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27 Jan 2019

US FDA approval of 0.5 ml dose of Sanofi’s Fluzone Quadrivalent in children as young as 6 months of age

The US Food and Drug Administration (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.

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 Immunization Practices meeting and the American Academy of Family Physicians Family Medicine Experience conference in October 2018

Sanofi Pasteur’s flu vaccine portfolio includes options to help protect all eligible patients from influenza. In addition to Fluzone Quadrivalent vaccine, the product portfolio includes Flublok Quadrivalent (influenza vaccine) and Fluzone High-Dose (influenza vaccine), the only two flu vaccines proven to help prevent more cases of flu in older adults, compared to their standard-dose flu vaccine comparators in randomized controlled trials. 

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