Biopharmaceutical company Sanofi revealed on Wednesday the receipt of approval from the US Food and Drug Administration for the use of the 0.5 ml dose of Fluzone Quadrivalent (influenza vaccine) to include children age six through 35 months for the upcoming 2019-20 season for this expanded age range.

The company's 0.5 ml dose is in addition to the 0.25 ml dose to help meet ongoing public health needs related to influenza, especially among vulnerable young children. The 0.5 ml dose is now approved for use in children six months through 35 months of age.

This US FDA's approval is supported by clinical data from the company's 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 six through 35 months of age had a safety profile, which 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.

Additionally, the health care providers can place 2019-20 reservations for all the company's vaccines, including the 0.5 ml presentations of Fluzone Quadrivalent vaccine for use in all appropriate pediatric patients via www.VaccineShoppe.com. The 0.25 ml dose of Fluzone Quadrivalent vaccine will remain available for 2019-20 reservations.

In conjunction, the detailed of the Phase IV safety results were presented by the company at the Pediatric Academic Societies meeting in April 2018, as well as at the Advisory Committee on Immunization Practices meeting and the American Academy of Family Physicians Family Medicine Experience conference in October 2018.