Sudden Sensorineural Hearing Loss after COVID-19 Vaccination: A Review of the Available Evidence through the Prism of Causality Assessment

被引:1
作者
Thai-Van, Hung [1 ,2 ,3 ]
Bagheri, Haleh [4 ]
Valnet-Rabier, Marie-Blanche [5 ]
机构
[1] Hosp Civils Lyon, Dept Audiol & Otoneurol Evaluat, F-69003 Lyon, France
[2] Inst Pasteur, Inst Audit, F-75015 Paris, France
[3] Univ Claude Bernard Lyon 1, Fac Med, F-69100 Villeurbanne, France
[4] Hop Univ Toulouse, Ctr Reg Pharmacovigilance Toulouse, Dept Med & Clin Pharmacol, CIC1436, F-31000 Toulouse, France
[5] Ctr Hosp Univ Besancon, Ctr Reg Pharmacovigilance & Informat Medicaments, Dept Clin Pharmacol, F-25000 Besancon, France
关键词
mRNA COVID-19 vaccine; audiogram; case series study; disproportionality analysis; pharmacovigilance; positive rechallenge; postmarketing; spontaneous reporting; sudden sensorineural hearing loss; safety signal; DRUG REACTION; SAFETY; PHARMACOVIGILANCE; PHARMACOEPIDEMIOLOGY; WITHDRAWALS; SARS-COV-2; ETIOLOGY;
D O I
10.3390/vaccines12020181
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Sudden sensorineural hearing loss (SSNHL), a rare audiological condition that accounts for 1% of all cases of sensorineural hearing loss, can cause permanent hearing damage. Soon after the launch of global COVID-19 vaccination campaigns, the World Health Organization released a signal detection about SSNHL cases following administration of various COVID-19 vaccines. Post-marketing studies have been conducted in different countries using either pharmacovigilance or medico-administrative databases to investigate SSNHL as a potential adverse effect of COVID-19 vaccines. Here, we examine the advantages and limitations of each type of post-marketing study available. While pharmacoepidemiological studies highlight the potential association between drug exposure and the event, pharmacovigilance approaches enable causality assessment. The latter objective can only be achieved if an expert evaluation is provided using internationally validated diagnostic criteria. For a rare adverse event such as SSNHL, case information and quantification of hearing loss are mandatory for assessing seriousness, severity, delay onset, differential diagnoses, corrective treatment, recovery, as well as functional sequelae. Appropriate methodology should be adopted depending on whether the target objective is to assess a global or individual risk.
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页数:13
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