1 introduction strengthening and ac- celerating future vaccine innovation and development for diseases of poverty.

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2 European Vaccine Initiative

3 1 Introduction Infectious diseases are key contributors to the devastating poverty in much of the world today. Every year diseases of poverty kill almost 9 million people, many of them children under five, and they are often associated with lifelong disability, which is a massive burden to bear. Stepping up research into their causes, treatment and prevention would have an enormous impact on efforts to lift people out of poverty, and to build a better world for future generations. The European Vaccine Initiative (EVI), with its partners and members, works toward this objective by strengthening and accelerating future vaccine innovation and development for diseases of poverty.

4 2 European Vaccine Initiative The overwhelming need for vaccines to fight diseases of poverty Diseases of poverty are a diverse group of communicable diseases caused by a variety of viruses, bacteria, protozoa and other parasites. They include diseases such as malaria, tuberculosis, leishmaniasis and schistosomiasis, as well as many others that are not yet high on the global agenda. 1 Diseases of poverty are predominantly endemic in low-income populations in certain regions of Africa, Asia and Latin America where the poorest and most vulnerable populations, who have less power to intervene, bear the brunt. Vaccination is one of the most efficient and cost-effective measures available for the prevention of illnesses and deaths from communicable diseases, resulting in both direct savings such as reduced medical costs, and indirect savings through increased productivity and reduced losses in working hours. However, whereas the need for effective, safe, and affordable vaccines for low income populations is steadily growing, no effective vaccines exist as yet for most diseases of poverty, which are under-researched and poorly understood, and the critical pipeline of future vaccine innovation remains noticeably empty. Vaccines have the power to fight diseases of poverty and to rid the poor and neglected from the burden of death, disabilities and deformities. 1 TDR: Global Report for Research on Infectious Diseases of Poverty. WHO, Geneva, Switzerland; 2012

5 3 The burden and impact of diseases of poverty In 2008, infectious (including parasitic) diseases were responsible for the death of more than 8.7 million people worldwide, the majority of whom were the poor living in low and middle income countries, and children under five years of age. 2 Example Malaria: Key Facts E 207 million cases worldwide E 627,000 deaths worldwide E Of all malaria deaths: E 90% in sub-saharan Africa E 77% in children under five E 3.4 billion people at risk half of the world population E 97 countries affected with ongoing malaria transmission E High economic cost: E 9 billion per year in direct losses E Loss of 1.3% of GDP growth per year for Source: (figures from 2012) 2 Global Health Observatory Data Repository [online database]. Cause-specific mortality Geneva, World Health Organization ( accessed April 2014)

6 4 European Vaccine Initiative The need for investment in vaccine research and development Despite their large global impact, less than 1% of the products approved by regulatory agencies for human use between 2000 and 2011 were vaccines for neglected diseases 3, and only about 1% of investments made worldwide in 2010 in global health research and development (R&D) was allocated to neglected diseases. Further investment in R&D is urgently needed to accelerate the development of new tools to fight diseases of poverty. New vaccines are the key to saving the lives of millions of children and their families, and to rid their lives of the burden of these devastating diseases. 3 Pedrique B et al, The Lancet 2013

7 5 The European Vaccine Initiative (EVI) EVI is an organisation dedicated to coordinating research and mobilising resources to accelerate the development of vaccines to fight diseases of poverty. EVI is a not-for-profit product development partnership (PDP) that promotes transparency, rigorous governance and clear and defined policies. Since its inception in 1998, EVI has recognised the power of partnerships and has engaged with partners worldwide involved in vaccine R&D; from academia and other research institutions, the private sector, governments and civil society organisations, including many partners from low and middle income countries affected by diseases of poverty. EVI is able to harness the knowledge and expertise from the leaders in the field. Advocacy EVI strives to sustain commitment to global health issues by: Engaging with major policy and decision makers, civil society, the scientific community and other relevant stakeholders on both national and international levels Vaccine R&D EVI advances the development of vaccines for low income populations by: Providing support and technical knowledge to the research community Building global research partnerships involving stakeholders from all relevant sectors Strengthening vaccine R&D infrastructure Harmonisation EVI supports good research practices and methodologies aimed at generating comparable and reproducible results by: Supporting the harmonisation for key laboratory assays employed in vaccine R&D through agreement on harmonised/ standardised laboratory procedures, preparations, and reagents Promoting the uptake and use of standardised assays and reagents Capacity Strengthening EVI enhances the capacity of its partners involved in vaccine R&D in different geographical regions by: Promoting education and training of students, researchers, clinicians and technical ad administrative staff Supporting construction and upgrade of infrastructures required for vaccine R&D and for conducting clinical trials EVI s core activities surrounding vaccines for diseases of poverty EVI Key Facts : E On average, for every Euro given to EVI 97% is directly invested in vaccine development E 48 million of funding received by EVI ( ) E 102 million of total resources mobilised by EVI together with its partner organisations ( ; 48 million of which received by EVI)

