The Children's Vaccine Initiative Achieving the Vision (1993) / Chapter Skim
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3 Resources and Infrastructure
3 Resources and Infrastructure
Pages 36-65
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RESOURCES IN THE UNITED STATES The United States supports a large number of public agencies and programs involved in vaccine-related activities (National Vaccine Advisory Committee, 1992~. Each year, the federal government spends hundreds of millions of dollars to conduct research for new and improved vaccines, ensure the safety of existing vaccines, purchase and distribute vaccines to the states, and conduct educational and other outreach activities to encourage vaccine use.
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, which is part of the Office of the Assistant Secretary for Health of the U.S. Department of Health and Human Services, is authorized to coordinate and provide direction to the nation's various vaccine-related efforts; this mandate is carried out under the guidance of the National Vaccine Advisory Committee, which is composed of representatives of government agencies, public health experts, private industry, and citizens groups.
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CBER has also received support from the National Vaccine Program Office (NVPO)
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Among other tasks, states must distribute and administer vaccines, develop and maintain systems that can be used to detect adverse events associated with vaccination, conduct disease surveillance, assess immunization levels, and provide professional educational materials about the importance of vaccination. CDC also has developed the national vaccine stockpile, currently having a 26-week reserve of most childhood vaccines, to manage any short-term interruption in supply.
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(Table 3-1~. Although CDC does not sustain overseas laboratories, it does support overseas field stations that conduct research and training in infectious diseases as collaborative activities with the host country.
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Vaccine research and development is also conducted at the U.S. Army Institute of Infectious Diseases (USAMRIID)
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DOD completed modernization of its own pilot vaccine manufacturing facility in 1992 at Forest Glen, Maryland, at an estimated cost of $5 million. This $25 million facility, expected to be fully validated and functional in October 1993, will be capable of producing up to 1 million doses of vaccine for clinical trials annually by using traditional or modern molecular biology techniques (Jerald C
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. Recommendations of the task force included the following: applied vaccine research, including studies on the most effective bacterial or viral carriers, increased temperature stability, improved efficacy and safety of adjuvants, and the development of preparations allowing for the controlled release of immunogens for single-dose vaccines; development of more effective, safer, and preferably, oral vaccines; and production of experimental vaccines on a pilot plant scale and under acceptable conditions for subsequent use in clinical trials (National Institute of Allergy and Infectious Diseases, 1992a)
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NICHD currently spends approximately $8 million tO $9 million on pediatric vaccine-related activities. National Vaccine Program Organized efforts to develop a vaccine policy for the United States began during World War II, when the Armed Forces Epidemiology Board planned the vaccine strategies for the war effort.
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The congressional committee that drafted the legislation believed that a National Vaccine Plan would provide the strongest argument for an infusion of new funds into vaccine and immunization programs. However, the Reagan Administration opposed the National Vaccine Program.
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run by the Health Resources and Services Administration have as a central mandate the provision of immunizations to particularly needy populations. Funds in the Maternal and Child Health Block Grant program are used by the states' local health departments to improve vaccine delivery services.
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Massachusetts holds licenses from FDA to manufacture several vaccines, including the combination diphtheria and tetanus toxoid and pertussis vaccine (DTP) , combination diphtheria-tetanus toxoids, and combination adult tetanus and diphtheria toxoids.
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Connaught Laboratories, Inc., in Swiftwater, Pennsylvania, is a wholly owned subsidiary of Connaught Laboratories Ltd., of Toronto, Canada. Connaught Laboratories Limited has, since 1989, been a subsidiary of Pasteur Merieux Serums et Vaccins, which is 51 percent owned by RhonePoulenc, a highly diversified French chemical and pharmaceutical company which is partially held by the government of France.
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Products in the development pipeline include a respiratory syncytial virus vaccine and a Sabin inactivated polio vaccine (Jane Scott, Lederle-Praxis Biologicals, personal communication, 1992; Pharmaceutical Manufacturers Association, 1990~. Lederle-Praxis Biologicals, which has traditionally focused exclusively on the U.S.
