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source: LA Times
London-based GlaxoSmithKline won U.S. approval to sell its vaccine to fight H1N1 influenza, also known as swine flu, after an eight-week delay.
London-based GlaxoSmithKline won U.S. approval to sell its vaccine to fight H1N1 influenza, also known as swine flu, after an eight-week delay.
The Food and Drug Administration cleared the vaccine as a strain change to Glaxo's FluLaval seasonal flu vaccine, the drug maker said Tuesday in an e-mailed statement.
The U.S. Health and Human Services Department has ordered 7.6 million doses of the swine flu vaccine as part of about 250 million doses secured from all manufacturers, the company said.
Although swine flu vaccines made by AstraZeneca, CSL Ltd., Novartis and Sanofi-Aventis were cleared for sale by the FDA on Sept. 15, Glaxo was left out because of challenges making a vaccine without an adjuvant, an ingredient added to boost potency so more people can be treated. U.S. officials decided not to use adjuvants in their immunization program.
Glaxo "expects to begin shipping the vaccine in December and to provide all 7.6 million doses by the end of the year," according to the statement. The vaccine will be produced at the company's plant in Quebec.
U.S. vaccine supplies have been held up by production delays at two drug makers and Glaxo's trouble winning regulatory approval, Nicole Lurie, the Health and Human Services department's assistant secretary for preparedness and response, said last month.
About 38 million doses of H1N1 vaccine were available as of Nov. 6 to be shipped to the U.S. for use by hospitals, health clinics and doctors, according to the U.S. Centers for Disease Control and Prevention.
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