Approach

CEPI wants to galvanise the development of new vaccines against diseases we know could cause the next devastating epidemic.

We will achieve our vision by creating an innovative partnership between public, private, philanthropic and civil organisations. It is ambitious both in its scope and in the breadth of organisations involved.

CEPI will take an end-to-end approach – we won’t take on discovery research or vaccine delivery, but we will work through all the steps in between. We will stay abreast of new discoveries and technologies, and we’ll work with other organisations to make sure any vaccines that are developed reach those who need them.

Equitable access will be a founding principle of CEPI, so that vaccines developed with its support are available to all who need them – price should not be a barrier – and they are available to populations with the most need.

We expect that many of the vaccines CEPI helps to develop will not be profit-making, and will work with our partners to ensure that the risks, costs and benefits of development are shared proportionately.

CEPI’s end-to-end gap-filling role: a sustainable partnership approach

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Preliminary Business Plan 2017-2021

In the preliminary Business Plan for the period 2017 – 2021, CEPI commits to tackle the barriers to epidemic vaccine development, advancing safe, effective, and affordable vaccines to contain outbreaks at the earliest possible stage.

The focus is on two main objectives:

  1. Advancing at least four vaccine candidates against two to three priority pathogens to proof-of-concept in five years, to enable clinical efficacy testing in the initial stages of a potential outbreak;
  2. Building technical and institutional platforms to accelerate R&D response to known or unknown pathogen emergencies. CEPI is also exploring how to support multivalent Ebola vaccine R&D and facilitate regulatory preparedness and stockpiling.

 

 

 

 

 

 

 

 

 

 

 

 

 


CEPI will ensure sustainability of its partnership approach by: securing industry participation through partnerships that share the risks and benefits of vaccine development; and supporting the long-term development of regional capabilities for epidemic vaccine preparedness. The CEPI Business Plan builds on scoping, research and analysis facilitated by consultations with over 80 organizations and more than 200 individuals since February 2016. This is a preliminary version of the Business Plan for the period 2017-2021 which will be further refined and updated by end 2017.

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What CEPI will do that's different

  • Stimulate, facilitate and finance the development of new vaccines against infections of epidemic potential, especially where pathways to regulatory approval and commercialisation are highly unpredictable.
  • Advance candidate vaccines through the development process, so safety and efficacy are proved in principle through human trials, before epidemics begin. This will enable rapid full trials or emergency deployment in outbreaks. 
  • Establish the technical capabilities and processes necessary to accelerate research, development, manufacturing and clinical trials in the context of an outbreak.
  • Work with industry, regulators and other bodies to ensure any vaccines developed get licensed and reach the people who need them.
  • Support the long-term development of epidemic vaccine preparedness within the countries most at risk from epidemic threats.

How CEPI will decide which diseases to focus on

CEPI will concentrate initially on vaccines for known epidemic threats. It will also build capabilities and partnerships that could rapidly be used against new epidemic diseases we are not aware of today, as and when these emerge. If successful, this model could eventually be extended to cover endemic diseases and other medical interventions.

The WHO R&D Blueprint for Action to Prevent Epidemics outlined a priority list of pathogens that urgently require medical countermeasures. CEPI's scientific advisory committee will use this list to identify those diseases where vaccine development is most technically and scientifically feasible. 

CEPI will prioritise infectious diseases that have:

  • the potential to become global public health emergencies 
  • feasible development approaches for vaccines

Background

Recent epidemics and pandemics have exposed serious flaws in the world’s capacity to prepare for and respond to infectious disease outbreaks.

The Ebola outbreak in West Africa and Zika in the Americas are the most recent instances. But there are many more, including SARS, MERS-CoV, chikungunya and Lassa.

In each outbreak, a vaccine could have slowed, halted or even prevented an epidemic. This would have saved many thousands of lives, and prevented profound social and economic disruption in the countries affected.

