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GlaxoSmithKline P.L.C. today said the federal Food and Drug Administration approved its H1N1 flu vaccine for use in the United States.
The U.S. government has ordered 7.6 million doses of the Glaxo vaccine as part of a total 250 million doses secured from several companies, including Sanofi-Pasteur and AstraZeneca.
Glaxo's vaccine will be produced in multi-dose vials from bulk vaccine produced at company operations in Quebec, Canada. The company, which is based in London but has major operations in the Philadelphia region, expects to start shipping the H1N1 vaccine to U.S. locations in December and deliver all 7.6 million doses by the end of the year.
GlaxoSmithKline already is selling its H1N1 vaccine in other countries, but that version of the shot includes an adjuvant, a compound that boosts the immune response to the vaccine and allows lower doses to be used.
U.S. officials had demanded that H1N1 vaccines contain no adjuvants out of concern that they might make people in this country less likely to get the shot. The decision has contributed to shortages of the vaccine.
Also yesterday, Glaxo said it had signed an agreement with the World Health Organization to donate 50 million doses of its adjuvanted pandemic H1N1 influenza vaccine to WHO to distribute in developing countries. Glaxo is working with WHO and health authorities to start shipping to developing countries by the end of this month.
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