GlaxoSmithKline To Make Unprecedented Vaccine Donation To WHO Pandemic Flu Stockpile

GlaxoSmithKline (NYSE:
GSK) today announced its intention to donate 50 million doses of H5N1
adjuvanted pre-pandemic influenza vaccine to the World Health Organization
(WHO) in support of its stockpile initiative. The donation will help
establish a much needed stockpile of pre-pandemic vaccines that can be
distributed to the world's poorest countries at short notice by the WHO.
Delivered over a three-year period, it will provide enough doses of vaccine
for 25 million people at 2 injections per person.



As the WHO has made clear, pandemic influenza poses a serious global
public health threat with substantial estimated morbidity and mortality.
The WHO has expressed its desire to create an international stockpile of
H5N1 pre- pandemic vaccines, a strategy which received the endorsement of
the 193 Member States in attendance at the World Health Assembly in Geneva
last month. GSK supports this proactive strategy of worldwide stockpiling
of H5N1 pre-pandemic vaccine which may be able to save millions of lives by
protecting some of the most vulnerable populations in the world at the
outbreak of a pandemic.



The exact strain that may cause an influenza pandemic cannot be
accurately predicted. Some experts believe that the avian H5N1 strain, now
endemic in many bird species across the world, is a likely candidate
pandemic strain. A tailored pandemic vaccine would not be available until
four to six months after a pandemic strain has been identified,
highlighting the need for earlier access to protection.



In addition to the donation, the company confirmed its intention to
provide additional doses of its H5N1 adjuvanted vaccine at preferential
prices to the WHO for GAVI-eligible countries following the necessary
regulatory approvals. In line with its long established tiered pricing
business model, GSK intends to provide its H5N1 pre pandemic vaccine to
middle and low income countries at preferential prices reflecting
individual countries' income level.



GSK is also prepared to make its adjuvant available to Governments for
public purchase in order to maximize the number of doses of H5N1 vaccines
available, demonstrating GSK's broader commitment to working with
Governments and organizations such as the WHO to provide a solution to this
potential public health crisis.



Adjuvant systems are a proprietary novel technology that the company
has been developing for over 10 years. An adjuvant is an ingredient that
can be added to the core antigen of a vaccine to stimulate higher immune
response while using a smaller amount of antigen. The 'antigen-sparing'
phenomenon for H5N1 adjuvanted influenza vaccine permits a large number of
vaccine doses to be produced for mass vaccination ensuring protection for
more people.



Jean-Pierre Garnier, CEO GlaxoSmithKline said: "An outbreak of pandemic
flu could have a devastating effect on some of the poorest countries on our
planet. As a healthcare company, GSK takes seriously its responsibility to
ensure access for the world's poorest people to our medicines and vaccines.
Today's announcement enables us to play a part in the WHO's efforts to
coordinate a more comprehensive global solution to this potential
healthcare crisis."
















Since 2000 GSK has invested $2 billion to expand and enhance its
manufacturing capacity and research capabilities for both influenza
vaccines and anti-virals. GSK will work with the WHO to finalize the
details of this donation in the coming months.



GSK has been working to develop pandemic influenza vaccines since 2000,
initially on the H2N2 and H9N2 strains. In March 2007, the company
announced data that demonstrated GSK's novel adjuvant system technology
allows a very low amount of antigen to be used to create a strong immune
response - the 'antigen-sparing' effect. GSK's candidate vaccine,
containing very low levels of antigen (3.8 micrograms), enabled over 80% of
individuals to produce a high immune response in humans exceeding the
registration criteria set by European and US regulatory authorities for
influenza vaccines (2 doses given 21 days apart). The GSK vaccine is
expected to protect against 'drifted' variants of the H5N1 virus. These
recent clinical data point to the potential public health benefits of
creating a stockpile of pre-pandemic influenza vaccine.



GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to improving the
quality of human life by enabling people to do more, feel better and live
longer. For company information, visit GlaxoSmithKline on the World Wide
Web at gsk.