If approved the Fluzone formulation will become the first vaccine using a novel microinjection system to be made available in the country. Sanofi developed the system in collaboration with Becton, Dickinson and Company (BD) to improve on currently used intramuscular delivery.
"We believe that Fluzone intradermal vaccine could be an important tool in increasing adult immunisation rates due to its ease of use for health-care providers and the high-level of interest expressed by patients for this immunisation option”, said Wayne Pisano, CEO of Sanofi Pasteur.
To make the system easier to use and boost immunisation rates the Sanofi and BD designed prefilled device uses a 1.5mm long ultra-thin needle to deliver vaccine into the dermal layer of the skin. In comparison, intramuscular vaccination typically uses needles 25mm to 40mm long.
High concentration of specialised immune cells in the dermal layer is believed to result in intradermal administration stimulating an antibody response. The microneedle device has an injection volume of 0.1ml, compared to 0.5ml for intramuscular injection.
Also, the dermal layer contains a network of lymphatic vessels feeding local lymph nodes, which gives the vaccine efficient access to the immune system. Sanofi says the device consistently deposits vaccine antigens in the dermal layer irrespective of gender, age, ethnicity or body mass.
Having had the supplemental biologics license application (sBLA) accepted by the US Food and Drug Administration (FDA) Sanofi anticipates an action date in the first half of 2011.
Sanofi has already licensed an influenza vaccine using microinjection under the brand names Intanza or IDflu in Europe, Australia, New Zealand and other markets.