Sanofi Pasteur, the vaccines division of French healthcare company Sanofi (SNY,SNYNF), Thursday said a decentralized marketing authorization application has been accepted for review in the European Union countries for a quadrivalent formulation of Vaxigrip(r), Sanofi Pasteur's seasonal inactivated split-virion influenza vaccine.
The application is intended to be presented in all countries of the world where Vaxigrip is currently commercialized, said the company. Once approved, the new quadrivalent vaccine is expected to be commercialized in Western European countries by Sanofi Pasteur MSD, the joint venture between MSD and Sanofi Pasteur, and in other countries, including Eastern Europ, 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. Sanofi further said development efforts are underway for a pediatric indication of this new quadrivalent influenza vaccine, for children from 6 months to 9 years of age.
Commenting on the development, Olivier Charmeil, 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."
Additionally, the company filed a supplemental Biologics License Application with the U.S. Food and Drug Administration in October last year, for a quadrivalent formulation of its Fluzone produced at the Sanofi Pasteur facility in Swiftwater, USA. The sBLA file has been accepted by the FDA for full review and an action date is anticipated in the second quarter, said the company.
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