Battling Malaria Strengthening the U.S. Military Malaria Vaccine Program (2006) / Chapter Skim
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2 The Malaria Threat and Need for a Vaccine
2 The Malaria Threat and Need for a Vaccine
Pages 13-20
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falciparum malaria) is thought to be around 1.1 million (WHO, 2002; Breman et al., 2004)
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Some actions involved TABLE 2-1 Major U.S. Military Actions, Deployments, or Overseas Exercises in Locations with a Malaria Threat Location Year Threat Morbidity and Mortality Civil War 18611865 P
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e Some operational areas were intense: Ia Drang Valley (1966) malaria rate 600/1000/year, equivalent of 2 maneuver battalions rendered inoperative.
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in Locations with a Malaria Threat (1990 Onward) Area Country Africa Kenya, Tanzania, Sierra Leone, Uganda, Cameroon, Zambia, Sudan, Ethiopia, Gambia Asia Indonesia/East Timor, Papua New Guinea, Solomon Islands, Malaysia, Thailand, Cambodia, Laos, India, Pakistan, Bangladesh, Myanmar, Sri Lanka Middle East Iran, Syria, Turkey, Saudi Arabia, Yemen Americas/ Panama, Honduras, Colombia, Brazil, Peru, Guatemala, Nicaragua, Haiti, Caribbean Dominican Republic NOTE: Increasing multidrug resistant P
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Soon reports of clinical failures occurred and by the mid-1990s clinical failure rates reached 50 percent in Southeast Asia. In the early 1970s, pioneering clinical trials by academic investigators (Clyde, 1975)
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One must anticipate that operational scenarios similar to the Marine expeditionary unit in Liberia will continue to occur elsewhere in Africa and in other malarious regions of the world. Currently troops sent to endemic areas are expected to take malaria prophylactic drugs as instructed and to use personal protective measures such as mosquito nets and insecticide-impregnated uniforms.
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The research and development costs estimated by the Top report for discovery through production and licensure of a single vaccine were $300 to $400 million, in year 2000. It is estimated that clinical trials represent 3040 percent of the total vaccine development cost.
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The biologics license application submitted to the FDA contains extensive information characterizing the product and summarizes the safety, immunogenicity, and efficacy data from well-designed clinical trials. The application also contains information documenting that the manufacturing processes result in a product that is consistent in relevant characteristics and in the clinical acceptability and immunogenicity of different lots.
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