FDA Licenses Sanofi Pasteur’s New Influenza Vaccine Delivered by Intradermal Microinjection
– Fluzone® Intradermal (Influenza Virus Vaccine) first to offer an immunization option with 90 percent smaller needle –
Swiftwater, Pa — May 10, 2011 /PRNewswire/ — Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today the U.S. Food and Drug Administration (FDA) has approved the company’s supplemental biologics license application (sBLA) for licensure of Fluzone Intradermal (Influenza Virus Vaccine). Fluzone Intradermal vaccine is indicated for active immunization of adults 18 through 64 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
“The microinjection delivery system utilized in Fluzone Intradermal vaccine provides reliable and easy delivery of the vaccine into the dermal layer of the skin, an attractive site for immunization,” said Olivier Charmeil, President and CEO, Sanofi Pasteur. “Sanofi Pasteur is proud to bring this innovation in influenza vaccine administration to the U.S., offering health-care providers a new tool that may help enhance adult influenza immunization rates.”
The new formulation of Fluzone Intradermal vaccine is the first influenza vaccine licensed in the U.S. that uses a novel microinjection system for intradermal delivery. Fluzone Intradermal vaccine features an ultra-fine needle that is 90 percent shorter than the typical needle used for intramuscular injection of influenza vaccine. Sanofi Pasteur has previously licensed microinjection intradermal influenza vaccines, marketed as Intanza® or IDflu® vaccines, in more than 40 countries including Australia, Canada and countries in Europe.
Fluzone Intradermal vaccine incorporates a new, easy-to-use, prefilled microinjection system designed to consistently deposit vaccine antigens into the dermal layer of the skin of adults. The dermal layer contains a high concentration of specialized cells known as dendritic cells, which play a key role in generating an immune response. In clinical trials, Fluzone Intradermal vaccine produced an immune response at rates similar to Fluzone vaccine administered intramuscularly.
Typically, adult influenza vaccines are administered into the muscle utilizing a needle 1 inch to 1.5 inches (25 mm to 38 mm) in length. Fluzone Intradermal vaccine features an ultra-fine needle that is 0.06 inches (1.5 mm) in length. Fluzone vaccine contains 15 mcg of hemagglutinin per strain of influenza in a 0.5 mL dose. Fluzone Intradermal vaccine contains 9 mcg of hemagglutinin per strain of influenza in a 0.1 mL dose.
Fluzone Intradermal vaccine will be available to health-care providers in the U.S. for the 2011-2012 influenza season. Health-care providers wishing to reserve vaccine can do so by visiting www.vaccineshoppe.com or by calling 1-800-VACCINE (1-800-822-2463).
Fluzone Intradermal Vaccine Immunogenicity and Safety
Clinical trials were conducted to evaluate the safety and immunogenicity of Fluzone Intradermal vaccine. Fluzone Intradermal vaccine was licensed based on data from a Phase III clinical trial in 4,276 adults 18 through 64 years of age (2,855 participants received Fluzone Intradermal vaccine and 1,421 participants received Fluzone vaccine via intramuscular administration). The study, which assessed the safety and immunogenicity of Fluzone Intradermal vaccine in comparison to Fluzone vaccine, was presented in October 2010 at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia. In the Phase III trial, Fluzone Intradermal vaccine was found to induce immunologic responses similar to licensed Fluzone vaccine.
Systemic reactogenicity of Fluzone Intradermal vaccine was comparable to that of intramuscular administration of Fluzone vaccine in the study. Intradermal microinjection deposits influenza vaccine near the surface of the skin; therefore, local reactions are more easily visible. The most common solicited injection-site reactions reported in participants given the intradermal vaccine were erythema (redness) (>75%), swelling (>50%), induration (hardness) (>50%), pain (>50%) and pruritus (itching) (>40%). The injection-site and systemic reactions with intradermal administration were transient, resolving in three to seven days without sequelae. The injection-site reactions were more frequent with participants given the intradermal vaccine compared to the intramuscular vaccine, with the exception of pain, which was similar.