GAVI and US Merck Link on Ebola Vaccine
Geneva, Switzerland-based GAVI (Global Alliance for Vaccines and Immunization), a public-private partnership, and Merck Sharp & Dohme (MSD), known in the US as Merck & Co, have signed an agreement to support the provision of a vaccine against Ebola.
The pact announced at the World Economic Forum in Davos, Switzerland, represents an advance purchase commitment by GAVI to help MSD take its vaccine candidate through late-stage clinical trials, licensing procedures and World Health Organization (WHO) prequalification.
Under the commitment, GAVI has provided $5 million toward 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, this would become one of the world’s first licensed Ebola vaccines, and GAVI would be able to begin purchasing the vaccine to build stocks in case the disease returns.
MSD will ensure that 300,000 doses are available from May 2016 for expanded-use clinical trials and/or emergency use as needed while development continues.
Seth Berkley, CEO of GAVI, said the Ebola crisis is a wake-up call. "Our innovative financing agreement with Merck will ensure that we are ahead of the curve for future Ebola outbreaks,” he added.
The US drugmaker has already submitted an application through WHO’s Emergency Use Assessment and Listing (EUAL) process. If approved, the vaccine could be used if another Ebola outbreak occurs before a license is granted.
Despite the vaccine still being under investigation, an interim analysis from a randomized phase III efficacy trial conducted in Guinea suggested that Rvsv G-ZEBOV-GP could be effective against Ebola Zaire. It is currently the only vaccine with published interim Phase III efficacy data. The Phase II trial is ongoing.
Research evaluating Rvsv G-ZEBOV-GP also continues in Phase I, II and III clinical trials at sites in the EU, Africa, the US and Canada.
Initially engineered by scientists from the Public Health Agency of Canada, Rvsv G-ZEBOV-GP was licensed to a subsidiary of NewLink Genetics. Merck & Co licensed the candidate from NewLink Genetics in late 2014 when the Ebola epidemic was at its worst.
GAVI said it continues to work with all vaccine manufacturers, including GlaxoSmithKline (GSK) and Johnson & Johnson’s ethical drugs arm Janssen, to advance development programs for an Ebola vaccine.
The Ebola epidemic in West Africa claimed the lives of more than 11,300 people and infected over 28,600. Although early-stage development of a vaccine started more than a decade ago, mainly to counter potential bioterrorism threats, no manufacturer had a vaccine in Phase III trials when the outbreak began.
