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The complexity and cost of vaccine manufacturing – An overview

Vaccine, 2017-07, Vol.35 (33), p.4064-4071 [Peer Reviewed Journal]

The Authors ;2017 The Authors ;Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved. ;Copyright Elsevier Limited Jul 24, 2017 ;2017 The Authors 2017 ;ISSN: 0264-410X ;EISSN: 1873-2518 ;DOI: 10.1016/j.vaccine.2017.06.003 ;PMID: 28647170

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Title:
The complexity and cost of vaccine manufacturing – An overview
Author: Plotkin, Stanley ; Robinson, James M ; Cunningham, Gerard ; Iqbal, Robyn ; Larsen, Shannon
Subjects: Allergy and Immunology ; Children ; Cost engineering ; Costs ; Developing countries ; Economic development ; Economic growth ; Economics ; Equipment costs ; Gavi ; Humans ; Immunization ; LDCs ; Licensure ; Manufacturing ; Manufacturing costs ; Manufacturing industry ; Marketing ; Markets ; Outbreaks ; Pricing ; Product development ; Quality ; R&D ; Research & development ; Review ; Technology Transfer ; Technology, Pharmaceutical - economics ; Technology, Pharmaceutical - methods ; UNICEF ; Vaccines ; Vaccines - isolation & purification ; WHO, Prequalification ; World Health Organization
Is Part Of: Vaccine, 2017-07, Vol.35 (33), p.4064-4071
Description: 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.
Publisher: Netherlands: Elsevier Ltd
Language: English
Identifier: ISSN: 0264-410X
EISSN: 1873-2518
DOI: 10.1016/j.vaccine.2017.06.003
PMID: 28647170
Source: MEDLINE
ProQuest Central

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The complexity and cost of vaccine manufacturing – An overview

The Authors ;2017 The Authors ;Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved. ;Copyright Elsevier Limited Jul 24, 2017 ;2017 The Authors 2017 ;ISSN: 0264-410X ;EISSN: 1873-2518 ;DOI: 10.1016/j.vaccine.2017.06.003 ;PMID: 28647170

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