Sanofi Pasteur, the vaccines division of the sanofi-aventis Group announced 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 A(H1N1) 2009 monovalent vaccine, produced at Sanofi Pasteur’s facility in Val de Reuil, France. 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 influenza A(H1N1) 2009 vaccine available. Panenza is an inactivated monovalent influenza A(H1N1) 2009 virus, 15 mcg dose, non-adjuvanted vaccine indicated for the active immunization of adults and children six months of age and older against influenza disease caused by pandemic A(H1N1) 2009 virus.
The approval of Panenza vaccine was supported by the review of data from clinical trials conducted in France and Finland in adults and children aged six 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 three years of age, immune response measurements showed that a single dose of Panenza influenza A (H1N1) 2009 monovalent vaccine induced a high antibody response 21 days post-vaccination that is considered protective. Panenza vaccine met the European Medicines Agency’s (EMEA) three immunological criteria. However, one or two doses of Panenza may be indicated depending on the age groups.
Influenza A(H1N1) 2009 monovalent inactivated influenza virus vaccine Panenza is manufactured at Sanofi Pasteur’s facility in Val de Reuil, France, using the same robust, 'tried and true' process as Sanofi Pasteur’s seasonal trivalent influenza virus vaccine licensed in Europe.