Fluzone Quadrivalent is FDA approved to treat influenza in children falling within the six to 35-month age .-Sanofi Pasteur.
The FDA has approved the 0.5mL dose of its influenza vaccine, Fluzone Quadrivalent, from Sanofi Pasteur, for treating children falling within the six to 35-month age bracket. The 0.5 mL dosage is already approved for use in patients aged three years and above along with the lesser 0.25 mL dose, which is approved for children in the six to 35-month age category.
The approval was based on data from a phase IV safety and immunogenicity study, which evaluated approximately 2,000 children. Data from the program showed that one or two doses of 0.5 mL vaccine in kids had a safety profile, comparable to one or two doses of 0.25 mL vaccine with no new safety concerns observed.
Sanofi�s influenza vaccine portfolio includes Flublok Quadrivalent and Fluzone High-Dose vaccine, approved for adults aged 18 years and older and senior subjects aged 65 years and above, respectively.