A review of policy, practices, and players governing and involved in the United States vaccine and immunization enterprise

Angela K. Shen, Alice Y. Tsai, Guthrie S. Birkhead

Research output: Contribution to journalArticle


Purpose - The purpose of this paper is to outline the organization and governance of the US vaccine and immunization enterprise. It describes the major components of the US system including the various relationships between major federal government entities, stakeholders, and advisory committees that inform government policymaking at various points in the system. Design/methodology/approach - The authors describe the complex interdependent network of partners that engage in a wide range of activities such as disease surveillance, research, vaccine development, regulatory licensure, practice recommendations, financing, service delivery, communications, and post-licensure monitoring. Findings - The US system of governance is highly participatory and focuses on a transparent and open engagement, with input from a wide range of partners to inform decision-making. This collaborative framework allows many inputs to be heard and helps support the US vaccine and immunization system as it evolves to meet the continued public health needs in the USA through the optimal use of safe and effective vaccines. Originality/value - This is an invited article on the US vaccine and immunization enterprise. The development and availability of vaccines in the USA has had profound impact on mortality and morbidity and public health (Centers for Disease Control and Prevention, 2011). The success of this enterprise is a result of a blended public and private sector system with partnerships at the federal, state, and local levels of government to optimize the use of safe and effective vaccines. Governance structures have been established to support the interaction and decision-making among the federal and non-federal actors toward the common goal of controlling and preventing infectious diseases.

Original languageEnglish (US)
Pages (from-to)138-151
Number of pages14
JournalInternational Journal of Health Governance
Issue number3
Publication statusPublished - 2017
Externally publishedYes



  • Health law or regulation
  • Health policy
  • Infectious diseases
  • Primary care
  • Public health regulations
  • Vaccines or vaccination

ASJC Scopus subject areas

  • Health Policy
  • Public Health, Environmental and Occupational Health
  • Palaeontology
  • Strategy and Management

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