Sanofi Pasteur has reported that the French drug agency has granted marketing authorisation in France for Panenza, its non-adjuvanted Influenza A(H1N1) 2009 monovalent vaccine. The vaccine was made available to French health authorities.
Panenzais a non-adjuvanted vaccine formulated to contain 15mcg hemagglutinin (HA) of influenza like virus. It is not intended to be distributed in the US where Sanofi Pasteur produces another non-adjuvanted A(H1N1)pandemic vaccine licensed in September 2009 by the FDA.
Sanofi Pasteur has filed a decentralised marketing authorisation application for Panenza vaccine in six European countries like Belgium, France, 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, 15mcg dose, non-adjuvanted vaccine indicated for the active immunisation of adults and children 6 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 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 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. Panenza is a registered trademark of Sanofi Pasteur’s influenza A(H1N1) vaccine in the EU and other countries.
Wayne Pisano, president and chief executive officer of Sanofi Pasteur, said: “Registration and on-schedule delivery of A(H1N1) 2009 influenza vaccines remain high priorities for Sanofi Pasteur to help support authorities’ pandemic immunisation efforts and address this public health challenge.
“The marketing authorization approval for Panenza represents a key regulatory step, as this nonadjuvanted vaccine could initially be selected in national immunisation programs to protect specific populations in some European countries.”