Change in the time and resources required for vaccine discovery and development from 1980 to 2010. In the 1980s vaccine discovery required a long time, while development periods were relatively short. More recently, the time involved in new vaccine discovery has shortened dramatically due to the availability of various new technologies. However, in the meantime the regulatory requirements have lengthened the development timelines substantially. This results in longer times for vaccine licensure and significant increases in development costs.

SOURCE: Adapted from Rappuoli and Alderem, 2011.

(Milstien and Candries, 2002). The burgeoning research and development budgets coupled with increasing regulatory complexity and the increased time required for the development of a new vaccine made the decision process very challenging and necessitated the use of sophisticated models to predict the returns on the investment.

Moreover, while high-income countries face greatly increased lengths of time and various financial and scientific challenges when developing new vaccines, as illustrated in Figure 1-1, developing vaccines for use only in low-income countries is perhaps even more challenging, as there are fewer mechanisms in place to develop those vaccines (Batson, 2005; Rappuoli and Alderem, 2011). It may take a number of additional years after a vaccine is commercially available in high-income countries to introduce the same vaccine in low-income countries. And even if a vaccine is available in high-income countries, it may be the case that models are unable to justify the investment required for the development of the same vaccine in low-income countries, where they may not be a profitable market; this is a particular challenge with innovative vaccines. An example is a conjugate vaccine against meningococcus A that was developed specifically for

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