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Layton, C., & Lenfestey, N. (2005). Influenza vaccine manufacturing. Issue brief. RTI International. Prepared for Office of Science and Data Policy, Department of Health and Human Services, Washington, DC
Influenza vaccine manufacturers have experienced intense scrutiny in recent years. Uncertain demand, short turnaround in vaccine production, evolving regulatory requirements, rising production costs, and mergers and acquisitions represent a few of the challenges facing manufacturers in this dynamically changing industry. This issue brief provides an overview of the following areas:
- key issues facing influenza vaccine manufacturers; - biology of the influenza virus and history of influenza vaccination; - influenza manufacturing process; - structure of the industry and nature of the influenza vaccine market; and - factors that influence manufacturer decision making—quantity of vaccine produced, investments in new technologies, and entry into and exit from the U.S. influenza vaccine market.