* Ethics panel cautions supplies will be limited
* Medics need "informed consent, community involvement"
* Vaccine testing usually takes years
(Updates throughout with quotes, details, background)
By Kate Kelland and Stephanie Nebehay
LONDON/GENEVA, Aug 12 It is ethical to offer
unproven drugs or vaccines to people infected or at risk in West
Africa's deadly Ebola outbreak, a World Health Organisation
panel of medical ethics experts ruled on Tuesday, but cautioned
supplies will be limited.
The panel said any provision of experimental Ebola medicines
would require "informed consent, freedom of choice,
confidentiality, respect for the person, preservation of dignity
and involvement of the community".
The drugs should also be properly tested in the best
possible clinical trials, it said.
The West Africa Ebola virus epidemic - the world's largest
and most deadly so far - has killed at least 1,013 of the more
than 1,848 people it has infected in Guinea, Liberia, Sierra
Leone and Nigeria. The WHO has declared it an international
"Ebola outbreaks can be contained using available
interventions like early detection and isolation, contact
tracing and monitoring, and adherence to rigorous procedures of
infection control," the panel said. "However, a specific
treatment or vaccine would be a potent asset to counter the
The ethics panel met to discuss whether various experimental
drugs and vaccines being developed for Ebola might be used in
the outbreak, despite not having been fully tested or licensed.
"A number of interventions have been through the laboratory
and animal study phases of development," it said in a statement
issued by the WHO.
It said it was likely that so-called "first in man" trials -
the first tests of a drug in humans - would be conducted over
the next two to four months, but cautioned that even after that
and if the trials proved successful, supplies would be limited.
"It is ... likely that the number of doses available for
further study and/or deployment from end 2014 onwards will
remain insufficient to meet demand," the statement said.
The ethics meeting was called after experimental Ebola drug
ZMapp, made by U.S. biotech company Mapp Biopharmaceutical, was
given to two American health workers infected with Ebola in
The scarce experimental drug, of which a WHO spokeswoman
said only 12 doses had been made, was due to be given to two
Liberian doctors after U.S. authorities approved its export,
Monrovia's information minister said on Tuesday. This would be
the first time the treatment has been used on Africans.
A 75-year-old priest in Spain who also received ZMapp has
since died. He contracted Ebola in Liberia.
"In the particular circumstances of this outbreak, and
provided certain conditions are met, the panel reached consensus
that it is ethical to offer unproven interventions with as yet
unknown efficacy and adverse effects, as potential treatment or
prevention," the panel's statement said.
There are no licensed treatments or vaccines for Ebola. As
well as Mapp, several other biotech companies and research teams
have been working on potential drugs.
Companies with possible treatments include Tekmira
Pharmaceuticals, Biocryst Pharmaceuticals and
GlaxoSmithKline and U.S. scientists at the National
Institute of Allergy and Infectious Diseases hope to start a
clinical trial of an experimental Ebola vaccine as soon as next
month, after promising test results in primates.
It would normally take many years to move such a vaccine
through three phases of clinical testing but some officials have
suggested emergency procedures could be put in place to make it
available in 2015, assuming it works in the early test phase.
Another experimental vaccine from Johnson & Johnson's
Crucell unit should enter Phase I clinical trials in
late 2015 or early 2016, while Profectus Biosciences is also
working with U.S. scientists on another preclinical vaccine.
(Additional reporting by Ben Hirschler, writing by Kate
Kelland; Editing by Janet Lawrence)