疫苗生产的复杂性与成本——概述

The complexity and cost of vaccine manufacturing - An overview.

作者信息

Plotkin Stanley, Robinson James M, Cunningham Gerard, Iqbal Robyn, Larsen Shannon

机构信息

University of Pennsylvania and Vaxconsult, USA.

Independent consultant, USA.

出版信息

Vaccine. 2017 Jul 24;35(33):4064-4071. doi: 10.1016/j.vaccine.2017.06.003. Epub 2017 Jun 21.

Abstract

As companies, countries, and governments consider investments in vaccine production for routine immunization and outbreak response, understanding the complexity and cost drivers associated with vaccine production will help to inform business decisions. Leading multinational corporations have good understanding of the complex manufacturing processes, high technological and R&D barriers to entry, and the costs associated with vaccine production. However, decision makers in developing countries, donors and investors may not be aware of the factors that continue to limit the number of new manufacturers and have caused attrition and consolidation among existing manufacturers. This paper describes the processes and cost drivers in acquiring and maintaining licensure of childhood vaccines. In addition, when export is the goal, we describe the requirements to supply those vaccines at affordable prices to low-resource markets, including the process of World Health Organization (WHO) prequalification and supporting policy recommendation. By providing a generalized and consolidated view of these requirements we seek to build awareness in the global community of the benefits and costs associated with vaccine manufacturing and the challenges associated with maintaining consistent supply. We show that while vaccine manufacture may prima facie seem an economic growth opportunity, the complexity and high fixed costs of vaccine manufacturing limit potential profit. Further, for most lower and middle income countries a large majority of the equipment, personnel and consumables will need to be imported for years, further limiting benefits to the local economy.

摘要

当公司、国家和政府考虑投资于常规免疫和应对疫情的疫苗生产时,了解与疫苗生产相关的复杂性和成本驱动因素将有助于做出商业决策。领先的跨国公司对复杂的制造流程、进入该领域的高科技和研发壁垒以及疫苗生产相关成本有很好的理解。然而,发展中国家的决策者、捐助者和投资者可能并不了解那些持续限制新制造商数量、导致现有制造商出现人员流失和合并的因素。本文描述了获取和维持儿童疫苗许可的流程及成本驱动因素。此外,当目标是出口时,我们阐述了以可承受的价格向资源匮乏市场供应这些疫苗的要求,包括世界卫生组织(WHO)预认证流程及相关政策建议。通过提供对这些要求的全面综合视角,我们旨在提高全球社会对疫苗生产相关的收益与成本以及维持稳定供应所面临挑战的认识。我们表明,虽然疫苗生产表面上看似是一个经济增长机会,但疫苗生产的复杂性和高固定成本限制了潜在利润。此外,对于大多数低收入和中等收入国家来说,大部分设备、人员和耗材在数年时间里都需要进口,这进一步限制了对当地经济的益处。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c31d/5518734/e2fd283ebf6f/gr1.jpg

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