CEPI—a new global R&amp;D organisation for epidemic preparedness and response
Authors: Børge Brende, Jeremy Farrar, Diane Gashumba, Carlos Moedas, Trevor Mundel, Yasuhisa Shiozaki, Harsh Vardhan, Johanna Wanka, John-Arne Røttingen
Journal: The Lancet (2017)

The outbreak of Ebola virus disease in west Africa in 2013–16 showed that the world is not sufficiently prepared to detect and respond to epidemic threats. It exposed a systemic need for stronger operational and strategic capabilities in infectious disease response, and for the development of more effective tools and technologies to manage, treat, and prevent disease. Evaluations of the Ebola response highlight that the global community must rethink how vaccines, diagnostics, and drugs for emerging infections are developed given their lack of commercial profitability, especially since outbreaks are most likely to occur in resource-constrained environments.1Gostin LO Tomori O Wibulpolprasert S et al.Toward a common secure future: four global commissions in the wake of Ebola.PLoS Med. 2016; 13: e1002042Crossref PubMed Scopus (69) Google Scholar Two Ebola panels called for a new global financing mechanism to invest US$1 billion annually; all panels recommended a strong normative and convening role for WHO.1Gostin LO Tomori O Wibulpolprasert S et al.Toward a common secure future: four global commissions in the wake of Ebola.PLoS Med. 2016; 13: e1002042Crossref PubMed Scopus (69) Google Scholar WHO has duly initiated a research and development (R&D) Blueprint to coordinate its own and other stakeholders' work on product-relevant R&D for infectious diseases with epidemic potential.2Kieny MP Røttingen JA Farrar J on behalf of the WHO R&D Blueprint team the R&D Blueprint Scientific Advisory GroupThe need for global R&D coordination for infectious diseases with epidemic potential.Lancet. 2016; 388: 460-461Summary Full Text Full Text PDF PubMed Scopus (27) Google Scholar A network of research funding organisations, the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R), has been initiated by the European Commission to coordinate rapid research response to public health emergencies.3Matthiessen L Colli W Delfraissy JF Hwang ES Mphahlele J Ouellette M on behalf of GloPID-R membersCoordinating funding in public health emergencies.Lancet. 2016; 387: 2197-2198Summary Full Text Full Text PDF PubMed Scopus (11) Google Scholar But there remains an urgent need for entities that can facilitate pooled funding and implementation of R&D for epidemic preparedness on a global scale, since these are not among WHO's core functions. In January, 2016, the World Economic Forum convened a group of representatives to explore the way forward, with vaccine development as the starting focus. The Ebola epidemic had shown that fast-track and collaborative development of vaccines was possible. More than 15 clinical vaccine trials (phase 1, 2, and 3) were planned and implemented within a year from August, 2014, and the ring vaccination trial in Guinea showed effectiveness of the replication-competent recombinant vesicular stomatitis virus (rVSV) vectored vaccine for the prevention of Ebola virus disease in interim and final reports.4Henao-Restrepo AM Longini IM Egger M et al.Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial.Lancet. 2015; 386: 857-866Summary Full Text Full Text PDF PubMed Scopus (639) Google Scholar, 5Henao-Restrepo AM Camacho A Longini IM et al.Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!).Lancet. 2016; (published online first Dec 22.)http://dx.doi.org/10.1016/S0140-6736(16)32621-6Google Scholar Now global efforts are also focused on Zika virus, another epidemic declared by WHO as a Public Health Emergency of International Concern6Heymann DL Hodgson A Sall AA et al.Zika virus and microcephaly: why is this situation a PHEIC?.Lancet. 2016; 387: 719-721Summary Full Text Full Text PDF PubMed Scopus (312) Google Scholar between February, 2016, and November, 2016. Vaccine development has been initiated and several candidates have entered initial clinical testing.7Vannice KS Giersing BK Kaslow DC et al.Meeting report: WHO consultation on considerations for regulatory expectations of Zika virus vaccines for use during an emergency.Vaccine. 2016; (published online Dec 1.)https://doi.org/10.1016/j.vaccine.2016.10.034Crossref Scopus (14) Google Scholar During the World Economic Forum meeting a consensus emerged on the need for a new approach to public–private collaboration to address epidemics and for exploring the establishment of a new financing mechanism. Now, CEPI—the Coalition for Epidemic Preparedness Innovations, a partnership between public, private, philanthropic, non-governmental, intergovernmental, and civil organisations, is launched on Jan 19 at the World Economic Forum's 2017 meeting. CEPI will be based in Oslo, Norway, with offices in the UK, India, and the USA, but will be a global organisation with partners on all continents. CEPI provides a new funding model for the development of vaccines against epidemic infectious diseases through pooling resources from several investors. This coalition will build a new system to advance the development of safe, effective, and affordable vaccines, ensuring that price is not a barrier to access for populations most at need. This will offer the world an insurance policy against the growing threat from emerging infectious diseases. CEPI will fill the gap between the normative functions of