severe disease. Furthermore, if the vaccine is highly efficacious, a randomized trial may provide useful information about the proportion of severe pneumonia caused by the vaccine-type pneumococci. This information is impossible to get in a postlicensure study, since those who get vaccine in an uncontrolled setting usually have very different risk factors for disease and different likely access to diagnostic testing (i.e. blood culture).23 Vaccine makers themselves may push for more than one randomized study to obtain pivotal trial-quality data.24 Indeed, there may be some benefit in conducting identically designed efficacy trials in many parts of the world at once, as was done with typhoid vaccine in the 1960s.25

The Public-/Private-Sector Interface26

The interface between the public and private sectors is different at each point along the vaccine R&D pipeline. Similarly, the sources of funding, the forces driving the system, accountability, and risks associated with R&D vary according to the perspective of the participant (Table 2).

During the early phases of research, when there is undefined potential and significant risk, industry may directly fund projects in public-sector labs or it may work collaboratively with the public sector. Later stages of vaccine development, which require major resources and long-term facility use, tend to be unique to industry, however.

Clinical research presents a number of opportunities for useful interactions between industry and others in both the developed and developing world. It is desirable, particularly for vaccines for the developing world, that these contacts be made as early as possible in the clinical-testing process. Manufacturing is capital intensive, and transferring to the developing world the ability to make vaccine is an extremely complex process. Even so-called turn-key operations, in which a modern plant is built from the ground up and staffed with trained personnel, can be plagued with problems related to product consistency and process validation.

From industry’s point of view, one major downside of interacting with the public sector is potential loss of control of the research process. This may happen, for instance, when a clinical trial being conducted by the government with vaccine supplied by industry goes awry, producing data that may not be

23  

Claire Broome.

24  

George Curlin.

25  

Myron Levine.

26  

Unless otherwise noted, the material in this section is based on presentations by Frank Malinoski, Dale Spriggs, and George Curlin.



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