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Baxter has received an A/H1N1 strain from the US Centers for Disease Control and Prevention in early May 2009 and is diligently working to deliver a pandemic vaccine for use as early as July 2009.
Using its Vero cell technology, Baxter has received European Medicines Agency (EMEA) 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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