Genetically Modified Vaccines - Additional Guidance Needed? - Live Online Use of regulations and interaction with authorities

Genetic modification technologies were widely used for vaccine development during the COVID-19 pandemic, for other vaccines and for veterinary vaccines. Several products have been approved around the world. In the EU, products that protect against infection with an infectious organism are by definition vaccines. And as such, vaccines are excluded from the ATMP guidelines - even if technologically they use techniques known from gene therapy. Particularly in the case of approaches that were not previously approved as medicines, such as mRNA lipid nanoparticles, some companies face a regulatory environment that does not seem fully transparent to them and in which there appears to be a lack of appropriate guidance.

This Live Online Training discusses the regulatory landscape for such genetically modified vaccines, especially when these gene therapy technologies overlap with traditional vaccine areas and vaccine regulations. This workshop will highlight the current regulatory situation and use case studies from manufacturers to show the challenges and hurdles in development, manufacturing and approval. It also seeks to identify the extent to which further guidance is needed beyond the existing guideline documents. One question could also be how this is viewed internationally when the requirements or classifications of the products differ, e.g. in Europe and in the USA.

The quality of a medicinal product, and thus also that of a vaccine, is of crucial importance for its safety and efficacy and thus for its suitability for the patient. Given the growing recognition of the increasingly important role of biological medicines in healthcare worldwide, competent authorities have already published a whole range of guidelines and helpful documents. Products such as ATMPs, but also genetically modified vaccines, have the potential to transform patient and healthcare delivery worldwide.

However, the development, characterisation and manufacture of these innovative medicines is particularly challenging due to their high complexity and emerging technologies. In the course of development, transfer and manufacture, new questions often arise that also need to be clarified from the regulatory side. Are further specifications from the authorities necessary for this? Where are there still gaps? What experience have manufacturers gained so far in the approval process? Especially with a view to worldwide use.