The global pharmaceutical giant, GSK, is to manufacture ten thousand doses of its experimental Ebola vaccine following the commencement yesterday in the UK of human trials of the medicine the world is pinning its hopes on to contain an unprecedented outbreak in parts of West Africa.
The aim is to have the 10,000 doses of the experimental vaccine ready so that if the ongoing human trials are successful, stocks can be made available immediately to the World Health Organisation (WHO) to fortify health workers who are high risk of being infected.
Britain’s trial of an experimental vaccine against Ebola began in Oxford yesterday with the first healthy volunteer receiving the vaccine.
Ruth Atkins, 48, was injected with the candidate Ebola vaccine on Wednesday after a clinical assessment. She was the first of 60 volunteers to participate in the trial.
“I volunteered because the situation in West Africa is so tragic and I thought being part of this vaccination process was something small I could do to hopefully make a huge impact,” said Atkins, a former nurse and now an NHS communications manager.
Speaking an hour after the vaccination, she said: “I feel absolutely fine, it felt no different to being vaccinated before going on holiday. I did not realise until today how many people behind the scenes have worked extra and unsociable hours to get this to trial so quickly,” she added.
The candidate vaccine against the Zaire species of Ebola circulating in West Africa has been co-developed by the US National Institutes of Health and GlaxoSmithKline. It uses an Ebola viral protein to generate an immune response, but does not contain infectious material, so it cannot transmit the disease to people who are vaccinated.
The trial at the University of Oxford is part of a series of safety tests of potential Ebola vaccines. They have been fast-tracked in response to the outbreak in West Africa, which has killed more than 2,450 people, according to the World Health Organisation (WHO).
Ian Hudson, chief executive of the UK Medicines and Healthcare Products Regulatory Agency, said: “Given the importance of Ebola as a risk to public health in some countries in Africa, we fast-tracked the review of the clinical trial application for this vaccine so that it was assessed and authorised by the MHRA’s experts in just four working days.”
“These are initial safety trials of the vaccine and it will be some time before we know whether the vaccine could protect people against Ebola,” added Adrian Hill, director of Oxford’s Jenner Institute. “But we are optimistic that the candidate vaccine may prove useful against the disease in the future.”
Animal research by the NIH and Okairos, a biotechnology company acquired last year by GSK, indicated that the vaccine protects monkeys exposed to Ebola without significant adverse effects. The NIH is testing the same vaccine in the US, in addition to a related vaccine designed to protect against two Ebola species.
Trials with healthy volunteers are required to confirm that the vaccine does not cause unforeseen problems and that it generates a good immune response in humans. The aim is to finish these this year.