Agreement will help prepare for future outbreaks and push vaccine towards regulatory approval
Gavi, the Vaccine Alliance and Merck Sharp & Dohme, a subsidiary of Merck & Co (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 Merck take the vaccine through licensure and WHO prequalification.
Under the Advance Purchase Commitment, Gavi has provided $5 million towards the development of Merck’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/or for emergency use as needed while vaccine development continues. Merck 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.
“The suffering caused by the Ebola crisis was a wake-up call to many in the global health community,” said Gavi CEO. “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.”
“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 VP, Strategic Communications, Global Public Policy and Population Health for Merck.
“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. The world is still worryingly underprepared for potential future health threats and a change of mindset is required to ensure we invest in research and development today to protect ourselves in years to come,” added Dr Berkley.
Reacting to the announcement, Dr Manica Balasegaram, Executive Director, Médecins Sans Frontières Access Campaign says, ““MSF is keen to know if 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. 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. We don’t think that public and philanthropic funders should pay twice for the R&D for this vaccine.”
Despite Merck’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.