WHO convenes Meeting for the Assisted Review of the Janssen Ebola Zaire Vaccine Clinical Trials Application by Representatives of Ethics Committee and National Regulatory Authority of Sierra Leone in Accra Ghana

Accra, 27 April 2015 - Despite signs of the Ebola Virus Disease (EVD) epidemic abating in West Africa, efforts continue to find an effective vaccine that can fight the virus both now and for future generations. As the race for an Ebola vaccine continues, experts gathered in Ghana from 8-10 April 2015 to review the clinical trial application for the Janssen Ebola Zaire Vaccine that will take place in Sierra Leone.

The meeting aimed to review the scientific and ethical aspects of the proposed vaccine trial in Sierra Leone to evaluate the immune response, identify any side effects and determine its effectiveness.

The meeting facilitated by WHO under the platform of the African Vaccine Regulatory Forum (AVAREF) was attended by 60 expert representatives of the Ethics Committee and the Pharmacy Board of Sierra Leone with support from Ghana’s Food and Drug Authority (GFDA), Health Canada, the European Medicines Agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) United Kingdom, and the United States Food and Drug Administration (US FDA). This meeting provided a forum for a thorough discussion on all scientific and ethical aspects of the proposed phase III clinical trial.

The meeting comes at a time when, despite the number of cases reducing, the goal of zero cases has not been reached.  As at 15 April, the outbreak, which has persisted for more than a year, has infected 25,826 people and resulted in 10,704 deaths, according to WHO. There still remains a need to develop a vaccine capable of protecting the population in this epidemic and any future ones

The importance of collaborative partnerships in this regard is critical. WHO Coordinator of Regulatory System Strengthening, Director of Essential Medicines and Health Products (EMP) Department, Mr. Michael Ward explains the partnership with AVAREF, "WHO plays a key enabling role in supporting the AVAREF network, so that it may fulfil its potential in accelerating the availability of preventative vaccines and other important therapies for the people of Africa."

The meeting concluded with a signed agreement by Sierra Leone and Crucell Holland B.V., study sponsor and one of the Janssen Pharmaceutical Companies of Johnson & Johnson noting that further documentation and timelines are required before a final regulatory decision could be provided.  AVAREF Chair Dr Beno Yakubu said, “Under the platform of AVAREF, this meeting is an indication of the due diligence taken by the pharmaceutical companies and partners to jointly ensure that the clinical trial process is of the highest ethical and scientific standards to ensure the safety of the volunteers and patients who will ultimately receive the vaccine.”

The meeting was co-chaired by Health Canada (Dr Lindsay Elmgren, Director, Centre for Biologics Evaluation), Ghana National Regulation Authority (NRA) CEO (Mr Hudu Mogtari) and the AVAREF Chair Dr Beno Yakubu).

Notes to the editor:

About the vaccine regimen:

The Ebola vaccine regimen in development at the Janssen Pharmaceutical Companies of Johnson & Johnson, which was discovered in a collaborative research program with the National Institutes of Health, uses a prime-boost combination of two components that are based on AdVac® technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and the MVA-BN® technology from Bavarian Nordic.  The company is collaborating with numerous partners, including London School of Hygiene and Tropical Medicine and Inserm, to accelerate the development of the vaccine regimen. Evaluation of the vaccine regimen commenced with Phase I clinical trial at the Oxford Vaccine Group in December 2014 and this has been followed by Phase 1 studies in the United States (US) and Africa (Kenya, Uganda, Tanzania).

Other Clinical Trials in Progress on Human Volunteers:

The ChAd3-ZEBOV, developed by GlaxoSmithKline (GSK), in collaboration with the US National Institute of Allergy and Infectious Diseases (NIAID) is in phase III clinical trial in Liberia and rVSV-ZEBOV, developed by NewLink Genetics and Merck Vaccines USA, in collaboration with the Public Health Agency of Canada and WHO entered Phase III trials in Guinea. The trial which commenced in March in Guinea is being undertaken in close collaboration with the Health Ministry of Health Guinea, Médecins Sans Frontières (MSF), Epicentre and the Norwegian Institute of Public Health. For more information visit:  first Ebola vaccine to be tested in affected communities one year into outbreak.

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For more information, please contact:

Dr Dicky Akanmori
Email: akanmorib [at] who.int

Dr Ahmed Bellah
Email: bellaham [at] who.int