Evidence Review of the Adverse Effects of COVID-19 Vaccination and Intramuscular Vaccine Administration (2024) / Chapter Skim
Currently Skimming:
4 Sensorineural Hearing Loss, Tinnitus, and COVID-19 Vaccines
4 Sensorineural Hearing Loss, Tinnitus, and COVID-19 Vaccines
Pages 113-132
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 113... ...
. SENSORINEURAL HEARING LOSS BOX 4-1 Conclusions for Sensorineural Hearing Loss Conclusion 4-1: The evidence is inadequate to accept or reject a causal relationship between the BNT162b2 vaccine and sensorineural hearing loss.
|
From page 114... ...
Central hearing loss or auditory processing disorders (Martin and Jerger, 2005; Task Force on Central Auditory Processing Consensus Development, 1996) , although more poorly understood and considered rare, especially among adults, occur when sound is encoded normally in the peripheral ear (e.g., no sign of sensorineural or conductive loss but deficits in the neural processing of auditory information mean that individuals struggle with understanding it despite functioning peripheral hearing (Katz, 2015)
|
From page 115... ...
Moreover, no literature offers substantive discussion of the potential for increased risk of an association by comorbid conditions, genetic predisposition, concurrent pharmacologic agent, or environmental exposures. The initial consideration is the possible direct viral involvement of the inner ear or the vestibulocochlear nerve (Kaliyappan et al., 2022)
|
From page 116... ...
Epidemiological Evidence Clinical trial results submitted to FDA for Emergency Use Authorization and/or full approval do not indicate a signal regarding sensorineural hearing loss and any of the vaccines under study (FDA, 2021, 2023a, 2023b, 2023c)
|
From page 117... ...
(2022) single arm ≥12 million doses reported doses years 11.6 6.29 per 1 million Ad26.COV2.S million doses doses 244 vaccinees 1.7% of all Clinical Otology BNT162b2 10 vaccinated Leong et convenience NY, NY, clinic at an 16–101 individuals had al.
|
From page 118... ...
Number of events refers to events in vaccinees only. CI: confidence interval; IQR: interquartile range; IR: incidence rate; SIR: standardized incidence rate; VAERS: Vaccine Adverse Event Reporting System.
|
From page 119... ...
(2023) compared the incidence rate of SSNHL in the 30-day window preceding vaccination and 0–54 days and more than 54 days after vaccination to that between January 1, 2019, and March 1, 2020, using a national Finnish electronic health database (n = 5.5 million people)
|
From page 120... ...
From Evidence to Conclusions The broader academic literature includes a handful of published articles reporting sudden sensorineural hearing loss (SSNHL) in individuals receiving COVID-19 vaccination; however, this level of evidence does not support an association between vaccination and SSNHL (Formeister et al., 2022; Jeong and Choi, 2021; Tsetsos et al., 2021)
|
From page 121... ...
Conclusion 4-4: The evidence is inadequate to accept or reject a causal relationship between the NVX-CoV2373 vaccine and sensorineural hearing loss. 3 Refers to the COVID-19 vaccine manufactured by Novavax.
|
From page 122... ...
Conclusion 4-7: The evidence is inadequate to accept or reject a causal relationship between the Ad26.COV2.S vaccine and tinnitus. Conclusion 4-8: The evidence is inadequate to accept or reject a causal relationship between the NVX-CoV2373 vaccine and tinnitus.
|
From page 123... ...
Little direct evidence exists for a direct link, but hypotheses appear in the literature; these mechanisms are not fully understood but thought to involve immune-mediated responses. One hypothesis is molecular mimicry, where the immune response against vaccine components crossreacts with inner ear antigens, leading to inflammation and damage.
|
From page 124... ...
PREPUBLICATION COPY -- Uncorrected Proofs
|
From page 125... ...
167.0 Median 13.53 per 1 million BNT162b2 age = million doses doses 50 years Frontera 128.1 Surveillance IQR 35– Not 13.90 per 1 et al. US VAERS mRNA-1273 million ; single arm 64 for all reported million doses (2022)
|
From page 126... ...
IQR: interquartile range; IR: incidence rate; VAERS: Vaccine Adverse Event Reporting System. SOURCES: Frontera et al., 2022; Kant et al., 2022; Leong et al., 2023; Whittaker et al., 2021.
|
From page 127... ...
(2021) conducted a population-based study using electronic health records data from 1,392 general practices in England contributing to the Clinical Practice Research Datalink AURUM database (August 2020–May 2021)
|
From page 128... ...
However, the epidemiological evidence review offered limited insight. Three surveillance and clinical sample studies suggest relatively low incidence after vaccination but lack comparator groups for inferential conclusions and suffer from biases, particularly selection, and confounding.
|
From page 129... ...
2022. Assessment of sudden sensorineural hearing loss after COVID-19 vaccination.
|
From page 130... ...
2021. Sudden sensorineural hearing loss after COVID-19 vaccination.
|
From page 131... ...
1977. Natural history of sudden sensorineural hearing loss.
|
From page 132... ...
2021. Sudden sensorineural hearing loss following the second dose of COVID-19 vaccine.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.