Info Service on Health Issues (May 07/03)
Winners and losers in the sharing of avian flu viruses
is emerging that viruses contributed by developing countries are being
used for commercial gain.
are being applied for pandemic flu vaccines from viruses sent by countries
with an outbreak to WHO centres. The article below details what has
been happening and the potential costs to developing countries.
is reproduced with permission from South-North Development Monitor (SUNS)
#6249, 10 May 2007.
Health: Winners and losers
in the sharing of avian flu viruses
By Martin Khor and Sangeeta
Shashikant, Geneva, 9 May 2007
At the World Health Assembly
last year, Thailand first raised the issue of the global inequities
in avian influenza, whereby developing countries would face shortages
of scarce and expensive vaccines in the event of a pandemic outbreak,
which experts consider a real possibility.
Early this year, Indonesia highlighted the issue when it suspended its
voluntary transfer of avian flu virus samples to WHO collaborating centres,
complaining that its viruses were being used for commercial activities
without its knowledge, and asking that a fair system be established
whereby developing countries are assured of vaccines and assisted with
technology to produce them.
Many developing countries are rightly concerned that due to the limits
on how fast pandemic vaccines can be produced after a pandemic outbreak,
there will be an acute shortage globally. Developed countries are already
forking out hundreds of millions of dollars to place advance orders
for vaccines. Developing countries cannot afford that, and fear they
will be left with grossly inadequate supplies or none to inoculate their
populations, as every country scrambles madly to get whatever quantities
On the other side of the equation, the developing countries have been
asked to donate samples of viruses as new human cases of avian influenza
occur, so that scientific work can be done to characterize the viruses
and track the development of the influenza. International law (as in
the Convention on Biological Diversity) and WHO's own guidelines assure
them that they would be informed of results of the scientific analysis
that the donated viruses will not be misused for commercial profit.
However, evidence is emerging that the viruses contributed by developing
countries are already being extensively used for commercial activities.
Health officials of at least one country, Indonesia, have complained
that they were not informed nor was their permission sought or obtained.
It is possible that prior consent was also not obtained from other countries.
This raises the issue of who gains and who is losing in this imbalanced
state of affairs.
Many commercial activities linked to the viruses are already taking
place. These include applications for patents, research aimed at vaccine
production, and sale of vaccines and other medical products. Lucrative
contracts for supplying large quantities of vaccines have already been
signed between drug companies and many developed countries.
If the Convention on Biological Diversity's principles and provisions
(which establish sovereign rights of a country to its genetic resources,
prior informed consent and benefit sharing) are adhered to, and if the
WHO's March 2005 Guidance on sharing flu viruses is followed, the country
of origin of the virus has rights in determining access to the virus,
and therefore conditions for access including benefit sharing arrangements.
The WHO's Guidance specifies that viruses should be shared by affected
countries to WHO centres and reference laboratories in order to prepare
a response to a flu epidemic. The principles include that the WHO reference
labs will seek permission from the originating country/lab to co-author
and/or publish results obtained from the analyses of viruses; and that
there will be no further distribution of viruses/specimens outside the
network of WHO reference labs without permission from the originating
However, patent applications and vaccine sales have been taking place
following the issuance of the March 2005 Guidance.
Applications for patents could include patents for the gene sequence
(or part of it) of the virus; patents of a gene sequence of a virus
that has been genetically-engineered, using part of the sequence of
the original virus; patenting of research or production techniques that
make use of the virus or its parts; patenting of the vaccine or other
products that make use of the virus and its genetic materials.
Patenting can have various effects. For example, if the gene sequence
(or parts of it) of the virus is patented, this may create problems
for others who want to research into or make products containing the
gene sequence or parts of it. The patenting of techniques can hinder
research or the development of the product. Patenting the final product
can raise the cost of vaccines, making it unaffordable especially in
Patents are being applied for pandemic flu vaccines, which make use
of parts of the gene sequences from viruses sent by countries with an
outbreak to the WHO centres. One patent application in the US was even
filed by a WTO collaborating centre, to patent modified influenza virus
that includes genes from a Vietnam influenza virus.
Other patent applications for vaccines involving parts of flu virus
strains have been made by universities in the USA and by companies.
There are also patent applications for techniques used in research and
A search on patent applications relevant to H5N1 influenza vaccines,
and which make use of parts of the avian flu viruses, found the following
-- An application for a US Patent by Hawaii Biotech Inc (USA) for a
Influenza recombinant subunit vaccine. This application, published in
February 2007, claims a new type of influenza vaccine and specific H5N1
vaccines made with the technology. It specifically makes patent claims
on genetic sequences from an influenza virus isolated in Indonesia in
2005 (A/Indonesia/5/05) and another isolated in China in 1997 (A/Hong
-- An application for a US Patent by St. Jude's Children's Hospital
(USA), which is a WHO Collaborating Centre, for a Modified Influenza
Virus for Monitoring and Improving Vaccine Efficiency. This application,
published in February 2007, makes claims on small changes to influenza
HA genes, intended to strengthen the immune system reaction to the genetically
engineered virus. It makes patent claims on any influenza HA gene modified
in a certain way and also specifically claims the modified HA gene from
an influenza virus isolated in Vietnam in 2004 (A/Vietnam/1203/04).
