At the start of this week, MSD, known as Merck in North America and Mexico, announced that the European Commission (EC) had granted its vaccine, now known as Ervebo (Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP) live), conditional approval for use in the European Union.
The following day, the WHO prequalified the vaccine for the first time, which will expedite licensing, access and roll-out in the countries most at risk.
The first approved vaccine has been years in the making and BioPharma-Reporter breaks down some of the key milestones on the journey to this point:
The most serious outbreak began in March 2014 in West Africa. Two and a half years after the first case was reported, this particular outbreak ended with more than 28,600 cases and 11,325 deaths, according to the US Centers for Disease Control and Prevention (CDC). The outbreak began in rural Guinea before spreading to include Liberia and Sierra Leone.
As the severity of the outbreak became clear, more funding was provided to pharmaceutical companies to encourage the development of a viable vaccine against the virus.
At the beginning of the epidemic, the WHO had called for the development of vaccines and treatments against the virus to be incentivized. Prior to 2014, there had been few cases of the virus and therefore little funding had been diverted into the development of a vaccine.
With West Africa still hard-hit by the virus, vaccine candidates emerged with the potential to become the first generation of vaccines to combat Ebola. This saw Bavarian Nordic partner with Johnson & Johnson and MSD publish promising Phase III data for its own vaccine.
Both vaccines then received support from governments and organizations around the world to aid in the manufacture and development.
The worst of the Ebola virus was felt in West Africa during 2014 to 2016; however, the virus did not disappear completely in the intervening years. The Democratic Republic of Congo has been repeatedly hit with ongoing outbreaks, which led to MSD’s investigational vaccine becoming a cornerstone of prevention.
This has seen the US government agree to help fund the manufacture of MSD’s vaccine for ongoing use over the next year.
All of this has led to the situation this week wherein the EC granted MSD conditional approval for its vaccine, which became the first effective treatment for the Ebola virus provided marketing approval. A decision by the US Food and Drug Administration is expected by March 2020.
MSD noted that it projects being able to begin the manufacture of licensed doses of the treatment in Germany immediately, to be made available by the third quarter of 2020. In the meantime, the company will supply investigational doses of the vaccine via donation to the countries in need.
Kenneth Frazier, CEO of Merck, said on the vaccine’s approval, “After recognizing the need and urgency for an Ebola Zaire vaccine, many came together across sectors to answer the global call for outbreak preparedness. We at MSD are honored to play a part in Ebola outbreak response efforts and we remain committed to our partners and the people we serve.”
Beyond the approval, MSD has plans to scale-up its Ebola vaccine supply and a second vaccine could be set for approval – as J&J has brought its own vaccine in front of the European Medicines Agency.