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FDA Approves Sanofi Pasteur’s Quadrivalent Flu Vaccine

Biodefense Vaccine ProgramThe U.S. Food and Drug Administration has approved the supplemental biologics license application (sBLA) for licensure of Sanofi Pasteur’s four-strain influenza vaccine, known as the Fluzone Quadrivalent vaccine.

Fluzone Quadrivalent vaccine is licensed for use in children six months of age and older, adolescents, and adults. Fluzone Quadrivalent is the newest addition to Sanofi’s Fluzone family of vaccines, which are currently administered to more than 50 million people in the U.S. each year.

The 2013-2014 influenza season will be the first in which quadrivalent influenza vaccines will be available in the U.S. Until this year, seasonal influenza vaccines included only one B strain. Fluzone Quadrivalent vaccine includes two A strains and two B strains to help protect against influenza disease.

Seasonal influenza vaccines in the U.S. contained only two strains (one strain of type A influenza and one strain of type B influenza) until 1978, when the decision was made to incorporate a second type A influenza strain to help provide protection against both A strains that were co-circulating. For the past 35 years, influenza vaccines have been trivalent to help protect against three strains of influenza virus: a type A(H1N1), a type A(H3N2) and one type B. However, since the 2001-2002 season, two distinct influenza B types (the Victoria and Yamagata lineages) have co-circulated with varying prevalence, making it difficult to predict the next season’s dominant B lineage strain. In six of the past 12 seasons, the dominant circulating B strain was from the B-lineage not selected for the vaccine. Even in years where the correct B lineage strain was selected for the vaccine, some influenza disease was caused by the B lineage omitted from the vaccine likely reducing the overall vaccine effectiveness against circulating influenza viruses.

“Protection against the type B flu strain may be an especially important factor that healthcare providers consider when immunizing children since influenza B causes a substantial number of illnesses, hospitalizations and deaths in the pediatric population,” said David Greenberg, MD, Vice President U.S. Scientific and Medical Affairs.

Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases.

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