The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
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Appendix D: Strategies for Achieving Full U.S. Participation in the Children's Vaccine Initiative
Appendix D: Strategies for Achieving Full U.S. Participation in the Children's Vaccine Initiative
Pages 170-183
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From page 170... ...
would require choosing among a range of strategies and options, each of which could have profound implications for the future development, production, delivery, and use of vaccines for children in economically disadvantaged countries of the world. To facilitate consideration of possible options, the committee devised three major "strategies.
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From page 171... ...
Under the current system, commercial manufacturers pursue the development of vaccines for which there is perceived to be adequate returns on investment. For the most part, commercial vaccine manufacturers cannot justify their investment either in the development of new vaccines or in the improvement of existing vaccines intended for predominately developingcountry markets.
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From page 172... ...
Assuming no fundamental changes in the current system of vaccine innovation summarized above, the committee identified three possible approaches for enhancing U.S. participation in the CVI: substantial increase in financial support for CVI vaccine research carried out by government agencies, federal purchase of existing vaccines for use in programs such as the EPI, and improvement in the delivery of existing vaccines.
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From page 173... ...
The purchase of existing vaccines is unlikely to lead to the development of new CVI vaccines under current market arrangements. In addition, because this approach is resource intensive, it is not likely to be sustainable in the long term, particularly with the advent of more expensive combination vaccines.
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From page 174... ...
Contribution to the Global CVI This option would enhance the quality control capacity of developing countries that are or would be capable of manufacturing CVI vaccine products and would foster production-sharing between the United States and those developing countries. It might also enable the United States to supply CVI vaccines to developing countries; however, under this option these vaccines would most likely be developed only if they also served an industrialized-count~y market.
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From page 175... ...
Both options hold the promise of facilitating the development of new vaccines against diseases of primary importance in developing countries as well as improvements in existing vaccines. Establishing partnerships between the public and private sectors through a brokering arrangement or establishing a CVI research and development facility would encourage the creation of technologically simple, low-cost vaccine technologies that could be easily transferred to vaccine manufacturers in developing countries.
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From page 176... ...
By guaranteeing a stable market for over a period of years and providing grants and various incentives, this option would both enable and encourage development-stage companies to develop CVI vaccines. One critical factor that this option does not address is the shortage of pilot production facilities in the United States.
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From page 177... ...
to the developing world through licensing agreements. Option 2: Develop an Entity with CVI-Related R&D and Pilot Manufacturing Capabilities In the event that the grants and contracts mechanism fails to stimulate sufficient private-sector interest, the creation of a publicly funded entity to conduct R&D and pilot manufacture for subsequent handoff to commercial manufacturers may be necessary.
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From page 178... ...
program seeks to encourage small businesses to engage in technological innovation and to commercialize discoveries originating in federally funded research and development through various mechanisms including grants, cooperative agreements, and contracts. To be eligible for the SBIR program, businesses must have fewer than 500 employees, be 51 percent U.S.
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From page 179... ...
With its own vaccine research and development and pilot manufacturing capabilities, the entity would enable the public sector to share the risk of developing vaccines that have marginal profitability. The entity could draw on relevant expertise in government laboratories and agencies and the private sector, perhaps through visiting scientists.
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From page 180... ...
Contribution to the Global CVI A new center for CVI research and development and pilot manufacture could lend considerable support to the CVI Product Development Groups and developing-country vaccine manufacturers. Also, as in option 1, the technology would be transferred to the developing world, through both licensing agreements and visiting scientist programs.
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From page 181... ...
electric cars and experimental batteries being tested on TVA facilities; (2) researching strategies to convert wood and farm products into alcohol for fuel; and (3)
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From page 182... ...
Despite the potential attractiveness of a vaccine manufacturer that would respond to unmet public health needs, the public sector does not have the experience in the large-scale manufacture of vaccines. In addition, efficient vaccine production does not lend itself to government procurement policies and bureaucracy, and this strategy does little to capitalize on the research, development, and manufacturing capabilites that already exist in the private sector.
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From page 183... ...
STRATEGIES FOR ACHIEVING FULL U.S. PARTICIPATION 183 and the extent to which each takes maximal advantage of U.S.
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