Sanofi Pasteur, the vaccines division of Sanofi, announced today that its quadrivalent influenza vaccine VaxigripTetra™ obtained a positive end of procedure from the German Reference Member State Paul Ehrlich Institute, as a conclusion of the European Decentralized Procedure. Marketing Authorizations can now be issued in the Reference Member State (Germany) and each of the Concerned Member States involved in this procedure. VaxigripTetra™ is a four-strain influenza vaccine, containing two A strains (A/H1N1 and A/H3N2) and two B strains (B/Victoria and B/Yamagata), for use in individuals aged 36 months or older. VaxigripTetra™ is the newest addition to the Vaxigrip® family of influenza vaccines.

generic influenza virion
3D influenza/CDC

Currently, the majority of seasonal influenza vaccines are trivalent meaning that they protect against three strains: two A strains and a single B strain (B/Victoria or B/Yamagata). However, two distinct influenza B strains (B/Victoria and B/Yamagata) now co-circulate worldwide in varying and unpredictable proportions. In recent years, influenza B viruses represented around 23% of the circulating strains around the world. These proportions can be as high as 90% during some seasons and are therefore an important cause of influenza disease. Given this current virological situation with the co-circulation of the two B strains, influenza vaccines need to be adapted and to fit with the current virological situation to ensure broader level of protection. Because trivalent influenza vaccines only contain one B strain, this co-circulation makes the selection of the right strains to be included in the seasonal vaccine very difficult to predict. As an example in Europe in 2015 92% of the documented B influenza cases were caused by the B/Victoria strain not included in the vaccine. Adding the second B strain to VaxigripTetra™ will address the unpredictability issue.

For over 60 years the expertise of Sanofi Pasteur has been committed to providing new immunization solutions for the prevention of influenza to better protect lives and help healthcare providers meet the specific immunization needs of all types of their patients. This new quadrivalent influenza vaccine, which includes both co-circulating B strains, completes our long line of Vaxigrip® family vaccines dedicated to fighting influenza infections and its complications. Once launched in Europe VaxigripTetra™ will offer broader protection for people from 36 months and older and support our public health ambition to constantly innovate to save lives worldwide said David Loew, Executive Vice President Sanofi Pasteur.

The World Health Organization includes quadrivalent influenza vaccines in its recommendations, statingQuadrivalent influenza vaccines that could potentially provide wider protection against influenza B viruses are becoming available and recommendations should not be limited to trivalent vaccine. 

From a public health perspective, using quadrivalent rather than trivalent influenza vaccines could have resulted in a further reduction of up to 1.6 million influenza cases, 37,300 influenza-related hospitalizations and 14,800 influenza-related deaths in the EU over a decade.

Sanofi Pasteur supports influenza immunization policies and is committed to developing vaccine solutions that fit with the influenza epidemiology. VaxigripTetra™ is the newest formulation designed by Sanofi Pasteur, offering a quadrivalent influenza vaccine. VaxigripTetra™ includes two A strains and two B strains to help provide broader protection for all age groups as of 36 months. Sanofi Pasteur intends to progressively switch all its trivalent influenza vaccines to quadrivalent influenza vaccines worldwide.