First Quadrivalent Intradermal Flu Vaccine Approved

Sanofi announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Fluzone Intradermal Quadrivalent vaccine for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses. Fluzone Intradermal Quadrivalent vaccine is indicated for adults aged 18–64.

The approval of Fluzone Intradermal Quadrivalent vaccine was based on data from a Phase 3 study of adults that compared this vaccine to two trivalent intradermal controls (n=3,355). Study results showed that antibody responses to all four strains in the Fluzone Intradermal Quadrivalent vaccine were non-inferior to those following the trivalent vaccine controls. The systemic safety profile of Fluzone Intradermal Quadrivalent vaccine was similar to that demonstrated with the Fluzone Intradermal vaccine.

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Fluzone Intradermal vaccine is currently available as a trivalent inactivated influenza vaccine. The new quadrivalent vaccine will be available during the 2015–2016 season.

For more information call (800) 822-2463 or visit Fluzone.com.

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