The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
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5 Investing in New and Improved Vaccines
5 Investing in New and Improved Vaccines
Pages 98-108
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From page 98... ...
in the United States. The states of Massachusetts and Michigan manufacture combination diphtheria and tetanus toxoids and pertussis vaccines for their respective populations, but procure the oral polio vaccine from Lederle-Praxis Biologicals and the combination measlesmumps-rubella vaccine from Merck and Co., Inc.
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From page 99... ...
The analogy has been made that pharmaceutical manufacturing is similar to chemistry, whereas vaccine production is more like agriculture: drugs can be synthesized and put in tablet form within days to weeks; however, it can take a year or more, with complicated intervening steps, between the first culture of a vaccine product and its eventual use in a child. Vaccine manufacturing also requires substantially greater investment in sophisticated and elaborate production facilities than is typically true for pharmaceutical production (Institute of Medicine, 1992~.
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From page 100... ...
Even if the technological feasibility of a vaccine product is established, commercial manufacturers may be unwilling to pursue development. The anticipated costs associated with R&D may be too high, patent issues may be too complex, the licensing process may present unacceptable obstacles, and the risks of liability may appear too great.
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From page 101... ...
The size of the market is defined by the birth cohort in the United States, roughly 4 million live births annually, and the number of visits children make to clinics or pediatricians to receive necessary booster shots. There are two major classes of buyers of childhood vaccines: the public sector (including federal and state governments)
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From page 102... ...
government. Speaking to a representative of a major vaccine manufacturer at a congressional hearing, Senator Paula Hawkins argued, "How can you justify charging nearly three times as much to the U.S.
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From page 103... ...
Indeed, in announcing his new childhood immunization initiative on February 12, 1993, President Clinton said, "I cannot believe that anyone seriously believes that America should manufacture vaccines for the world, sell them cheaper in foreign countries, and immunize fewer kids as a percentage of the population than any nation in this hemisphere but Bolivia and Haiti (Clinton, 1993~. Intellectual Property For the purposes of this report, intellectual property rights include patents, patent applications, and know-how.
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From page 104... ...
303,309 (1980) , a landmark legal decision that affirmed the patentability of microbial life forms and "anything under the sun that is made by the hand of man.n Increasingly, layers of patent applications are filed-often by different groups and companies-on techniques, components, and genetic subassemblies of microbial systems used in the manufacture of biologics.
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From page 105... ...
Requests for injunctions are sometimes refused when the patent infringer is meeting a public health need that would otherwise go unserved. To grant such an injunction in private litigation is entirely within the discretion of courts, however, and few private companies are willing to bank on the court's unwillingness to grant such a remedy.
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From page 106... ...
, authorized by the U.S. Congress in 1986 and implemented in 1988, was an attempt both to compensate the families of children adversely affected by government-mandated vaccines and to shore up the vaccine industry by eliminating liability risk through the imposition of a vaccine excise tax (Public Health SeIvice Act, 1987; 100 Stat.
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From page 107... ...
It is too early to assess the program's impact on future cases of liability against individual manufacturers, and it is not entirely clear that the compensation program is having the desired impact on the number of vaccine manufacturers in the business (see Appendix B)
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From page 108... ...
Childhood vaccine research and development issues. April 8.
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