Gavi, the Global Alliance for Vaccines and Immunsation, is paying Merck & Co $5 million to support the development of its Ebola vaccine rVSV-ZEBOV, on the understanding that it will be filed with regulators by the end of next year.
The vaccine was initially engineered by scientists at Canada’s Public Health Agency and licensed to NewLink Genetics. Merck then licensed rVSV-ZEBOV from NewLink when the Ebola outbreak was at its worst, to accelerate its development and availability.
rVSV-ZEBOV is currently the only vaccine with published interim Phase III efficacy data, showing 100% efficacy in a trial in West Africa. If approved, it would become one of the world’s first licensed Ebola vaccines, and Gavi would be able to begin purchasing the jab to create a stockpile for future outbreaks.
Under the deal, Merck will also ensure that 300,000 doses of the vaccine are available from May 2016 for use in expanded use clinical trials and/or for emergency use as needed while vaccine development continues. The firm has already submitted an application through WHO’s Emergency Use Assessment and Listing procedure which, if approved, will allow rVSV-ZEBOV to be used if another public health emergency with Ebola occurs before it is licensed.
The Ebola epidemic in West Africa took more than 11,300 lives and infected over 28,600 people, leaving health systems in affected nations in turmoil. “The suffering caused by the Ebola crisis was a wake-up call to many in the global health community,” said Gavi chief executive Seth Berkley. “New threats require smart solutions and our innovative financing agreement with Merck will ensure that we are ahead of the curve for future Ebola outbreaks.”
“The most recent Ebola-related death in Sierra Leone and the fact that we know the reservoirs of Ebola still exist, underline why we must learn lessons from the devastating impact of the crisis and ensure we are better prepared for infectious disease outbreaks,” he added.
As such, Gavi is also working with other vaccine manufacturers, such as GSK and Janssen, to advance their Ebola vaccine development programmes in case a new outbreak occurs.
Médecins Sans Frontières (MSF) said it is encouraged by the news that Merck and Gavi have reached an agreement to purchase and stockpile the vaccine, but also seeks clarification on whether "this advance purchase commitment will allow for the vaccine to be used in any country where a Zaire Ebola strain outbreak occurs. An outbreak in any country will require the rapid deployment of doses to prevent the spread of the disease and quick access is critical”.
“We want to understand how Gavi and Merck will set the price, especially in the long-term, and to receive confirmation that the final price will be set close to the cost of production,” said Manica Balasegaram, executive director of MSF’s Access Campaign.
“Given prior public and philanthropic investment in this vaccine, we hope Merck bucks the pharmaceutical company trend and will be as transparent as possible on the funding contributions, R&D funding, development incentives and pricing structure of the rVSV-ZEBOV vaccine,” she added, stressing that public and philanthropic funders shouldn’t pay twice for the R&D for this vaccine.