News Feature | October 6, 2014

GSK, NewLink Race To Bring Ebola Vaccines Online By 2015

By Estel Grace Masangkay

Government IT News For VARs --October 29, 2014

The World Health Organization revealed that pharmaceutical companies GlaxoSmithKline and NewLink Genetics are working double time to ramp up their capacity to produce Ebola vaccine candidates. The companies hope to bring an effective Ebola vaccine online by 2015, reports Reuters.

Both companies are currently conducting Phase 1 trials of their vaccine candidates in healthy volunteers. GSK dosed its first healthy volunteer in the U.K. last month as part of its safety trials to test its vaccine against the Zaire strain of Ebola virus. The study will assess whether GSK’s vaccine is safe and able to stimulate the production of antibodies to fight the deadly virus. A total of 60 volunteers will be enrolled for the trial, which is expected to be completed by the end of year. GSK expects to deploy the vaccines on an emergency basis shortly after the trials’ conclusion.

Last month, biopharmaceutical company NewLink Genetics announced that the U.S. Food and Drug Administration (FDA) had given the green light for the initiation of its own Phase1 trial for its Ebola vaccine candidate. The vaccine was originally developed by the Public Health Agency of Canada (PHAC) and is currently licensed to NewLink’s subsidiary, BioProtection Systems. The vaccine targets the protein coating of the virus and stimulates antibody response for virus neutralization. Approximately 40 healthy volunteers will be given the vaccine in the trial, which will investigate different dosing schedules and methods of extending the drug to other vulnerable populations.

“Both [GSK and NewLink] are working to augment their manufacturing capacity. The goal is a very significant increase in scale during the first half of 2015. The next step is to make these vaccines available as soon as possible – and in sufficient quantities – to protect critical frontline workers and to make a difference in the epidemic’s future evolution,” the WHO stated in its two-day meeting.

With the first report of Ebola’s presence in the U.S. following its recent outbreak in Africa, the urgency to quickly test and manufacture Ebola vaccines has intensified. Time reports that one of the ways clinical trials can be accelerated is through the ‘wedge’ approach. The goal is to study a “slice” or “wedge” of a target population for the first step of the trial. Investigators then apply the insights gathered from that first stage on to the the next as a new population “slice” is studied. Such methods can help speed up clinical trials for the vaccines, which normally takes a few years to go through the development program and secure regulatory approval.