HHS buys ‘experimental’ Glaxo flu vaccine

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U.S. health officials on Tuesday approved the importation of up to 4 million doses of influenza vaccine made by GlaxoSmithKline, bringing the U.S. total to 65 million vaccines for this flu season.

The Health and Human Services Department said it would buy 1.2 million doses immediately, leaving another 2.8 million doses from the company available later in the flu season.

Regulators have been working to find overseas sources of the flu vaccine after losing almost half the country’s anticipated supply in October, when one of two major makers, Chiron Corp., lost the license for its British plant because of contamination problems.

“With the latest purchase we will be able to protect more high-risk Americans this flu season in communities across the country,” Health and Human Services Secretary Tommy Thompson said.

Officials approved Glaxo’s vaccine, called Fluarix, as an investigational drug, which means patients will have to sign an informed consent form before receiving the shot.

Europe’s biggest drugmaker said it aimed to supply Fluarix to the United States on a permanent basis in the future. After upgrading its manufacturing plant in Dresden, Germany, the company said it hopes to supply 10 million to 20 million doses for the 2005-2006 flu season.

“GlaxoSmithKline is committed to pursuing a long-term strategy to gain FDA approval for Fluarix in the United States,” said Chris Viehbacher, Glaxo head of U.S. pharmaceuticals.

U.S. officials had hoped to vaccinate 100 million Americans against the flu this season, in part to encourage more companies to get back into the business of making flu vaccines for Americans.

Only two companies, California-based Chiron and Aventis-Pasteur, a subsidiary of French pharmaceutical company Sanofi-Aventis, make flu shots for the U.S. market. In addition, Maryland-based MedImmune makes an inhaled vaccine called FluMist. 

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