36-4.07).

Yanir and colleagues reported that the total age- and sex-weighted SIR was 1.35 (95% CI, 1.09-1.53) after the first vaccine dose and 1.23 (95% CI, 0.98-1.53 ) after the second dose, with a very small dose. effect size.

“Given these results, together with the good prognosis for patients with SSNHL, we suggest that the benefits of [Pfizer] The COVID-19 vaccine outweighs its potential link with SSNHL, “the researchers wrote.

Pfizer, Moderna, J&J vaccine and SSNHL

In a separate cross-sectional, population-based study conducted in the United States, Eric J. Formeister, MD, MS, a fellow in otology and neurotology at Johns Hopkins Medicine, and colleagues analyzed data on probable cases of SSNHL reported to the CDC’s Vaccine Adverse Events Reporting System (VAERS) from December 14, 2020 to July 16, 2021. Physicians and patients are in able to report cases through VAERS, which sometimes leads to duplicate or fake cases of SSNHL, Formeister told Healio.

Erik Formeister

Eric J. Formeister

The researchers also analyzed a case series of 21 patients at two tertiary care centers and a local practice that developed SSNHL within 3 weeks of a Pfizer, Moderna or Johnson & Johnson COVID-19 vaccination.

In total, Formeister and colleagues identified 555 incidents of probable SSNHL in VAERS. The average age of the subjects was 54 years and 55% were women. Most likely cases of SSNHL involved the Pfizer vaccine (55%), followed by the Moderna vaccine (40%) and the Johnson & Johnson vaccine (5%). The mean time to onset of symptoms was 6 days.

These 555 cases represented an incidence estimate of 0.6 to 28 cases of SSNHL per 100,000 people a year. The frequency of reports of SSNHL was similar across vaccine manufacturers: 0.16 cases per 100,000 doses for the Pfizer and Moderna vaccines and 0.22 cases per 100,000 doses for the Johnson & Johnson vaccine.

Among the 14 patients in the case series with post-treatment audiometric data, 57.1% experienced an improvement after treatment, according to the researchers.

“We can not say with certainty that there is an association [between the COVID-19 vaccinations and SSNHL]and we can not say with certainty that there is no association, ”said Formeister.

The lack of a robust reporting system hampered the investigation, he added.

Risk vs. benefit of COVID-19 vaccines

Angela K. Ulrich, PhD, MPH, an assistant professor in the Center for Infectious Disease Research and Policy at the University of Minnesota School of Public Health, and colleagues responded to the results of both studies in a related leader.

Together, the studies represented nearly 200 million COVID-19 vaccine doses, according to the authors. The results indicate the need for further investigation of the association between COVID-19 vaccination and SSNHL, as both studies lacked key data.

“The many benefits of COVID-19 vaccines significantly outweigh the rare risks associated with vaccination,” Ulrich and colleagues wrote. “Targeted identification of sudden sensorineural hearing loss will assist in future studies of this condition as a result of interest as well as assessments of potential adverse events following immunization and will assist in the timely recognition of sudden sensorineural hearing loss.”

They added that hearing loss can be reduced or reversed if SSNHL is diagnosed early, emphasizing the importance of ongoing monitoring and reporting of rare side effects such as SSNHL after vaccination.

References:

Formeister EJ, et al. JAMA Otolaryngol Head Neck Surg. 2022; doi: 10.1001 / jamaoto.2021.4414.

Ulrich AK, et al. JAMA Otolaryngol Head Neck Surg. 2022; doi: 10.1001 / jamaoto.2021.4279.

Yanir Y, et al. JAMA Otolaryngol Head Neck Surg. 2022; doi: 10.1001 / jamaoto.2021.4278.

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