-- An application for a US Patent by University of Pittsburgh (USA),
for Vaccines for the rapid response to pandemic avian influenza. This
application, published in January 2007, claims new human and animal
influenza vaccines based on (theoretically) replication-deficient adenoviruses.
These genetically engineered vaccines incorporate genetic sequences
from H5N1 viruses. This application claims pieces of any influenza HA
gene used in the adenovirus-based vaccine. It specifically makes claims
on the HA gene from an influenza virus isolated in Vietnam in 2004 (A/Vietnam/1203/04).
-- An application for a Patent in the US, European Union, Australia,
Canada, by Medimmune Vaccines Inc. (USA) and the US government for Influenza
hemagglutinin and neuraminidase variants. This patent application claims
any influenza HA and NA gene modified and used in specific ways. The
patent application specifically uses H5N1 types isolated in Vietnam
and China as examples (A/Vietnam/1203/2004, A/Hong Kong/491/97, and
-- An application for a US Patent by Noranax Inc. (USA) for Functional
influenza virus-like particles (VLPs). This patent covers methods of
producing methods of producing VLPs from influenza viruses. For the
VLP to be useful as a vaccine, it must be derived from a specific flu
isolate, or a close relative, that it is intended to protect against.
The patent application claims any such VLP. According to recent company
statements, the patent application technology has been applied to generate
VLPs from recent Indonesian influenza isolates, most likely the A/Indonesia/5/2005
strain recommended for vaccine development by WHO. The company says
its patent claims cover this Indonesia-derived candidate vaccine.
Patent applications in the above cases were also filed with the Patent
Cooperation Treaty (which is linked to the World Intellectual Property
Organisation), which helps facilitate applications in many countries
that are a party to the treaty.
Regarding commercially-related activities, the international drug industry's
federation in 2006 listed 31 R&D projects for avian pandemic flu
vaccines being undertaken by drug companies, all of them from the USA,
European countries and Japan. The projects involve various avian flu
virus strains, including H5N1 viruses from Vietnam and Hong Kong, and
other virus strains from China, Panama, and Singapore. Several developed
countries have been buying from drug companies and stockpiling large
quantities of pre-pandemic vaccines, and have placed orders in advance
for large quantities of pandemic vaccines in the event of a pandemic.
According to its November 2006 press release, Sanofi Pasteur (the vaccines
business of the Sanofi-Aventis Group) signed a $117.9 million contract
with the US Health Department (HHS) for the production of bulk concentrate
of a new type of H5N1 pre-pandemic vaccines.
"This contract covers clade 2 of H5N1 virus (A/Indonesia) for use
in the US government stockpile. Previous stockpile contracts covered
the clade 1 form of H5N1," said the release, adding that the H5N1
clade 2 bulk material is being manufactured from a seed virus provided
by the US Centres for Disease Control and Prevention (a WHO Collaborating
[The press release explained that most of the viruses circulating during
the past 4 years falls into two distinct clades. Clade 1 viruses circulated
in Cambodia, Thailand and Vietnam were responsible for human infections
in those countries in 2004 and 2005. Clade 2 viruses circulated in birds
in China and Indonesia in 2003-04 and spread westward to the Middle
East, Europe and Africa.]
Sanofi also stated it was awarded a contract by the French Ministry
of Health to produce a 1.4 million dose stockpile of the H5N1 candidate
being studied by Sanofi. Under the agreement, Sanofi could also be called
upon to provide enough vaccine to protect up to 28 million people in
France in the event of a pandemic being declared, once the actual virus
strain responsible is identified.
Sanofi has also entered into agreements with Italy and Australia to
supply vaccines in the event of a pandemic influenza outbreak, and that
it has other agreements with the US government involving development
of pandemic vaccine stockpiles, production of investigational doses
and the development of cell culture technology.
In September 2004, the company signed a contract with HHS to produce
two million doses of bulk vaccine derived from the H5N1 viral strain.
The H5N1 vaccine will be manufactured from a seed virus provided by
the National Institute of Allergy and Infectious Diseases (NIAID), part
of the US National Institutes of Health (NIH).
In September 2005, the HHS awarded a $150 million contract to Sanofi
Pasteur to produce a vaccine to for the H5N1 influenza virus strain.
In April 2007, Sanofi Aventis announced that the US Food and Drug Authority
had approved for the first time in the US of a vaccine against H5N1
avian influenza for use with humans. The approval was based on a clinical
trial by the NIAID, completed in 2005.
According to a February 2007 paper by NIAID, "The H5N1 reference
virus (the strain used to produce the H5N1 vaccines for NIAID's clinical
trials) was developed by researchers at St. Jude Children's Research
Hospital" in the US. The seed virus for the production of the vaccine
was derived from the A/Vietnam/2004 and all other genes were derived
from the A/PR/8/34 virus, a laboratory strain.
