The U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Sanofi’s 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. The shot is indicated for adults 18 through 64 years of age for active immunization for the prevention of influenza 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 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. According to the Centers for Disease Control and Prevention (CDC), in six of the past 13 influenza seasons (2001-2013), the B strain included in the vaccine did not match the predominant B strain in circulation.
“Fluzone Intradermal Quadrivalent was developed to help address this frequent B-strain mismatch and broaden coverage against influenza by incorporating a B strain from each lineage,” stated Sanofi.