MSD and GAVI agree Ebola vaccine deal
pharmafile | January 20, 2016 | News story | Manufacturing and Production, Research and Development | Ebola, GAVI, MSD, WHO
MSD and the global vaccine alliance Gavi have agreed a deal to provide 300,000 dosesof an Ebola virus vaccine, to continue trials and begin preparation for future outbreaks of the deadly virus.
The deal, announced today at the World Economic Forum in Davos, establishes an Advance Purchase Commitment between Gavi that provides $5 million towards the development of MSD’s rVSV-G-ZEBOV-GP live attenuated Ebola Zaire vaccine, on the understanding that it will be submitted for licensure by the end of 2017. If approved, it would become one of the world’s first licensed Ebola vaccines and Gavi would be able to begin purchasing the vaccine to create a stockpile for future outbreaks.
Additionally, Merck will ensure that 300,000 doses of the vaccine are available from May 2016, for use in expanded use clinical trials, and also available for emergency use as needed while vaccine development continues. Merck has already submitted an application through the World Health Organisation (WHO) Emergency Use Assessment and Listing (EUAL) procedure. If the EUAL is approved, this will provide an opportunity for the investigational vaccine to be used if another public health emergency with Ebola occurs before the vaccine is licensed.
On 14 January, WHO announced that no new Ebola cases had been reported in the three worst affected countries in the preceding 42 days. However just a day later WHO issues a warning that sporadic flare-ups could occur, Sierra Leone reported an Ebola-related death. At its height the Ebola epidemic in West Africa claimed the lives of more than 11,300 people and infected over 28,600.
Since the start of the outbreak in Guinea in December 2013, vaccine manufacturers have been working to develop a vaccine – no company had a vaccine in Phase III trials when the outbreak began. Gavi continues to work with all vaccine manufacturers, including GSK and Johnson & Johnson, who still have vaccines in clinical trials. Gavi has previously committed $300 million – potentially up to 12 million doses – to stockpile any Ebola vaccine that is recommended by WHO.
Gavi chief executive Dr Seth Berkley says: “The suffering caused by the Ebola crisis was a wake-up call to many in the global health community. New threats require smart solutions and our innovative financing agreement will ensure that we are ahead of the curve for future Ebola outbreaks.”
While Dr Julie Gerberding, executive vice president of strategic communications and global public policy and population health at MSD says: “We applaud Gavi for this bold step to be a part of the solution to address a disease that has impacted so many lives.”
Dr Jeremy Farrar, Director of the Wellcome Trust, which co-funded clinical trials of the VSV Ebola vaccine, says: “The remarkable results from clinical trials of the VSV Ebola vaccine and the promising progress of other vaccine candidates were among the few positive outcomes to emerge from the epidemic. I’m delighted that Gavi has committed to supporting the continued development of the vaccine towards licensure, which is the ultimate goal to enable it to reach those who need it most. It should also give others working in this space the confidence needed to carry on pursuing alternative vaccines.
“As we saw with the new confirmed case, the Ebola epidemic is likely to have a long tail and it’s possible that several more isolated cases will emerge in the coming weeks and months. This vaccine, therefore, could still play an important role in containing any additional flare ups of this outbreak, as well as being available to help prevent future epidemics.”
Gavi board chair Dr Ngozi Okonjo-Iweala adds: “Ensuring a vaccine will be available to protect people who might have missed out due to a market failure lies at the heart of what makes Gavi so important in global health. It is our moral duty to ensure that people do not miss out simply because of where they are born or whether they can afford to pay.”
- The clinical-stage vaccine development company Profectus announced today it has launched a Phase I trial of an Ebola virus vaccine. The Phase 1 trial will evaluate the safety and immunogenicity of Profectus’ Ebola virus vaccine administered at various dose levels. The filovirus vaccine program is based on the company’s highly attenuated vesicular stomatitis virus (VSV) vector, and the program is supported by the US Department of Defense, the non-profit organisation Battelle, the Biomedical Advanced Research and Development Authority (BARDA) and the National Institutes of Health.
Lilian Anekwe
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