The overseas laboratories are important sites for planning and carrying out field trials, studying naturally acquired immunity, and training. The funding of the overseas laboratories under the new management structure must be carefully considered during the transition.
It is clear that if the MIDRP Malaria Vaccine Program is to produce a malaria vaccine, a large increase in funding will be necessary. Military needs for a vaccine are unique and specific, and will not be met by others. Although the program has done an impressive amount of work with the relatively small budget available, and has been able to leverage significant outside funding, the overall amount available is not sufficient for advanced development of even one candidate antigen.
Recommendation 5.8: Sufficient funding should be made available to support the infrastructure to produce pilot-lot formulations of MIDRP malaria vaccine candidates in-house at the pilot production plant at Forest Glen (an invaluable part of the MIDRP Malaria Vaccine Program). Although pilot lots of all candidate vaccines cannot be made at Forest Glen, the ability to prepare certain candidates removes a major obstacle that would otherwise impede the program.
Recommendation 5.9: A formal economic analysis would be helpful to clarify current costs of malaria (both P. falciparum and P. vivax) prevention, treatment, and case management. This economic analysis would reveal the direct (monetary) and indirect (lost work time) costs that would be averted by both a first-generation vaccine (to be used in conjunction with chemoprophylaxis) and a second-generation vaccine (to replace chemoprophylaxis).
Recommendation 5.10: Given that malaria remains a major problem for U.S. military personnel deployed to endemic areas and this threat is not diminishing in importance with time, the MIDRP program to develop a malaria vaccine compatible with the needs for protecting U.S. military personnel should be fully supported. To increase the likelihood of achieving the current goals for a first-generation vaccine and to test the limited number of vaccine candidates described above will almost certainly require a several-fold increase in the current malaria vaccine development budget by 2010, with continuation at that level to at least 2015.