Vaccines | Free Full-Text | Sudden Sensorineural Hearing Loss after COVID-19 Vaccination: A Review of the Available Evidence through the Prism of Causality Assessment
1. Available Epidemiological Data on Sudden Sensorineural Hearing Loss
Here, we sought to explain why, depending on the methodology used, contradictory results can be observed with regard to the incidence of SSNHL after COVID-19 vaccination. As a matter of fact, the frequency of an adverse event (AE) determines the methodological approaches to generating a safety signal. For very rare adverse events, pharmaco-epidemiological data can be less appropriate. Conversely, data from spontaneous notification and exhaustive pharmacovigilance monitoring may be more effective, particularly in the context of the COVID-19 vaccination campaign.
2. What Do We Currently Know about SSNHL Observed after mRNA COVID-19 Vaccination?
3. Quantification of Sudden Sensorineural Hearing Loss after COVID-19 Vaccination
4. Evaluation of Hearing Recovery in SSNHL Post-COVID-19 Vaccination: Benefits of Active Audiogram-Based Surveillance
5. When an Adverse Event Becomes an Adverse Effect and Then a Signal
The CA, from the WHO point of view, is “the systematic review of data about an AEFI case; it aims to determine the likelihood of a causal association between the event and the vaccine received” and “the quality of the CA depends upon (1) the performance of the AEFI reporting system in terms of responsiveness, effectiveness and quality of investigation and reports, (2) the availability of adequate medical and laboratory services and access to background information; and (3) the quality of the causality review process”.
At the individual level, the question to answer is more likely to be “Did the vaccine given to a particular individual cause the particular event reported?” In this situation, the scientific basis for the criteria which are assessed in the process includes temporal relationship, the definitive proof that the vaccine caused the event, biological plausibility, consideration of alternative explanations, and prior evidence that the vaccine in question can cause a similar event in the vaccine, notably with the concept of rechallenge.
Only once the event is considered as a reaction can a signal evaluation be opened with the objective of drawing conclusions on the presence or absence of a causal association between an AE and a vaccine and identifying a need for additional data collection or considering risk minimisation measures.
It is essential to recognise that the CA of an AEFI in an individual patient is an exercise in medical differential diagnosis as it can be performed to diagnose diabetes or multiple sclerosis.
6. Two Different but Complementary Approaches to Safety Signal Evaluation
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