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Sanofi Pasteur submits Fluzone Intradermal microinjection sBLA

Sanofi Pasteur has submitted a supplemental biologics license application (sBLA) for Fluzone Intradermal (Influenza Virus Vaccine) with the US Food and Drug Administration (FDA).

Sanofi Pasteur claims that the influenza immunization has been made possible with the development of a new, easy-to-use, pre-filled microinjection system developed in collaboration with BD (Becton, Dickinson and Company).

Sanofi Pasteur president and CEO Wayne Pisano said that upon FDA licensure, this new formulation of Fluzone vaccine will be the first vaccine available in the US using a novel microinjection system for intradermal delivery of vaccine.

Sanofi Pasteur is seeking licensure of Fluzone Intradermal vaccine in the US for adults 18 years through 64 years of age.

Sanofi Pasteur already has licensed a microinjection system influenza vaccine, marketed as Intanza/IDflu, in Europe, Australia, New Zealand and other countries.