early clinical trials of candidate vaccines in humans. Important information to be garnered includes the precise correlates of malarial immunity, the molecular basis for the duration of protection, and the necessary elements of the antigenic repertoire that must be included in an effective, multicomponent malaria vaccine.
A substantial remaining problem in accelerating malaria vaccine research and development is the number of options that must be weighed and selected. Scores of parasite-derived proteins and parts of proteins have been identified, any of which may be important components of a useful vaccine. Several means for producing antigens, a number of new adjuvants, and new concepts such as nucleic acid vaccines and particle delivery systems must all be considered, and the most promising approaches tested, before substantial progress toward a new, effective malaria vaccine is ensured.
There is currently no effective single locus of U.S. governmental activities directed toward malaria vaccine research and development. The Federal Malaria Vaccine Coordinating Committee (FMVCC) has attempted to fulfill this role, but lacks the authority and resources to do so (see Chapter 6 for a description of FMVCC). As a result, government-funded vaccine development remains disarticulated, with no overall strategy in place, and there is inadequate communication and coordination among malaria vaccine researchers and developers in government, academia, and industry.
The consequences of this lack are profound. Representatives of industry at the workshop complained about the lack of a necessary “point of contact” in government that they could go to with questions or concerns relating to malaria vaccine product development. They noted that the lack of a federal strategy for vaccine development—one that necessarily focuses on a limited number of vaccine entities judged to have the highest probability of success—further discourages industry's involvement in malaria vaccine development.
This lack of coordinated effort and strategic planning in the U.S. domestic arena extends to the international arena. As noted by the participants in the workshop, with the exception of FMVCC, there is no U.S. entity that effectively represents the views and concerns of the U.S. government, academia, and industry abroad.