FDA to Review Fluzone Quadrivalent 0.5mL Dose for Younger Patients

The supplemental Biologics License Application (sBLA) to expand the age indication of Fluzone Quadrivalent 0.5mL dose (Influenza Vaccine; Sanofi Pasteur) to include children aged 6 to 35 months has been accepted by the Food and Drug Administration (FDA). The currently approved dose for this age group is 0.25mL, with the 0.5mL only approved for those ≥3 years.

The sBLA included clinical data from a Phase 4 study that enrolled nearly 2000 children and assessed the safety and immunogenicity of the 0.5mL dose. The results from the trial will be presented at medical meetings later this year.

“We are one step closer to potentially offering clinicians the option to use 0.5mL dose of Fluzone Quadrivalent vaccine with all of their eligible pediatric patients 6 months of age and older,” said Dr. David P. Greenberg, Associate VP and Regional Medical Head of North America, Sanofi Pasteur.

The FDA has set a Prescription Drug User Fee Act target action date of January 28, 2019. If approved, healthcare professionals will be able to use the 0.5mL dose of Fluzone Quadrivalent vaccine for children as young as 6 months for the 2019-2020 influenza season.

For more information visit Sanofi.us.