Vaccine Innovation Meta-Model for Pandemic Contexts

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2023-02-13 DOI:10.1007/s12247-023-09708-7
Beatriz C. Fialho, Leandro Gauss, Priscila F. Soares, Maurício Z. Medeiros, Daniel P. Lacerda
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引用次数: 1

Abstract

Abstract

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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大流行背景下的疫苗创新元模型
摘要目的在过去十年中,传染病的连续爆发和流行对全球公共卫生机构的应急准备和响应系统提出了挑战,在这种情况下,疫苗已成为加强全球卫生安全的核心。然而,疫苗研发(R&D)是一个复杂、漫长、充满风险、不确定和昂贵的过程。除了严格、耗时的法规遵从外,一种新疫苗的注册需要多个候选者和多年的时间。在 COVID-19 大流行这样的全球健康危机中,这无疑是不受欢迎的。因此,本研究旨在了解大流行背景下研发模式的转变及其对疫苗创新价值链的影响。方法为此,本文对 27 篇文章和报告(2011-2021 年)进行了系统的文献综述和元综合,这些文章和报告涉及全球健康威胁、疾病爆发、流行病或大流行背景下的疫苗研发。结果将研究结果综合为一个元模型,该模型描述了大流行背景下的快速研发、其驱动力、创新、机制以及对疫苗创新价值链的影响。结论该研究表明,在大流行病背景下,基于监管机构、行业和学术界之间的密切合作并利用使能技术的快速研发流程可以将安全、稳定和有效的疫苗推向市场所需的时间大幅缩短,与传统研发流程相比平均缩短 11 年。此外,药物警戒和对真实世界证据的严格监控对于确保在大流行期间授权使用优质安全的产品至关重要。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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