An extension of the Benefit Risk Assessment of VaccinEs toolkit to evaluate Comirnaty and Spikevax vaccination in the European Union.
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) wi...
| Publicado en: | European Journal of Public Health Vol. 35; no. 5; pp. 1007 - 1014 |
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| Autores principales: | , , , , , , , , , , , |
| Formato: | equations & formulas research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
Oct2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=188809842&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 188809842 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 11011262 BHW jtl: European Journal of Public Health issn: 11011262 maglogo: N pubinfo: dt: Oct2025 vid: 35 iid: 5 pid: 622 pub: Oxford University Press / USA artinfo: ui: 188809842 188809842 188809842 10.1093/eurpub/ckaf135 188809842 ppf: 1007 ppct: 7 formats: fmt: – @attributes: type: T – @attributes: type: P tig: atl: An extension of the Benefit Risk Assessment of VaccinEs toolkit to evaluate Comirnaty and Spikevax vaccination in the European Union. aug: au: Loedy, Neilshan Dorta, Hector G Abrams, Steven Crèvecoeur, Jonas Morales, Daniel R Cohet, Catherine Willem, Lander Molenberghs, Geert Hens, Niel Kurz, Xavier Quinten, Chantal Verbeeck, Johan affil: Data Science Institute, I-Biostat, Hasselt University, Diepenbeek, Belgium sug: subj: Risk Assessment COVID-19 Vaccines Therapeutic Use COVID-19 Prevention and Control European Union COVID-19 Vaccines Administration and Dosage Human Confidence Intervals Odds Ratio Funding Source Immunization Public Health ab: 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 estimates. The analysis assumes fixed population dynamics and behaviour. Additionally, BRAVE assesses risks associated with mRNA-based vaccines (myocarditis or pericarditis) by comparing observed incidence rates in vaccinated individuals with background incidence rates. mRNA vaccines were estimated to directly prevent 11.150 million [95% confidence interval (CI): 10.876–11.345] confirmed COVID-19 infections, 0.739 million (95% CI: 0.727–0.744) COVID-19 hospitalizations, 0.107 million (95% CI: 0.104–0.109) ICU admissions, and 0.187 million (95% CI: 0.182–0.189) COVID-19-related deaths in the EU/EEA between 13 December 2020 and 31 December 2021. Despite increased vaccination-associated myocarditis or pericarditis observed in younger men, the benefits of vaccination still outweigh these risks. Our study supports the benefit/risk profile of COVID-19 vaccines and emphasizes the utility of employing a flexible toolkit to assess risks and benefits of vaccination. This user-friendly and adaptable toolkit can serve as a blueprint for similar tools, enhancing preparedness for future public health crises. pubtype: Academic Journal doctype: equations & formulas research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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