Sanofi Pasteur announced that the FDA has approved Fluzone Intradermal (influenza virus vaccine) for the active immunization of adults 18–64 years old against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. This approval was based on data from a Phase 3 clinical trial in 4,276 adults 18–64 years old that showed systemic reactogenicity of Fluzone Intradermal vaccine to be comparable to that of intramuscular administration of Fluzone vaccine.
Fluzone Intradermal uses a novel microinjection system featuring an ultra-fine needle that is that is 0.06 inches (1.5mm) in length and contains 9mcg of hemagglutinin per strain of influenza in a 0.1mL dose. Fluzone, given intramuscularly, is administered utilizing a needle 1–1.5 inches (25–38mm) in length and contains 15mcg of hemagglutinin per strain of influenza in a 0.5mL dose.
Fluzone Intradermal will be available for the upcoming 2011–2012 influenza season.
For more information call (800) VACCINE or visit www.sanofipasteur.us.