INYVAX · Optimisation of the development of Poverty-Related-Diseases (PRD) vaccines by a transversal approach, addressing common gaps and challenges

A number of new vaccines are being developed against Poverty-Related infectious diseases of major public health importance at a global level. The development of all those vaccines is facing the same kind of challenges and gaps, which still prevent 1) the establishment of readily accessible formulation and scale-up process development capacity for neglected diseases vaccines. 2) the establishment of a systematic approach for prioritizing formulation of vaccine candidates using accepted pre-clinical criteria. 3) the development of information-sharing tools to strengthen connections between the scientists, the developers and the clinical investigators. To address those challenges, the European vaccine community needs to establish a shared vision and goals and to identify the activities that could address some of the above-mentioned challenges. The cooperation between the different groups of PRD vaccine developers can bring innovative approaches for accelerating the development of effective vaccines. Among those challenges, several can be addressed through coordination across poverty related diseases, such as: 1) difficulties in accessing to some technology platforms, such as synthetic peptides, recombinant proteins, … for GMP development, and therefore in making rationale decisions on the best industrial approach for the pharmaceutical development, 2) difficulties in accessing certain know-how, such as lyophilisation and lack of formulation platform accessible to academic group, 3) difficulties to access to some delivery platforms, such as adjuvants, virus-like particles … for GMP development and/or to assess the quality and regulatory compliance of those platforms, 4) difficulties to harmonise the safety data collection, 5) the insufficient number of trained scientists able to play leadership in vaccine development