was needed for the late development phase (Greco, 2004). The average time required for new vaccine development was estimated at 10 years (Struck, 1996).

By far, the two major direct costs in a decade-long vaccine development program that results in licensure of a final product are the clinical trials (mainly phase 2 and 3) and the construction and furbishing of a manufacturing facility where the vaccine can be produced following licensure. Depending on the specific vaccine, considerable costs early on may also be expended in process development to learn how to manufacture the vaccine in an economic and consistent manner. 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. The biologics license application also describes the features of the facility that will manufacture the vaccine. The costs of constructing and furbishing a manufacturing facility vary greatly from one vaccine to another. This depends not only on the characteristics of the specific vaccine but also on the maximal number of doses that the facility is expected to produce.

In summary, the estimated cost to achieve a high likelihood of development of a successful new vaccine ranges upward from a minimum of $300 million, spent over at least 10 years. Although the cost and time commitments to produce a vaccine seem enormous, these have to be balanced against the current expenses for prevention and treatment of malaria and the ineffectiveness of current prevention and control methods leading to high casualty numbers in many deployments (see Table 2-1).

Recommendation 2.2: The DoD should formally acknowledge the high cost of developing any new vaccine and the fact that the Military Infectious Diseases Research Program (MIDRP) Malaria Vaccine Program is severely underfunded in relation to the goal. To increase the probability of success, this discrepancy needs to be rectified.



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