The vaccine industry is in a time where there is a lot to be excited about around new developments. However, these new approaches to vaccine development bring significant challenges in terms of bringing them to market. Earlier this year the VaccineNation team were able to sit down with Dr Bettina Klug, Scientific Administrator at the Paul-Ehrlich-Institut to understand her thought on the sector ahead of her speaking engagement at the World Vaccine Congress in October.
Vaccine Nation: What are some of the most pressing issues you are facing in developing vaccines and why?
Dr Bettina Klug: [Some of the most pressing issues include] The development of vaccines for emerging diseases, the entire development program has to be done in a short time frame. The disease, pathogen (e.g. virus) and the immune response have to be studied in parallel to the vaccine development.
There are quite a few infectious diseases for which a vaccine don’t exist despite the need. The development is hampered by biological factors, mainly a protective immunity cannot be elicited in humans, the pathogen might express strategies to evade the immune response. These mechanisms need to be understood and target antigens will be identified.
Further emphasis will be needed on the development of new adjuvants which not only enhance the immunity of a vaccine but also direct the immune response (e.g. T-cell response, B-cell response).
In some cases there might be the need to co-administer “immunostimulants” at the same time point as the vaccination i.e. cytokines to enhance or tailor the immune response.
VN: How does your case study address some of these issues and what can delegates look forward to in your talk?
BK: I will introduce the regulatory requirements for live genetically modified vaccines in Europe. These types of vaccines are quite promising since they address some of the problems in the development of new vaccines: e.g. the development of tailored vaccines e.g. B or T cell epitopes, selection of immunodominant epitopes, and incorporation of immunemodulators in the vaccine.
VN: How are current legal and regulatory requirements expected to affect vaccine development in the future?
BK: There is an established set of requirements for the MAAs of vaccines; the same requirements for quality, safety and efficacy apply also for the GMO vaccines. These requirements are substituted by specific guidelines.
These requirements need to be communicated and the incentives foreseen for small and medium sized companies needs to be communicated to the stakeholder.
To hear more from Dr Klug on the future of genetic modification within vaccines, make sure you join us at the World Vaccine Congress on 13-15 October. Early booking discounts end this Friday, 15 August, so click here to book today and save 300 EUR.