Improving modes of delivery, deployment, and uptake of vaccines through phase IV/implementation research
HORIZON JU Research and Innovation Actions
Basic Information
- Identifier
- HORIZON-JU-GH-EDCTP3-2023-02-01-two-stage
- Programme
- Research and Innovation actions supporting the global health EDCTP3 Joint Undertaking
- Programme Period
- 2021 - 2027
- Status
- Closed (31094503)
- Opening Date
- June 26, 2023
- Deadline
- September 27, 2023
- Deadline Model
- two-stage
- Budget
- €26,000,000
- Min Grant Amount
- €5,000,000
- Max Grant Amount
- €5,000,000
- Expected Number of Grants
- 5
- Keywords
- HORIZON-JU-GH-EDCTP3-2023-02-01-two-stageHORIZON-JU-GH-EDCTP3-2023-02-two-stageClinical researchClinical trialsGlobal healthInfectious diseasesPublic healthVaccines
Description
Expected impacts of the calls under the 2023 work programme of the Global Health EDCTP3 JU
Activities funded under the 2023 calls for proposals should contribute to:
- Achieve SDG3 ‘Ensure healthy lives and promote well-being for all at all ages’ in sub-Saharan African countries;
- Enable the implementation of the short and medium term actions foreseen by the AU EU Innovation Agenda[1] (expected to be adopted in June 2023) in the area of Public Health
- Provide evidence for informed health policies and guidelines within public health systems in sub-Saharan Africa and at international level;
- Strengthen clinical research capability in sub-Saharan Africa to rapidly respond to emerging epidemics;
- Enable a regulatory environment that can ensure effective development, delivery, and uptake of new or improved safe health technologies guaranteeing that trials in sub-Saharan African countries meet international standards;
- Increase cost effectiveness of public investment through collaboration of funders of clinical trials in the area of infectious diseases in sub-Saharan Africa;
- Strengthen health systems to ensure uptake of effective health technologies and innovations;
- Enhance sustainable global scientific collaboration in health research and international cooperation across sub-Saharan Africa.
- Improve opportunities for training of researchers and healthcare professionals in sub-Saharan Africa.
[1]Working document of the AU EU Innovation Agenda available online at: https://research-and-innovation.ec.europa.eu/system/files/2022-02/final_au-eu_ia_14_february.pdf
Expected Outcome:This topic aims at supporting activities that contribute to one or several of the expected impacts for this call. To that end, proposals submitted under this topic should aim for delivering results that are directed, tailored towards, and contributing to all the following expected outcomes:
- Public health authorities and health care professionals in sub-Saharan Africa (SSA) have access to novel logistical and clinical solutions for vaccine delivery and have a better understanding of the behavioural barriers driving vaccine hesitancy, resulting in improved rates of vaccine deployment and uptake, particularly in poor and vulnerable communities.
- People in SSA have improved access, coverage, and trust in vaccines against all preventable infectious diseases within the scope of the Global Health EDCTP3[1]. Better tools as well as data on immunisation levels and the individual and public health benefit of immunization will drive vaccination even in hard-to-reach regions, thus helping to contribute towards the WHO Immunization Agenda 2030[2].
Health professionals and especially clinicians as well as policy makers have access to comprehensive phase IV/implementation research results, making use of them to ensure widespread translation and adoption of research findings into national and international policy guidelines for better delivery, deployment, and uptake of vaccines in clinical practice in SSA.
[1]Strategic Research and Innovation Agenda of the Global Health EDCTP3 Joint Undertaking: ec_rtd_edctp3-sria-2022.pdf (europa.eu)
[2]Immunization Agenda 2030: A Global Strategy To Leave No One Behind (who.int)
Scope:Despite offering strong protection against infectious diseases, global vaccination rates have been declining for a few years resulting in the re-emergence of preventable infectious diseases that were thought to be on the verge of elimination. This trend further worsened during the COVID-19 pandemic because of severe interruptions in public health services, restrictions of non-urgent medical care and diversion of limited health care resources, resulting in cancellation or delays of routine vaccinations. Underserved communities in SSA have been most affected, leaving them less protected against vaccine-preventable diseases. Under immunised individuals and zero-dose-children (not having received any vaccine) are also found in other communities. Furthermore, there has been a significant erosion of trust in governments and public health institutions that coordinate and conduct such immunisation efforts. Novel logistical and clinical solutions for vaccine delivery and a better understanding of the behavioural barriers driving vaccine hesitancy in SSA as well as better data to document beneficial vaccine effects on individual and public health are therefore of critical importance. Furthermore, there remain open questions on the use of vaccines, also in view of changing environments.
