Regulatory challenges to the development of new vaccines: Mapping emergent relations between science, evidence and policy.

This project aims to study the regulatory challenges to the development of new vaccines. This project will engage and build upon the expertise of a multidisciplinary team as they investigate the important evolving relationships between science, evidence and policy. In doing so, the study will fill a crucial gap in the literature by drawing national and international comparisons and by generating novel insights on how emerging regulation impacts on the development of new vaccines. A multi-sited ethnographic approach is employed with three cases being investigated and compared. Study 1 is an examination of the new questions and issues for the field of cervical cancer prevention with the availability of vaccination against high risk HPV. Study 2 examines the innovation and production of the pandemic influenza vaccine in Canada. Study 3 presents a contrasting approach of the African Meningitis vaccine and the implementation of the regulatory framework in Burkina Faso, from which developed and developing country comparisons and lessons are drawn.