Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced that its adjuvanted A(H1N1) monovalent influenza vaccine, Humenza, has received a positive opinion from Europe's Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).

The CHMP is recommending the marketing authorization of Humenza vaccine in European Union countries for the active immunization of persons 6 months of age and older against influenza disease caused by the pandemic A(H1N1) 2009 virus.

The positive opinion granted today to Humenza vaccine through the European centralized marketing authorization application process was based on a review of results from clinical trials on Sanofi Pasteur's A(H1N1) AF03-adjuvanted influenza vaccine candidate. These trials--conducted in healthy children (6 months to 17 years of age), adults and the elderly--evaluated the safety of Humenza vaccine and its ability to elicit a sero-protective immune response to the A(H1N1) pandemic strain now circulating.

Humenza vaccine's safety profile is satisfactory in all age-groups in the studies and similar to that of adjuvanted pandemic influenza vaccines already licensed. In all age-groups--children 6 months to 17 years of age, adults and the elderly--immune response measurements showed that a single dose of Humenza influenza A(H1N1) monovalent vaccine induced a high antibody response 21 days post-vaccination that meets the three EMA immunological criteria and is considered sero-protective.

As the world leader in research, development and manufacturing of influenza vaccines, Sanofi Pasteur is committed to a three-pronged public-health mission: to produce and deliver the southern hemisphere seasonal influenza vaccine, to produce the northern hemisphere seasonal influenza vaccine for later in 2010 and to work with the world's health authorities to safeguard human health during the current pandemic and to prepare for any future threats. Sanofi Pasteur is working diligently on all fronts.

Sanofi Pasteur's adjuvanted A(H1N1) 2009 monovalent inactivated influenza vaccine, Humenza, is manufactured at Sanofi Pasteur's facility in Val de Reuil, France, using the same process as Sanofi Pasteur's seasonal trivalent influenza vaccine licensed in Europe.

Humenza vaccine contains 3.8 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1)-like virus and includes Sanofi Pasteur's proprietary AF03-adjuvant, designed to stimulate the immune system to increase an immunological response.

Humenza vaccine is not intended to be distributed in the US, where Sanofi Pasteur produces another A(H1N1) pandemic vaccine licensed by the United States' Food & Drug Administration.

Sanofi Pasteur operates influenza vaccine production facilities in Val de Reuil, France and in Swiftwater, Pa. (US). All Sanofi Pasteur influenza vaccine facilities have been designed to switch from seasonal influenza vaccine production to pandemic influenza vaccine production.

Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide. For the 2008-2009 influenza season, the company produced more than 45 per cent of the influenza vaccines distributed in the US.