FDA approves Sanofi's Fluzone Intradermal Quadrivalent vaccine

SWIFTWATER, Pa. — Sanofi Pasteur, the vaccines division of Sanofi, on Friday announced that the U.S. Food and Drug Administration has approved the supplemental biologics license application 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 ages 18 years through 64 years 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 Greenberg, VP scientific and medical affairs, and chief medical officer, Sanofi Pasteur U.S."Fluzone Intradermal Quadrivalent vaccine will offer another influenza vaccination option for healthcare 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% 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 has noted that in six (approximately 50%) of the past 13 influenza seasons (2001-13), 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, SVP 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% 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.