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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.

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.

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.

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.

One of the causes of the Iranian revolution of 1978–1979 was that the Iranian government had serious administrative deficiencies. Amir Taheri, a well-known Iranian journalist, wrote in the mid-1978 that public disturbances were “due to an accumulation of discontent with tight control, over-centralization, lack of sufficient open debate and a general feeling that corruption and inefficiency together with arrogance have struck the bureaucracy.”¹ These administrative problems were not new. An important scholarly examination of the Iranian political system in the early1970s concluded that the “problems of governance in Iran are profound. Inefficiency is their hallmark….”²