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Infrastructure |
PROLOGUE
The Infrastructure For Vaccine Development
The announcement by the U.S. Centers for Disease Control and Prevention (CDC) in March 2005 that rubella has been eliminated from the United States represents the latest in a long line of tributes to the power of immunization to protect the health of populations. The story of rubella is instructive. By 1965 there were some 12.5 million cases of rubella reported in the United States, culminating in 12,000 babies of rubella-infected pregnant women being born deaf, blind, or both; 6,200 stillbirths; and more than 5,000 abortions. In the wake of the development of a vaccine and an aggressive immunization program, by 2004 only nine rubella infections were reported domestically. In fact, as Walter Orenstein and colleagues tell us, vaccines have reduced illness due to such highly virulent diseases such as smallpox, diphtheria, measles, mumps, pertussis, and polio by at least 87 percent, and in some cases upwards of 99 percent.
This year in particular, the intense "horse trading" characterizing the budget season on Capitol Hill illustrates the heightened necessity of ensuring that the maximum "bang" is gleaned for every health-related "buck" appropriated. In such an environment, the value of vaccine technology takes on increasing importance. Experts have consistently ranked immunization as one of the most cost-effective health interventions of the modern age. For example, as Orenstein notes, for every dollar allocated to childhood vaccination against nine vaccine-preventable diseases, $5.80 was saved in direct medical costs. Yet despite all of the evidence, apart from brief interludes when lawmakers’ attention was focused on addressing moments of crisis, as occurred during the vaccine supply shortage of 2004, discourse on ensuring the integrity of the vaccine development and production infrastructure has largely languished.
The papers that follow offer readers a window into the complex, multidimensional public-private partnership governing the development of vaccines. First, Orenstein and colleagues offer a comprehensive roadmap for negotiating the vaccine infrastructure. Next, Alexandra Minna Stern and Howard Markel provide a historical perspective, drawing lessons from the past, with implications for the future of vaccinology. Paul Offit, with an accompanying Perspective by Stanley Plotkin, takes on the issue of the steady decline in the number of pharmaceutical companies electing to stay in the vaccine business, while Margaret Coleman and colleagues fill in the missing pieces of the puzzle by reporting on dialogue between the CDC and the vaccine industry in which industry airs its concerns. Finally, Margaret McCluskey and her colleagues shed light on the practical obstacles confronting vaccine researchers, providing guidance to policymakers on how best to facilitate development of an HIV vaccine.
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