WHO: World on the verge of an effective Ebola vaccine
Geneva ¦ 31 July 2015 – Results from an interim analysis of the Guinea Phase III efficacy vaccine trial show that VSV-EBOV (Merck, Sharp & Dohme) is highly effective against Ebola. The independent body of international experts – the Data and Safety Monitoring Board – that conducted the review, advised that the trial should continue. Preliminary results from analyses of these interim data are published today in the British journal The Lancet.
“This is an extremely promising development,” said Dr Margaret Chan, Director-General of the World Health Organization. “The credit goes to the Guinean Government, the people living in the communities and our partners in this project. An effective vaccine will be another very important tool for both current and future Ebola outbreaks.”
While the vaccine up to now shows 100% efficacy in individuals, more conclusive evidence is needed on its capacity to protect populations through what is called “herd immunity”. To that end, the Guinean national regulatory authority and ethics review committee have approved continuation of the trial.
A line of defence against a terrible disease
“This is Guinea’s gift to West Africa and the world,” said Dr Sakoba Keita, Guinea’s national coordinator for the Ebola response. “The thousands of volunteers from Conakry and other areas of Lower Guinea, but also the many Guinean doctors, data managers and community mobilisers have contributed to finding a line of defence against a terrible disease.”
“The ‘ring’ vaccination method adopted for the vaccine trial is based on the smallpox eradication strategy,” said John-Arne Røttingen, Director of the Division of Infectious Disease Control at the Norwegian Institute of Public Health and Chair of the Study Steering Group. “The premise is that by vaccinating all people who have come into contact with an infected person you create a protective ‘ring’ and stop the virus from spreading further. This strategy has helped us to follow the dispersed epidemic in Guinea, and will provide a way to continue this as a public health intervention in trial mode.”
The Guinea vaccination trial began in affected communities on 23 March 2015 to evaluate the efficacy, effectiveness and safety of a single dose of the vaccine VSV-EBOV by using a ring vaccination strategy. To date, over 4 000 close contacts of almost 100 Ebola patients, including family members, neighbours, and co-workers, have voluntarily participated in the trial.
The trial stopped randomisation on 26 July to allow for all people at risk to receive the vaccine immediately, and to minimize the time necessary to gather more conclusive evidence needed for eventual licensure of the product. Until now, 50% of the rings were vaccinated 3 weeks after the identification of an infected patient to provide a term of comparison with rings that were vaccinated immediately. This now stops. In addition, the trial will now include 13 to 17-year-old and possibly 6 to 12-year-old children on the basis of new evidence of the vaccine’s safety.
If the vaccine is effective, then we are protecting frontline workers from the virus
“In parallel with the ring vaccination, we are also conducting a trial of the same vaccine on frontline workers,” said Bertrand Draguez, Medical Director at Médecins sans Frontières. “These people have worked tirelessly and put their lives at risk every day to take care of sick people. If the vaccine is effective, then we are already protecting them from the virus. With such high efficacy, all affected countries should immediately start and multiply ring vaccinations to break chains of transmission and vaccinate all frontline workers to protect them.”
The trial is being implemented by the Guinean authorities, WHO, Médecins sans Frontières (MSF) and the Norwegian Institute of Public Health, with support from a broad partnership of international and national organizations.
“This is a remarkable result which shows the power of equitable international partnerships and flexibility,” said Jeremy Farrar, Director of the Wellcome Trust, one of the funders of the trial. “This partnership also shows that such critical work is possible in the midst of a terrible epidemic. It should change how the world responds to such emerging infectious disease threats. We, and all our partners, remain fully committed to giving the world a safe and effective vaccine.”
“This record-breaking work marks a turning point in the history of health R&D,” said Assistant Director-General Marie-Paule Kieny, who leads the Ebola Research and Development effort at WHO. “We now know that the urgency of saving lives can accelerate R&D. We will harness this positive experience to develop a global R&D preparedness framework so that if another major disease outbreak ever happens again, for any disease, the world can act quickly and efficiently to develop and use medical tools and prevent a large-scale tragedy.”
