Research & Development
Sanofi to launch FDA approved Fluzone High-Dose Quadrivalent for immunization during 2020-2021 influenza season
5 November 2019 -

Healthcare company Sanofi reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for a supplemental Biologics License Application for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older.

With a launch in autumn 2020 in time for the 2020-2021 flu season, the company stated that the Fluzone High-Dose Quadrivalent is given to people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.

In 2009, Fluzone High-Dose (Influenza Vaccine) was approved by the US FDA as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain, revealed the company.

Following the US FDA approval, this is the final step toward the company's complete transition to quadrivalent influenza vaccines in the US. It will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.

This US FDA approval was based on data from nearly 32,000 adults 65 years of age and older over two influenza seasons in the US and Canada. Fluzone High-Dose prevented 24% more cases of influenza caused by any circulating influenza strain and 51% more cases of influenza caused by strains similar to those contained in the vaccine compared to Fluzone, concluded the company.