Vaccines 2.0 - developing the next generation of vaccines

Infectious diseases, including antimicrobial resistant (AMR) infections, remain a major threat to health and health security in the EU and globally. The availability of more effective, accessible and affordable vaccines would provide the most cost-effective preventive measure against the health threat of epidemics and AMR pathogens. Vaccines against diseases, such as AIDS, tuberculosis (TB), malaria, neglected tropical diseases, hepatitis C and water-borne diseases are essential to achieve the WHO targets to control the spread of infectious diseases. The first generation of vaccines against some of the pathogens have proven to be suboptimal and not effective enough to protect the population. Many viruses of pandemic potential are variable in their surface antigen composition, and novel technologies are required to develop efficient vaccines against each new variant efficiently and in a short timeframe. To ensure that more effective, accessible and affordable vaccines against all major infectious diseases become a reality, it is essential to sustain a diverse and modernised vaccine development pipeline.

Proposals should aim to diversify and accelerate the global vaccine research and development pipeline, and to strengthen the current leading role of the EU in vaccine research and development. Proposals should cover those pathogens, which still lack vaccines of sufficient efficacy, but where earlier efforts have already produced promising vaccine candidates.

The proposals should address several of the following areas:

• Innovation and integration of expertise and capabilities, including alignment of preclinical and clinical models, biomarker studies and new vaccine approaches from discovery to late stage development, from bench-based research to clinical development of promising preventive candidates.
• Application of iterative processes (including cross-learning, back-translation steps, integrative analysis of data) to allow exploitation and integration of novel findings between clinical, preclinical and discovery research and development.
• Deciphering mechanisms of protection of candidates, new approaches to antigen discovery and immunogen engineering, reverse vaccinology, evaluation of vaccines in novel platforms and technologies, novel adjuvants, innovative vaccine manufacturing approaches, relevant animal models, evaluation of alternative vaccine delivery routes.
• Effective, evidence-based decision-making for progression of vaccine candidates in the pipeline based on transparent and objective portfolio management. Regulatory requirements be considered. Sex, gender, age and socio-economic factors should be taken into account.