The EDCTP “Emergency Funding Mechanism” allows rapid mobilisation of research funding based on a call for expressions of interest in exceptional and duly substantiated emergencies. EDCTP considers a situation as an emergency if it is unforeseen and presents a serious and immediate risk to human health. The “Emergency” status is adopted only after an official declaration of a situation as 1) a Public Health Emergency of International Concern (PHEIC) according to the World Health Organization, or 2) a public health emergency under Decision 1082/2013/EU or 3) an emergency under applicable national frameworks and regulations.
Following the novel Coronavirus disease (COVID-19) outbreak in December 2019, there has been an unprecedented rapid spread across more than 181 countries, with more than 1 million confirmed cases globally(1) as of 3 April 2020.
On 30 January 2020, following the recommendations of the Emergency Committee, the WHO Director-General declared that the COVID-19 outbreak constitutes a Public Health Emergency of International Concern (PHEIC) (2). On 11 March 2020, the WHO made the assessment that COVID-19 can be characterised as a pandemic (3), following alarming levels of infection spread and disease severity.
In the light of rising numbers of cases being reported from affected countries, including several sub-Saharan African countries, the EDCTP Association has agreed to activate the emergency funding mechanism to support Research & Innovation Actions (RIAs) as part of the European response to the COVID-19 emergency.
EDCTP invites expressions of interest proposals for RIAs to support research activities in sub-Saharan Africa to manage and/or prevent the spread of the current COVID-19 outbreak. Proposals must demonstrate the following:
- Addressing urgent research questions in the context of the current COVID-19 outbreak, in line with the research priorities of the Global Research Roadmap (4) and the WHO R&D Blueprint for rapid activation of R&D activities during epidemics.
- Strengthening of national and local research capacity.
- Coordination and collaboration with other research and/or humanitarian activities operational in the countries affected, following principles of good participatory practice for emerging and re-emerging pathogens (5).
- Compliance with International Council on Harmonisation – Good Clinical Practice (ICH-GCP), regulatory and ethical standards.
- Commitment to open access and data sharing principles.
Proposals should provide novel, critical and timely insights into the COVID-19 outbreak in sub-Saharan Africa and/or potential avenues for its management or prevention. Proposals must be timely, with rapid activation, to enable early and valuable outcomes to be established and/or to access time-dependent resources.
The call for expressions of interest priorities are based on the research gaps identified by the WHO Strategic and Technical Advisory Group for Infectious Hazards (STAG-IH) in its meeting of 12 March 2020.
The STAG-IH recommendations incorporate the research priorities agreed by the WHO Research and Development Blueprint Scientific Advisory Group that met on 2 March 2020, in Geneva, Switzerland, to prioritise the recommendations of an earlier WHO-GloPID-R meeting on COVID-19 research held on 11-12 February 2020.
Proposals submitted under this expression of interest must address one or more of the following research gaps:
- Understanding of the natural history of infection to better define the period of infectiousness and transmissibility; improve surveillance capabilities to more accurately estimate the reproductive number in various outbreak settings and improve understanding of the role of asymptomatic infection in transmission.
- Promote the development, adaptation, evaluation, and implementation of point-of-care diagnostic tests that can be used to screen all patients presenting with a history consistent with COVID-19 infection.
- Support standardised, best evidence-based approaches for clinical management and better health outcomes for patients by contributing to the implementation of randomised, controlled trials for diagnostics and therapeutics as promising agents emerge, taking usability, including multi-centre/country trials and access in resource-constrained settings, into account.
- Validation and adaptation of existing serological tests, including those that have been developed by commercial entities, and establishment of biobanks and serum panels of well characterised COVID-19 sera to support such efforts.
Applicants should be aware that proposals funded under this call for expressions of interest will be required to make available their research data of urgent policy relevance, at the latest within 30 days after it has been generated, through open access or, if agreed by the EDCTP Association or by the European Commission, by giving access rights to those third parties that need the research data to address the public health emergency, in accordance with the relevant option of Article 29.3 (1c) of the H2020 model grant agreement.
It is expected that quality-controlled data are shared in accordance with the FAIR (findable, accessible, interoperable and re-usable) principles. The use of harmonised protocols in collaboration with ongoing EDCTP2 actions is recommended for this purpose.
A draft data management plan (DMP) must be submitted preferably with the proposal and at the latest before the signature of the grant agreement. The DMP should address the relevant aspects of making the data FAIR, including what data the project will generate, whether and how the data will be made accessible for verification and re-use, and how it will be circulated and preserved.
Eligibility of costs: costs related to data management and data sharing are eligible for reimbursement during the project duration.
The use of WHO harmonised protocols (such as the solidarity protocol and the generic protocol on the surveillance and clinical epidemiology) is highly recommended for this purpose. Proposals must also commit to open access to results and publications generated from the action, and to fair access to products developed or evaluated under this funding mechanism to address the declared Public Health Emergency.
Beneficiaries in grants awarded under actions relating to this Public Health Emergency will be allowed to charge the cost of clinical studies on the basis of unit costs established in line with a methodology set up in the Commission Decision C(2016) 7553, which is available on the H2020 Funding and tenders Portal.
EDCTP considers that proposals for activities of between 6 and 24 months duration would allow to contribute appropriately to this specific challenge.
Proposals funded under this mechanism should answer the most pressing questions raised by responders in sub-Saharan Africa to the ongoing Public Health Emergency, as part of the efforts to manage and prevent the spread of the current pandemic. Proposals should result in new knowledge to manage and prevent the current COVID-19 outbreak, as well as strengthen the capacities of at-risk countries to manage outbreaks.
A proposal/application will only be considered eligible if:
- Its content corresponds, wholly or in part, to the topic/contest description for which it is submitted
- It complies with the eligibility conditions set out below, depending on the type of action:
- Consortia comprising a minimum of three independent legal entities are eligible to apply. Two of the legal entities shall be established in two different Participating States (European Partner States) (6) and one of the legal entities must be established in a sub-Saharan African country (7). All three legal entities shall be independent of each other.
- ‘Sole participants’ formed by several legal entities (e.g. European Research Infrastructure Consortia, European Groupings of Territorial Cooperation, central purchasing bodies) are eligible if the above-mentioned minimum conditions are satisfied by the legal entities forming together the sole participant.
- Applicants from non-EU and non-sub-Saharan African countries are free to take part in the EDCTP2 programme, however, they are not automatically entitled to funding. Applicants may be granted funding if their participation is considered essential for carrying out actions in the grant. It has to be demonstrated that participation by the applicant has clear benefits to the consortium such as outstanding expertise/competence, access to research infrastructure, particular geographical environments and/or data.
(6) The following European countries are EDCTP Participating States: Austria, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden and United Kingdom.
(7) The following African countries are eligible: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo (Democratic Republic), Congo (Republic), Côte d’Ivoire, Djibouti, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mozambique, Namibia, Niger, Nigeria, Rwanda, São Tomé and Príncipe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, South Sudan, Sudan, Swaziland, Tanzania, Togo, Uganda, Zambia, Zimbabwe.