Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol.

Evolution of the data and methods in real-world COVID-19 vaccine effectiveness studies on mortality: a scoping review protocol.

Publication date: Mar 19, 2024

Early evidence on COVID-19 vaccine efficacy came from randomised trials. Many important questions subsequently about vaccine effectiveness (VE) have been addressed using real-world studies (RWS) and have informed most vaccination policies globally. As the questions about VE have evolved during the pandemic so have data, study design, and analytical choices. This scoping review aims to characterise this evolution and provide insights for future pandemic planning-specifically, what kinds of questions are asked at different stages of a pandemic, and what data infrastructure and methods are used? We will identify relevant studies in the Johns Hopkins Bloomberg School of Public Health VIEW-hub database, which curates both published and preprint VE RWS identified from PubMed, Embase, Scopus, Web of Science, the WHO COVID Database, MMWR, Eurosurveillance, medRxiv, bioRxiv, SSRN, Europe PMC, Research Square, Knowledge Hub, and Google. We will include RWS of COVID-19 VE that reported COVID-19-specific or all-cause mortality (coded as ‘death’ in the ‘effectiveness studies’ data set). Information on study characteristics; study context; data sources; design and analytic methods that address confounding will be extracted by single reviewer and checked for accuracy and discussed in a small group setting by methodological and analytic experts. A timeline mapping approach will be used to capture the evolution of this body of literature. By describing the evolution of RWS of VE through the COVID-19 pandemic, we will help identify options for VE studies and inform policy makers on the minimal data and analytic infrastructure needed to support rapid RWS of VE in future pandemics and of healthcare strategies more broadly. As data is in the public domain, ethical approval is not required. Findings of this study will be disseminated through peer-reviewed publications, conference presentations, and working-papers to policy makers. https://doi. org/10. 17605/OSF. IO/ZHDKR.

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Concepts Keywords
Death COVID-19
Google Mortality
Vaccine Protocols & guidelines


Type Source Name
disease MESH COVID-19
disease VO vaccine effectiveness
disease VO protocol
disease VO vaccine efficacy
disease VO vaccination
disease VO study design
drug DRUGBANK Huperzine B
disease MESH ‘death
disease VO effectiveness
disease VO data set
disease IDO production
disease MESH comorbidity
drug DRUGBANK Indoleacetic acid
drug DRUGBANK Coenzyme M
disease MESH infection
disease MESH incidental findings
drug DRUGBANK Spinosad
disease IDO intervention
disease IDO history
disease VO document
disease VO effective
disease VO vaccine
disease IDO country
disease VO population
disease VO vaccinated
disease VO unvaccinated
disease VO report
drug DRUGBANK Trestolone
disease IDO site
disease IDO process
disease IDO quality
disease MESH infectious disease
pathway REACTOME Infectious disease
drug DRUGBANK Gold
disease VO USA
disease VO Canada
disease MESH breakthrough infections
disease MESH Reinfections
drug DRUGBANK (S)-Des-Me-Ampa
disease VO regulatory agency
disease VO organization

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