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Commercial realities have drastically reduced private investment in the development of new public health tools, but increased awareness of this situation has resulted in the emergence of a variety of research-based, nonprofit organizations. We reviewed current vaccine developments and developed a framework for efficient research and development investments in this area.
We have identified several key “push” and “pull” forces within the vaccine research and product development environment and have examined their impacts on the process. These forces affect the global vaccine pipeline, which is composed of all individual vaccine initiatives and global partnerships (i.e., stakeholders), All of these research and development stakeholders must work together to establish and promote a global, sustainable research and development pipeline that delivers optimal vaccines and immunization technologies.
VACCINES ARE THE cornerstone of the fight against communicable diseases. This has been proven by the success of smallpox eradication, the drastic reduction in polio cases during the past 20 years, the progress toward tetanus elimination, and the reduction of measles mortality. Despite these achievements, infectious diseases are still responsible for nearly 30% of all deaths worldwide; more than 15 million people die every year, mostly in low-income and middle-income countries.1 Approximately 1.5 million of these deaths could have been prevented if the currently available vaccines were made universally available. Additionally, licensed vaccines to combat many deadly childhood diseases do not yet exist (Figure 1 ▶).2
FIGURE 1
FIGURE 1—
Causes of death in children aged younger than 5 years.
Achievement of the United Nations (UN) Millennium Development Goals relies in part on the availability of new tools through research and product development, innovation, and breakthroughs. Goals (such as halving current child mortality figures by the year 2015 [Goal 4]; combating HIV/AIDS, malaria, and other diseases [Goal 6]; forging a global partnership for development; and partnerships ensuring access to medicines [Goal 8]) are highly pertinent to the vaccine community. In 2005 the World Health Assembly adopted an ambitious and comprehensive plan, the Global Immunization Vision and Strategy 2006–2015 (GIVS), for fighting vaccine-preventable diseases.3 This strategy has 3 priority objectives: (1) immunize more people against more diseases, (2) introduce a range of newly available vaccines and technologies, and (3) provide a number of critical health interventions through immunization. Development of new and improved vaccines, and enhanced coverage for old and new vaccines alike, will contribute substantially to global efforts to reduce disease burden and, in so doing, will reduce poverty.
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DRIVING FORCES FOR RESEARCH AND DEVELOPMENT
The research and product development process bridges the gap between scientific discovery and the delivery of tools for health intervention. Vaccines used today are the product of discovery and development during past decades. The aim of the research and product development process4 is to design effective and consistent methods for the identification and production of potential vaccines, test them for safety and efficacy in preclinical studies, and establish their efficacy in humans. There is a clear responsibility throughout vaccine development to both adhere to and be guided by a structured framework that embodies registration requirements and normative guidelines. This framework collectively ensures the ethics, safety, and quality of the research, manufacturing, and clinical development during the research and product development process.
It often takes more than 10 years to deliver a final, licensed vaccine,5 and requires not only excellence during research and product development but also managerial and funding commitment throughout the endeavor. The cost of developing a vaccine—from research and discovery to product registration—is estimated to be between US $200 million and US $500 million per vaccine.6 This figure includes vaccines that are abandoned during the development process. In short, vaccine research and product development is lengthy, complex, and loaded with binary outcome risks.
Several driving forces have an impact on the research and product development process that develops vaccines for nonprofit or low-profit markets that can be grouped into 2 categories: “push” and “pull”—terms that are commonly used when business strategies are being developed. Abstractly, a product is developed either because of a clear demand—a “pull”—for the vaccine in the marketplace or because it becomes technically and operationally feasible—a “push.” In practice, the actual delivery of the product to the population in need is dependent on the concerted action of both forces (Figure 2 ▶
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