Contribution to the Coalition for Epidemics Preparedness Initiative (CEPI) - vaccine development for priority diseases

This is a topic for a grant awarded without a call for proposals (Article 195 (e) of the EU Financial Regulation). CEPI is a key global initiative that comprehensively and systematically addresses vaccine development for priority pathogens causing epidemic and pandemic threats.

CEPI has been a key partner for implementing the common Union response to the COVID-19 epidemic. With this funding, CEPI will be able to award grants to third parties through competitive calls for proposals. The focus will be on development of new medical countermeasures to prevent and contain infectious diseases that have epidemic potential, before these diseases become global health emergencies. The call(s) will be issued by CEPI, to fund advanced pre-clinical as well as clinical research on new vaccines for the prevention of emerging and re-emerging infectious diseases, with a view to preventing future epidemics. It will be aligned with activities of the European Health Emergency Preparedness and Response Authority (HERA) and a new Partnership for Pandemic Preparedness.

Expected Outcome:

Proposals should set out a credible pathway to contributing to one or several expected impacts of destination: “Tackling diseases and reducing disease burden”.

Project Results under this action are expected to contribute to all of the following expected outcomes:

• Health care providers have access to newly developed medical countermeasures against prioritised pathogens with epidemic potential.
• Citizens benefit from improvements in prevention and containment of epidemics.
• Research funders, policymakers and the research community will have better tools and solutions to achieve the Sustainable Development Goal 3.3[[https://sustainabledevelopment.un.org/topics/sustainabledevelopmentgoals]], “to combat communicable diseases"" and to implement 3.B “to support the research and development of vaccines for the communicable diseases that primarily affect developing countries, and provide access to affordable essential vaccines”.

Scope:

This grant will be awarded without a call for proposals according to Article 195 (e) of the EU Financial Regulation and Article 24(3)(b) of the Horizon Europe Regulation to the legal entities identified below as CEPI has been a key partner for implementing the common Union response to the COVID-19 epidemic.

The Coalition for Epidemic Preparedness Innovations (CEPI) is an international non-profit association established under Norwegian Law. It was founded by the Governments of Norway, Germany, Japan, India, the Bill & Melinda Gates Foundation (BMGF) and the Wellcome Trust, and launched during the World Economic Forum in Davos 2017. Its objective is to finance and coordinate the development of new medical countermeasures to prevent and contain infectious diseases that have epidemic potential, before these diseases become global health emergencies. The Horizon Europe funding will be used to enhance and expand CEPI’s activities. This action will also contribute to the implementation of the Union’s strategy for international cooperation in research and innovation and the EU’s development policy, in particular attention will be given to the constraints national health systems face in low- and middle-income countries.

Accordingly, the proposals should cover all of the following activities:

• Vaccine research and development for emerging pathogens to stop future epidemics.
• Research to advance adaptable vaccine technologies that can be used for rapid vaccine and immunoprophylactic development against previously unknown pathogens.
• Engagement with relevant stakeholders in the area of epidemic preparedness ensuring collaboration and coordination and avoiding duplication.

This action is expected to engage with other relevant initiatives, such as the new Partnership for Pandemic Preparedness.

With the grant from the European Union, CEPI will be able to award one or several grants to third parties through competitive calls for proposals. The call(s) will be issued to fund advanced pre-clinical as well as clinical research on new vaccines for the prevention of emerging and re-emerging infectious diseases, with a view to preventing future epidemics. For this purpose this action is also expected to engage with HERA. The expected recipients of the grant(s) issued by CEPI include research institutes, universities, SMEs as well as large companies, all active in research and innovation on new and improved vaccines.

Award criteria:

The criteria are described in General Annex D. The following exceptions apply: The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 3 (Implementation). The cumulative threshold will be 12.

Legal and financial set-up of the Grant Agreements:

The funding rate will be 70%.

Financial support provided by CEPI to third parties is one of the primary activities of this action in order to be able to achieve its objectives as CEPI does not have the capacity to develop new medical countermeasures itself. The maximum amount to be granted to a third party is EUR 35 million. This is justified by the high cost of development for new vaccines, that reach tens of millions of Euros[[ Gouglas, D. et al.: Estimating the cost of vaccine development against epidemic infectious diseases: a cost minimisation study. Lancet Global Health Vol. 6 (12) E1386-E1396. DOI: https://doi.org/10.1016/S2214-109X(18)30346-2, https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(18)30346-2/fulltext]].