2021 End of Year Message from Dr Michael Makanga, EDCTP Executive Director

20 December 2021

Dear Colleagues, Partners and Friends,

 

Akin to 2020, this year has remained very challenging due to the protracted negative impact of the COVID-19 pandemic. Nonetheless, the second EDCTP programme has demonstrated laudable resilience and is yielding very tangible results on various fronts. Our grants portfolio has grown to a total cash value of €814.30 million invested in 431 projects – 84% towards research & development; and 16% towards highly transformative capacity development initiatives. These involve 41 African, 19 European and 8 other countries, and a corresponding constellation of 305 African and 203 European institutions, which characterise the highly collaborative nature of the programme.

“Despite the protracted COVID-19 pandemic, the second EDCTP programme (EDCTP2) has demonstrated laudable resilience and is yielding very tangible results on various fronts. After 8 years of implementing the EDCTP2 programme with the cooperation of the many EDCTP partners and constituencies, as well as the fully committed and reliable High Representatives and EDCTP staff, we are enthused to share our progress in the journey, so far.”

Dr Michael Makanga, EDCTP Executive Director

Details of these are summarised in our summary of achievements:

 

EDCTP Summary of achievements 2014-2021
Download (PDF)

Research and development (R&D) through clinical trials and product-focused implementation research constitute the majority of investments in our portfolio. Our total investment has now reached €684 million (about 84% of grants funding), supporting 140 clinical research grants, several of which involve multiple clinical trials. Of these, 63% are Phase II and III trials, and many target highly vulnerable populations, including pregnant women, newborns, children and adolescents. A further 17% of projects are post-licensing (Phase IV) studies, including product-focused implementation studies, generating evidence highly relevant to policymakers.

 

This year we have registered some notable R&D successes which include among others:

  • Malaria vaccines R&D: the Multi-Stage Malaria Vaccine Consortium (MMVC) published their Burkina Faso Phase IIb study results which demonstrated that the malaria vaccine candidate R21/Matrix-M is safe, immunogenic and has an efficacy of 77%, exceeding the WHO goal of 75% efficacy for malaria vaccines.
  • Neglected infectious diseases therapeutics R&D: The Paediatric Praziquantel Consortium that is developing arpraziquantel, a new paediatric medication to treat schistosomiasis in preschool-aged children (3 months to 6 years), successfully completed its pivotal Phase III trial in Côte d’Ivoire and Kenya. The results of this trial, co-funded by the Global Health Innovative Technology (GHIT) Fund and EDCTP, confirm a favourable efficacy and safety profile for arpraziquantel for this population group. This allows the programme to progress towards regulatory file submission to the European Medicines Agency (EMA). Moreover, EDCTP and GHIT are already co-investing in the Consortium’s treatment access programme in Côte d’Ivoire, Kenya and Uganda. This ‘ADOPT’ programme prepares for large-scale access and delivery of the Consortium’s novel paediatric medication.
  • HIV co-infections therapeutics R&D: We are filling the gap in funding for research on cryptococcal meningitis with advanced HIV disease. The AMBITION-cm Phase III trial carried out in five African countries and is the largest HIV-associated cryptococcal meningitis treatment trial ever undertaken. This trial evaluating whether a single high-dose of liposomal amphotericin B works as well as the 7-day treatment regimen has revealed very encouraging results.

In the area of capacity development (about 16% of our grants funding), we have now invested in 201 fellowship grants (40% females and 60% males) representing 24 African countries supporting the career development of current and aspiring African scientific leaders. Moreover, 534 Africa trainees (46% females and 54% males) from 33 countries are benefiting from hands-on-training in the context of larger clinical research grants (among others: 35 post-doctoral candidates and 408 (Bachelor’s, Master’s, and PhD) students. Furthermore, a cohort of 150 epidemiologists and biostatisticians have started training from a joint initiative launched last year with the Africa Centres for Disease Control and Prevention (Africa CDC). Overall, presently the long-term training activities have 46% female participation, and the regional diversity and gender equality in science continue to be bridged. We are also helping to develop an enabling environment for clinical research, by strengthening national regulatory and ethical review capacities – with 38 countries benefiting from such grants. EDCTP has continued to galvanise its funding strategy to build upon successes and lessons learned, and through working with partners such as Africa CDC, the WHO Regional Office for Africa (WHO-AFRO) and the African Union Development Agency (AUDA-NEPAD). As part of our long-term strategy to capacity development, we have renewed the funding for the four regional networks of excellence following their satisfactory mid-term evaluation. Other ongoing activities include three grants to build national pharmacovigilance activities and several new grants to build capacity to use research evidence in policymaking, are in grant agreement preparation.

