The complexity and cost of vaccine manufacturing - An overview.

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.

journal_name

Vaccine

journal_title

Vaccine

authors

Plotkin S,Robinson JM,Cunningham G,Iqbal R,Larsen S

doi

10.1016/j.vaccine.2017.06.003

subject

Has Abstract

pub_date

2017-07-24 00:00:00

pages

4064-4071

issue

33

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(17)30770-3

journal_volume

35

pub_type

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