Fast track for GSK's Ebola vaccine
29.08.2014 - Just a week ago, Glaxosmithkline defused the WHO’s claim that an Ebola vaccine could be ready by 2015. Now, the British company’s own candidate vaccine is to be rushed to human trials with the help of funding from an international consortium.
A candidate Ebola vaccine, co-developed by the US National Institutes of Health (NIH), could be given to healthy volunteers in the UK, Gambia and Mali as early as September, said GSK. This is part of an series of safety trials of potential vaccines aimed at preventing the disease that has killed more than 1,400 people in the current outbreak in West Africa. Money for the accelarated human trials comes from an international consortium in response to the Ebola epidemic, which the World Health Organisation recently declared a public health emergency of international concern. A £2.8m (€3.5m) grant from the Wellcome Trust, the Medical Research Council and the UK Department for International Development will allow a team led by Professor Adrian Hill, of the Jenner Institute at the University of Oxford, to start safety tests of the vaccine alongside similar trials in the US run by NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
The consortium’s funding will also enable GSK to begin manufacturing up to around 10,000 additional doses of the vaccine at the same time as the initial clinical trials, so that if the trials are successful stocks could then be made available immediately by GSK to the WHO to create an emergency immunisation programme for high-risk communities. Before the vaccine can be rolled out to larger at-risk populations – even on an experimental basis –, safety trials with small groups of healthy volunteers are required to ensure that the vaccine does not cause unforeseen side effects, and that it generates a good immune response to Ebola in humans. Pre-clinical research indicated that the candidate provides promising protection in non-human primates exposed to Ebola without significant adverse effects. "There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection," said NIAID Director Anthony S. Fauci. The institute is testing this same vaccine in the US, in addition to a related vaccine that is designed to protect against two Ebola species. This collaborative multi-trial approach is supposed to ensure the fastest possible progress to determining the best candidate vaccine approach and delivery.
GSK’s acquired the vaccine candidate last year when they bought Okairos, a Swiss-Italian biotechnology company specialised on genetic vaccines for €247m. After their earlier reluctance, the drug maker is now more optimistic. "[GSK] will do the best we can, along with WHO and our partners, to speed up development and explore ways in which the vaccine could contribute to the control of this or future Ebola outbreaks," said Moncef Slaoui, Chairman of Global R&D and Vaccines at GSK, and added: "Today’s announcement shows how private and public partners can pull together to respond to this critical public health emergency."