Ebola proved that we can develop vaccines quickly, even in extremely challenging conditions. During the outbreak the global scientific community, including pharmaceutical companies, academics, funders, emergency responders and the WHO, made tremendous efforts to accelerate clinical trials of several promising vaccines. 

But we can’t continue to rely on ad-hoc partnerships and the goodwill of a handful of companies. We need a sustainable model for epidemic vaccine development.

A mandate for change

Since Ebola, an international consensus has been building around two clear R&D issues:

  • current models for stimulating epidemic product development are failing
  • a new system is urgently needed.

Discussions about epidemic preparedness began in March 2015 with an expert meeting in Berlin. It was convened by German Chancellor Angela Merkel, in the run up to the G7, and chaired by Bill Gates.

In July 2015, Stanley Plotkin, Adel Mahmoud and Wellcome Trust Director Jeremy Farrar, writing in the New England Journal of Medicine, proposed a global vaccine development fund. 

The Foundation for Vaccine Research was pivotal in building support for that proposal.

Four expert reports into the Ebola outbreak reached the same conclusion: a new system is needed to drive product innovation to prevent and contain future infectious disease epidemics. 

Another meeting in October 2015, hosted by WHO and the Norwegian Institute of Public Health in Oslo, identified the need for global financing and coordination of efforts.

Then at the 2016 World Economic Forum in Davos, leaders from international organisations, governments, industry, public and philanthropic R&D funders, academia, NGOs and civil society groups agreed to collaborate to create such a mechanism.

This started a process that has resulted in CEPI – the Coalition for Epidemic Preparedness Innovations.

2014

Mar

The World Health Organization’s regional office reports an outbreak of Ebola virus disease in Guinea, West Africa

Aug

Ebola is declared a Public Health Emergency of International Concern by the WHO. The eventual death toll is over 11,000 lives – mostly in Guinea, Liberia and Sierra Leone.

Oct

High-level meeting at WHO in Geneva concludes that phase III Ebola vaccine trials in West Africa should move ahead quickly

2015

Mar

Clinical trials of a promising candidate Ebola vaccine – rVSV-EBOV – begin in Guinea. A paper in the Lancet shows it is almost 100% effective at preventing transmission, but the results come too late to significantly lessen the epidemic.

May

A Summit on Ebola Research and Development at the WHO in in Geneva looks at some of the lessons learned during the Ebola outbreak, kicking off development of the R&D Blueprint.

Jun

Ebola is a key focus of the G7 summit in Bavaria. German Chancellor Angela Merkel makes a compelling case for global health reform.

Jul

The first of four reports into the epidemic is released by the Ebola Interim Assessment Panel, chaired by Dame Barbara Stocking. It highlights the inadequate funding for R&D for neglected diseases

Jul

Stanley Plotkin, Adel Mahmoud and Jeremy Farrar publish an article in the New England Journal of Medicine, outlining the case for a global vaccine development fund

Oct

WHO and the Norwegian Institute of Public Health host the Oslo consultation on Financing of R&D Preparedness and Response to Epidemic Emergencies. It identifies the need for global financing and coordination of activities.

Nov

The Harvard and London School of Hygiene and Tropical Medicine’s Independent Panel on the Global Response to Ebola publishes its report. It outlines ten essential reforms.

2016

Jan

The National Academy of Medicine’s Global Health Risk Framework published. The third of four post-Ebola reports puts the cost of epidemics at $60bn a year. It calls infectious disease pandemics "one of the potent threats to humankind".

Jan

At the World Economic Forum in Davos, stakeholders from international organisations, governments, industry, public and philanthropic R&D funders, academia, NGOs and civil society groups begin the process of founding CEPI.

Feb

Report of the UN High-level Panel on the Global Response to Health Crises is published. It says that vaccines are often inaccessible or unaffordable to vulnerable populations, even where they exist.

May

The World Health Organization publishes its R&D Blueprint for Action to Prevent Epidemics. It includes a list of priority pathogens likely to cause severe outbreaks in the near future.

Aug

CEPI appoints an interim board and scientific advisory committee ahead of a full launch in 2017.