Limited Market for Ebola Vaccine Hinders Development

Financial hurdles delay biopharmaceutical companies from developing treatment amidst largest Ebola hemorrhagic fever outbreak in history.

Despite rampant fears gripping the globe over the largest recorded outbreak of Ebola hemorrhagic fever in history, efforts to develop a vaccine for the virus have been stunted due to limited funding and testing difficulties.

Although the outbreak in Africa has generated worldwide concerns, progress on the development of a vaccine have been slow due to a number of factors, chief among them a lack of funding. Due to a limited market for an Ebola vaccine, large pharmaceutical companies are hard-pressed to justify sinking resources into research and development.

“I don’t see why anybody except the US government would get involved in developing these kinds of countermeasures,” Dr. Sina Bavari of the US Army Medical Research Institute of Infectious Diseases (USAMRIID), told NBC News. “There is no market in it.”

The NBC report also noted developmental difficulties stemming from the unpredictability of the virus, which makes it problematic to find a sufficient amount high-risk individuals in whom to test the vaccine.

According to The World Health Organization (WHO), there are more than 1200 suspected cases, more than 800 confirmed cases, and more than 700 deaths from Ebola in 3 West African countries. The incubation period for the disease ranges from 2 to 21 days, with the most common symptoms including fever, headache, vomiting, diarrhea, joint and muscle pain, and weakness.

Without efforts by large biopharmaceutical manufacturers, the task of developing an Ebola vaccine has fallen to smaller niche firms.

A drug in development by BioCryst Pharmaceuticals, called BCX4430, has exhibited the potential to treat a broad spectrum of activity in multiple viruses with a favorable preliminary safety profile. Although the drug has shown efficacy in a small study of nonhuman primates in treating Marburg disease, which is closely related to the Ebola virus, BCX4430 has not yet been evaluated in humans.

Further along in development is a drug by Tekmira Pharmaceuticals Corporation, called TKM-Ebola, which is currently in a Phase I clinical hold by the FDA. Tekmira started human testing the treatment in January 2014, but on July 3 the study was placed on hold until the company clarifies how the treatment works.

Tekmira stated in a press release that it anticipates the hold to be lifted during the 4th quarter of 2014.

“It is important to highlight that the study protocol for the TKM-Ebola Phase I trial called for an interim review of the data from the single ascending dose portion of the trial before proceeding to the multiple ascending dose portion of the study. I wish to emphasize this trial is unique. It represents the first RNAi study involving the daily treatment of healthy volunteers, without steroid pre-medication or any other type of pre-medication, and with multiple ascending doses,” said Dr. Mark Murray, president and CEO of Tekmira Pharmaceuticals, in the press release. “Furthermore, the multiple ascending dose portion of the study, as originally proposed, reflects the intense dosing regimen that would be used in patients lethally infected with Ebola virus.”

The National Institutes of Health announced on July 31 that it would be launching an early-stage trial for an experimental Ebola vaccine in September, with the results expected back in January 2015, according to a report from USA Today.

The potential for a global outbreak is limited, however, as Ebola can only be transmitted through mucous membranes or an area of broken skin that comes into contact with the bodily fluids of an infected person or materials contaminated with body fluids, according to WHO.

Short of a vaccine to treat Ebola, aid workers are attempting to contain the virus through public health measures and by isolating the infected.

“What works for Ebola is good old-fashioned public health,” Thomas Frieden, director of the US Centers for Disease Control and Prevention, said in a report on Nature. “It would be great to have a vaccine, but it’s not easy to do and not clear who you’d test it on.”