GMO Regulatory Aspects of Novel Investigational Vaccine Candidates

Recent scientific and technical developments create novel opportunities for vaccine development. Regulatory compliance has to be ensured from preclinical research to market authorization, whereby different legal frameworks that go beyond quality, efficacy or patient safety aspects need to be taken into account. As academia and start-ups are often focused on gathering scientific evidence, the regulatory maze is often regarded by applicants as challenging in the overall pathway to clinical translation. This is particularly true for applications concerning vaccine candidates containing or consisting of genetically modified organisms (GMOs). Active communication between applicants and competent authorities or advisory bodies early in the development stages facilitates a correct implementation of the regulatory frameworks and is of utmost importance to identify challenges or hurdles in order to avoid unnecessary delay in scientific review. Based on the state-of-play in Belgium, this chapter discusses examples of regulatory journeys of applications with genetically modified viral vectors and novel vaccine candidates that have been reviewed by GMO national competent authorities in Belgium and in Europe. They highlight the need of having a comprehensive view of global perspec-tives early in the development to facilitate the translation of research to clinical development or even market authorization.