An Intriguing Program Takes on Tropical Diseases—But Not Ebola

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infect 20,000 people. But there has been action. In parallel with the NIH/GSK activity in the U.S., a public-private consortium is conducting a Phase 1 safety trial with a slightly different GSK vaccine in the United Kingdom, Mali and the Gambia. That effort is being funded by the Wellcome Trust, the Medical Research Council, and the UK Department for International Development.

In addition to the collaboration with GSK (which acquired the vaccines when it bought the Swiss firm Okairos last year), the NIH is fast-tracking a vaccine program that combines technology from Crucell, part of the Johnson & Johnson (NYSE: JNJ) conglomerate, and Danish drug maker Bavarian Nordic. A Phase 1 safety trial could start early next year.

In an emergency session last Friday, WHO tagged the GSK vaccines as the field’s “most advanced” candidates which, if successful, could be ready for healthcare workers by the end of this year.

That’s an important point: nine months since the outbreak first registered, the most advanced vaccine being rushed into clinical trials would, best-case scenario, be available only to healthcare workers. Not to the general population.
Meanwhile, drugs to treat people already infected do not exist, although there is hope. You’ve probably heard of ZMapp by now. It’s never been tested in formal human trials, but it should be soon, thanks to a huge injection of federal dollars.

Five of seven people with Ebola who received ZMapp on an emergency basis have recovered. And the drug’s maker, Mapp Biopharmaceutical of San Diego, and other researchers reported last week in Nature that ZMapp had excellent results in monkeys.

As promising as the treatment sounds, it absolutely needs to go through clinical testing and prove viable in a larger-scale manufacturing program—no small task for a mixture of three monoclonal antibodies extracted from genetically modified tobacco plants. “We may eventually need and rely on those types of drugs, they’re very important,” says Christian Sandrock, a critical-care doctor in Sacramento, CA, and a top public health official for the surrounding county. (Sacramento had an Ebola false alarm in August.)

But Sandrock, an infectious disease specialist who has spent time in Africa and would be on the front lines of an epidemic response the U.S., understands the need to proceed with caution. “Just a couple of cases don’t mean anything,” he says. “It’s hard sometimes, but as doctors, we live in a world where we want hardcore science to help us make decisions.”

WHO field workers in Sierra Leone during the Ebola outbreak. (Credit: WHO/Stephane Saporito)

WHO field workers in Sierra Leone during the Ebola outbreak. (Credit: WHO/Stephane Saporito)

Would that science—and approved treatments—be available today if, seven years ago, the U.S. government had included Ebola on its list for the priority review voucher program? Several people I talked to called the program “interesting” or “useful.” But on its own, the program isn’t powerful enough to “motivate a company to direct their drug discovery and development programs,” BVGH’s Dent told me.

One of the program’s originators has a different view. “It’s largely gone according to our expectations,” says David Ridley, one of three Duke University health economists whose 2006 paper set the idea in motion. “We thought it would … Next Page »

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2 responses to “An Intriguing Program Takes on Tropical Diseases—But Not Ebola”

  1. Joe Citizen says:

    I saw online a paper from 2000 — right, 14 years back, in the prestigious journal Nature, claiming the authors had developed a very successful vaccine, at least in macaques, I like the article for the info on these special programs but can you put out something about what went wrong, if anything did, with the vaccine research, that one and others in the past decade or so? Can we get effective vaccine through a crash program, even a few thousand inoculations is enough to protect the health care workers.

  2. Joe Citizen says:

    Also, the ZMapp sounds good but there were very favorable reports on other antivirals, not mentioned here. ????