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提高疫苗生产能力——关键瓶颈和经验教训。

Upscaling vaccine manufacturing capacity - key bottlenecks and lessons learned.

机构信息

Athena Institute, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

Athena Institute, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.

出版信息

Vaccine. 2023 Jul 5;41(30):4359-4368. doi: 10.1016/j.vaccine.2023.05.027. Epub 2023 Jun 3.

DOI:10.1016/j.vaccine.2023.05.027
PMID:37277250
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10239264/
Abstract

The COVID-19 pandemic put enormous pressure on the vaccine production chain as billions of vaccines had to be produced in the shortest timeframe possible. Vaccine production chains struggled to keep up with demand, resulting in disruptions and production delays. This study aimed to make an inventory of challenges and opportunities that occurred in the production chain of the COVID-19 vaccine. Insights derived through approximately 80 interviews and roundtable discussions were combined with findings from a scoping literature review. Data were analysed through an inductive process where barriers and opportunities were linked to specific facets of the production chain. Key bottlenecks identified include a lack of manufacturing facilities, a lack of tech-transfer personnel, inefficient arrangement of production stakeholders, critical shortages in raw materials, and restricting protectionist measures. A need for a central governing body to map out shortages and to coordinate allocation of available resource became evident. Other suggested solutions were to repurpose existing facilities and to build in more flexibility in the production process by making materials interchangeable. Also, simplification of the production chain could be achieved through geographical reengagement of processes. Three overarching themes were identified, impacting overall functioning of the vaccine production chain: regulatory and visibility, collaboration and communication, and funding and policy. The results in this study showed a multitude of interdependent processes underlying the vaccine production chain, executed by diverse stakeholders with differing objectives. It characterizes the global complexity of the pharmaceutical production chain and highlights its extreme vulnerability to disruptions. More resilience and robustness must be integrated into the vaccine production chain, and low-middle income countries should be empowered to manufacture vaccines themselves. In conclusion, there's a need to rethink the production system for vaccines and other essential medicines in order to become better prepared for future health crises.

摘要

新冠疫情大流行给疫苗生产链带来了巨大的压力,因为需要在尽可能短的时间内生产数十亿支疫苗。疫苗生产链难以满足需求,导致生产中断和延迟。本研究旨在梳理新冠疫苗生产链中出现的挑战和机遇。通过大约 80 次访谈和圆桌讨论获得的见解与文献综述的研究结果相结合。通过归纳过程分析数据,将障碍和机遇与生产链的特定方面联系起来。确定的主要瓶颈包括缺乏制造设施、缺乏技术转让人员、生产利益相关者的安排效率低下、原材料严重短缺以及限制保护主义措施。显然需要一个中央管理机构来规划短缺情况,并协调可用资源的分配。其他建议的解决方案包括重新利用现有设施,并通过使材料可互换来增加生产过程的灵活性。此外,通过重新参与地理流程,可以简化生产链。确定了三个总体主题,影响疫苗生产链的整体运作:监管和可见度、合作与沟通以及资金和政策。本研究的结果显示,疫苗生产链背后存在着许多相互依存的过程,由具有不同目标的不同利益相关者执行。它描绘了全球制药生产链的复杂性,并强调了其对中断的极端脆弱性。必须在疫苗生产链中融入更多的弹性和稳健性,并且应该赋予中低收入国家自行制造疫苗的能力。总之,需要重新思考疫苗和其他基本药物的生产系统,以便为未来的健康危机做好更好的准备。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/877cfe594e3e/fx3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/2c60d0706e7a/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/af06a68b6bfc/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/efe8002bf346/fx1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/1a39d772f11d/fx2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/877cfe594e3e/fx3_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/2c60d0706e7a/gr1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/af06a68b6bfc/gr2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/efe8002bf346/fx1_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/1a39d772f11d/fx2_lrg.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3a53/10239264/877cfe594e3e/fx3_lrg.jpg

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