Deadline: 1 December 2014
The Innovative Medicines Initiative (IMI) improving health by speeding up the development of, and patient access to, innovative medicines, particularly in areas where there is an unmet medical or social need has announced its second call for proposals on Ebola and other filoviral haemorrhagic fevers. The IMI intends to complement the ongoing European and international efforts by offering a multi-company, cross-sector and multi-stakeholder programmatic approach to address the challenges of Ebola virus disease (EVD) and other filoviral haemorrhagic fevers.
Topics
- Vaccine development Phase I, II, and III
- Manufacturing capability
- Stability of vaccines during transport and storage
- Deployment and compliance of vaccination regimens
- Rapid diagnostic tests
Applicants are required to submit individual proposals for each topic.
Total Budget, Challenges, Scope, and Expected Impact of each individual topics
Topic 1: Vaccine development Phase I, II, and III. EUR70-110 million financial and EUR10-20 million in-kind contribution.
Challenge: urgent public health need – progression of vaccine candidates currently in development.
Scope: The applicants must have vaccine candidates available and demonstrate the ability to roll out clinical trial vaccination programs in EU/Africa, and to conduct studies in areas where Ebola virus disease is endemic. The clinical development program(s) need(s) to be aligned with the global effort coordinated by the WHO (World Health Organization).
Expected Impact: major impact on global health, both at the individual and the public health level. Learning from this program will also have an impact on the worldwide capacity to quickly develop vaccines in situations of global public health emergencies.
Topic 2: Manufacturing Capability. EUR10-20 million financial & EUR70-110 million in-kind contribution.
Challenge: manufacturing the quantity of vaccine doses necessary for large scale clinical testing and that can be thereafter urgently deployed.
Scope: generate additional data to help provide the necessary scientific, technical and regulatory justifications to seek a reclassification of such vectors such that they require BSL-1 containment, thereby opening up the potential for more manufacturers to assist in responding to the current outbreak.
Expected Impact: The project will deliver a manufacturing platform to provide the capacity for producing the required number of vaccine doses in GMP quality. This will impact for European competitiveness in the area of biological production under appropriate biological safety level conditions.
Topic 3: Stability of Vaccines During Transport and Storage. EUR 2million financial & EUR2 million in-kind contribution.
Challenge: The vaccine candidates need to be stored and transported at low temperature to maintain activity.
Scope: Proposals that cover stability testing and supporting analytical capabilities to be applied at all stages of the shipping, storage and deployment process are encouraged.
Expected Impact: Better availability of Ebola vaccines. Novel tools and technologies for distributing current vaccines that require very low temperatures for stability.
Topic 4: Deployment and compliance of vaccination regimens. EUR25 million financial & EUR25 million in-kind contribution.
Challenge: guaranteeing that the right vaccine dose is given at the right time. Community acceptance of the vaccine is another challenge.
Scope: Research on community vaccine acceptance and attitude towards vaccines. Proposals that will use mobile communication strategies to increase awareness, acceptance and subject recruitment in the vaccination campaigns or will create specific apps to remind participants of their appointments and keep track of their response or side effects are encouraged. Considerations on how monitoring of adverse events could be put in place, and how vaccines who get a fever should be handled are accepted.
Expected Impact: a fully validated tool or system that captures critical information for each vaccine (date, dose, batch no.), allows for automated recalls to the vaccine for subsequent doses, central tracking of overall vaccination coverage and compliance, all in a user friendly, cost economic way.
Topic 5: Rapid Diagnostic Tests. EUR7.5 million financial & EUR7.5 million in-kind contribution.
Challenge: additional technologies addressing various healthcare facilities settings will be important to maintain surveillance in the long term. Limitations of time and procedures requiring infrastructure and specific training is a challenge.
Scope: projects must include a phase of clinical validation in the field under real-world conditions, address manufacturing and access path to ensure sustainable distribution including taking into account ethical considerations and the health systems context.
Expected Impact: Increased availability of rapid diagnostic tests for EVD, providing in a first step immediate impact on public health in regions where the disease is endemic; and possible impact on business opportunities for European SMEs active in this area.
