There is intense interest among scholars and the public about the
risks, benefits, and pricing of pharmaceuticals but 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 studies including
vaccines for diphtheria, tetanus, pertussis, seasonal influenza,
chicken pox, and shingles that 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.
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