Preflucel approved for European repeat mutual recognition

Baxter International recently announced the approval of PREFLUCEL, its seasonal influenza vaccine, for a European repeat mutual recognition procedure by the Austrian agency for Health Food and Safety.

As a result, PREFLUCEL will be made available for the 2011-2012 flu season by 13 participating European Union countries, including Germany, Spain, the United Kingdom and the Nordic countries. They will formally implement PREFLUCEL’s license at that time.

Baxter has created a season vaccine that is composed of purified, inactivated split influenza virons. It is the result of dedicated product development effort to create a vaccine that is well-tolerated and can be manufactured every flu season.

PREFLUCEL is made using Vero cell technology, Baxter’s proprietary technology platform. It is a method that differs from tradition production methods that utilize embryonated chickens. Those production methods have been in existence for decades.

The vaccine is indicated for the use of protecting from influenza in adults older than 18 years of age and in elderly populations.

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

British medical journal The Lancet reported that PREFUCEL was safe and effective. Studies showed a 78.5 percent protective rate against influenza strains contained in the vaccine.