WHO and the procurement and delivery mandate of Gavi, the Vaccine Alliance, and close an important gap in global health architecture. CEPI has two main objectives: to advance vaccine candidates against priority pathogens and to build technical and institutional platforms that accelerate the R&D response to known or unknown pathogen emergencies. A description of how plans for CEPI developed and its business plan are outlined by one of us (J-AR) and representatives of the wider partnership in another report.8Røttingen J-A, Gouglas D, Feinberg M, et al. New vaccines against epidemic infectious diseases. New Engl J Med (in press).Google Scholar For known high-priority threats, as defined by the WHO R&D Blueprint list,2Kieny MP Røttingen JA Farrar J on behalf of the WHO R&D Blueprint team the R&D Blueprint Scientific Advisory GroupThe need for global R&D coordination for infectious diseases with epidemic potential.Lancet. 2016; 388: 460-461Summary Full Text Full Text PDF PubMed Scopus (27) Google Scholar CEPI has a just-in-case strategy to push vaccine candidates from late preclinical through proof of concept and safety phase 2 trials. CEPI has decided to start by tackling Middle East respiratory syndrome coronavirus (MERS), Nipah virus infection, and Lassa fever, as well as scoping potential support for vaccines against Ebola (other strains than Zaire), Marburg, and Zika viruses. However, although CEPI knows these viruses could cause the next major outbreak, we are aware that it is more likely to arise from an unknown pathogen. Therefore, CEPI also has a just-in-time strategy, which aims to create the ability to respond quickly to new threats by investing in validating adaptable vaccine technology platforms and production facilities. CEPI needs to raise US$1 billion over 5 years to deliver on these strategies. This emphasis on preventing and preparing for outbreaks, epidemics, and pandemics comes at a time when globalisation, urbanisation, and environmental and climate change mean that infectious diseases are increasingly global threats that respect no borders. Health protection is therefore dependent on investing collectively in global health security. The chain is no stronger than its weakest link. So the global community must invest in domestic capabilities that meet International Health Regulations requirements and establish core national capacities in all countries through building countries' workforce capabilities, strengthening real-time surveillance, and strengthening laboratory systems for earlier detection of potential threats. The global community must also invest in global capabilities such as the development of biomedical countermeasures. Although no-one knows what the next outbreak will be, we must develop the required arsenal now. No country can do this on its own. Countries need to invest in an insurance that collectively enables us to respond faster and mitigate risk to lives and livelihoods. CEPI is such a global health insurance mechanism. CEPI can achieve much more with pooled resources than any nation can achieve alone. Countries must invest together to generate global public goods. They need to act jointly because investments that protect the poorest people will make the world safer for all of us. We represent the first public and philanthropic funders to invest in CEPI. We have so far collectively committed about US$460 million to a pooled fund, and are working to mobilise more. The European Commission will contribute to CEPI's objectives and plans to co-fund actions with CEPI, such as through the Innovative Medicines Initiative. Together, we see such a coalition as an important investment for global epidemic preparedness. The impact of epidemics such as Zika virus, Ebola virus disease, and severe acute respiratory syndrome (SARS) on national and regional economies has shown that no country can afford not to invest in protection against outbreaks. However, more investors are needed—both to reach the US$1 billion over 5 years that would enable CEPI to realise this first phase of its mission, and because the initiative will be most successful with participation from countries of all sizes, geographical regions, and levels of economic development. CEPI will have a crucial role in generating necessary global public goods for populations in need. Global health governance calls for institutional innovations that can operate with the public and private sectors, governments, and non-governmental organisations, and that can build on normative guidance from UN organisations, such as WHO, to develop technologies that can be procured by delivery-oriented global health organisations and regional and national government agencies. CEPI will fill this gap in global health R&D, and we welcome more partners—both investors and implementers. We represent governments and foundations who are investing in CEPI. BB is Minister of Foreign Affairs for the Government of Norway. JF is Director of the Wellcome Trust. DG is Minister of Health for the Rwandan Government. CM is the European Commission's Directorate-General for Research and Innovation. TM is President of the Global Health Division for the Bill & Melinda Gates Foundation. YS is Minister of Health, Labour, and Welfare for the Japanese Government. HV is Minister of Science and Technology for the Indian Government. JW is Federal Minister of Education and Research for the German Government. J-AR is Interim Chief Executive Officer of CEPI.