Given the importance of vaccines in public health programs, governments and donors have invested in vaccine R&D and production in low-resource settings. Where Expanded Program on Immunization (EPI) vaccines are provided, vaccine uptake has increased and childhood morbidity and mortality have fallen. These include: supply security, control over production scheduling and sustainability, control of costs, socio-economic development, and rapid response to local epidemics including emerging infectious diseases. 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.ĭespite the market dominance of vaccine manufacturers based in high and middle-income countries, there are many reasons why a low-income country or regional grouping of countries may want to establish their own vaccine 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. 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. 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. This paper describes the processes and cost drivers in acquiring and maintaining licensure of childhood vaccines. 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. 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. 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.
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