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 perspectives
early in the development to facilitate the translation of research to clinical
development or even market authorization.