Sanofi Pasteur, the vaccines division of Sanofi announced that a decentralized marketing authorization application has been accepted for review in the European Union countries for a quadrivalent (four-strain) formulation of Vaxigrip, its seasonal inactivated split-virion influenza vaccine produced at its facility in Val de Reuil, France. The file has been accepted for review by France’s Agence nationale de sécurité du medicament et des produits de santé (ANSM) as the regulatory agency for the “Reference Member State”, and by national regulatory agencies from the EU countries.
Olivier Charmeil, president and CEO of Sanofi Pasteur, said, “The inclusion in the seasonal influenza vaccine of the four influenza viruses anticipated to circulate in the forthcoming season has the potential to reduce the risk of influenza disease and influenzarelated complications, specifically hospitalizations and deaths among those, at risk, who contract the disease.”
Annual influenza vaccination is considered to date as the most effective method for preventing seasonal flu and its complications. Vaccination is especially important for people at higher risk of serious influenza complications and for people who live with or care for high risk individuals.
Currently licensed trivalent seasonal influenza vaccines are formulated every year, based on the seasonal recommendations made by the World Health Organization (WHO) and national authorities, and contain inactivated strains that confer protection against three different influenza viruses: two influenza A virus subtypes (H3N2 and H1N1) and one influenza B virus.
Influenza viruses are capable of evading the body’s immune system by undergoing continuous genetic variation and may change from season to season.
Individuals are susceptible to new strains despite previous infection by other influenza viruses. Additionally, 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 country or in a region in seasons to come.
Sanofi Pasteur’s new quadrivalent influenza vaccine includes two A strains and two B strains corresponding to both of the B lineages.
The marketing authorization application for the quadrivalent version of Vaxigrip is intended to be presented in all countries of the world where Vaxigrip (licensed trivalent vaccine) is currently commercialized. Once approved, the new quadrivalent vaccine will be commercialized in Western European countries by Sanofi Pasteur MSD (the joint venture between MSD and Sanofi Pasteur), and in other countries (including Eastern Europe) by Sanofi Pasteur.
The current application is for the active immunization of children and adults from 9 years of age for the prevention of influenza disease caused by influenza virus subtypes A and B contained in the vaccine. It is based on a clinical development programme that involved more than 3,000 adults aged 18 to 60, seniors aged 60 and over and children/teenagers 9 to 17 years old. Clinical trials evaluated the safety of Sanofi Pasteur’s new quadrivalent influenza vaccine and its ability to generate an immune response compared to trivalent vaccines. In parallel, development efforts are underway for a pediatric indication of this new quadrivalent influenza vaccine, for children from six months to nine years of age.
Additionally, Sanofi Pasteur filed, in October 2012, a Supplemental Biologics License Application (sBLA) with the US Food and Drug Administration (FDA) for a quadrivalent formulation of its Fluzone (Influenza Virus Vaccine) produced at the Sanofi Pasteur facility in Swiftwater, Pa. (USA). The sBLA file has been accepted by the FDA for full review and an action date is anticipated in the second quarter of 2013.
As a world leader in the research, development and manufacturing of influenza vaccines, Sanofi Pasteur is dedicated to saving lives through the development of innovative new influenza vaccines.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme.