Drugmakers may need indemnity for fast-tracked Ebola vaccines

By Reuters

Oct 23, 2014 09:33 PM EDT

Drugmakers are looking for some kind of indemnity from governments or multilateral agencies against possible losses or claims arising from the widespread emergency use of new Ebola vaccines in Africa.

While the issue will not delay the industry's work to accelerate production and clinical testing of three experimental vaccines, it is likely to be discussed at a high-level meeting in Geneva on Thursday.

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

GlaxoSmithKline (GSK.L) Chief Executive Andrew Witty said a system of indemnity made sense given the unique situation in which companies are being urged by the WHO to fast-track the supply of novel vaccines in a matter of months rather than years.

There is currently no proven vaccine against Ebola and drug companies have been wary in the past of investing in the area, since the commercial opportunity is small. Potential losses or claims arising from the use of new vaccines would represent an additional hurdle.

Many drug companies are now discussing ways to help out with production, including some like Pfizer (PFE.N) that are not directly involved in Ebola vaccine development.

Witty said indemnity was not a concern for the early phase of testing, when thousands of doses are expected to be given to frontline healthcare workers as part of a clinical trial program in January, but it would be needed when vaccines were rushed into much more widespread use.

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

"That's a situation where we would look for some kind of indemnification, either from governments or from multilateral agencies."

Brian Greenwood, a professor of clinical tropical medicine at the London School of Hygiene and Tropical Medicine, agrees that drug companies should not have to shoulder all the risk. "There would have to be some sort of guarantee," he told Reuters.


Leading drugmakers say they are ready to work together to speed up the supply of Ebola vaccines.

Johnson & Johnson (JNJ.N) research head Paul Stoffels, who hopes to produce more than 1 million doses of an Ebola vaccine next year, said he was discussing collaboration with both GSK and other companies such as Pfizer, which has significant capacity to make a variety of biotech drugs and vaccines.

"We are looking at capabilities for biological production to upscale further," Stoffels said in Geneva.

The meeting is set to discuss ways to streamline the vaccine supply process and ensure there are adequate financial resources.

"WHO is organizing this meeting to discuss how to access vaccines when they are proven safe and how to finance them," a spokesman for the United Nations agency said.

Europe is also set to provide 200 million euros ($250 million) of funding to develop new Ebola vaccines, as well as drugs and diagnostic tests, sources said. An announcement on the European move is now expected for next week.

"We are now in a situation where we are desperate and we are looking for solutions," Yvette Stevens, Sierra Leone ambassador to the U.N. in Geneva, told Reuters.

GSK currently has the most advanced vaccine, the first doses of which are expected to be ready for use late this year, while clinical trials on a second vaccine from NewLink Genetics (NLNK.O) have just started and J&J will begin testing a third one in January.

"This is an unprecedented pace of development. We are literally doing in maybe five or six months what would normally take five or six years," Witty said. "I've already ordered five production lines to allow us to expand production."

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