Fluzone High-Dose Quadrivalent Receives FDA Approval

The FDA has approved a supplemental Biologics License Application for an influenza vaccine (Fluzone High-Dose Quadrivalent, Sanofi) for use in adult patients 65 years and older. The vaccinations will be available in fall 2020, in time for the 2020-2021 flu season.

The FDA approval was based on data from a phase 3 immunogenicity and safety study in which the influenza vaccine achieved the primary endpoint of non-inferior immunogenicity compared with 2 trivalent formulations of the vaccination, each containing 1 of the 2 influenza B strains recommended for the inclusion of the vaccine for the 2017-2018 influenza season.

In the secondary endpoint of the trial, each B strain in the influenza vaccination induced a superior immune response compared with the trivalent formulation not containing the corresponding B strain.

The rates of local and systematic reactions that occurred following immunization with the influenza vaccination were similar to those induced by trivalent formulations. The most common adverse events included injection-site pain (41.3%), myalgia (22.7%), headache (14.4%), and malaise (13.2%). Onset usually occurred within the first 3 days after vaccination and the majority of solicited events were resolved in those 3 days.

The findings of the phase 3 trial were published in Vaccine in September 2019.

According to the company press release, the approval is the first step toward the company’s complete transition to quadrivalent influenza vaccines in the United States. The vaccination will be available for immunization efforts for the 2020-2021 influenza season.

Results from a previously randomized controlled trial evaluating nearly 32,000 adults 65 years of age and older over 2 influenza seasons in the United States found that the vaccine prevented 24% more cases of influenza caused by any circulating influenza strain. Furthermore, 51% more cases of influenza caused by strains similar to those contained in the vaccine compared with the standard dose vaccine.

Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.

Reference

• FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older [press release]. Sanofi website. Published November 4, 2019. http://www.news.sanofi.us/2019-11-04-FDA-approves-Fluzone-R-High-Dose-Quadrivalent-Influenza-Vaccine-for-adults-65-years-of-age-and-older. Accessed November 5, 2019.