The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
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7 A Strategy to Enhance U.S. Participation in the Children's Vaccine Initiative
7 A Strategy to Enhance U.S. Participation in the Children's Vaccine Initiative
Pages 128-146
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From page 128... ...
seeks to harness new scientific technologies to advance the immunization of children throughout the world. The ideal CVI vaccine will require fewer doses and will be given near birth, be heat stable, effective against diseases for which vaccines are currently unavailable, and be affordable.
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From page 129... ...
A NATIONAL VACCINE AUTHORITY In the committee's view, the United States, through both the public and private sectors, has the potential to contribute most significantly to the achievement of the goals of the global CVI through the development and production of CVI vaccines (Chapters 3 and 4~. However, it has become clear to the committee that the fragmented system of vaccine research, development, and manufacture in the United States, which produces highquality vaccines for the domestic market, is not likely to produce the vast majority of CVI vaccines (Chapters 3, 4, and S)
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From page 130... ...
Because the private sector alone cannot sustain the costs and risks associated with the development of most CVI vaccines, and because the successful development of vaccines requires an integrated process, the committee recommends that an entity, tentatively called the National Vaccine Authority (NWA) , be organized to advance the development, production, and procurement of new and improved vaccines of limited commercial potential but of global public health need.
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From page 131... ...
tax credits, · investment-tax credits for firms that undertake CVI activities, · Small Business Innovation Research program grants for CVI products, · Cooperative Research and Development Agreements (CRADAs) , · access to an NVA pilot production facility, · financial assistance with clinical trials, and · assistance in assembling intellectual property rights.
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From page 132... ...
military personnel.) Setting Priorities and Product Characterization The first step in vaccine development is to set the priorities and describe the desired characteristics for a target vaccine.
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From page 133... ...
CVI vaccine development in conjunction with the global CVI · Characterize desired vaccine products · Assemble intellectual property rights · Advance CVI product development through the private sector · Conduct in-house vaccine-related R&D · Assist companies in the production of pilot lots of vaccine · Support clinical testing and field trials of candidate vaccines Transfer CVI-related vaccine technology to developing-country manufacturers · Train U.S. and overseas nationals in the principles of vaccine development, pilot manufacture, and quality control · Arrange and contribute to the procurement of NVA vaccines · Evaluate and redefine needs · Represent the United States in international CVI forums such as the Consultative Group .
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From page 134... ...
(The NVA could also take advantage of technology embodied in patents that were not the result of federally funded research. If CVI research or the supply of CVI products is By or for" the U.S.
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From page 135... ...
To accelerate the process of vaccine development, all R&D on NVA vaccines would be done under conditions of Good Laboratory Practices so that the results could be used in support of Investigational New Drug Applications and future Product License Applications. Manufacture of pilot lots of vaccine would be performed under Good Laboratory Practices and, whenever possible, current Good Manufacturing Practices on a scale sufficiently large to simulate closely the future manufacturing scale.
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From page 136... ...
Most private-sector collaborators will develop production methodologies in line with accepted quality control standards. The NVA, which would have some expertise in regulatory affairs, could serve as a link with the FDA and between vaccine development companies in the United States, foreign regulatory authorities involved in vaccine licensing, and international agencies such as the World Health Organization (WHO)
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From page 137... ...
To the extent that the risk and financial burden of vaccine development and clinical trials have been assumed by the public sector and the market size has been defined, it would become possible to negotiate licensing agreements that guarantee lower vaccine prices. The commercial vaccine manufacturers that license vaccines from the NVA would focus on efficient, high-volume manufacture at the lowest possible cost.
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From page 138... ...
The NVA must be organized in a way that enables it to work in partnership with commercial manufacturers. Appropriate partnerships for vaccine development, large-scale manufacturing, or marketing and distribution will be essential to making new vaccines available at an accelerated pace.
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From page 139... ...
The actual cost will depend on whether existing public-sector vaccine research and manufacturing capabilities are expanded or a new, freestanding unit is constructed and staffed. The proposed facilities should include applied research laboratories; pilot production capabilities for bacterial, viral, and parasitic vaccines (both at the bench-level scale and at a scale required to prepare sufficient amounts of vaccines for clinical trials)
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From page 140... ...
Agency for International Development The U.S. Agency for International Development commits substantial resources to the support of immunization programs and vaccine-related research around the world.
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The department's vaccine program is product development oriented and has a successful track record getting vaccine products developed, licensed, and utilized.
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From page 142... ...
There are six DOD field laboratories around the world, each of which has the capacity to conduct and evaluate the results of vaccine field trials. DOD might fear that an expanded mission in vaccine development would divert resources from its primary mission: protecting U.S.
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From page 143... ...
The agengy's experience in product development is less extensive, but is growing particularly through the use of CRADAs and since the establishment of the vaccine evaluation units (see Chapter 6~. The National Vaccine Progran' The National Vaccine Program (NVP)
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From page 144... ...
The committee believes that the NVA, through a dynamic partnership between the public and private sectors, will offer the United States a new tool for ensuring the availability of novel vaccines and vaccinerelated technologies for use in immunization programs around the world and in the domestic public health arena. The creation of an NVA-administered development and procurement program for C~I vaccines could greatly reduce the barriers to entry into vaccine production that many new biotechnology firms now face.
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From page 145... ...
NOTE 1. The development of the first meningococcal vaccine is a good example of how the DOD approaches vaccine development and how the committee anticipates the NVA to function.
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