There is intense interest among scholars and the public about the risks, benefits, and pricing of pharmaceuticalsbut relatively little attention has been devoted to vaccine markets and the political, economic, and regulatory factors that influence their development. In this important new study, Ernst R. Berndt, Rena N. Denoncourt, and Anjli C. Warner investigate the key business drivers and challenges of vaccine markets, the complex interactions among their important stakeholders, and the emerging opportunities for growth. U.S. Markets for Vaccines: Characteristics, Case Studies, and Controversies examines several case studiesincluding vaccines for diphtheria, tetanus, pertussis, seasonal influenza, chicken pox, and shinglesthat demonstrate the diverse dynamics of vaccine markets. The authors consider the role of intellectual property protection in the discovery process, preclinical and clinical development issues, manufacturing and cost characteristics, and the challenges of marketing, product differentiation, pricing, and distribution. They also explore the process of obtaining regulatory approval from the U.S.
Food and Drug Administration and earning a spot on the Centers for Disease Control and Prevention's vaccination schedules for pediatric and adult populations. Finally, the authors address the controversial debate over an alleged link between childhood vaccinations and autism. Drawing upon extensive interviews with representatives from industry, insurance providers, government agencies, health-care providers, and academia, U.S. Markets for Vaccines offers a balanced and comprehensive snapshot of the changing landscape for vaccine markets.