Accordingly, the proposed research is expected to deliver on the following:
- Carry out phase IV/implementation research studies on the deployment and uptake of registered vaccines[1] in SSA, examining operational aspects, access, coverage, vaccine acceptability/hesitancy, community engagement, real-life impact on overall health and cost-effectiveness;
- Develop and test novel logistical solutions for vaccination;
- As relevant, develop and test novel clinical solutions for vaccine delivery, including new delivery modes;
- Gain a better understanding of different health care systems in sub-Saharan Africa as regards the factors driving structural inequalities in vaccine deliveries;
- Identify the social, economic, political, religious, cultural, and personal factors driving vaccine hesitancy in SSA and develop targeted solutions, as appropriate. Vaccine hesitancy should be considered in the context of the specificities of different types of vaccines and their perceived risks and benefits. It is further essential to investigate the factors that are undermining coverage in different countries, regions, or communities both in terms of vaccine types and doses received. In many cases, this means targeted collaborations with local leaders who can effectively address their communities’ concerns and with caregivers who bring children to vaccination services. Applicants are also encouraged to develop evidence-based tools that can guide people towards informed vaccination decisions, delivering tailored information based on each user’s concerns;
Applicants need to concisely describe any prior research findings and explain how the proposal builds on these results. Building on relevant results from projects supported under previous EDCTP programmes is encouraged.
The implementation research to be conducted must involve vulnerable groups, including participants from poorer, underserved, or hard-to-reach communities in SSA. The full range of relevant determining characteristics (sex, gender, age, socio-economic status, etc.) needs to be considered. Applicants are also encouraged to provide methodologies for translating research findings into public health practice and policy guidelines. They are welcome to draw on any relevant lessons from the COVID-19 vaccination strategies.
Proposals are expected to come from research consortia with a strong representation of institutions and researchers from African countries, including involvement of franco/lusophone countries where possible and relevant.
The proposals should involve all stakeholders, most notably policy makers, public health authorities, health care professionals and end-users. The applicants must ensure strong community engagement. International cooperation is encouraged, and the proposed research is expected to be multidisciplinary through the involvement of medical sciences, psychological sciences, social sciences, and the humanities.
All projects funded under this topic are strongly encouraged to participate in networking and joint activities, as appropriate. These networking and joint activities could, for example, involve the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Therefore, proposals are expected to include a budget for the attendance to regular joint meetings and may consider covering the costs of any other potential joint activities without the prerequisite to detail concrete joint activities at this stage. The details of these joint activities will be defined during the grant agreement preparation phase. In this regard, the Global Health EDCTP3 Joint Undertaking may take on the role of facilitator for networking and exchanges, including with relevant stakeholders, if appropriate.
[1]It is recognized that the vaccines may not have a marketing authorization in the country or all the countries where the study is being carried out. Registered vaccines need to meet WHO-recommended standards of quality, safety and immunogenicity: Health products policy and standards (who.int)
Eligibility & Conditions
General conditions
2. Eligible countries:
The conditions are described in General Annex B except for the specific conditions for GH EDCTP3 funding as regards Entities eligible for funding and Consortium composition, the specific issue of legal entities from which countries can be the coordinator and the obligation to designate a scientific project leader. Participation conditions related to Russia’s illegal invasion of Ukraine are also set out below.
Replacing relevant sections in General Annex B to the Horizon Europe work programmes on Eligibility
Entities eligible to participate
Given the illegal invasion of Ukraine by Russia and the involvement of Belarus, the currently context does not allow the implementation of the actions foreseen in this programme with legal entities established in Russia, Belarus, or in non-government-controlled territories of Ukraine. Therefore, such legal entities are not eligible to participate in any capacity. This criterion also applies in cases where the action involves financial support given by grant beneficiaries to third parties established in Russia, Belarus or in non-government-controlled territories of Ukraine (in accordance with Article 204 of the Financial Regulation No 2018/1046).
