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NewLink says FDA allows human testing of Ebola vaccine

Source: Reuters - Thu, 4 Sep 2014 12:16 GMT
Author: Reuters
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Sept 4 (Reuters) - NewLink Genetics Corp said the U.S. Food and Drug Administration allowed the company to start testing an experimental Ebola vaccine in humans.

The move follows a decision to begin initial human testing of a GlaxoSmithKline vaccine this month and an approval to fast track tests of a Johnson & Johnson vaccine.

The race to develop new drugs and vaccines has been spurred by a World Health Organisation ruling that it is ethical to use experimental products in the current epidemic, given the high death toll.

NewLink's vaccine, which has shown success in animals, was developed by Canadian government scientists and licensed to the company.

The Ames, Iowa-based company's stock was up 4 percent at $27.11 on the Nasdaq in premarket trade on Thursday.

The vaccine works by using a weakened virus, a pathogen found in livestock called vesicular stomatitis virus (VSV).

One of the virus's genes is replaced by a gene from the Ebola virus. The Ebola gene makes a harmless protein that sits on the virus's outer coat.

The idea is that after the VSV is injected, the body's immune system will recognize the Ebola protein as foreign and begin making antibodies that destroy Ebola viruses, all of which have the protein.

The study will evaluate how 40 healthy adults respond to various doses of vaccine.

Reuters exclusively reported last month that the company had enough doses on hand to launch its first human safety trial this summer. (Reporting by Natalie Grover in Bangalore; Editing by Saumyadeb Chakrabarty)

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