Baxter International Inc. announced 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, MD, 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 per cent protective efficacy against the influenza strains contained in the vaccine and a low adverse event profile.

Production of Preflucel using Baxter's Vero cell technology allows for the use of the natural virus, which is identical in protein composition to the virus circulating in nature. Egg-based vaccine production cannot use the natural virus, and must instead wait until genetically modified virus strains are available. Preflucel is free of preservatives, antibiotics and egg proteins, and is suitable for adult and elderly populations, as well as people with egg or antibiotic allergies in those age groups.

Investigators studied the safety, immunogenicity and protective efficacy of Preflucel through a randomized, double-blind, placebo-controlled phase III trial conducted in more than 7,200 healthy volunteers in the United States during the 2008/2009 influenza season.

Study results indicated that participants responded positively to the vaccine, with 78.5 per cent protective efficacy against Culture-Confirmed Influenza Infection (CCII) and robust immune responses (measured as seroprotection rates) against the three viral strains contained in the vaccine: A/H1N1- (88.0%), A/H3N2- (93.3%) and B-specific (97.1%).

The vaccine was well tolerated, with no treatment-related serious adverse events reported during the trial. The strong 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.

Preflucel clinical studies involved more than 15,000 participants, of which more than 9,000 adult and elderly participants received the vaccine. The most common adverse reactions were pain at the injection site, headache, fatigue, myalgia and malaise.

Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.