Recently we undertook the research for the 15th annual World Vaccine Congress, and so asked what the biggest challenges are for each segment of the market. When we spoke to vaccine manufacturers, these came up as the 4 biggest issues:
Adjuvants are often lauded as the way forward to make vaccines more effective, but given how new they are and the variety of adjuvants being developed, lots of questions are posed around getting adjuvanted vaccines approved. The main questions posted were:
- What is going on with regulation?
- What is accepted?
- What is different in the US vs. Europe vs. the rest of the world?
- What is needed to take an adjuvant into the clinic?
2) Clinical trials
Clinical trials take a long time and are very costly, therefore vaccine manufacturers big and small are very keen to find new ways of doing trials to bring products to market faster. Some of the most common questions were:
- How can we speed up clinical trials without compromising the safety of participants and future patients?
- What new models are there to make clinical trials more efficient?
- What new criteria could be considered and pre-clinical stage to avoid falling at the first hurdle?
3) Regulation for innovative vaccine platforms
With all this innovation in vaccine platforms, how those will be regulated becomes a huge concern. Many of the technologies are unprecedented or only a handful have made it to approval stage, so nearly every vaccine manufacturer we spoke to asked about how regulators will deal with new approaches such as DNA vaccines, VLPs, different viral vectors, and nanoparticles.
4) Scaling up new vaccine types
With new approaches to vaccines come the need for new ways of manufacturing them, particularly thinking in terms of scale. So questions were asked around:
- What are the new production platforms?
- How we can assess them?
- What tools there are to assess if the technologies are effective?
- Will disposable technologies to be the most efficient and cost-effective as we move towards new vaccine formulations?
These questions have formed the basis of the agenda for the World Vaccine Congress on 13-15 October in Brussels, so for more information and to book your place click here.