Establishing government-operated vaccine programs: an industry perspective.

During 2000-2002, shortages of numerous routinely administered pediatric vaccines occurred. The reasons for these shortages were varied, but they included policy, manufacturing, and regulatory issues. The use of government manufacturing programs has been proposed as a way to stabilize the fragile vaccine supply and to prevent periodic shortages. Although such programs might be useful for defense needs, it is likely that such an approach would have limited value for routinely administered vaccines. Each of the vaccine components would require a dedicated manufacturing facility, and many components are administered in combination vaccines. Timing is also an important consideration. The restarting of an idled manufacturing facility would take many months; in addition, it often takes nearly 12 months to produce and release a single lot of vaccine. Finally, government-owned programs would face the same issues of regulatory changes, technological advancements, and facility updates as non-government-owned programs do--all of which would require sustained operation and investment. A secure and stable vaccine supply is best built by establishing the importance and value of our vaccine programs, which would, in turn, provide incentives to manufacturers to build capacity and inventories.