WHO: No
Ebola vaccine before mid-2015 U.N. agency expediting trials of experimental drugs by
Jerome Corsi
NEW YORK – The World Health
Organization said Wednesday that the manufacture, financing and distribution of
a large-scale Ebola vaccine is not possible until the middle of next year at
the earliest.
WHO is expediting Phase 1 and Phase
2 trials on two highly promising experimental Ebola vaccines, hoping to obtain
approval next February.
“The Ebola outbreak currently ravaging parts of West Africa
is the most severe acute public health emergency in modern times,” WHO said in
a statement issued from Geneva. “Never before in recent history has a biosafety
level 4 pathogen infected so many people so quickly, over such a wide
geographical area, for so long.”
One of the vaccines, cAd3-ZEBOV, has been developed by
GlaxoSmithKline in collaboration with the U.S. National Institute of Allergy
and Infectious Diseases. It uses a chimpanzee-derived adenovirus vector with an
Ebola virus gene inserted.
The
second, rVSV-ZEBOV, was developed by the Public Health Agency of Canada in
Winnipeg. The license for commercialization of the Canadian vaccine is held by
an American company, NewLink Genetics, located in Ames, Iowa. The vaccine uses
an attenuated or weakened vesicular stomatitis virus, a pathogen found in
livestock, replacing one of its genes with an Ebola virus gene.
WHO reported two phase 1 trials of the cAd3-ZEBOV started in
September in the U.S. and the U.K., and the first phase 1 trial of VSV-ZEBOV is
due to start in early October in the U.S.
WHO
further reported the government of Canada has donated 800 vials of rVSV-ZEBOV
to WHO, a donation expected to translate into some 1,500 to 2,000 doses of the
vaccine for use in Phase 1 trials.
Both companies told WHO that despite their dedication to
augment current manufacturing capacity, production of the vaccines on a
large-scale will not be possible until mid-year 2015.
“One shared mindset was readily apparent during the two-day
discussions, namely that nothing must be allowed to slow down the goal of
making vaccines accessible to people in affected West African countries,” WHO
reported. “The phrase, ‘Nothing can be allowed to delay this work,’ was heard
over and over again.”
Still,
WHO offered no hope large-scale production of either vaccine could be rushed
ahead of 2015.
“Our ambition is to accomplish, within a matter of months,
work that normally takes from two to four years, without compromising
international standards for safety and efficacy,” WHO declared.
WHO acknowledged the barriers to rapid deployment of an
approved vaccine faces a wide range of barriers, including the perceptions of
the West African countries affected by the virus toward vaccines in general and
practical difficulties in constructing and operating the infrastructure needed
to store the candidate vaccines at a required temperature of minus 80 degrees
Celsius.
WHO set the following timetable for the two experimental
vaccines:
October 2014: Mechanisms for evaluating and sharing data in
real time must be prepared and agreed upon and the remainder of the Phase 1
trials must be started;
October–November 2014: Agreed common protocols (including
for phase 2 studies) across different sites must be developed;
October–November 2014: Preparation
of sites in affected countries for phase 2 b should start as soon as possible;
November–December 2014: Initial
safety data from phase 1 trials will be available;
January 2015: GMP (Good
Manufacturing Practices) grade vaccine doses will be available for phase 2 as
soon as possible;
January–February 2015: Phase 2
studies to be approved and initiated in affected and non-affected countries (as
appropriate);
As soon as possible after data on
efficacy become available: Planning for large-scale vaccination, including
systems for vaccine financing, allocation, and use.
Source:http://www.wnd.com/2014/10/who-no-ebola-vaccine-before-mid-2015/
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