Sanofi Pasteur has received approval from US Food and Drug Administration (FDA) for its Fluzone Intradermal Quadrivalent vaccine.
The vaccine will provide protection against four strains of influenza virus.
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The FDA approved the vaccine’s supplemental biologics license application (sBLA) for adults aged 18-64 for active immunisation to prevent influenza, caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Sanofi Pasteur US scientific and medical affairs vice-president David Greenberg said: "Influenza B is a common cause of influenza-related morbidity and mortality across all age groups.
"Fluzone Intradermal Quadrivalent vaccine will offer another influenza vaccination option for health care providers and their adult patients with broad coverage against influenza viruses that may be predominant, coupled with the efficiency of using the intradermal microinjection system."
Approval for the vaccine was based on results from a Phase III clinical trial, which comprised 3,355 adults.
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By GlobalDataThe trial included B strains from both lineages, to two trivalent intradermal controls and licensed trivalent Fluzone Intradermal vaccine containing a B strain of one lineage and an investigational intradermal vaccine that contained a B strain from the opposite lineage.
According to the company, the study showed the vaccine can improve vaccine effectiveness by generating immune responses to influenza strains from both B lineages simultaneously.
Sanofi Pasteur plans to introduce the vaccine in the US during 2015-2016 influenza season. Fluzone Intradermal vaccine was previously available in trivalent formulation for three years.
Image: Image of newly identified H1N1 influenza virus, taken in Centers for Disease Control and Prevention (CDC) Influenza. Photo: courtesy of Svajcr.
