A flu vaccine developed by Sanofi for adults over 65 years has been approved by the US Food and Drug Administration (FDA).
Fluzone High-Dose (Influenza Vaccine) 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, which contains an additional influenza B strain, has been approved this week.
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.
David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur, said: “We have submitted filings with additional regulatory bodies outside the U.S. and anticipate approval in the European Union next spring.”
This approval is the final step toward the company’s complete transition to quadrivalent influenza vaccines in the US.
Fluzone High-Dose Quadrivalent will be made available for immunisation efforts during the 2020-2021 influenza season. Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.
The approval was based on data from a Phase 3 immunogenicity and safety study, in which Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to two trivalent formulations of Fluzone High-Dose, each containing one of the two influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season.
In a secondary endpoint of the trial, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared to the trivalent formulation not containing the corresponding B strain.
Fluzone High-Dose is the first and only influenza vaccine proven to provide superior efficacy compared to Fluzone (Influenza Vaccine) in adults 65 years of age and older, based on results in a randomised controlled trial.