It took GlaxoSmithKline 30 years to get its new malaria vaccine ready for regulatory review. But global health officials--driven by a worldwide clamor--are excitedly pointing to GSK ($GSK) now as one of its prime candidates for getting a vaccine to fight Ebola in a matter of months.
"Since this is an emergency, we can put emergency procedures in place ... so that we can have a vaccine available by 2015," Jean-Marie Okwo Bele, the head of immunization and vaccines at the WHO, told a French radio broadcaster, according to The Independent.
As it stands, GSK says it can get its vaccine--obtained in the $325 million buyout last year of Okairos--into the clinic for initial human studies "later this year," according to a statement on its website. But the pharma giant, a big player in the vaccine industry, also has been very cautious on offering a timeline, mindful of the exacting and time-consuming nature of the business.
"GSK and the (NIH's Vaccine Research Center) appreciate the very serious nature of the current Ebola outbreak, however, our vaccine candidate is at a very early stage of development and is not yet ready for use in these circumstances," the company noted.
Getting a giant player like GSK into the game as quickly as possible could help improve health officials' credibility in their frenzied scramble for an Ebola vaccine after watching research in the field languish and die for years for lack of support. With hundreds of victims dying in possibly the worst ever outbreak of the Ebola virus--which was identified back in the 1970s--the WHO has declared this an international health crisis as worries spread that this time the virus could spread like wildfire. And the world's largest media organizations have gladly jumped on board for the ride, helping spread fears of contagion.
Okairos was spun out of Merck ($MRK) back in 2007, pursuing a new approach to vaccines, which traditionally have relied on generating an antibody response. Okairos, a 2012 Fierce 15 company which remains a separate unit in GSK, makes genetic vaccines, using an adenovirus vector to spur a CDR8 T cell attack. Its lead programs are in mid-stage development for malaria and hepatitis C, with Ebola way back in 6th place with a preclinical program in place. Health officials now essentially want to make it the top priority overnight.
GSK isn't alone. Inovio ($INO) and Vaxart--two small biotechs--both have worked on Ebola vaccines. But Vaxart said it stopped work two years ago after it failed to find the money to continue its efforts.
"There's no business model for this, unfortunately," Dr. Charles Chiu, an associate professor of laboratory medicine and infectious diseases at UCSF, told the Chronicle recently. "We're talking about a viral disease that really disproportionately affects the poorest segment of the population in developing countries. As a result, without incentives, we're very unlikely to see a vaccine in the near future."
That won't work anymore. The new business model for Ebola vaccines now rests in the hands of the WHO, which would like to see it go from 0 to 150 mph in a matter of months.
- here's the story from The Independent
Special Report: Okairos – 2012 Fierce 15