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Baxter International completes H1N1 vaccine testing, may distribute soon


DEERFIELD, Ill. Baxter International on Friday announced that it may have a vaccine for the novel H1N1 pandemic ready for commercial distribution as early as next month.

The company stated that it has completed testing and evaluation of the A(H1N1) influenza virus and is now in full-scale production of a commercial A(H1N1) vaccine using its Vero cell culture technology.

With its Vero cell technology, Baxter has received European Medicines Agency approval for a mock-up pandemic vaccine called Celvapan, the brand name for the company's pandemic vaccine. The qualification, development and manufacturing processes used in gaining mock-up licensure for Celvapan apply as the company uses this new influenza A(H1N1) virus strain to produce a pandemic vaccine. The Celvapan EMEA licensure supports fast track approval of a pandemic vaccine containing the A(H1N1) virus strain. Baxter will submit the A(H1N1) vaccine for approval upon completion of initial manufacturing runs.

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