Another company, GlaxoSmithKline (GSK), entered into a supply contract
with the Swiss Federal Office of Public Health for 8 million doses of
GSK's H5N1 antigen influenza vaccine and its proprietary adjuvant for
pre-pandemic use, according to a 23 October 2006 report in Medical News
According to the report, the order provides enough doses, one per head
of the entire Swiss population, to help prepare the immune system against
the threat of a human influenza. The contract also provides for an advance
purchase agreement for 7.5 million doses of a GSK pandemic vaccine which
will be manufactured once a pandemic strain is identified by the WHO.
On 12 March 2007, Medical News Today reported on GSK's announcement
that clinical trial data from two new studies show that for the first
time GSK's candidate pre-pandemic split antigen H5N1 vaccine, formulated
with GSK's proprietary adjuvant system, provides a substantial level
of cross-immunity against a 'drifted' (diverse) strain of H5N1.
According to the report: "In vivo data from the pre-clinical studies
demonstrated that GSK's adjuvanted vaccine, containing the Vietnam H5N1
strain, was not only able to protect against challenge with the vaccine
virus strain but it also provides 96% (22/23) cross-protection against
a lethal challenge with the drifted Indonesia strain of H5N1, giving
an additional boost to hopes that pre-pandemic vaccination is a viable
strategy for inclusion in pandemic preparedness plans."
The report added that in May 2006, GSK received an HHS contract worth
$274 million to develop cell-culture technology to speed the development
of new cell culture-based seasonal and pandemic influenza vaccines,
and to scale-up its cell culture manufacturing capability; in November
2006 GSK received a $40 million initial order for bulk H5N1 antigen
from HHS while in January 2007 GSK received from the HHS a $63.3 million
contract to develop antigen-sparing H5N1 pandemic influenza vaccines.
On 4 January 2007, GSK entered into an Advance Purchase Agreement with
the Danish government to supply its split candidate pandemic antigen
and proprietary adjuvant once a pandemic has been declared.
Another company Novavax Inc. is reported by Medical News Today (on 4
May 2007) as saying that it has received positive study results from
a live virus challenge to ferrets inoculated with its pandemic influenza
vaccine, paving the way for clinical trials this year.
The report adds that "In the study, ferrets were inoculated with
the company's virus-like particle (VLP) vaccine made from an Indonesian
strain of H5N1 avian influenza." The ferrets were then challenged
with live H5N1 virus, and all ferrets that received the Novavax vaccine
According to the study, ferrets that received Novavax's H5N1 vaccine
were protected not only against the Indonesian strain of avian flu but
also were cross-protected against a separate strain originating in Vietnam.
One set of clear winners are the vaccine manufacturers which have already
obtained many hundreds of millions worth of contracts to supply pre-pandemic
and pandemic vaccines from the developed countries.
These countries are also giving several millions of dollars to the companies
in grants and subsidies for research and development activities.
The UPI agency on 8 February 2007 reported on a business analysis that
the global vaccine market is expected to top $10 billion dollars in
2007 and $ 23.8 billion dollars by 2012, with Flu vaccines sales forecasted
to grow to $14 billion by 2012.
Influenza, HIV and cancer will be the biggest growth areas in the vaccine
market, and "the biggest growth in the flu-vaccine market will
come in the area of vaccines for pandemics that could be caused by the
H5N1 strain of bird flu," added the report.
The developed countries are the other set of winners as they are able
to fork out the high cost of stockpiling pre-pandemic vaccines and to
make advance bookings for pandemic vaccines. The scene is set for the
rich to survive a global pandemic.
Moreover, under the present WHO-organised scheme, the developing countries
have become obliged to donate their avian influenza viruses to WHO collaborating
centres and reference laboratories, which are located in the developed
The centres and laboratories have been passing on the viruses or the
information contained in the viruses to other institutions, including
companies, even if this is not in line with the CBD or the WHO Guidance.
The companies and developed countries are making commercial use of the
viruses as they wish.
Meanwhile, the developing countries have so far not benefited from this
scheme. They face potential astronomical bills, should they wish to
purchase vaccines in sufficient quantities to protect their populations.
An Influenza Bulletin published by the US CDC provides a catalogue with
prices for influenza vaccines licensed for use in the US for the 2005-2006
flu season, which show that the prices range from $10 to $25 per dose.
A Bloomberg news article of April 6 reported that "Indonesians
spend an average of $30 annually on health care, compared with $5,700
in the US, according to the World Health Report. Glaxo's flu vaccine
costs $6 to $11 a shot in markets around the world, and receiving a
flu shot from a doctor can cost as much as $59 in Jakarta."
With inadequate financial resources to purchase vaccines, developing
countries will suffer the most in the event of a pandemic outbreak.
As it is, they already suffer immense economic losses from having to
cull poultry in areas of avian flu outbreaks.
If a pandemic of the human version of avian flu emerges, the cost to
life, economy and society in these countries could be of unimaginable
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