Anosmia: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Yi-Chun Carol Liu; Flor M Munoz; Hector S Izurieta; Arina A Tamborska; Tom Solomon; Barbara J Law; Nipun Chhabra

doi:10.1016/j.vaccine.2022.11.022

Anosmia: Brighton Collaboration case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Vaccine. 2023 Mar 10;41(11):1902-1910. doi: 10.1016/j.vaccine.2022.11.022. Epub 2023 Feb 10.

Authors

Yi-Chun Carol Liu¹, Flor M Munoz², Hector S Izurieta³, Arina A Tamborska⁴, Tom Solomon⁵, Barbara J Law⁶, Nipun Chhabra⁷

Affiliations

¹ Department of Surgery, Division of Pediatric Otolaryngology, Baylor College of Medicine, and Texas Children's Hospital, Houston, TX, USA. Electronic address: [email protected].
² Department of Pediatrics, Division of Infectious Diseases, Baylor College of Medicine and Texas Children's Hospital, Houston, TX, USA.
³ Office of Vaccine Research and Review (OVRR), CBER, U.S. Food and Drug Administration, Silver Spring, MD, USA.
⁴ National Institute for Health Research Health Protection Research Unit in Emerging and Zoonotic Infections, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Merseyside, United Kingdom; Department of Neurology, The Walton Centre NHS Foundation Trust, Liverpool, United Kingdom; Clinical Infection Microbiology and Immunology, Institute for Infection, Veterinary and Ecological Sciences, University of Liverpool, United Kingdom.
⁵ National Institute for Health Research Health Protection Research Unit in Emerging and Zoonotic Infections, Institute of Infection, Veterinary and Ecological Sciences, University of Liverpool, Merseyside, United Kingdom.
⁶ Brighton Collaboration, Decatur, GA, USA.
⁷ Department of Otolaryngology, Case Western Reserve University, Cleveland, OH, USA; VA Northeast Ohio Healthcare System, Cleveland, OH, USA; University Hospitals Ear, Nose & Throat Institute, Cleveland, OH, USA.

PMID: 36775774
DOI: 10.1016/j.vaccine.2022.11.022

Abstract

This is a Brighton Collaboration case definition of anosmia to be used in the evaluation of adverse events following immunization, and for epidemiologic studies for the assessment of background incidence or hypothesis testing. The case definition was developed by a group of experts convened by the Coalition for Epidemic Preparedness Innovations (CEPI) in the context of active development of SARS-CoV-2 vaccines. The case definition format of the Brighton Collaboration was followed to develop a consensus definition and defined levels of certainty, after an exhaustive review of the literature and expert consultation. The document underwent peer review by the Brighton Collaboration Network and by two expert reviewers prior to submission.

Keywords: Adverse event; Anosmia; Case definition; Guidelines; Immunization.

Publication types

Review
Research Support, Non-U.S. Gov't

MeSH terms

Anosmia / etiology
COVID-19 Vaccines*
COVID-19* / epidemiology
COVID-19* / prevention & control
Data Collection
Humans
Immunization / adverse effects
SARS-CoV-2

Substances

COVID-19 Vaccines