8 6 European Vaccine Initiative Highlight Vaccine R&D The AMA1-DiCo project - a novel approach towards a malaria vaccine Apical Membrane Antigen 1 (AMA-1) is a leading candidate for a vaccine against Plasmodium falciparum, one of the parasites causing malaria. This antigen was identified as a malaria vaccine candidate during investigations of the role of human antibodies in naturally acquired immunity in children from three endemic populations. It was shown that in different communities in Kenya and the Gambia, antibodies against parts of the AMA1 protein were associated with protection from subsequent malaria infections. To cover the diversity of the natural AMA1 protein, three artificial proteins were synthesised and are being tested for their potential as a vaccine candidate. Thanks to support from EVI, the AMA1-DiCo (DiCo = diversity covering) vaccine candidate was then successfully moved forward from the pre-clinical phase into active clinical development. The first clinical testing (phase I) of this vaccine candidate started early in 2014 in France, with subsequent transition to the target population in Burkina Faso. The project which received funding from EVI via the Dutch Directorate-General for International Cooperation (DGIS) and the Irish Aid of a total of approximately 3 million, brings together 13 partner organisations from Europe (BE, DE, FR, NL, UK), Burkina Faso and the USA, including six partner organisations from the private sector. The diversity covering approach developed in the AMA1- DiCo project is now successfully being used for the development of a universal influenza vaccine candidate, which can provide broad coverage against different strains, in the EDUFLUVAC project coordinated by EVI. The universal influenza vaccine candidate aims at conferring better protection against epidemic influenza. If successful, this vaccine would offer a tremendous advantage because it would eliminate the need for a seasonal vaccine and annual vaccination campaigns.

9 7 E Dr. Sodiomon Sirima, Executive Director, Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Ouagadougou, Burkina Faso This project has been a big plus to my team. We were already familiar with cellular immunology through other studies but this project helped us to master these techniques in our labs. Together with the previous findings on the AMA1 vaccine candidate we expect that AMA1-DiCo which has more diversity will be an efficient vaccine and we hope to be the front line contributors to the development of an effective second generation malaria vaccine. The support from EVI has been fundamental in moving this project forward. This clinical trial has also provided the opportunity to collaborate with new partners such Centre d Investigation Clinique en Vaccinologie Cochin-Pasteur and Institut national de la santé et de la recherche médicale from France and others, opening up a new horizon for partnership.

10 8 European Vaccine Initiative The critical role of EVI in supporting the development of tomorrow s vaccines Vaccines are highly complex molecules designed to stimulate the body s natural immune system to fight infection. Vaccination is one of the most efficient and cost-effective measures available for the prevention of illnesses and deaths from diseases of poverty. Their development is time-consuming, complex and unpredictable, and involves various, increasingly expensive phases. Vaccine candidates Years Antigen Discovery cgmp Manufacture Formulation, Fill & Finish Toxicology, Stability, Potency Industrial Scale-up Antigen Validation In vitro and animal testing Immunogenicity, Efficacy and Safety Phase I Safety Immunogenicity Phase II Safety Immunogenicity Efficacy Phase III Clinical efficacy Phase IV Translational Gap EVI focuses on one of the most challenging stages of vaccine development -translational research- where many vaccine candidates fail.

