The Food and Drug Administration (FDA) has approved the expanded use of Fluzone Quadrivalent (influenza vaccine; Sanofi Pasteur) 0.5mL to include pediatric patients aged 6 through 35 months. Both the 0.25mL and 0.5mL will be available for the upcoming 2019/20 flu season for this age range.
The approval was based on findings from a Phase 4 safety and immunogenicity study that included ~2000 children. The data showed 1 or 2 doses of 0.5mL vaccine in patients aged 6 through 35 months demonstrated a safety profile similar to 1 or 2 doses of 0.25mL vaccine with no new safety concerns. Additional results were presented at multiple scientific meetings in 2018.
“Offering pediatricians the convenience of the same 0.5mL dose option for children, may help streamline immunization efforts,” said Dr David P. Greenberg, Regional Medical Head North America, Sanofi Pasteur.
Orders for all Sanofi Pasteur vaccines for the 2019/20 season may be placed through Vaccine-Shoppe.com. Other Fluzone vaccines include: Fluzone Intradermal Quadrivalent, Fluzone High-Dose (trivalent), Fluzone Intradermal, and Fluzone (trivalent).
For more information call (800) 822-2463 or visit SanofiPasteur.us.