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 While the issue will not delay the industry's ongoing 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 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.
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.
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Leading drugmakers say they are ready to work together to speed up
the development and production of Ebola vaccines, and the meeting in
Geneva is set to discuss ways to streamline the 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 expected to announce 200 million euros ($250 million)
of funding to develop new Ebola vaccines, as well as drugs and
diagnostic tests, sources said on Wednesday.
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 have just
started and Johnson & Johnson will commence 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."
(Additional reporting by Kate Kelland; Editing by Giles Elgood)
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