FDA approves sNDA for Fluzone Quadrivalent for influenza.- Sanofi

The FDA has approved a supplemental Biologics License Application for Fluzone High-Dose Quadrivalent (Influenza Vaccine), from Sanofi, for use in adults 65 years of age and older. 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 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. This 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 will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.

FDA approval was based on data from a Phase III 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.

Rates of local and systemic reactions that occurred following immunization with Fluzone High-Dose Quadrivalent were similar to those induced by trivalent formulations of Fluzone High-Dose. The most common reactions occurring after administration were injection-site pain (41.3 percent), myalgia (22.7 percent), headache (14.4 percent), and malaise (13.2 percent). Onset usually occurred within the first three days after vaccination, and the majority of solicited reactions were resolved within three days of vaccination. Results from the study were published in Vaccine in September 2019.