GlaxoSmithKline Plc. has received the European Union approval for the world’s first wide-spectrum pre-pandemic vaccine against the H5N1 strain of bird flu.

The approval from the European Medicine Agency makes Prepandrix the first vaccine to receive a license for use in the 27-member region.

 The vaccine is designed for use before or in the early stages of a flu pandemic. Health experts fear that H5N1 strain of bird flu could mutate into a form that could be spread among humans, threatening millions of people.

GSK chief executive Jean-Pierre Garnier said the drug “represents one of the swing factors affecting us in 2008. This is important for the company but it is more important in terms of global health,” he was quoted as saying by Telegraph.co.uk.

Glaxo is one of the several drugmakers including Novartis SA and Sanofi Aventis, and Baxter International Inc. of the U.S. developing vaccines against H5N1 bird flu.

So far, Glaxo has received orders for Prepandrix from several government including the US, Switzerland and Finland. The company sold 146 million pounds of its pre-pandemic vaccine and bulk antigen last year.

The company has invested $2 billion over the last few years to boost production capacity at its plants for influenza vaccines and its antiviral flu treatment Relenza.

The bird flu virus began ravaging Asian poultry stocks in late 2003. According to the World Health Organization, there have been 382 human cases worldwide since 2003, 241 of them fatal. Indonesia is the hardest hit regions of all, with 108 of the deaths and is seen by health experts as a potential hotspot for a pandemic.