LONDON – A $1 billion program to develop vaccines against emerging infectious diseases that, like Zika and Ebola viruses, have the potential to cause serious epidemics, will be launched at the World Economic Forum in Davos, Switzerland.
The Coalition for Epidemic Preparedness Innovations (CEPI) wants to advance new vaccines to the end of phase II, so they can be on the shelf and ready for phase III trials when an outbreak occurs. Its formation is a response to expert reports on the 2014 – 2015 Ebola epidemic, which called for a new system to stimulate development of vaccines against similar threats.
CEPI intends to capitalize on "plug and play" DNA and RNA technologies that allow for rapid discovery of antibodies against previously unknown pathogens, and also to invest in standby facilities for development and manufacturing.
An initial investment of $460 million has come from the governments of Germany, Japan and Norway, the Bill and Melinda Gates Foundation (BMGF) and the U.K. medical charity Wellcome Trust. That is almost half of what CEPI needs to fund its 2017 – 2022 plans, and it called on other governments and foundations to contribute, with the aim of completing its fundraising by the end of 2017.
The coalition has now opened a call for proposals from researchers and companies to support its work. For diseases that could cause serious epidemics, as outlined in the World Health Organization's (WHO) priority list, CEPI will develop vaccine candidates "just in case."
Vaccines can provide protection, but too little is being done to develop them as an insurance policy, said Jeremy Farrar, director of the Wellcome Trust. "CEPI is our chance to learn the lessons of recent [Ebola and Zika] tragedies and outsmart epidemics with new vaccines," he said.
The initial targets will be Middle East respiratory syndrome coronavirus (MERS-Cov) and Lassa and Nipah viruses, which have known potential to cause serious epidemics. The aim is to develop two vaccine candidates against each, so they are available without delay if an outbreak occurs.
CEPI also intends to scope support for vaccines against multiple strains of Ebola and the related Marburg virus, and against Zika.
Ebola and Zika showed the world is "tragically unprepared" to detect local outbreaks and respond quickly enough, said Bill Gates, co-chair of BMGF. "Without investments in R&D, we will remain unequipped when we face the next threat. The ability to rapidly develop and deliver vaccines when new, unknown diseases emerge offers our best hope to outpace outbreaks," Gates said.
Along with the cash donors, CEPI has backing from WHO, the European Union, the Indian government, academic vaccines groups and companies, including Glaxosmithkline plc (GSK), Sanofi SA, Merck & Co Inc., Takeda Pharmaceutical Co. Ltd. and Pfizer Inc.
GSK has made a proposal to set up a "biopreparedness organization" on a cost coverage basis. "[This] dedicated and permanent facility would use our scientific expertise and technologies to develop vaccines that could be deployed to protect citizens in the world's poorest countries against future epidemics and pandemics," said Andrew Witty, GSK CEO.
For Nima Farzan, CEO of travelers' vaccines specialist Paxvax Inc., of Redwood City, Calif., who is the U.S. Biotechnology Innovation Organization's representative on the CEPI board, a collaborative approach is vital. "Working alone, industry players face barriers to vaccine development," he said.
The 2014 – 2015 Ebola outbreak killed more than 11,000 people and cost an estimated $2.2 billion, according to CEPI. A multilayered response accelerated clinical trials of several vaccines, resulting in the development of one effective product. (See BioWorld Today, Dec. 27, 2016.)
But that success relied on ad hoc collaboration and the commitment of vaccines companies, a model that is not robust enough for future outbreaks of emerging diseases.
CEPI's interim CEO, John-Arne Røttingen, said the R&D response to the Ebola epidemic in West Africa was both a success and a failure. "Never before have industry, government agencies, academia and NGOs collaborated so effectively to plan and conduct more than a dozen clinical vaccine trials in less than a year. But it also showed that the R&D system is not prepared for these threats. CEPI will build on the spirit of working together that was ignited by Ebola to create a new R&D system for epidemics," he said.
The formation of CEPI was proposed by Farrar and others in an article in The New England Journal of Medicine in July 2015, in which they wrote, "If a global vaccine development fund had enabled just one candidate Ebola vaccine to be tested for safety and immunogenicity in humans before the 2014 outbreak in West Africa, public health workers could have begun vaccinating people at the start of the epidemic, potentially saving thousands of lives."
CEPI will now build a new system to advance the development of vaccines, ensuring that price is not a barrier to access. It will operate as a public-private partnership to stimulate, finance and coordinate vaccine development, particularly when that is unlikely to occur through market incentives alone.
"The vaccines [we] help to develop will not be profit-making, and [we] will work with our partners to ensure that the risks, costs and benefits of development are shared proportionately," CEPI said.
In separate news from the World Economic Forum, 22 biopharma companies launched Access Accelerated, a global effort to advance access to non-communicable disease prevention and care in low and lower-middle income countries. Contributing companies include Almirall SA, Astellas Pharmaceuticals Inc., Bayer AG, Bristol-Myers Squibb Co., Celgene Corp., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Eisai Ltd., Eli Lilly and Co., GSK, Johnson & Johnson, Merck & Co. Inc., Merck KGaA, Novartis AG, Pfizer Inc., Roche Holding AG, Sanofi, Shionogi Co. Ltd., Takeda Pharmaceutical Co. Ltd. and UCB SA.