Panenza, Sanofi Pasteur's H1N1 vaccine, approved in France

LYON, France — Sanofi Pasteur, the vaccines division of the sanofi-aventis Group announced Nov. 16 that the French drug agency Afssaps (Agence française de sécurité sanitaire des produits de santé) has granted marketing authorization in France for Panenza, its non-adjuvanted Influenza H1N1 2009 monovalent vaccine, produced at Sanofi Pasteur’s facility in Val de Reuil.  The vaccine was made available to French health authorities.

“Registration and on-schedule delivery of A(H1N1) 2009 influenza vaccines remain high priorities for Sanofi Pasteur to help support authorities’ pandemic immunization efforts and address this public health challenge,” said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur.  “The marketing authorization approval for Panenza represents a key regulatory step, as this non-adjuvanted vaccine could initially be selected in national immunization programs to protect specific populations in some European countries.”

Sanofi Pasteur has filed a decentralized marketing authorization application for Panenza vaccine in six European Union countries — Belgium, France (acting as “Reference Member State”), Germany, Italy, Luxembourg and Spain - in response to recommendations by the authorities from these countries to make a non-adjuvanted H1N1 influenza vaccine available. Panenza is an inactivated monovalent H1N1 influenza virus, 15 mcg dose, non-adjuvanted vaccine indicated for the active immunization of adults and children 6 months of age and older against influenza caused by the H1N1 virus.

The approval of Panenza was supported by the review of data from clinical trials conducted in France and Finland in adults and children aged 6 months and older. Panenza vaccine’s safety profile was similar to that of Sanofi Pasteur’s seasonal trivalent influenza vaccine. In adults and children over 3 years of age, immune response measurements showed that a single dose of Panenza induced a high antibody response 21 days post-vaccination that is considered protective. Panenza met the European Medicines Agency’s three immunological criteria. However, one or two doses of Panenza may be indicated depending on the age groups. 

Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide. For the 2008-09 influenza season, the company produced more than 45 percent of the influenza vaccines distributed in the U.S.