and administering safe and effective vaccines for all people. The Introduction highlights key issues in the health care delivery system and in society, and also comments on the significance of the evolving 2009 novel H1N1 influenza pandemic.


The NCVIA called for the Secretary of Health and Human Services to serve as the director of the National Vaccine Program,4 for a plan outlining the activities of the program to be updated annually,5 an advisory committee to provide guidance to the secretary and the program, and a budget to support specific types of program activities. The act also listed nine responsibilities for the program and its director (Public Law 99-660, Title XXI, Subtitle 1, Section 2102):

  1. Vaccine research

  2. Vaccine development

  3. Safety and efficacy testing of vaccines

  4. Licensing of vaccine manufacturers and vaccines

  5. Production and procurement of vaccines

  6. Distribution and use of vaccines

  7. Evaluating the need for and the effectiveness and adverse effects of vaccines and immunization activities

  8. Coordinating governmental and non-governmental activities

  9. Funding of federal agencies

Although the National Vaccine Program has had some great successes and there have been examples of effective coordination, neither NVPO (whose stated work is to provide “leadership and coordination among Federal agencies, as they work together to carry out the goals of the National Vaccine Plan”) nor the plan have functioned as intended in the 1986 legislation. This report includes several case studies that illustrate gaps or limitations in the program’s ability to perform important functions without the benefit of a strong, capable, and adequately resourced NVPO. These issues


Although the 1986 legislation did not specify the placement of NVPO and its relationship to the Secretary of HHS, delegation of authority by the secretary led to placement of the office in the Office of the Assistant Secretary for Health (ASH), and made the ASH the head of the National Vaccine Program. The National Vaccine Advisory Committee (NVAC) charter states that “Pursuant to the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (46 FR 61318, dated December 2, 1977; as amended in 52 FR 23502, dated June 22, 1987), the ASH shall serve as Director of the National Vaccine Program.”


In 1998 the requirement for annual updates of the National Vaccine Plan was repealed by Public Law 105-362, Title VI, § 601(a)(1)(H), Nov. 10, 1998, 112 Stat. 3285.

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