The COVID-19 pandemic has presented an unusual memento of the continuing threat posed by emerging infections. Resulting from the emergency COVID-19 funding initiative launched last year, 27 projects are ongoing involving 26 countries across sub-Saharan Africa. Close to two years on from the declaration of COVID-19 as a pandemic, many research questions have been answered, others are still under investigation and new questions are emerging. Our work has contributed to the case studies report for the report on Funding and undertaking research during the first year of the COVID-19 pandemic: COVID CIRCLE lessons for funders. EDCTP fellows have also played a very critical role in their host countries as part of the COVID-19 response.  Additionally, our two large EDCTP-funded consortia – ALERRT and PANDORA-ID-NET – as well as the four regional networks of excellence, continue their work to enhance the capacity of African regions to prepare for and respond to infectious disease outbreaks and are actively involved in the COVID-19 response.

In the area of EU coordination, EDCTP Participating States’ total cash contribution has grown to €175.43 M by the end of 2021. The European Participating States are supporting the centrally managed EDCTP COVID-19 emergency funding initiative and their contribution of approximately €11 M constitutes 83% of the total grants budget. Additionally, a total of €1.157 billion through 301 European Participating States’ Initiated Activities (PSIAs) has been committed through the EDCTP 2014-2020 workplans.

As part of African participation, the 16 sub-Saharan African countries which are members of the EDCTP Association have submitted 120 Participating States’ Initiated Activities (PSIAs) to a total committed value of €67 M through the EDCTP 2014-2020 workplans. Two new African countries, Kenya and Côte d’Ivoire, have recently joined the Association.

Partnerships are core to our work. At the end of 2021, 305 African and 203 European institutions in 68 countries (41 in sub-Saharan African, 19 in Europe and eight other countries) are involved in EDCTP projects. In addition, we have leveraged financial contributions of €412.45M (total cash and in kind) from global partners through joint calls and strategic calls for proposals requiring confounding. Details of these are summarised in our summary of achievements.

Following a broad range of stakeholders’ consultations and with support from WHO, EDCTP and the Amsterdam Institute for Global Health and Development (AIGHD) launched the Global Tuberculosis (TB) Vaccines R&D roadmap. This living document is intended to provide a shared set of priorities to guide the activities of all stakeholders with an interest in TB vaccine development and use. Additionally, in collaboration with Tuberculosis Vaccine Initiative (TBVI), we made available online several new tools to support future TB vaccine clinical trials, including tools to support preparations for a regulatory plan, a data management plan and clinical trial protocol synopses; as well as a comprehensive registry of trial sites in sub-Saharan Africa with capacities to conduct TB vaccine studies.

Our tenth EDCTP Forum was successfully held in Maputo, Mozambique and virtually from 17 to 21 October, with the theme Equity in research for health. Around 50 delegates were present in Maputo and over 2000 delegates registered for attendance online. The Forum had an excellent scientific programme and very strong political support – it was opened by His Excellency Mr Filipe Jacinto Nyusi, the President of the Republic of Mozambique. Four EDCTP Prizes recognising the achievements of outstanding researchers and research teams were awarded to promote scientific research and Africa-European collaboration.

In the area of cooperation with other EU initiatives, United Nations, and development cooperation agencies, we have three ongoing projects which secured financial support from the US Agency for International Development (USAID) and the Swedish International Development Cooperation Agency (Sida). We are supporting 6 new projects from the second strategic call requiring co-funding from development cooperation agencies. We have also formalised cooperation through cooperation agreements with WHO-AFRO; and the African Union (both the Africa CDC and AUDA-NEPAD). Moreover, the European Clinical Research Infrastructure Network (ECRIN) and EDCTP hosted a session on clinical trial infrastructure and capacity building in Africa at the Africa-Europe Science and Innovation Summit on 17 June 2021. This session brought together key global health actors and the resulting recommendations have been integrated in the consultation of the Advisory Group on Research and Innovation for Africa-Europe Cooperation, assisting the European Commission with advice on how best to boost cooperation between the two continents through research and innovation.

On the global front, EDCTP organised a virtual meeting during the second edition of the Science Summit around the 76th United Nations General Assembly (UNGA76) in September 2021. This session aimed to advance the broader discussion on how to ensure sustained support and advancement along the continuum of product development for infectious diseases, including scale-up, implementation and access in sub-Saharan Africa and globally, in the pursuit of achieving the health-related targets of the 2030 Agenda for Sustainable Development.

Significant progress has been made in preparation for the successor programme to EDCTP2 – the Global Health EDCTP3 Joint Undertaking.  On 19 November the European Commission announced the adoption of 10 European Partnerships set up between the European Union, Member States and/or the industry, including the Global Health EDCTP3 Partnership.

In conclusion, I take this opportunity to thank everyone involved in the EDCTP programme for your steadfast efforts and contributions towards our achievements.

I wish you all together with your families and significant others a blessed festive season and a fruitful 2022.

Dr Michael Makanga