21 October 2014

GSK fast-tracks development of Ebola vaccine candidate

Update: On 22 October 2014, GSK announced its 3rd quarter results for fiscal 2014. At the accompanying analyst call, Sir Andrew Witty, CEO of GSK said: "Given the apparent health emergency we are leaving no stone unturned in this project and, if all goes well, I fully expect GSK to be the first company in a position to make a vaccine available to health agencies and governments, hopefully towards the end of 2014."

GSK has announced that it is working closely with the World Health Organization (WHO), regulators and other partners to respond to the Ebola outbreak, accelerating development of its investigational Ebola vaccine, and ramping up production as quickly as possible.

According to the company, development of the vaccine candidate is progressing "at an unprecedented rate", with first phase 1 safety trials with the vaccine candidate under way in the US, UK and Mali. Further trials are due to start in the coming weeks.

"We are actively exploring with relevant organisations and partners all opportunities to accelerate the development of manufacturing at an industrial scale so that if the trials are successful, we will be in a position to significantly ramp up production of the vaccine candidate to help combat this or future Ebola outbreaks," the company said in a statement on its website dated October 18. 

Initial data from the phase 1 trials are expected by the end of the year and if successful, the next phases of the clinical trial programme will begin in early 2015. This will involve the vaccination of frontline healthcare workers in Sierra Leone, Guinea and Liberia. "If the vaccine candidate is able to protect these healthcare workers as we hope it will, it could significantly contribute to efforts to bring this epidemic under control," the company added.

GSK is also working with the WHO, regulators and other stakeholders on logistics, to determine how and when near-term supplies of the Ebola vaccine could be made available for targeted vaccination of additional healthcare workers and other people at high risk of infection in the affected countries where the impact would be most likely to limit the further spread of the epidemic. Safety and the supply chain will come into play for mass vaccination campaigns. GSK said it will depend on whether the vaccine candidate provides protection against Ebola without causing significant side effects and how quickly large enough quantities can be made.

GSK acquired this Ebola vaccine candidate through the acquisition of a biotechnology company, Okairos, in May 2013 and has since been working with the US National Institutes of Health to develop this vaccine candidate in response to the threat of Ebola.

The WHO and partner organizations said tools are being developed to help any country to intensify and accelerate their readiness.

One of these tools is a comprehensive checklist of core principles, standards, capacities and practices, which all countries should have or meet. The checklist can be used by countries to assess their level of preparedness, guide their efforts to strengthen themselves and to request assistance. Items on the checklist include infection prevention control, contact tracing, case management, surveillance, laboratory capacity, safe burial, public awareness and community engagement and national legislation and regulation to support country readiness.

“While we rightly focus on stopping the outbreak in affected countries, we should not forget that all other countries are at risk, albeit at varying levels,” said WHO Regional Director for Africa, Dr Luis Sambo.

Also under development is a framework to measure the key milestones and mutual accountability for assessment by international partners and countries. The tools are being reviewed by experts and will be made public available shortly, stated the WHO on October 10.

Read the blog post on what we know about Ebola so far here