Sanofi (SNYNF,SNY) said that the U.S. Food and Drug Administration has approved a supplemental Biologics License Application for Fluzone High-Dose Quadrivalent or Influenza Vaccine for use in adults 65 years of age and older.
Fluzone High-Dose was approved by the FDA in 2009 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.
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.
The company noted that the approval is the final step toward the company's complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season.
Sanofi Pasteur noted that it will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.
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