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The Canadian Press - ONLINE EDITION

Ebola scientists eager to be vaccinated, hope vaccine use spurs production

By: Helen Branswell, THE CANADIAN PRESS--

5/04/2009 1:30 PM | Comments: 0

TORONTO - The emergency use of a Canadian-made Ebola vaccine may have breathed new life into stymied efforts to get experimental vaccines for Ebola and similarly deadly viruses made, scientists say.

They are hoping to strike while the iron is hot, using heightened awareness of the risk these dangerous viruses pose to press for production of emergency stocks of vaccine and potentially even expensive human clinical trials.

The Ebola vaccine, made at the National Microbiology Laboratory in Winnipeg, was given to an unnamed German researcher last month after she accidentally pricked herself with the needle of a syringe containing Ebola virus. The woman, who did not develop symptoms of the disease, was given the all-clear by her doctors late last week.

"There is a lot of interest at the moment and some people find it positive that ... the vaccine was offered and actually given to her," says Dr. Heinz Feldmann, who led the team that designed the Ebola vaccine as well as one for a cousin virus, Marburg.

"The question remains the money."

Ebola and Marburg viruses trigger ghastly viral hemorrhagic fevers that kill between 50 and 90 per cent of people who become infected.

The tight-knit circle of scientists who work on these viruses has been frustrated in efforts to push experimental vaccines through the testing pipeline and to the point where the products could be used.

Despite promising results in animal trials, major financial, logistical and regulatory hurdles impeded their development. But the community of researchers sees the German case and the need it identifies as a chance to finally break the logjam.

"I'm hopeful," says Feldmann, who is now chief of the laboratory of virology at the U.S. National Institute of Allergy and Infectious Diseases' Rocky Mountain Laboratories in Hamilton, Mont.

"But in my view, it would have to happen within the next couple of weeks or months because otherwise people will forget and it will basically end up (stalling) as it has ended up in the few times before."

He and colleagues in this field sincerely hope the vaccines can eventually be used to halt the devastating outbreaks that can wipe out whole African villages. They also hope the vaccines could be used to save Great Apes, which also fall prey to these pathogens.

But the scientists also have a keen self interest.

"We would all love to vaccinate ourselves. We're just not allowed to," says Tom Geisbert, who led the animal testing on nearly all of the current experimental vaccines while working at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md.

As a first step, the special pathogens researchers would like to see development of emergency stocks of vaccine that could be situated in virtually all Level 4 laboratories as a fallback in case of a lab accident. Level 4 is the highest level of biosafety and biosecurity; researchers working in these labs handle the most dangerous pathogens known to humankind.

They envisage the lab emergency equivalent of an EpiPen, the adrenaline injector carried by people who have allergies that can trigger anaphylactic shock.

"Like 'Break glass, grab vial.' Because that's a big fear we all have," Geisbert says, who was recently named associate director of the new National Emerging Infectious Diseases Laboratories Institute at Boston University.

He added that if the vaccine is unlicensed, a standing protocol for compassionate use in the case of a lab accident would also need to be pre-approved.

The Winnipeg-made vaccines would likely be the product of choice for a lab accident response. They are the only Ebola and Marburg vaccines that have been shown to improve survival chances after exposure to the viruses. The alternatives work like standard vaccines, requiring pre-exposure administration.

"I've worked with almost every one of them and put them into monkeys," Geisbert says. "And if I had to vaccinate myself with one, it would be the ... (Winnipeg-made ones) by a landslide."

Despite the obvious need, getting someone to pay for production of test lots made to vaccine industry standards has proven to be a serious hurdle in most cases. An exception is work being done at the U.S. National Institute of Allergy and Infectious Diseases, which is conducting safety trials of an Ebola vaccine in human volunteers.

It is estimated that producing even a single lot of clinical-grade vaccine for testing would cost between $2 million and $3 million. Testing it in animals and then humans would cost millions more.

Vaccine manufacturers are unlikely to absorb those costs, because there is no financial incentive to develop these vaccines. Outbreaks occur sporadically and in some of the poorest countries in the world.

It is generally assumed that if any of these products are to be made, it will be with funds from a government interested in stockpiling vaccine as a hedge against an act of bioterrorism.

Dr. Frank Plummer, the scientific director of the Winnipeg lab, says they have received some grant money from a Department of National Defence agency to pursue work on these vaccines. The agency, which goes by the acronym CRTI, funds counterterrorism research.

Plummer says the Winnipeg group has a contract with a German company to do the genetic work needed to make test lots of the Ebola and Marburg vaccines. That work should be completed in 18 to 24 months. And negotiations are underway with a U.S. company to manufacture clinical trial lots of the vaccines.

This process was in the works before the German lab accident. But Plummer admits the efforts may move into a higher gear as a result of the German incident. "I think this will encourage us to move it along a little faster."

"We've been having on-again, off-again discussions with our legal people about what we need to have in place to be able to use this in Canada," Plummer says.

"And the impetus to get those completed and to some kind of conclusions is obviously more now, with this having occurred."

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