The first batch of pharmaceutical company GlaxoSmithKline’s Ebola vaccine has arrived in Liberia.
The shipment that contained an initial 300 vials of the vaccine is the first to arrive in one of the main Ebola-affected countries. It will be used to start the first large-scale efficacy trial of experimental Ebola vaccines in coming weeks, according to a statement by the pharmaceutical company.
The vaccine is currently being tested in five small phase I clinical trials in the UK, USA, Switzerland and Mali, and involves around 200 healthy volunteers in total.
“Initial data from these trials show that the candidate vaccine has an acceptable safety profile, including in a West African population, and across the different doses evaluated. Based on the safety and immunological data available from these trials, GSK has selected the most appropriate dosage level to advance to the next phases of clinical testing,” GSK said.
Results from the first of the phase I studies were published in November 2014 and results from the remaining phase I studies will be published in the coming months.
The selected dose will now be tested in a large phase III clinical trial led by the National Institutes of Health (NIH) in the US, which is expected to involve up to 30,000 people, one third of whom will receive GSK’s candidate Ebola vaccine.
The trial will compare the candidate vaccine to a control vaccine in order to assess whether the immune response seen in phase I trials actually translates into meaningful protection against Ebola. It will begin in Liberia in the coming weeks, and if GSK gets a regulatory approval, further shipments of vaccines will follow.
“Shipping the vaccine today is a major achievement and shows that we remain on track with the accelerated development of our candidate Ebola vaccine. The initial phase I data we have seen are encouraging and give us confidence to progress to the next phases of clinical testing which will involve the vaccination of thousands of volunteers, including frontline healthcare workers. If the candidate vaccine is able to protect these people, as we hope it will, it could significantly contribute to efforts to bring this epidemic under control and prevent future outbreaks,” said Dr Moncef Slaoui, chairman of Global Vaccines at GSK.
“It is important to remember that this vaccine is still in development, and any potential future use in mass vaccination campaigns will depend on whether the World Health Organisation (WHO), regulators and other stakeholders are satisfied that the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large quantities of vaccine can be made,” he continued.
The WHO and Centers for Disease Control and Prevention (CDC) in the USA assist GSK with the design and to potentially support trials in other affected countries, particularly Sierra Leone and Guinea, in the coming months. In parallel, GSK plans to begin large phase II safety trials in non-affected West African countries.
More than €1 billion was pledged by member states and the European Commission to fight the Ebola crisis. The Council has appointed Humanitarian Aid Commissioner Christos Stylianides as the EU Ebola Coordinator.
Mobile laboratories, humanitarian experts, and specialists in dangerous infectious diseases have been deployed to the region.
The €280 million call for proposals, launched by Commission and the European pharmaceutical industry, is under the Innovative Medicines Initiative (IMI).
€140 million will come from Horizon 2020, the EU's framework programme for research and innovation, and €140 million from the pharmaceutical companies which are members of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The research will involve large-scale clinical trials of new vaccines in the Ebola-affected countries as well as the development of fast diagnostic tests and new approaches to manufacture and distribute vaccines.
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