Vaccine Innovation Meta-Model for Pandemic Contexts.

Autor: Fialho BC; Bio-Manguinhos/Fiocruz Immunobiological Technology Institute, Rio de Janeiro, RJ Brazil., Gauss L; Production and Systems Engineering Graduate Program, Unisinos, São Leopoldo, RS Brazil., Soares PF; Bio-Manguinhos/Fiocruz Immunobiological Technology Institute, Rio de Janeiro, RJ Brazil., Medeiros MZ; Bio-Manguinhos/Fiocruz Immunobiological Technology Institute, Rio de Janeiro, RJ Brazil., Lacerda DP; Production and Systems Engineering Graduate Program, Unisinos, São Leopoldo, RS Brazil.
Jazyk: angličtina
Zdroj: Journal of pharmaceutical innovation [J Pharm Innov] 2023 Feb 13, pp. 1-49. Date of Electronic Publication: 2023 Feb 13.
DOI: 10.1007/s12247-023-09708-7
Abstrakt: 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.
Competing Interests: Conflict of InterestWe wish to confirm that there are no known conflicts of interest associated with this publication and there has been no significant financial support for this work that could have influenced its outcome.
(© 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.)
Databáze: MEDLINE
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