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Pin to quick picksGlaxosmithkline Share News (GSK)

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UPDATE 1-Drugmakers may need indemnity for fast-tracked Ebola vaccines

Thu, 23rd Oct 2014 10:04

* Governments or multilateral agencies may offer indemnity

* Topic expected to be discussed at Geneva vaccines meeting

* Companies say issue won't delay accelerated vaccine work (Edits)

By Ben Hirschler and Stephanie Nebehay

LONDON/GENEVA, Oct 23 (Reuters) - Drugmakers are looking forsome kind of indemnity from governments or multilateral agenciesagainst possible losses or claims arising from the widespreademergency use of new Ebola vaccines in Africa.

While the issue will not delay the industry's ongoing workto accelerate production and clinical testing of threeexperimental vaccines, it is likely to be discussed at ahigh-level meeting in Geneva on Thursday.

World Health Organization (WHO) Director-General MargaretChan will chair the meeting, which includes industry executives,representatives from countries including those affected byEbola, drug regulators and funders.

GlaxoSmithKline Chief Executive Andrew Witty said asystem of indemnity made sense given the unique situation inwhich companies are being urged by the WHO to fast-track thesupply of novel vaccines in a matter of months rather thanyears.

There is currently no proven vaccine against Ebola and drugcompanies have been wary in the past of investing in the area,since the commercial opportunity is small. Potential losses orclaims arising from the use of new vaccines would represent anadditional hurdle.

Witty said indemnity was not a concern for the early phaseof testing, when thousands of doses are expected to be given tofrontline healthcare workers as part of a clinical trialprogramme in January, but it would be needed when vaccines wererushed into much more widespread use.

"I think it is reasonable that there should be some level ofindemnification because the vaccine is essentially being used inan emergency situation before we've all had the chance toconfirm its absolute profile," he told BBC radio.

"That's a situation where we would look for some kind ofindemnification, either from governments or from multilateralagencies."

Brian Greenwood, a professor of clinical tropical medicineat the London School of Hygiene and Tropical Medicine, agreesthat drug companies should not have to shoulder all the risk.

"There would have to be some sort of guarantee," he toldReuters.

Leading drugmakers say they are ready to work together tospeed up the development and production of Ebola vaccines, andthe meeting in Geneva is set to discuss ways to streamline theprocess and ensure there are adequate financial resources.

"WHO is organising this meeting to discuss how to accessvaccines when they are proven safe and how to finance them," aspokesman for the United Nations agency said.

Europe is also expected to announce 200 million euros ($250million) of funding to develop new Ebola vaccines, as well asdrugs and diagnostic tests, sources said on Wednesday.

GSK currently has the most advanced vaccine, the first dosesof which are expected to be ready for use late this year, whileclinical trials on a second vaccine from NewLink Genetics have just started and Johnson & Johnson willcommence testing a third one in January.

"This is an unprecedented pace of development. We areliterally doing in maybe five or six months what would normallytake five or six years," Witty said. "I've already ordered fiveproduction lines to allow us to expand production." (Additional reporting by Kate Kelland; Editing by Giles Elgood)

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