global entity with a governing board that includes representatives of WHO, UNICEF, and various nations (such as USAID for the United States). GAVI has been a coordinating mechanism for a number of major immunization initiatives such as the Vaccine Fund, the International Financing Facility for Immunization (IFFIm), and Advanced Market Commitments (AMCs). Finally, there are several disease-specific vaccine initiatives, including the Meningitis Vaccine Project, the Malaria Vaccine Initiative, and the AERAS Global TB Vaccine Foundation.

In June 2009 the committee held a meeting with stakeholders on Goal 5 in the National Vaccine Plan. Several themes surfaced during the meeting, reflecting areas of agreement about major challenges and opportunities in the field. These themes include the following:

  • Programmatic and infrastructure challenges, including most prominently surveillance and epidemiologic research to provide burden of disease data needed to inform vaccine research on and the development of new vaccines and to assess rates of vaccine-related adverse events,

  • The promise of PDPs and the U.S. government role,

  • Competing priorities: program-specific versus broader health infrastructure objectives and investment; periodic intensification of immunization (e.g., polio campaigns) versus routine immunization programs, and

  • Creating a viable market for vaccines using both innovative and well-established financing mechanisms (e.g., IFFIm, differential pricing).

CHALLENGES AND OPPORTUNITIES IN A CHANGING LANDSCAPE

In Chapter 1, the committee cites a 1997 paper prepared by the U.S. National Vaccine Advisory Committee on the “delicate fabric” of the public-private vaccine development enterprise (NVAC, 1997). A contemporary update of that paper would reflect greater complexity and a similar level of fragility. Also, it is no longer applicable to speak of the American enterprise without reference to the fact that it is part of a global network of national and international governmental, commercial, academic, and civil society actors. The makers of vaccines licensed for the United States are largely multinational corporations.

There are multiple barriers to ensuring that developing countries can immunize against major vaccine-preventable diseases. These include market-related factors (lack of incentive to develop vaccines for neglected diseases that affect low- and middle-income countries), financing (for both vaccine development and purchase), operational problems (lack of immunization infrastructure, health care workforce), managerial expertise, scientific and technical issues (such as the challenges encountered in developing HIV and



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