Wednesday, May 11, 2005

Uncertainties Dominate Flu Vaccine Summit

"GlaxoSmithKline is seeking U.S. approval of its Fluarix vaccine, and an FDA inspection of its plant in Dresden, Germany, went well, company official Dr. Vincent Ahonkhai said. U.S. licensing would add about 10 million doses to the market, he said." - Associated Press
 
However, according to this CDC report, the U.S. government has already invested in 1.2 million doses of this as of yet unapproved (by the FDA) vaccine.
 
"In response to this season's influenza vaccine supply shortage, the Department of Health and Human Services (DHHS) has purchased 1.2 million doses of 2004--05 inactivated influenza vaccine from GlaxoSmithKline (GSK). The GSK vaccine is produced, licensed, and distributed globally but is not licensed for use in the United States; therefore, it will be administered in the United States under an Investigational New Drug (IND) protocol." - CDC

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