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EU approves bird flu vaccine

20th May 2008

The European drugs regulator has given the go-ahead to GlaxoSmithKline's pre-pandemic avian influenza vaccine, a form of vaccine which may confer initial protection in the early stages of an influenza pandemic before an updated version becomes available.

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Prepandrix, which is designed to give protection against the H5N1 strain of the virus, is the first such vaccine to get a licence across the 27 EU member countries.

GSK said it was planning for a predicted influenza pandemic - which may or may not be caused by H5N1 - by investing in the development of two bird flu vaccines, and by boosting production of the antiviral drug Relenza through its own manufacturing plants and through capacity shared with partners.

Other governments, including the US and Switzerland, have already started stockpiling Prepandrix, which GSK says has worked effectively against various H5N1 strains circulating in Asia, Europe and Africa.

Experts warn that the H5N1 virus, which has ripped through poultry flocks in East Asia since 2003, could mutate into a form transmissible between humans, killing millions.

Sanofi Aventis and Novartis have also been working on bird flu vaccines.

Meanwhile, GSK says it has invested a total of US$2 billion in research and expanding production capacity.

The UK government has stockpiled millions of doses of Roche's antiviral Tamiflu in the event of a pandemic caused by a strain of H5N1, but is now reviewing its position after receiving advice that its one-drug strategy may be flawed.

The World Health Organisation (WHO) reports a cumulative total of 382 human cases of the H5N1 bird flu, mostly in southeast Asia, of which 241 have been fatal.

Most cases have been in poultry workers and at present the virus cannot pass that easily from human to human. But global experts have warned for several years that an influenza pandemic is long overdue, urging governments to make preparation well in advance.

GSK, which is likely to receive a boost from the news that H5N1 may now be showing some resistance to Tamiflu, has added several manufacturing lines to meet current demand and stockpile orders for Relenza.

The company’s two H5N1 flu vaccines went into clinical trials in Germany in March 2006.


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