Gavi, the Vaccine Alliance and Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (known as MSD outside the US and Canada) have signed an agreement to support the provision of a vaccine to protect against future deadly Ebola outbreaks. The agreement, announced at the World Economic Forum in Davos, will help MSD take the vaccine through licensure and World Health Organization (WHO) prequalification.
Under the Advance Purchase Commitment, Gavi has provided $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, MSD will ensure that 300,000 doses of the vaccine are available from May 2016 for use in clinical trials and/or for emergency use as needed while vaccine development continues. MSD has already submitted an application through WHO’s 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.
“We are very pleased to join with Gavi in announcing this Advance Purchase Commitment agreement to support the provision of MSD’s investigational monovalent Ebola Zaire vaccine - in case of a resurgence of the Ebola outbreak or a new outbreak,” said Dr. Julie Gerberding, Executive Vice-President, Strategic Communications, Global Public Policy and Population Health for MSD. “We applaud Gavi for this bold step to be a part of the solution to address a disease that has impacted so many lives.”
The Ebola epidemic in West Africa claimed the lives of more than 11,300 people and infected over 28,600. On January 14, WHO announced that no new Ebola cases had been reported in the three worst affected countries in the preceding 42 days. Shortly, following the announcement, which included a warning that sporadic flare-ups could occur, Sierra Leone reported an Ebola-related death.
Vaccine manufacturers have been working since the beginning of the Ebola outbreak to develop an effective, safe vaccine. Although early-stage development took place more than a decade ago, mainly to counter potential bioterrorism threats, no manufacturer had a vaccine in phase III trials when the outbreak began. Gavi continues to work with all vaccine manufacturers, including GSK and Janssen Pharmaceutical Companies of Johnson & Johnson, that are advancing their development programme of the Ebola vaccine in order to be prepared should a new outbreak occur.
Ebola outbreaks have mainly affected rural areas in the poorest developing countries and have been brought under control quickly by local authorities. This means the development of Ebola vaccines has been a lower priority compared to other vaccines.
“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,” said Gavi Board Chair Dr. Ngozi Okonjo-Iweala. “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.”
In December 2014, the Gavi Board committed significant funding for the purchase of Ebola vaccines, once approved. At Gavi’s replenishment conference, held in January 2015, Dr Jacques Cholat, President of MSD Vaccines, announced the company’s commitment to provide its Ebola vaccine to the world’s poorest countries at the lowest possible, not-for-profit access price when it becomes fully licensed.
Despite MSD’s vaccine still being in the investigative phase, interim analysis from a randomised phase III vaccine efficacy trial conducted in Guinea suggested that the rVSV∆G-ZEBOV-GP vaccine could be effective against Ebola Zaire; it’s currently the only vaccine with published interim Phase III efficacy data. The Phase III study is ongoing.
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