FDA approves Fluzone Intradermal Quadrivalent vaccine to prevent four strains of influenza virus

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus. Fluzone Intradermal Quadrivalent vaccine is indicated for adults 18 through 64 years of age for active immunization for the prevention of influenza ("the flu") caused by influenza A subtype viruses and type B viruses contained in the vaccine.

"Influenza B is a common cause of influenza-related morbidity and mortality across all age groups," said David P. Greenberg, M.D., Vice President, Scientific & Medical Affairs, and Chief Medical Officer, Sanofi Pasteur US. "Fluzone Intradermal Quadrivalent vaccine will offer another influenza vaccination option for health care providers and their adult patients with broad coverage against influenza viruses that may be predominant, coupled with the efficiency of using the intradermal microinjection system."

Traditional three-strain—or trivalent—influenza vaccines contain two strains of influenza A and one strain of influenza B. Influenza B represents 20 to 25 percent of circulating influenza strains and is associated with substantial morbidity and mortality. Two distinct families (lineages) of influenza B (Victoria and Yamagata) have been co-circulating worldwide for over a decade, making it difficult to predict which will predominate during a given season. In fact, the Centers for Disease Control and Prevention (CDC) has noted that in six (approximately 50 percent) of the past 13 influenza seasons (2001-2013), the B strain included in the vaccine did not match the predominant B strain in circulation. Accurately predicting which influenza strains will predominate during the upcoming season is critical as the degree of match between circulating and vaccine strains can significantly impact the effectiveness of seasonal influenza vaccines.

"An intradermal vaccine provides a similar level of protection to the traditional flu shot," said John Shiver, Senior Vice President, Research and Development, Sanofi Pasteur. "Fluzone Intradermal Quadrivalent vaccine offers four-strain protection in a microinjection system that is convenient, efficient and easy to use, allowing for streamlined administration by health care providers."

Fluzone Intradermal Quadrivalent vaccine was developed to help address frequent B-strain mismatches and broaden coverage against influenza by incorporating a B strain from each lineage. The vaccine is administered directly into the skin through a small, 1.5 mm micro-needle, which is 90 percent smaller than typical needles used for intramuscular injection of influenza vaccines. Because the skin has a high concentration of immune cells, an intradermal vaccine is able to use the skin's natural defenses. In addition, the microinjection system is ideal for those immunizing since it has a pre-affixed needle and a needle shield.

Fluzone Intradermal Quadrivalent Vaccine Immunogenicity and Safety
The FDA approval of Fluzone Intradermal Quadrivalent vaccine was based on results from a phase III clinical study of 3,355 adults that compared this vaccine, which included B strains from both lineages, to two trivalent intradermal controls: licensed trivalent Fluzone Intradermal vaccine that contained a B strain of one lineage and an investigational intradermal vaccine that contained a B strain from the opposite lineage. In the study, antibody responses to all four strains in Fluzone Intradermal Quadrivalent vaccine were found to be non-inferior to those following the trivalent vaccine controls with respect to the strains contained in each, demonstrating that Fluzone Intradermal Quadrivalent vaccine could improve vaccine effectiveness by generating robust immune responses to influenza strains from both B lineages simultaneously.

Additionally, the study showed that Fluzone Intradermal Quadrivalent vaccine had a systemic safety profile that was comparable to that observed with Fluzone Intradermal vaccine and the investigational intradermal vaccine. The most commonly reported solicited reactions were pain, pruritus (itching), erythema (redness), swelling, and induration (hardness) at the injection site; myalgia (muscle ache), headache, and malaise. Most of these reactions were mild or moderate in intensity and occurred within three days of vaccination.

The development of Fluzone Intradermal Quadrivalent vaccine builds on the experience of Fluzone Intradermal vaccine and entails the addition of a second B strain to cover both B lineages. The vaccine will be made available in the United States during the 2015-2016 influenza season.