Vaccines in the pipeline: the path from development to use in the United States.

New vaccines in the United States go through a complex process on their path from development to the domestic market involving an intricate partnership of public and private agencies and organizations. This process includes licensure by the US Food and Drug Administration, the development of recommendations by the Advisory Committee on Immunization Practices, and safety oversight post-licensure. This article examines the roles of the US Food and Drug Administration and the Centers for Disease Control and Prevention as well as certain professional organizations in governing the testing, marketing, and usage of new vaccines. Vaccines currently in development to treat numerous infectious and noninfectious diseases are also examined and compared with frameworks of domestic vaccine development prioritization, past and present, as assessed by the Institute of Medicine.