malaria vaccines suitable for DoD needs. Malaria is a severe ongoing threat for U.S. military personnel deployed to malaria-endemic areas of the world, and current malaria prevention and control methods are indisputably inadequate.

COST AND TIME NEEDED TO PRODUCE A VACCINE

Assuming that a successful vaccine can be developed and produced, what are the likely costs of this task? These were estimated in a 2000 report from an independent committee of experts chaired by Franklin Top, M.D., that was convened to make recommendations on improving the DoD acquisition process for vaccines (Top et al, 2000). The report, Department of Defense Acquisition of Vaccine Production (referred to here as the “Top report”) examined the feasibility of vaccine production for defense against biological agents, but the findings are also relevant to naturally occurring diseases. They included cost estimates for vaccine development and production, and some summary findings of this report are reproduced in Table 2-3.

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 30–40 percent of the total vaccine development cost. The additional costs listed in Table 2-3 represent what would be required if the DoD were actually to produce a number of vaccines in-house (estimated by this report at 8 different vaccines, requiring human resources of approximately 2,500 skilled individuals). The concept here for a government-owned, contractor-operated facility is for full vaccine production, not just pilot-lot production.

The estimates of the Top report are compatible with those of Greco who used a $300 million estimate, of which the majority ($210 million)

TABLE 2-3 Industry Benchmark Cost Estimates for Vaccine Production

Element

Cost/Product (in $ millions)

Research and development

300–400

Facility capital costs

370 initiala

Additional production, labs, and support

75–115b

Manufacturing operations and maintenance

30–35 per year

a First three vaccines.

b For each vaccine beyond initial 3 to 4.

SOURCE: Top et al., 2000.



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