The 30-year evolution of oral cholera vaccines: A case study of a collaborative network alternative innovation model.

Cholera outbreaks have been rapidly increasing around the world. While long-term cholera prevention and control measures rely on improvements in water, sanitation, and hygiene, oral cholera vaccines (OCVs) are used for prevention and control in the short-to-medium term. OCVs lack the market incentives available in other more profitable disease areas. The development of OCVs was made possible through an alternative innovation model, which sustained innovation across multiple generations of the product for more than three decades. To examine how this alternative innovation model worked, we conducted 18 semi-structured interviews with key stakeholders related to the development of several OCVs, including "Dukoral", "Shanchol", and "Euvichol-Plus", as well as additional cholera vaccines currently under development. Interview data was analyzed thematically according to the resources used by organizations (including funding, knowledge, relationships, and manufacturing), and the practices they implemented during each stage of the R&D process (including knowledge management and intellectual property strategies, approaches to transparency, and global access strategies). Next, we created participatory network maps to illustrate the structure of the relationships between stakeholders and how these evolved over time. We found that a core group of stakeholders were able to influence policies to promote the use of OCVs, and successfully develop, finance, and obtain WHO Prequalification for safe, effective, and affordable OCVs for global procurement and distribution. The evolution of OCVs demonstrates how a collaborative network innovation model can successfully develop new pharmaceutical products that are affordable and well-suited for use in context. This model could be applied to other areas of pharmaceutical innovation, such as pandemic preparedness, for more equitable outcomes for global public health.