GSK's Ebola vaccine gets FDA go-ahead for phase I human trials
- Bloomberg's Anna Edney reports that the FDA on Monday approved GlaxoSmithKline's experimental Ebola vaccine for phase I human clinical trials.
- GSK's vaccine is being developed in collaboration with the U.S. National Institutes for Health (NIH). World Health Organization (WHO) officials have said that an effective vaccine could be expedited through the approval process early next year under emergency protocols.
- The phase I tests for GSK's vaccine could begin as early as next week. It may take at least a month to assess the vaccine's effect on humans. The vaccine does not contain an infectious Ebola strain, but rather a cold virus that contains two Ebola genes.
As the Ebola outbreak continues to wreak havoc in West Africa, where it has already killed nearly 1,500 people, and Central Africa, where a new strain of the virus has broken out, public health officials are understandably in a rush to find effective treatments and a vaccine. GSK officials were careful to downplay expectations for a speedy vaccine approval earlier this month, calling it a "long, complex process."
"It is difficult to accelerate this process because of the many important steps that a candidate vaccine must go through to ensure that it is safe and effective," said GSK spokespeople.
Bloomberg reports that public health authorities have yet to decide whether or not to provide GSK's vaccine to health workers and other at-risk people in Africa during the clinical testing period. Other companies pursuing Ebola treatments include CA-based Mapp Biopharmaceutical with its promising treatment, ZMapp, as well as Canada's Tekmira Pharmaceuticals with TKM-Ebola.
Seeking Alpha also lists the six other companies currently working on Ebola treatments: Sarepta Therapeutics (AVI-7537); NewLink Genetics (Ebola vaccine); BioCryst Pharmaceuticals (BCX4430); Nanoviricides (NV-INF-1); Inovio Pharmaceuticals (SynCon DNA vaccine); and FujiFilm (Favipiravir). These treatments are all in the preclinical stage.