The US FDA will review a supplemental Biologics License Application to expand the age indication of the 0.5 mL dose of Sanofi Pasteur’s Fluzone Quadrivalent influenza vaccine to include children 6-35 months of age. Per the Prescription Drug User Fee Act, the target action date is January 28, 2019. If approved, physicians will be able to reserve the vaccine for young children for the 2019–2020 flu season.
The application is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children. Detailed results from the Phase IV, randomized, observer-blinded, controlled, multicenter study will be presented at medical meetings later this year.
“We are dedicated to helping protect patients of all ages against the flu, which can be especially severe and life threatening for more vulnerable groups such as younger children,” said Dr David P. Greenberg, Associate Vice President and Regional Medical Head of North America, Sanofi Pasteur. “We are one step closer to potentially offering clinicians the option to use 0.5 mL dose of Fluzone Quadrivalent vaccine with all of their eligible pediatric patients 6 months of age and older.”
Fluzone Quadrivalent vaccine is designed to help protect people 6 months of age and older against the four flu viruses that cause the most disease: two influenza A subtypes, A(H1N1) and A(H3N2), and two influenza B lineages, Victoria and Yamagata. A 0.25-mL dose of Fluzone Quadrivalent vaccine is currently approved for use in children 6 through 35 months of age; a 0.5-mL dose is approved for people 36 months of age and older.