Updated on 12 April 2013
Quadrivalent vaccine formulation, Vaxigrip, will be reviewd by France's Agence nationale de sécurité du medicament et des produits de santé (ANSM) on behalf of the EU
Singapore: Sanofi Pasteur has been accepted for review in the European Union for a quadrivalent (four-strain) formulation of Vaxigrip. 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.
"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 influenza-related complications, specifically hospitalizations and deaths among those, at risk, who contract the disease," said Mr Olivier Charmeil, president and CEO, Sanofi Pasteur.
Annual influenza vaccination is considered as 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, including 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.