In Interim Results from Phase 3 Study, Merck’s Investigational Ebola Vaccine Efficacious; Study is Continuing
Global Collaboration Enabled Vaccine to Move from First-in-Human Studies to Initial Phase 3 Results Within One Year
July 31, 2015
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (known as MSD outside the US and Canada) said today that its investigational Ebola vaccine candidate, rVSV-ZEBOV, was found to have 100 percent efficacy in an analysis of interim data from a Phase 3 ring vaccination trial in Guinea. Preliminary conclusions from this study, which is continuing, were published on-line today in The Lancet. The authors report that vaccine efficacy was 100 percent (95% confidence interval: 74.7 – 100%; p=0.0036) following vaccination with a single dose of the rVSV-ZEBOV vaccine. It appeared that all vaccinated individuals were protected against Ebola virus infection within 6 to 10 days of vaccination.
“Building on pioneering early work by the Public Health Agency of Canada and NewLink Genetics Corporation, the extraordinary efforts of the team in Guinea and other experts have yielded interim results that suggest a potential role for our rVSV-ZEBOV vaccine in the fight against Ebola disease.”
To date, more than 4,000 participants have received the vaccine in this innovative trial, called “Ebola ça suffit” or “Ebola, that’s enough.” The trial was conducted by a team that included researchers from the World Health Organization (WHO), the Norwegian Institute of Public Health, the Health Ministry of Guinea and Médecins sans Frontières, among others. The results from this continuing study, as well as other studies already underway (see below) and additional studies to be conducted, will be used to support worldwide regulatory submissions.
“Merck has an enduring commitment to develop vaccines and medicines that address the world’s most devastating infectious diseases,” said Dr. Roger M. Perlmutter, president of Merck Research Laboratories. “Building on pioneering early work by the Public Health Agency of Canada and NewLink Genetics Corporation, the extraordinary efforts of the team in Guinea and other experts have yielded interim results that suggest a potential role for our rVSV-ZEBOV vaccine in the fight against Ebola disease.”…
Gavi: Encouraging trial results offer significant hope for rapid availability of Ebola vaccine to end current outbreak
Ring vaccination trial data suggests vaccine is highly effective.
Geneva, 31 July 2015 – An Ebola vaccine should be made available to stop infections in affected communities in West Africa as soon as possible, Gavi CEO Dr Seth Berkley said today, after interim trial results from the World Health Organization suggested it is 100% effective at preventing the disease.
Interim results of the trials of the rVSV-ZEBOV vaccine, which began in the Basse-Guinée area of Guinea in March 2015, were published in The Lancet. Funded and organised by a consortium of partners including the Guinean Government, the Canadian Government, the Norwegian Government, Médecins Sans Frontières, the Wellcome Trust, and the WHO, the trial involved vaccinating more than 3,500 people using ring vaccination, a known public health approach, to study the effects of the vaccine on volunteers.
Ring vaccination involves tracing known contacts of an Ebola patient and vaccinating them as soon as possible, thereby creating a ring of immunised people to prevent further spread of the virus. The trial also showed that infection rates fell in the broader community, beyond those vaccinated, indicating that ring vaccination is an effective strategy to help end the on-going outbreak. The trial also compared the effects of immediate vaccination with delayed vaccination. Following the positive trial results, delayed vaccination was stopped and the vaccine was offered immediately following all cases of Ebola.
“Today’s Ebola vaccine trial results offer tremendous hope to communities that have been blighted by the devastating impact of the outbreak,” said Dr Berkley. “These communities need an effective vaccine sooner rather than later and Gavi stands ready to support the implementation of a WHO-recommended Ebola vaccine while continuing to work closely with all partners involved in the Ebola response.”
“The consortium of partners should be congratulated on the remarkable speed with which it put together these important and practical trials,” added Dr Berkley. “The global community will rightly expect the pace – alongside a high level of diligence – to be maintained so that people in affected communities and others living in countries at risk of Ebola can have access to a vaccine as soon as possible. We need to be ready to act wherever the virus is a threat.”
The Ebola crisis has claimed the lives of more than 11,000 people, with nearly 28,000 infected, in West Africa in the past 20 months. There is currently no treatment for the disease, which, according to the WHO, has an average fatality rate of around 50%.
In December 2014, the Gavi Board agreed to make funding available to purchase doses of Ebola vaccine, once approved by the WHO. The funding is also available to support the operational costs countries face when introducing an Ebola vaccine and to help rebuild severely damaged health systems.
Through the funding, Gavi is also helping Ebola-affected countries to restart their routine immunisation systems, which were devastated by the Ebola outbreak. As well as supporting immunisation campaigns, Gavi funding will enable Guinea, Liberia and Sierra Leone to recruit and retrain health workers, upgrade supply chains and trace children who have missed out on vaccinations.