An extension of the Benefit Risk Assessment of VaccinEs toolkit to evaluate Comirnaty and Spikevax vaccination in the European Union.

ABSTRACT: Amid the global COVID-19 pandemic, vaccines were conditionally authorized for human use to protect against severe infection. The Benefit Risk Assessment of VaccinEs (BRAVE) toolkit, a user-friendly R Shiny application, was developed retrospectively together with the European Medicine Agency (EMA) with the aim of fulfilling the need for flexible tools to assess vaccine benefits and risks during and outside a pandemic situation. This study employed BRAVE to evaluate the impact of COVID-19 mRNA vaccines across 30 European Union (EU)/EEA countries by quantifying the number of prevented clinical events [i.e. confirmed infections, hospitalizations, intensive care unit (ICU) admissions, and deaths], using a probabilistic model informed by real-time incidence data and vaccine effectiveness estimat

SUBMITTER: Loedy N 

PROVIDER: S-EPMC12529280 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature