Sanofi Pasteur announces new quadrivalent influenza vaccine Phase III pediatric data

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today new Phase III data for its investigational quadrivalent influenza vaccine (QIV) in children 6 months through 8 years of age. This pediatric study evaluated the safety and immunogenicity of QIV compared to currently licensed Fluzone^® (Influenza Virus Vaccine). Results of the study were presented today at the Annual Meeting of the Pediatric Academic Societies in Boston.

The data from this pediatric study of QIV support the results of prior studies in adults. The non-inferiority comparisons demonstrate that the addition of a fourth influenza strain (a second B strain) to the investigational vaccine does not adversely affect the safety and immunogenicity profiles of QIV compared to those of licensed Fluzone vaccine. 

"Fluzone vaccine is the only influenza vaccine licensed and available in the U.S. for use in children as young as 6 months of age along with formulations of Fluzone vaccine available for the full spectrum of the population through the oldest adults," said David Greenberg, M.D., Senior Director, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "We believe that a quadrivalent Fluzone vaccine could provide an important public health benefit for people of all ages by providing coverage against an extra B virus strain of influenza. Influenza B is responsible for a substantial burden of disease and influenza-associated complications and hospitalizations in children."

Currently, seasonal influenza vaccines contain the three influenza virus strains anticipated to circulate in a given year based on global surveillance of influenza virus activity during the prior year. The annual trivalent inactivated influenza vaccine (TIV) formulation includes two A strains and one B strain. However, for over a decade, two distinct influenza B families (lineages) have co-circulated with varying prevalence, making it difficult to predict which B-lineage strain will predominate in a given year. In fact, approximately half of the time, the B-lineage strain selected for the annual vaccine has not matched the B-lineage strain that predominately circulated in a given season. Even in years where the predominant B-lineage strain is selected for the vaccine, some influenza disease occurs from the other circulating B-lineage strain not in the vaccine. Inclusion of a strain from each of the two B lineages is a public health measure that can help reduce unnecessary cases of influenza disease that could be vaccine-preventable if the additional strain were in the vaccine.