To be eligible for funding, applicants must be established in one of the following countries:
- The Member States of the European Union, including their outermost regions: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden;
- The Overseas Countries and Territories (OCTs) linked to the Member States: Aruba (NL), Bonaire (NL), Curação (NL), French Polynesia (FR), French Southern and Antarctic Territories (FR), Greenland (DK), New Caledonia (FR), Saba (NL), Saint Barthélemy (FR), Sint Eustatius (NL), Sint Maarten (NL), St. Pierre and Miquelon (FR), Wallis and Futuna Islands (FR);
- Countries associated to Horizon Europe[1]; Albania, Armenia, Bosnia and Herzegovina, Faroe Islands, Georgia, Iceland, Israel, Kosovo[2], Moldova, Montenegro, North Macedonia, Norway, Serbia, Tunisia, Turkey, Ukraine. Considering the Union’s interest to retain, in principle, relations with the countries associated to Horizon 2020, most third countries associated to Horizon 2020 are expected to be associated to Horizon Europe with an intention to secure uninterrupted continuity between Horizon 2020 and Horizon Europe. In addition, other third countries can also become associated to Horizon Europe during the programme. For the purposes of the eligibility conditions, applicants established in Horizon 2020 Associated Countries or in other third countries negotiating association to Horizon Europe will be treated as entities established in an Associated Country, if the Horizon Europe association agreement with the third country concerned applies at the time of signature of the grant agreement[3];
- The following low- and middle-income countries which are constituent states of the EDCTP Association[4]: Burkina Faso, Cameroon, Congo, Côte d’Ivoire, Democratic Republic of the Congo, Ethiopia, Gabon, The Gambia, Ghana, Guinea, Kenya, Liberia, Malawi, Mali, Mozambique, Niger, Nigeria, Rwanda, Senegal, South Africa, Tanzania, Uganda, Zambia, Zimbabwe.
Legal entities which are established in countries not listed above will be eligible for funding if provided for in the specific call conditions, or if their participation is considered essential for implementing the action by the granting authority.
Consortium composition
Unless otherwise provided for in the specific call conditions, for all actions, due to the policy objectives of the GH EDCTP3 JU, legal entities forming a consortium are eligible to participate in actions under the programme provided that the consortium includes:
- At least three legal entities established in different countries, where legal entities are eligible to receive funding;
- At least one independent legal entity established in a Member State or an associated country; and
- At least one independent legal entity established in a sub-Saharan African (SSA) country that is a member of the EDCTP Association.
Specific cases:
Affiliated entities – Affiliated entities are eligible for funding if they are established in one of the countries listed above.
International organisations – International European research organisations are eligible to receive funding. Other international organisations are not eligible to receive funding unless their participation is considered essential for implementing the action by the granting authority. International organisations with headquarters in a Member State or associated country are eligible to receive funding when provided for in the specific call conditions.
Specific rules on which legal entities can be the coordinator of an indirect action
According to article 110 of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[5], where entities established in a third country without an agreement to protect the financial interests of the Union participate with funding in an indirect action, the financial coordinator of the indirect action shall be established in a Member State or associated country. Of the SSA countries members of the EDCTP Association, only South Africa concluded such an agreement.[6]
Scientific project leader
If the coordinator is not established in a country in sub-Saharan Africa (SSA), the designation of a scientific project leader established in a SSA country member of the EDCTP Association with the roles as described below is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity.
The scientific project leader oversees the project scientific governance and leadership. For this purpose, proposals must include a work package where the details of scientific project leadership are laid down. The scientific project leader should indicatively perform the following tasks:
- During the call for proposals and selection process, coordinate meetings on and drafting of the full project proposal;
- Work with the coordinator and other beneficiaries on the drafting and negotiation of the consortium agreement and other legal agreements among the beneficiaries;
- Act as the key contact point for the GH EDCTP3 regarding all scientific action governance issues, steer and provide oversight in the development of the scientific actions, acting as the key contact point for the GH EDCTP3 JU for these matters including external communication, other than the ones entrusted directly to the coordinator as per the Model Grant Agreement;
- Support and collaborate with the coordinator on its monitoring activities and the adoption of appropriate internal measures, to ensure that beneficiaries are fulfilling their obligations regarding budget, timeline, deliverables, and scientific quality;
- Review the action’s deliverables and reports before their submission by the coordinator;
- Lead the work packages(s) related to the tasks of scientific project leadership.
