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Friday, 24 October 2014 16:38

Ebola Vaccine, Ready for Test, Sat on the Shelf

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GALVESTON, Tex. — Almost a decade ago, scientists from Canada and the United States reported that they had created a vaccine that was 100 percent effective in protecting monkeys against the Ebola virus. The results were published in a respected journal, and health officials called them exciting. The researchers said tests in people might start within two years, and a product could potentially be ready for licensing by 2010 or 2011.

It never happened. The vaccine sat on a shelf. Only now is it undergoing the most basic safety tests in humans — with nearly 5,000 people dead from Ebola and an epidemic raging out of control in West Africa.

Its development stalled in part because Ebola is rare, and until now, outbreaks had infected only a few hundred people at a time. But experts also acknowledge that the absence of follow-up on such a promising candidate reflects a broader failure to produce medicines and vaccines for diseases that afflict poor countries. Most drug companies have resisted spending the enormous sums needed to develop products useful mostly to countries with little ability to pay.

Now, as the growing epidemic devastates West Africa and is seen as a potential threat to other regions as well, governments and aid groups have begun to open their wallets. A flurry of research to test drugs and vaccines is underway, with studies starting for several candidates, including the vaccine produced nearly a decade ago.

A federal official said in an interview on Thursday that two large studies involving thousands of patients were planned to begin soon in West Africa, and were expected to be described in detail on Friday by the World Health Organization.

With no vaccines or proven drugs available, the stepped-up efforts are a desperate measure to stop a disease that has defied traditional means of containing it.

“There’s never been a big market for Ebola vaccines,” said Thomas W. Geisbert, an Ebola expert here at the University of Texas Medical Branch in Galveston, and one of the developers of the vaccine that worked so well in monkeys. “So big pharma, who are they going to sell it to?” Dr. Geisbert added: “It takes a crisis sometimes to get people talking. ‘O.K. We’ve got to do something here.’ ”

To that point, the research may have cost a few million dollars, but tests in humans and scaling up production can cost hundreds of millions, and bringing a new vaccine all the way to market typically costs $1 billion to $1.5 billion, Dr. Crowe said. “Who’s going to pay for that?” he asked. “People invest in order to get money back.”

The Ebola vaccine on which Dr. Geisbert collaborated is made from another virus, V.S.V., for vesicular stomatitis virus, which causes a mouth disease in cattle but rarely infects people. It had been used successfully in making other vaccines.

The researchers altered V.S.V. by removing one of its genes — rendering the virus harmless — and inserting a gene from Ebola. The transplanted gene forces V.S.V. to sprout Ebola proteins on its surface. The proteins cannot cause illness, but they provoke an immune response that in monkeys, considered a good surrogate for humans, fought off the disease.

The vaccine was actually produced in Winnipeg, Manitoba, by the Public Health Agency of Canada. The Canadian government patented it, and 800 to 1,000 vials of the vaccine were produced. In 2010, it licensed the vaccine, known as VSV-EBOV, to NewLink Genetics in Ames, Iowa.

The Canadian government donated the existing vials to the World Health Organization, and safety tests of the vaccine in healthy volunteers have begun.

NewLink’s product is one of two leading vaccines being tested. The other, which uses a cold virus that infects chimpanzees, was developed by researchers at the National Institutes of Health and GlaxoSmithKline. The first tests of an earlier version of it, employing a different cold virus, began in 2003.

Several other vaccine candidates, not as far along, are also in the pipeline and may be ready for safety testing next year. Once any drugs or treatments pass the safety tests, they will be available for use in larger numbers of people, and health officials are grappling with whether they should be tested for efficacy in the traditional way, in which some people at risk are given placebos instead of the active drug.

Read 1844 times Last modified on Sunday, 26 October 2014 23:27

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