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Vaccine Innovation Meta-Model for Pandemic Contexts

PURPOSE: Over the past decade, successive outbreaks and epidemics of infectious diseases have challenged the emergency preparedness and response systems of global public health institutions, a context in which vaccines have become the centerpiece to strengthening global health security. Nevertheless...

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Autores principales: Fialho, Beatriz C., Gauss, Leandro, Soares, Priscila F., Medeiros, Maurício Z., Lacerda, Daniel P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9924881/
https://www.ncbi.nlm.nih.gov/pubmed/36818394
http://dx.doi.org/10.1007/s12247-023-09708-7
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author Fialho, Beatriz C.
Gauss, Leandro
Soares, Priscila F.
Medeiros, Maurício Z.
Lacerda, Daniel P.
author_facet Fialho, Beatriz C.
Gauss, Leandro
Soares, Priscila F.
Medeiros, Maurício Z.
Lacerda, Daniel P.
author_sort Fialho, Beatriz C.
collection PubMed
description PURPOSE: Over the past decade, successive outbreaks and epidemics of infectious diseases have challenged the emergency preparedness and response systems of global public health institutions, a context in which vaccines have become the centerpiece to strengthening global health security. Nevertheless, vaccine research and development (R&D) is a complex, lengthy, risky, uncertain, and expensive process. Alongside strict, time-consuming regulatory compliance, it takes multiple candidates and many years to register a new vaccine. This is certainly not welcome in a global health crisis such as the COVID-19 pandemic. Therefore, this study aims to understand the R&D paradigm shift in pandemic contexts and its impacts on the value chain of vaccine innovation. METHODS: To that end, this paper carried out a systematic literature review and meta-synthesis of 27 articles and reports (2011–2021) that addressed vaccine R&D in contexts of global health threats, disease outbreaks, epidemics, or pandemics. RESULTS: The research findings are synthesized in a meta-model, which describes a fast-track R&D for pandemic contexts, its driving forces, innovations, mechanisms, and impacts in the value chain of vaccine innovation. CONCLUSIONS: The study demonstrates that, in pandemic contexts, a fast-track R&D process based on close collaboration among regulators, industry, and academia and leveraging enabling technologies can drastically reduce the time required to bring safe, stable, and effective vaccines to market by an average of 11 years compared to the traditional R&D process. Furthermore, pharmacovigilance and rigorous monitoring of real-world evidence became critical to ensuring that quality and safe products were authorized for use during a pandemic.
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spelling pubmed-99248812023-02-14 Vaccine Innovation Meta-Model for Pandemic Contexts Fialho, Beatriz C. Gauss, Leandro Soares, Priscila F. Medeiros, Maurício Z. Lacerda, Daniel P. J Pharm Innov Original Article PURPOSE: Over the past decade, successive outbreaks and epidemics of infectious diseases have challenged the emergency preparedness and response systems of global public health institutions, a context in which vaccines have become the centerpiece to strengthening global health security. Nevertheless, vaccine research and development (R&D) is a complex, lengthy, risky, uncertain, and expensive process. Alongside strict, time-consuming regulatory compliance, it takes multiple candidates and many years to register a new vaccine. This is certainly not welcome in a global health crisis such as the COVID-19 pandemic. Therefore, this study aims to understand the R&D paradigm shift in pandemic contexts and its impacts on the value chain of vaccine innovation. METHODS: To that end, this paper carried out a systematic literature review and meta-synthesis of 27 articles and reports (2011–2021) that addressed vaccine R&D in contexts of global health threats, disease outbreaks, epidemics, or pandemics. RESULTS: The research findings are synthesized in a meta-model, which describes a fast-track R&D for pandemic contexts, its driving forces, innovations, mechanisms, and impacts in the value chain of vaccine innovation. CONCLUSIONS: The study demonstrates that, in pandemic contexts, a fast-track R&D process based on close collaboration among regulators, industry, and academia and leveraging enabling technologies can drastically reduce the time required to bring safe, stable, and effective vaccines to market by an average of 11 years compared to the traditional R&D process. Furthermore, pharmacovigilance and rigorous monitoring of real-world evidence became critical to ensuring that quality and safe products were authorized for use during a pandemic. Springer US 2023-02-13 /pmc/articles/PMC9924881/ /pubmed/36818394 http://dx.doi.org/10.1007/s12247-023-09708-7 Text en © The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature 2023, Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law. This article is made available via the PMC Open Access Subset for unrestricted research re-use and secondary analysis in any form or by any means with acknowledgement of the original source. These permissions are granted for the duration of the World Health Organization (WHO) declaration of COVID-19 as a global pandemic.
spellingShingle Original Article
Fialho, Beatriz C.
Gauss, Leandro
Soares, Priscila F.
Medeiros, Maurício Z.
Lacerda, Daniel P.
Vaccine Innovation Meta-Model for Pandemic Contexts
title Vaccine Innovation Meta-Model for Pandemic Contexts
title_full Vaccine Innovation Meta-Model for Pandemic Contexts
title_fullStr Vaccine Innovation Meta-Model for Pandemic Contexts
title_full_unstemmed Vaccine Innovation Meta-Model for Pandemic Contexts
title_short Vaccine Innovation Meta-Model for Pandemic Contexts
title_sort vaccine innovation meta-model for pandemic contexts
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9924881/
https://www.ncbi.nlm.nih.gov/pubmed/36818394
http://dx.doi.org/10.1007/s12247-023-09708-7
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