GlaxoSmithKline said this morning that it has received permission from European medical regulators to market a human bird flu vaccine it has already sold to several governments to stockpile in preparation for a pandemic.
The ruling from the European Medicines Agency makes Prepandrix, which targets the H5N1 virus, the first vaccine to receive a license for pre-pandemic use in all 27-member European Union states.
Glaxo already has orders from Switzerland and the United States for the vaccine that it has spent some €1.3 billion ($2 billion) developing, based on the bird flu virus from Vietnam.
Switzerland has ordered 8 million doses - enough to cover the country's entire population. The US Department of Health and Human Services has ordered 27.5 million doses.
"This vaccine marks a significant step in the world's ability to cope with an influenza pandemic," said Glaxo chief executive officer Jean-Pierre Garnier.
However, Glaxo is just one of several pharmaceutical companies, including Novartis SA and Sanofi Aventis, developing vaccines against H5N1 bird flu.
Experts believe H5N1, which has killed at least 241 people worldwide, is the most likely candidate to mutate into a pandemic virus.
Since late 2003, the virus has been circulating in Asia, Europe and Africa, and several distinct H5N1 strains have arisen.
Glaxo has said that its vaccine works against these other versions of the virus as well, announcing study results last year showing that that it even reacts against the Indonesian type of H5N1, a genetically different virus.
Agencies