Fluzone Quadrivalent 0.5mL Receives Expanded Approval
January 23, 2018 – The U.S. FDA has granted an expanded approval to Fluzone® Quadrivalent (influenza vaccine) 0.5mL, manufactured by Sanofi Pasteur. The vaccine may now be used to provide active immunization for patients as young as six months of age to help prevent influenza type A and B infection.
Previously, children six to 35 months of age could only be vaccinated with the 0.25mL dosage strength of Fluzone. Making the 0.5mL dosage strength available for patients in this age group may help streamline the immunization process for physicians, allowing them to stock a single dosage strength to treat a wider range of patients.
Fluzone 0.5mL demonstrated a similar safety profile to Fluzone 0.25mL in clinical studies and stimulated a robust immune response in children ages six to 35 months. The recommended vaccination schedule is determined based on patient age and vaccination history.
Although physicians may now use the 0.5mL dosage strength for patients as young as six months of age, the 0.25mL strength will remain available for the 2019-2020 flu season.