11 9 Through its work with several leading global R&D stakeholders, EVI enables vaccines for diseases of poverty to progress through development efficiently and effectively by: coordinating and mobilising resources; facilitating funding; and providing expertise in vaccine development and project management. Using this cross-disciplinary approach, by utilising its network and the latest technologies and research processes, EVI is able to address the gaps and disparities in vaccine R&D to ultimately deliver accessible and cost-effective vaccines for low income populations. EVI identifies barriers and provides solutions to bottlenecks in vaccine development by building dedicated teams that possess the focus and capacity to lead the vaccine development process. The war against diseases of poverty can be won, but it requires continuous commitment from the entire community, including funders, policy makers and researchers. Now, more than ever, it requires a major collaborative effort from all parties. Key achievements EVI With the resources raised since its inception, EVI to date has accomplished the following: Vaccines preparations since inception Vaccines candidates in phase I clinical trials Active vaccine candidates Transitioned to partners for phase II clinical trials

12 10 European Vaccine Initiative Highlight Capacity Strengthening The Malaria Vectored Vaccines Consortium (MVVC) The MVVC was set up with the aim of integrating capacity building and networking in the design and conduct of phase I and II clinical trials of viral vectored malaria vaccine candidates in East and West African adults, children and infants. Besides capacity strengthening, the overall objective of the project was to develop a safe, effective and affordable malaria vaccine for use by the malaria-endemic populations of the world. In the context of this project, a new clinical trial centre was created in Keur Socé, Senegal, and additional site infrastructure and laboratory equipment upgrades were completed in Banfora, Burkina Faso. Both sites are now functioning effectively. An ambitious training programme was also implemented for both scientific-technical and administrative staff. E Professor Adrian Hill, Director, The Jenner Institute, University of Oxford, Oxford, United Kingdom The support of EVI has been very important to the excellent progress of the malaria vaccine programme of the Jenner Institute over the last few years. EVI has funded the clinical development of several of our vaccine candidates, has been our partner in other vaccine development projects, and has been the coordinator in another project that is driving the clinical development of the world s leading vectored malaria vaccine candidates in clinical trials in four African countries. EVI has provided considerable added value through its broad connectivity in the vaccine world, identifying potential collaborators, recommending field sites and formulating strategy. E Victorine Mensah, Scientific Officer, Cheikh Anta Diop University, Dakar, Senegal The high quality coordination of the project by EVI; the manifold and pertinent training workshops that have been held; the vaccine trial we conducted under guidance of the Jenner Institute; and, above all, the numerous interaction opportunities with scientists of international reputation had a big impact in my career development. My enthusiasm for research has increased and I feel now more prepared than ever for more challenges.

13 11 Highlight Advocacy Dr. Odile Leroy during a round table with German Members of Parliament in July E Dr. Odile Leroy, Executive Director EVI, Heidelberg, Germany We call upon all European Union Member States to further increase their national funding for the development of products against poverty-related and neglected diseases. EU Member States support should also be aligned with funding provided by the European Commission in order to exploit synergies, and mechanisms should be devised to strengthen the collaboration of product development partnerships so we can achieve the objectives we are all striving for: to improve and save lives.

14 12 European Vaccine Initiative EVI s globe-spanning network of partner countries Global partners diagram E EVI has 32 partner countries, E EVI works with 46 public institutions (10 in Africa) E And with 19 private companies

15 13 EVI s Core Values Accountability E Accountability to our stakeholders, donors and beneficiaries E Effectiveness in fulfilling our mandate E Responsible representation of issues and problems in the global community Transparency E High standards of disclosure of information E Standardised, regular and adequate reporting in compliance with relevant requirements Integrity E Adherence to the European Code of Conduct for Research Integrity How you can help The time and resource-intense vaccine development process on average results in less than one out of ten vaccine candidates ever reaching the market. Sustainable funding is urgently needed to continue supporting the development of safe and effective vaccines that prevent the diseases currently impairing the lives of hundreds of millions of people. Your support will help to achieve EVI s vision of a world free of the intolerable burden of diseases of poverty within the coming decades. To discuss the many ways you can support EVI please contact us at: European Vaccine Initiative UniversitätsKlinikum Heidelberg Im Neuenheimer Feld Heidelberg Germany Tel: contact.us@euvaccine.eu

16 European Vaccine Initiative UniversitätsKlinikum Heidelberg Im Neuenheimer Feld Heidelberg Germany Tel: see more