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GSK wins U.S. approval for H1N1 vaccine

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GlaxoSmithKline has won approval from U.S. regulators to sell its vaccine to fight H1N1, making it the last major drug manufacturer to receive clearance in this country.

The British company with its North American headquarters in Research Triangle Park also said that the U.S. Health Department has ordered 7.6 million doses of the swine flu shot.

GSK will make the vaccine at its factory in Quebec. The company expects to begin shipping the U.S. doses in December and provide all of them by the end of the year.

In September, the U.S. Food and Drug Administration approved vaccines made by four of the five companies expected to manufacture swine flu vaccines. At that time, GSK officials said they expected to win approval "as soon as possible."

GSK was left out because of challenges making a vaccine without an adjuvant, an ingredient added to boost potency so more people can be treated, Bloomberg News reported.

U.S. vaccine supplies have been held up by production snags at two drugmakers and GSK's delays in winning approval, Bloomberg reported.


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Beginning to wonder if this swine flu is actually something else--
a bio-weapon attack by Ole Al Qaeda. Of course, we don't want to stampede
the public, but looks as if it's stampeded, anyway, with the long lines at the clinics and the shortage of the vaccine.

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About the blogger

Assistant Business Editor Alan M. Wolf joined the N&O in 1999 covering the business of health care. He became an editor in 2001, and helps oversee the paper's daily business coverage and Sunday Work&Money section. He lives in Clayton with his wife and two children. Reach him at 919-829-4572 or e-mail him.