Posted by Michael Wonder on 24 Jan 2019
FDA approves use of 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) in children as young as 6 months of age
23 January 2019 - The 0.5 mL dose is now approved for use in children 6 months through 35 months of age.
The U.S. FDA has approved the use of the 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Sanofi Pasteur, the vaccine division of Sanofi, will have the 0.5 mL dose, in addition to the 0.25 mL dose, available for the upcoming 2019-20 season for this expanded age range.
Today's approval is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children, which demonstrated that one or two doses of 0.5 mL of vaccine in children 6 through 35 months of age had a safety profile that was comparable to one or two doses of 0.25 mL of vaccine with no new safety concerns observed, and induced a robust immune response. Detailed results were presented at the Pediatric Academic Societies meeting in April 2018, as well as at the Advisory Committee on Immunisation Practices meeting and the American Academy of Family Physicians Family Medicine Experience conference in October 2018.
