After receiving a positive recommendation from experts at the European Medicines Agency in February, GlaxoSmithKline (GSK), the biggest drug maker in Europe, has been given the green light from the European Commission for the first human vaccine against H5N1 bird flu. GSK is just one of several pharmaceutical companies, including Novartis SA and Sanofi Aventis that are developing bird flu vaccines, but the approval by European medical regulators puts GSK ahead of its rivals in the vaccine race.

Since 2003, H5N1 has been circulating in Asia, Europe and Africa and has killed approximately 240 people. It has remained primarily a virus affecting birds, with most human cases being traced to direct or indirect contact with infected birds. But experts fear that the virus could mutate into a form that could be spread between humans, creating the next global pandemic. "This vaccine marks a significant step in the world's ability to cope with an influenza pandemic," said Jean-Pierre Garnier, GSK¡¯s Chief Executive Officer.

The vaccine, Prepandrix, activates an immune response to the H5N1 strain of bird flu and contains a special additive that allows a very low dose of active ingredient to be used in each shot. GSK says that study results show that its vaccine also works against other strains of the virus that have arisen, including the Indonesian type of H5N1, which is a genetically different virus. It is the first vaccine to receive a license for use in the 27-member EU region.

GSK has already sold 3.3 million doses of the vaccine to the UK government. Switzerland placed an order for 8 million doses, enough to cover its entire population and the U.S. Department of Health and Human Services has placed an order for 27.5 million doses. Finland has also ordered doses, and GSK is in negotiations with several other countries about supplying them. In an attempt to create a pandemic stockpile for poor countries, GSK has agreed to donate 50 million doses of the vaccine to the World Health Organization. The vaccines will be delivered over a 3-year period and should provide enough doses for 25 million people, with each person needing two shots.

Since this new vaccine protects against different strains of H5N1, theoretically it should give a degree of protection until a more precisely tailored pandemic vaccine can be produced, which could likely take 4-6 months from the time a pandemic strain is identified. The Royal College of General Practitioners has recommended that the Department of Health vaccinate all patients in at-risk groups, such as healthcare workers, poultry workers, and the elderly, with a pre-pandemic H5N1 vaccine to help protect against an influenza pandemic.

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