Baxter announces European rMRP approval of PREFLUCEL seasonal influenza vaccine

Baxter International Inc. announced today the approval of a European repeat mutual recognition procedure (rMRP) by the Austrian Agency for Health and Food Safety for Baxter's PREFLUCEL seasonal influenza vaccine. The 13 participating European Union countries, including Germany, Spain, United Kingdom and Nordic countries, will formally implement the license on a national level to make PREFLUCEL available for the 2011-12 influenza season.

PREFLUCEL, a seasonal vaccine composed of purified, inactivated split influenza virions, is the result of dedicated product development efforts to provide a well-tolerated and effective innovative vaccine that can be dependably manufactured for each influenza season. PREFLUCEL is manufactured using Vero cell technology, Baxter's proprietary technology platform, offering an innovative method of vaccine production compared to conventional embryonated chicken egg production, which has been used for decades. It is indicated for prophylaxis of influenza in adults older than 18 years and elderly populations.

"Baxter is encouraged by the rMRP approval of PREFLUCEL and looks forward to making this vaccine available in many countries in Europe," said Hartmut Ehrlich, M.D., vice president of global research and development for Baxter's BioScience business. "We are committed to offering our latest advancement in vaccine technology to effectively protect individuals and communities from seasonal influenza."

Results of a recently published study in The Lancet demonstrated effectiveness and tolerability of Baxter's PREFLUCEL in protecting against seasonal influenza. The study data showed 78.5 percent protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile.

Source:

Baxter International Inc.

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