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      SARS-CoV-2 vaccine-associated-tinnitus: A review

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          Abstract

          The global vaccination drive against severe acute respiratory syndrome coronavirus-2 is being pursued at a historic pace. Unexpected adverse effects have been reported following vaccination, including thrombotic thrombocytopenia, myocarditis, amongst others. More recently, some cases of tinnitus are reported post-vaccination. According to the Vaccine Adverse Events Reporting System (VAERS), 12,247 cases of coronavirus post-vaccination tinnitus have been reported till 14 th September 2021. To the best of our knowledge, this is the first review evaluating any otologic manifestation following vaccine administration and aims to evaluate the potential pathophysiology, clinical approach, and treatment. Although the incidence is infrequent, there is a need to understand the precise mechanisms and treatment for vaccine-associated-tinnitus.

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          Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

          Fernando P Polack, Stephen J. Thomas, Nicholas R.E. Kitchin … (2023)
          Abstract Background Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (Covid-19) have afflicted tens of millions of people in a worldwide pandemic. Safe and effective vaccines are needed urgently. Methods In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). BNT162b2 is a lipid nanoparticle–formulated, nucleoside-modified RNA vaccine that encodes a prefusion stabilized, membrane-anchored SARS-CoV-2 full-length spike protein. The primary end points were efficacy of the vaccine against laboratory-confirmed Covid-19 and safety. Results A total of 43,548 participants underwent randomization, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo. There were 8 cases of Covid-19 with onset at least 7 days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo; BNT162b2 was 95% effective in preventing Covid-19 (95% credible interval, 90.3 to 97.6). Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. Among 10 cases of severe Covid-19 with onset after the first dose, 9 occurred in placebo recipients and 1 in a BNT162b2 recipient. The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. The incidence of serious adverse events was low and was similar in the vaccine and placebo groups. Conclusions A two-dose regimen of BNT162b2 conferred 95% protection against Covid-19 in persons 16 years of age or older. Safety over a median of 2 months was similar to that of other viral vaccines. (Funded by BioNTech and Pfizer; ClinicalTrials.gov number, NCT04368728.)
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            Vaccine hesitancy: Definition, scope and determinants.

            Noni MacDonald (2015)
            The SAGE Working Group on Vaccine Hesitancy concluded that vaccine hesitancy refers to delay in acceptance or refusal of vaccination despite availability of vaccination services. Vaccine hesitancy is complex and context specific, varying across time, place and vaccines. It is influenced by factors such as complacency, convenience and confidence. The Working Group retained the term 'vaccine' rather than 'vaccination' hesitancy, although the latter more correctly implies the broader range of immunization concerns, as vaccine hesitancy is the more commonly used term. While high levels of hesitancy lead to low vaccine demand, low levels of hesitancy do not necessarily mean high vaccine demand. The Vaccine Hesitancy Determinants Matrix displays the factors influencing the behavioral decision to accept, delay or reject some or all vaccines under three categories: contextual, individual and group, and vaccine/vaccination-specific influences.
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              The PRISMA 2020 statement: An updated guideline for reporting systematic reviews

              Matthew J L Page, Joanne E. Mckenzie, Patrick Bossuyt … (2021)
              The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did, and what they found. Over the past decade, advances in systematic review methodology and terminology have necessitated an update to the guideline. The PRISMA 2020 statement replaces the 2009 statement and includes new reporting guidance that reflects advances in methods to identify, select, appraise, and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. In this article, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews.
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                Author and article information

                Journal
                Journal ID (nlm-ta): Ann Med Surg (Lond)
                Journal ID (iso-abbrev): Ann Med Surg (Lond)
                Title: Annals of Medicine and Surgery
                Publisher: Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd.
                ISSN (Electronic): 2049-0801
                Publication date PMC-release: 25 January 2022
                Publication date (Electronic): 25 January 2022
                Electronic Location Identifier: 103293
                Affiliations
                [a ]Dow University of Health Sciences, Karachi, Pakistan
                [b ]Kabir Medical College, Gandhara University, Peshawar, Pakistan
                [c ]Department of Internal Medicine, Hamad Medical Corporation, Doha, Qatar
                Author notes
                [∗ ]Corresponding author. Kabir Medical College Gandhara University, Peshawar, 25000, Pakistan.
                [∗∗ ]Corresponding author.
                Article
                Publisher Item ID: S2049-0801(22)00053-X Publisher ID: 103293
                DOI: 10.1016/j.amsu.2022.103293
                PMC ID: 8788157
                PubMed ID: 35096388
                SO-VID: 15da731a-9ab0-483e-88a0-a7b6a9724e48
                Copyright © © 2022 Published by Elsevier Ltd on behalf of IJS Publishing Group Ltd.
                License:

                Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

                History
                Date received : 27 October 2021
                Date revision received : 12 January 2022
                Date accepted : 23 January 2022
                Categories
                Subject: Review

                Keywords: covid-19,covid-19 vaccine,sars-cov-2,vaccine-associated tinnitus,tinnitus,ear ringing
                Data availability:
                Keywords: covid-19, covid-19 vaccine, sars-cov-2, vaccine-associated tinnitus, tinnitus, ear ringing

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