FDA Authorizes Use of Unapproved Ebola Virus Test

2014 Ebola Outbreak in West Africa – Guinea, Liberia, Sierra Leone and Nigeria. Courtesy/CDC

HSNW News:

As Ebola continues to spread throughout West Africa, the Food and Drug Administration (FDA) has authorized the use of an unapproved Ebola virus test developed by the Department of Defense for use in individuals, including U.S. military personnel and responders, who may be at risk of infection because of their work with individuals who might have the virus.

“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,” FDA spokeswoman Stephanie Yao said in a statement. The Test-tube diagnostic test is one of the Pentagon’s investment in developing a vaccine or cure for Ebola.

Tekmira and BioCryst Pharmaceuticals, recipients of funding for Ebola treatments from the Defense Threat Reduction Agency, both have therapeutic candidates for early stage Ebola.

Tom Frieden, head of the Centers for Disease Control and Prevention (CDC) has assured that the chances of an Ebola outbreak in the United States are low, despite the admission of two infected American aid workers to a containment unit at Emory University Hospital. Both of those workers have received ZMapp, an experimental treatment developed by Mapp Biopharmaceutical Inc., for use with individuals infected with Ebola.

The Los Angeles Times notes that individuals infected with the Ebola virus will develop flu-like symptoms such as fever, vomiting, muscle aches, and weariness, but as the virus continues to multiply and destroy the cell that line blood vessels, patients will suffer bleeding and possible organ failure. Of the 1,711 individuals reported to be infected in West Africa, roughly 55 percent have died.

Health officials expect to approve an Ebola vaccine by the end of 2015. “There are a few vaccines in the pipeline,” said Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases. The most promising vaccine in the development process was designed by the Vaccine Research Center, an arm of the National Institutes of Health (NIH).

“We’ve tested it in monkeys,” Fauci said. “The results were quite impressive.”

The NIH is also supporting the Crucell biopharmaceutical company and Profectus Biosciences in their development of an Ebola vaccine. Thomas Jefferson University also is developing a candidate Ebola vaccine based on “the established rabies vaccine,” the NIH reported.

The first recipients of an approved vaccine would be healthcare providers who work with Ebola patients, as they face the highest risk of infection.

Source: Homeland Security News Wire