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Baxter Preflucel seasonal influenza vaccine gets approval in Austria

Baxter International Preflucel vaccine, manufactured using proprietary Vero cell technology, has received Austrian Agency for Health and Food Safety (AGES) approval.

The Preflucel vaccine was shown to be effective in preventing seasonal influenza and is indicated for prophylaxis of influenza in adults and the elderly, the company said.

According to Baxter, Vero cell technology, free of preservatives, uses the natural virus, identical in protein composition to the virus circulating in nature, instead of genetically modified virus strains, which are used by egg manufacturers.

The immune response of Preflucel was further demonstrated by meeting the criteria for immunogenicity set by the European Medicines Agency and the US Food and Drug Administration in all Phase III clinical studies completed.

Baxter BioScience Global R&D and Medical Affairs vice president Hartmut Ehrlich said that not only has Preflucel demonstrated excellent immunogenicity with respect to the three viral strains identified as most likely to cause illness by the World Health Organization, but it also demonstrated a greater than 70% protection rate against all circulating flu strains.

Preflucel is now available in Austria and will also be available in the Czech Republic during the 2010 to 2011 flu season.

Baxter expects to submit for approval of Preflucel in additional countries in Europe in 2010 through a Mutual Recognition Procedure (MRP).