Annex 1 to the grant agreement and the consortium agreement should address the relationship of the scientific project leader with the coordinator regarding their respective tasks, for example sharing of the information received from or sent to the GH EDCTP3 JU on all issues of interest for the proper scientific management of the action.
[1]The list is correct at the time of adoption of this work programme. Please see the Horizon Europe List of Participating Countries on the Funding & Tenders Portal for up-to-date information on the current list and on the position for Associated Countries. https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/guidance/list-3rd-country-participation_horizon-euratom_en.pdf
[2]This designation is without prejudice to positions on status and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence.
[3]Association of New Zealand is expected to take effect during 2023.
[4]The list is correct at the time of adoption of this work programme. For an update, please check the EDCTP Association website www.edctp.org.
[5]Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014. OJ L 427, 30.11.2021, p. 17–119; https://eur-lex.europa.eu/eli/reg/2021/2085
3. Other eligibility conditions: described in Annex B of the Work Programme General Annexes
4. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes
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Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes
Replacing relevant section in General Annex D to the Horizon Europe work programmes
Scores and weighting
Evaluation scores will be awarded for the criteria, and not for the different aspects listed in the table. For full applications, each criterion will be scored out of 5. The threshold for individual criteria 1 (Excellence) and 2 (Impact) will be 4 and for criteria 3 (Quality and efficiency of the implementation) will be 3. The overall threshold, applying to the sum of the three individual scores, will be 12.
Proposals that pass the individual threshold and the overall threshold will be considered for funding, within the limits of the available call budget. Other proposals will be rejected.
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Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual
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Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes
Implementing the provision on affordable access as defined in Article 114 of the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe, grants awarded under this topic will have to submit the following deliverables:
1. Stewardship plan
Beneficiaries must prepare stewardship plans outlining how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse, or abuse of health technologies (e.g., antimicrobials). A draft plan must be submitted after half the duration of the project has elapsed and a final plan must be submitted with the final report.
2. Global access plan
With the final report, beneficiaries must submit an appropriate and proportionate global access plan that covers registration targets, plans to meet demand, flexible approaches to IP and other strategies that reflect ability to pay and ensure that economic barriers to access are low.
Also in line with Article 114 of the Council Regulation 2021/2085, participants will be subject to the following additional exploitation obligations:
- Participants must – up to four years after the end of the action (see Data Sheet, Point 1) – use their best efforts to ensure that resulting health technologies and services will be broadly available and accessible, as soon as possible and at fair and reasonable conditions. In this respect, if, despite a participants’ best efforts, the results are not exploited within one year after the end of the action, participants must (unless otherwise agreed in writing with the granting authority) use the Horizon Results Platform to find interested parties to exploit the results.
- In case the participants cannot fulfil the preceding obligation, the participants must (if requested by the granting authority) grant non-exclusive licences - under fair and reasonable conditions - to their results to legal entities that commit to rapidly and broadly exploiting the resulting health technologies and services and ensure that they are broadly available and accessible, as soon as possible and at fair and reasonable conditions.
- In case of transfer of the ownership or licensing of results, participants must pass on such additional exploitation obligations to the legal entities exploiting the results.
- For up to four years after the action (see Data Sheet, Point 1), the funding body must be informed every year about the status of the development of the product and any other exploitation of the results through an annual report that is due on each anniversary of the end of the grant agreement.
6. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes
Specific conditions
7. Specific conditions: described in the specific topic of the Work Programme
Scientific Project Leader
For all projects under this topic, if the coordinator is not established in a country in sub-Saharan Africa (SSA), the designation of a scientific project leader established in a SSA country member of the EDCTP Association with the roles as described in the introduction is mandatory. A work package on ‘scientific project leadership’ must be included in the proposals and budget needs to be provided for this activity.
Grant Conditions - EC objection to transfer of ownership to a third party in a third country
According to the Horizon Europe rules, and to protect Union interests, the right for the GH EDCTP3 to object to transfers of ownership of results or to grants of an exclusive licence regarding results should apply to participants. Therefore, the provisions set out in General Annex G to the Horizon Europe work programmes on the right to object apply generally. It should be noted that in accordance with the Council Regulation 2021/2085 establishing the Joint Undertakings under Horizon Europe[1] and the Model Grant Agreement, the right to object applies also to participants that have not received funding from the JU and for the periods set therein.
