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 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. MANUFACTURING
CAPACITY
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.
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"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."
(Additional reporting by Kate Kelland and Marina Depetris; Editing
by Giles Elgood and David Stamp)
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