Processing Magazine

Glaxo gets approval for bird flu vaccine

May 19, 2008
The Associated Press is reporting that GlaxoSmithKline said recently that it has received permission from European regulators to market a human bird flu vaccine, the first pharmaceutical to receive a license for pre-pandemic use in all 27-member European Union states.

Glaxo, which has spent some $2 billion developing the vaccine that targets the H5N1 virus, already has orders for 8 million doses from Switzerland, enough to cover that country''s entire population, and an order for 27.5 million doses from U.S. Department of Health and Human Services.

Experts believe H5N1, an influenza virus subtype which has killed at least 241 people worldwide, is the most likely candidate to mutate into a pandemic virus.

Emmanuel Hanon, vice president of the Influenza Vaccine Franchise at Glaxo, said that Finland and several other European countries had also placed orders.

GlaxoSmithKline PLC is just one of several pharmaceutical companies, including Novartis SA and Sanofi Aventis, developing vaccines against H5N1 bird flu.

Since late 2003, the virus has been circulating in Asia, Europe and Africa, and several distinct 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.

If a vaccine protects against different H5N1 strains, people could theoretically be pre-vaccinated before getting a booster shot with a new formulation containing the pandemic strain once the global outbreak strikes.

But if it is another flu subtype that causes the next pandemic, like H7 or H9, which have also caused human bird flu cases, vaccines created using the H5N1 strain will likely be useless.

Hanon said that the license from the European Medicines Agency equated to formal validation of the quality and efficiency of the vaccine.

Glaxo has agreed to donate 50 million doses of the vaccine to the World Health Organization in an attempt to create a pandemic vaccine stockpile for poor countries. The vaccines will be delivered over a three-year period and should provide enough doses for 25 million people. Each person needs two shots.

Hanon said that full production capacity would be determined after an outbreak.