[1] Council Regulation (EU) 2021/2085 of 19 November 2021 establishing the Joint Undertakings under Horizon Europe and repealing Regulations (EC) No 219/2007, (EU) No 557/2014, (EU) No 558/2014, (EU) No 559/2014, (EU) No 560/2014, (EU) No 561/2014 and (EU) No 642/2014; OJ L 427, 30.11.2021, p. 17
Documents
Please note that this call is not part of the ‘blind evaluation pilot’. Nevertheless, the standard template available on this page for the single-stage proposal is the standard template for calls that are part of this ‘blind evaluation pilot’.
The template for preparing the application, which is available once you press the “start submission” field is correct.
Standard application form — call-specific application form is available in the Submission System
Standard application form (HE RIA IA Stage 1)
Standard evaluation form — will be used with the necessary adaptations
Standard evaluation form (HE RIA, IA and CSA Stage 1)
MGA
Call-specific instructions
Additional documents:
Annex 2 - In-kind contributions (IKAA plan)
HE Main Work Programme 2023–2024 – 1. General Introduction
HE Main Work Programme 2023–2024 – 4. Health
HE Main Work Programme 2023–2024 – 13. General Annexes
HE Framework Programme and Rules for Participation Regulation 2021/695
HE Specific Programme Decision 2021/764
Rules for Legal Entity Validation, LEAR Appointment and Financial Capacity Assessment
EU Grants AGA — Annotated Model Grant Agreement
Funding & Tenders Portal Online Manual
Support & Resources
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Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe.
Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management.
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Latest Updates
| HORIZON-JU-GH-EDCTP3-2023-02-01-two-stage | HORIZON-JU-GH-EDCTP3-2023-02-02-two-stage | |
| Number of proposals submitted (including proposals transferred from or to other calls) | 15 | 21 |
| Number of inadmissible proposals | 0 | 0 |
| Number of ineligible proposals | 0 | 0 |
| Number of above-threshold proposals | 8 | 17 |
| Total budget requested for above-threshold proposals | 41.921.200 | 80.967.544 |
| Number of proposals retained for funding | 5 | 5 |
| Number of proposals in the reserve list | 3 | 3 |
| Funding threshold | 13 | 13,5* |
| Number of proposals with scores lower or equal to 15 and higher or equal to 14 | 3 | 4 |
| Number of proposals with scores lower than 14 and higher or equal to 13 | 2 | 6 |
| Number of proposals with scores lower than 13 and higher or equal to 10 | 3 | 7 |
*Proposals with the same score were ranked according to the priority order procedure set out in the General Annexes to the Work Programme or specific arrangements in the specific call/topic conditions.
Summary of observer report:
During the period of observation, the Independent Observer followed remotely the compilation of the IERs by the individual experts, the compilation of draft CR by rapporteurs, the feedback being provided by the individual experts within SEP, followed a sample of full consensus meetings and panel meetings. During this assessment IO noted that the proceedings of the evaluation were open, transparent and professionally conducted, ensuring that the outcome was of very high quality. Thus, the main observations can be summarised as follows:
a) The evaluation was open, fair and rigorous and in accordance with the relevant rules and established procedures.
b) Consensus Meetings (CMs) and Panel Meetings (PMs) were professionally conducted and throughout the process, overall moved smoothly, without any major issues
Some recommendations for consideration on improving the evaluation process have been suggested, where applicable.
- HORIZON-JU-GH-EDCTP3-2023-02-01-two-stage: 8 points
- HORIZON-JU-GH-EDCTP3-2023-02-02-two-stage: 9 points
- Number of proposals submitted (including proposals transferred from or to other calls): 79
- Number of ineligible proposals: 5
- Number of above-threshold proposals: 37
- Total budget requested for above-threshold proposals: 180.986.064
EVALUATION RESULTS STAGE 1
- HORIZON-JU-GH-EDCTP3-2023-02-01-two-stage: 8 points
- HORIZON-JU-GH-EDCTP3-2023-02-02-two-stage: 9 points
- Number of proposals submitted (including proposals transferred from or to other calls): 79
- Number of ineligible proposals: 5
- Number of above-threshold proposals: 37
- Total budget requested for above-threshold proposals: 180.986.064
- HORIZON-JU-GH-EDCTP3-2023-02-01-two-stage: 28 proposals
- HORIZON-JU-GH-EDCTP3-2023-02-02-two-stage: 51 proposals
The 2nd stage deadline has been postponed to 03/04/2024