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As of the beginning of 1992, SB had both an improved pertussis vaccine and an improved polio vaccine in phase III clinical trials. Although the company produces a number of vaccines, only its hepatitis B vaccine is approved for sale in the United States.
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is a biotechnology company with research and production facilities in Beltsville, Mainland. In 1991, phase III clinical testing of the company's acellular pertussis vaccine (in combination with diphtheria vaccine and tetanus toxoids)
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MedImmune is collaborating with Merck on the AIDS vaccine and with Connaught Laboratories, Inc., on the Lyme disease vaccine. A number of other BCG-based vaccines-against pneumococcal pneumonia, hepatitis B
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, health education for parents expecting a child, and advocacy for state and national legislation concerning maternal, prenatal, and child health (March of Dimes Birth Defects Foundation, 1991~. Rockefeller Foundation Located in New York City, the Rockefeller Foundation is one of the oldest and largest philanthropic entities in the United States.
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The Rotary initiative PolioPlus has made grants to nearly 100 developing countries for the purchase of polio vaccine from the United Nations Children's Fund and Pan American Health Organization sources. Rotary International was among the first donors to support the CVI by providing funds for the product development group on a heat-stable oral polio vaccine (OPV)
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government agencies, private firms, and other organizations involved in vaccine-related activities, and despite specific legislation mandating a National Vaccine Plan, there has been no overall strategy guiding the research, production, procurement, and distribution of childhood vaccines in the United States. As noted in a recent Institute of Medicine report, ".
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PAHO raises money to assist its 38 member countries in carrying out health programs, disseminates scientific and technical information throughout the inter-American region, trains health-care workers and strengthens national training institutions, and hires scientific and technical experts to address priority health issues in Latin America and the Caribbean (Pan American Health Organization, undated)
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Financed by voluntary contributions from governments, $1.4 billion was pledged to UNDP from member nations in 1991 (United Nations Development Program, 1992~. UNDP is currently exploring the possibility of setting up an international vaccine institute in East Asia tO facilitate improvements in vaccine quality and tO promote technology transfer.
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It is currently financing a project in the People's Republic of China to build new vaccine manufacturing facilities for DTP, oral polio vaccine, and measles vaccine. World Health Organization Created in 1948, WHO is an intergovernmental organization within the United Nations system that is responsible for coordinating and directing international public health matters.
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Program for Vaccine Development The Program for Vaccine Development (PVD) , which was initiated by the Director-General of WHO in 1984, coordinates international vaccine development with academic institutions and other scientific groups and encourages the participation and training of scientists from developing countries.
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. State Bacteriological Laboratories in Sweden and the State Serum Institute of Denmark also import or produce vaccines that are deemed necessary for their respective national immunization programs.
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The measles vaccine has improved ~., significantly and is now in its fourth generation, yet Brazil has been unable to gain access to this improved vaccine production technology (Homma and Knouss, 1992~. Private-Sector Resources As of 1992, seven private European vaccine manufacturers produced the majority of vaccines used by Europe and much of the rest of the world.
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, which is attempting to establish a large scale production capacity for DTP, tetanus toxoids, oral polio vaccine, and measles vaccine in the People's Republic of China through joint development, training, and technology transfer. Another ongoing project involves the upgrading and modernization of DTP production and quality control in Indonesia (this activity is supported by a loan from the Dutch government)
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Nongovernmental Organizations Finally, several international nongovernmental organizations support key aspects of immunization programs around the world. Task Force for Child Survival and Development Formed in 1984, the Task Force for Child Survival and Development is supported by the World Health Organization, UNICEF, the World Bank, the United Nations Development Program, and the Rockefeller Foundation.
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1991. Memo to Friends of the National Vaccine Program.
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National Institute of Allergy and Infectious Diseases.
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