Vaccines: their power, their challenges
Vaccination is among the most impactful and cost-effective medical interventions ever introduced for prevention of infectious diseases. Each year vaccines prevent 2-3 million deaths from diseases like diphtheria, tetanus, pertussis and measles1, as well as prevent infection-related cancers and protect the health of the vulnerable. Promising research on therapeutic vaccines also opens new horizons for the treatment of diseases. Nonetheless, several countries are having a comeback of vaccine-preventable diseases2, with mistrust in vaccines playing a key role in this phenomenon. Additionally, for a number of major infectious diseases suboptimal or no vaccines exist. Currently, the many challenges faced in vaccine research and development make the development of vaccines lengthy, complex and with a high risk of failure.
What is the EU doing in the area of vaccination
The EU is actively involved in the global efforts to overcome these challenges. The political commitment in support of vaccination is laid down in the Commission Communication and Council recommendation on strengthened cooperation against vaccine-preventable diseases3 adopted in December 2018, aiming to increase vaccination coverage, foster support to research and innovation, and strengthen EU cooperation on vaccine-preventable diseases. Among the many actions proposed is the establishment of a European Information Sharing System; the creation of a European vaccination information portal by 2019; and an increase in the effectiveness and efficiency of EU and national funding for vaccine R&D.4
What the EC does to overcome challenges in vaccine research and innovation
A number of scientific challenges to developing new and better vaccines remain, as well a need to understand and address the determinants for the decrease in vaccine uptake. The Commission is strongly committed to providing solutions to these challenges, as well as to strengthening the involvement of all relevant stakeholders in the research process (e.g. patient community, social scientists) and supporting the generation of high quality data for evidence-based recommendations.
Through the current framework programme for research and innovation, Horizon 2020 (H2020), so far over €620 million have been invested on vaccine R&I.5 A significant amount of this EU investment went to large consortia performing translational collaborative research spanning work from discovery to first-in human studies, with projects generating results such as predictive tools as well as promising vaccine candidates against HIV, TB and malaria. Horizon 2020 has also provided funding for the development of vaccines against several neglected-infectious diseases and influenza, as well as Ebola.
The H2020 portfolio also includes projects tasked to evaluate vaccine effectiveness. The I-MOVE+6 project developed a platform to measure and compare the effectiveness and impact of influenza and pneumococcal vaccines, as well as vaccination strategies in the elderly. The generated data provided useful insights to public health authorities on these vaccines and on how to use them effectively. The Commission is also supporting the second phase of TRANSVAC, a collaborative infrastructure project which supports innovation for both prophylactic and therapeutic vaccine development and functions as leverage and innovation catalyst between vaccine R&D stakeholders.
The Commission has also supported research to understand behaviours towards vaccination. The TELL ME7 collaborative project provided evidence and developed models for improved risk communication and strategies addressing vaccine-hesitant groups, among others. The E-com@EU8 project developed communication plans for Under-Vaccinated Groups (UVGs), a tool useful for health professionals, health agencies and Institutes of Public Health (IPH) in periods of outbreaks.
In addition to the direct investment through H2020, a number of partnerships and initiatives have been created to enable for more effective types of cooperation, covering different needs in vaccine R&I, and creating incentives for industry investment in vaccine development.
To accelerate the development of medical products, including vaccines, for poverty-associated and neglected infectious diseases, in 2003 the European and Developing Countries Clinical Trials Partnership9 (EDCTP) was launched. A partnership between African and European countries and the EU, it is currently in its second phase (2014-2024), with a budget of €1.3bn.
The Innovative Medicine Initiative10 (IMI), a partnership between the EU and European Federation of Pharmaceutical Industry and Association (EFPIA), was created to speed-up the development of, and patient access to, innovative medicines. Now in its second phase and with a budget of €3.27bn, IMI is substantially supporting vaccine research. Through IMI’s Ebola+ programme, with a budget of over €200 million, Ebola vaccine candidates have been funded, as well as tools to facilitate the deployment and acceptance of such vaccines, which are now being used in the Democratic Republic of Congo (DRC) and neighbouring countries in the global effort to contain the current epidemic.
The 2014 Ebola outbreak evidenced that the current market processes did not aid the development of products for diseases with epidemic potential. To help tackle this challenge, the Coalition for Epidemic Preparedness Innovations11 (CEPI), an innovative global alliance supported by H2020, was established in 2016 with the aim to finance and coordinate the development of new vaccines to prevent and contain infectious disease epidemics.
Due to the high failure rate during the product development stages, investment in vaccine R&I is risky, therefore giving financial incentives an important role to play in overcoming this challenge. In 2015 the Commission launched the InnovFin Infectious Diseases Financial Facility (IDFF)12, jointly with the European Investment Bank (EIB), to facilitate and accelerate access to finance for innovative businesses and other innovative entities in Europe.
A glance on the future
Horizon Europe, the new EU research and innovation programme, is now under preparation. Its three pillars (Excellent Science; Global Challenges and European Industrial Competitiveness; Innovative Europe) and activities targeted to widen participation and strengthen the European Research Area, will build on the efforts and successes of the previous programme. Horizon Europe will provide new models and opportunities to boost and improve vaccine development and will be instrumental in further stimulating cross-fertilisation and international collaborations to bring public health benefits to the citizens.
1 – WHO Immunization coverage. http://www.who.int/mediacentre/factsheets/fs378/en/
2 – https://ecdc.europa.eu/en/about-uswho-we-aredisease-programmes/vaccine-preventable-diseases-programme
3 – https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32018H1228(01)&from=GA
4 – https://ec.europa.eu/health/sites/health/files/vaccination/docs/2019-2022_roadmap_en.pdf
5 – https://cordis.europa.eu/projects/en
6 – http://www.i-moveplus.eu/
7 – https://www.tellmeproject.eu/content/project-summary
8 – http://ecomeu.info/
9 – http://www.edctp.org/
10 – https://www.imi.europa.eu/
11 – https://cepi.net/
12 – https://www.eib.org/en/products/blending/innovfin/index.htm
Acting Director, People Directorate, Directorate-General for Research and Innovation, European Commission
Policy officer, Directorate-General for Research and Innovation, European Commission
Julia Molto Lopez
Programme assistant EU policies, Directorate-General for Research and Innovation, European Commission
Head of Unit Combatting diseases, Directorate-General for Research and Innovation, European Commission