The test-tube diagnostic test was developed by the
"The test is designed for use in individuals, including
"Specifically, the test is intended for use in individuals with signs and symptoms of infection with Ebola Zaire virus, who are at risk for exposure to the virus or who may have been exposed to the virus."
Although health officials insist the chances of an Ebola virus outbreak in the U.S. are extraordinarily low, the admission of two infected aid workers to a special containment unit at Emory University Hospital in Atlanta has sparked fears among the public.
On Wednesday, officials at New York's
Initially, infection will cause flu-like symptoms such as fever, vomiting, muscle aches and weariness. As the virus continues to multiply and damages the cells that line blood vessels, patients will suffer bleeding and possible organ failure.
In this latest West African outbreak, the virus has killed roughly 55% of those infected, experts say.
The FDA said it is working with other government agencies to speed up the development of potential Ebola treatments.
Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said he would like to see potential Ebola vaccines get fast-tracked by the FDA.
"There are a few vaccines in the pipeline," he said.
Vaccines work by exposing the body to foreign microbes or substances that simulate an attack on the body, and essentially train the immune system to defend itself against a real, future invader such as the Ebola virus.
For a vaccine to work properly, it must be administered prior to infection and given time to work.
The vaccines now under development are not the same type of experimental drug that was given to a pair of American aid workers infected in Liberia. That drug, called ZMapp, is being developed by Mapp Pharmaceutical Inc., and is a mix of three monoclonal antibodies produced in plants. It is intended to be given to patients shortly after they become infected.
The experimental vaccine that is furthest ahead in the development process was designed by the Vaccine Research Center, an arm of the
"We've tested it in monkeys," Fauci said. "The results were quite impressive."
Phase 1 clinical trials are expected to begin in late September and run until January, Fauci said. During that time, researchers will give the vaccine to humans to determine whether it is safe, and whether it prompts a protective response. In this case, a protective response would be the production of special antibodies that prevent the Ebola virus from attaching to and entering the body's cells.
Unlike animal tests, where monkeys are actually infected with Ebola to determine the drug's effectiveness, human test subjects will not be infected with the disease.
If the vaccine is shown to be safe, and induces a protective response, research will progress to larger clinical trials and then to production of the vaccine.
"I would hope that we have something by the end of 2015," Fauci said. "Even fast-tracking it, it might take that long."
The first recipients of an approved vaccine would likely be healthcare providers who work with Ebola patients, as they face the greatest risk of infection. (The virus is transmitted through bodily fluids.)
In addition to the Vaccine Research Center's proposed vaccine, the NIH is also supporting the Crucell biopharmaceutical company in the development of a vaccine for the Ebola and Marburg viruses as well as Profectus Biosciences in its development of an Ebola vaccine.
The NIH said it was also working with Thomas Jefferson Univeristy "to develop a candidate Ebola vaccine based on the established rabies vaccine."
"Two other companies, Tekmira and
"The Department of Defense is working with a company called Newlink to develop an Ebola vaccine candidate. BioCryst, with NIH support, is working to develop an antiviral drug to treat Ebola virus that is expected to begin Phase 1 testing later this year."