Executive Summary

Europe has a long history of vaccine discovery, development and manufacturing, and benefits from a strong industrial infrastructure. More than 80% of the vaccines for worldwide use are produced in and exported from Europe. With its numerous centers of excellence in vaccinology and related disciplines, Europe has the capacity and capability of continuing to lead the discovery of next generation vaccines capable of addressing unmet medical needs and emergency situations. However, without a clear roadmap for Europe’s vaccines R&D and the political, legal, economic and structural measures that will best incentivise, reward and accelerate this research, today’s leadership is at risk.

Despite the strong heritage in vaccines R&D, Europe does not have an integrated vaccines R&D agenda. Nor does it have the sort of vaccine and biotechnology R&D clusters that are proving so productive in other parts of the world. IPROVE is the first EU funded attempt to develop such a holistic view on this important sector. IPROVE has concentrated efforts on integrating all elements that drive the entire vaccines value chain from basic research through to development and implementation of vaccination programmes. The ultimate goal of IPROVE is to help steer European competitiveness in this field for the delivery and benefit of innovative prophylactic and therapeutic vaccines.

The roadmap was developed through a joined up and participatory stakeholder consultation process organised around seven main thematic topics of consultation; i) Vaccine R&D; ii) Therapeutic Vaccines; iii) Production and Manufacturing; iv) Infrastructures; v) Vaccine SME needs; vi) Training; vii) Communications and Acceptance of Vaccination. Each of these thematic areas was addressed through separate multi-stakeholder consultation workshops. The intention was to cover as much as possible of the critical areas of intervention relevant to the entire innovation value chain. The roadmap has highlighted that it remains a clear necessity to continue investing in the basic and fundamental science underpinning vaccine research. This research needs to be multidisciplinary and connected across microbiology, immunology, structural biology systems and bioinformatics. A more rational approach for antigen selection and vaccine design should be prioritised and recommendations are made on the need to support and accelerate research into novel adjuvants, the development of vaccine vectors, and prime-boost strategies, as well as, the investigation of novel routes of immunisation.

From a development perspective, goals include the simplification and a more evidence-based and less empirical approach to the design of clinical studies, better tools and approaches for data collection, extraction, analysis, and interpretation in order to support more efficient translation of innovation into practice. Furthermore, the roadmap calls for more attention to innovation of the manufacturing, regulatory and quality control cycle, to enable more affordable, faster, more flexible and less wasteful production. We critically point out the need for more funding and partnership across sectors to support the networks and multidisciplinary infrastructures that are essential to vaccines’ R&D innovation.

The consultation also reinforced the fact that vaccines are only as good as their vaccine implementation programmes, and that more must be done to understand and address vaccination hesitancy on the part of both the general public and healthcare professionals. Perhaps reassuringly, the IPROVE findings and recommendations are broadly consistent with those of similar initiatives in EU Member States or further afield. IPROVE highlights the potential added value of a more pan-European approach that has the political will, policy and financial environment which reinforces co-operation but also facilitates the development of physical European Research Clusters for vaccines that bring the science, entrepreneurs, investors and the most innovative vaccine producers together. Such a pan-European approach will require a political, policy and fiscal framework across public health, regulatory, and funding domains that recognises, incentivises and rewards the immense value of vaccination. In this regard, developing a long-term vision and commitment is paramount in respect to facilitating the establishment of effective partnerships across stakeholders at all levels.

It is beyond the scope of IPROVE to define the specific mechanisms and financial instruments that can build this pan-European vaccine ERA, however reflection is invited, and it is recommended that the EU fosters such thinking as a critical next step in order to sustain its leadership in this strategic sector.