Sanofi Receives FDA Approval for 0.5 mL Dose of Fluzone® Quadrivalent Influenza Vaccine in Children Aged 6–35 Months

January 25, 2019 /BIOON/ -- French pharmaceutical giant Sanofi recently announced that the U.S. Food and Drug Administration (FDA) has approved the use of a 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) for infants and young children aged 6 to 35 months. Sanofi Pasteur, the vaccines division of Sanofi, stated that in addition to the 0.25 mL dose, the 0.5 mL dose will be introduced for this expanded age group during the 2019–2020 influenza season. Fluzone Quadrivalent is an inactivated influenza vaccine indicated for the prevention of influenza in individuals aged ≥6 months. The vaccine provides protection against two influenza A strains and two influenza B strains.

Dr. David P. Greenberg, Medical Director for Sanofi Pasteur in North America, stated, “The convenience of offering the same 0.5 mL dose for children may help simplify immunization efforts. Reports from the 2017–2018 influenza season highlighted the sobering potential threat of influenza, particularly among unvaccinated children. We are committed every day to providing solutions that help meet the ongoing public health needs related to influenza, especially among vulnerable populations such as young children.”

This approval is supported by clinical data from a Phase IV safety and immunogenicity study involving nearly 2,000 pediatric subjects. The study demonstrated that in children aged 6–35 months, the safety profile of one or two 0.5 mL doses of the vaccine was comparable to that of one or two 0.25 mL doses, with no new safety concerns identified and robust immune responses elicited. Detailed results from this study were presented at the Pediatric Academic Societies Meeting in April 2018, as well as at the Advisory Committee on Immunization Practices (ACIP) meeting and the American Academy of Family Physicians’ Family Medicine Experience (FMX) conference in October 2018.

Sanofi Pasteur’s influenza vaccine portfolio includes regimens designed to help protect all eligible patients from influenza infection. In addition to Fluzone Quadrivalent, the portfolio comprises Flublok Quadrivalent (influenza vaccine) and Fluzone High-Dose (influenza vaccine), two influenza vaccines that have been demonstrated in randomized controlled trials to help prevent more influenza cases in older adults compared with standard-dose influenza vaccine products. In these same studies, the most common local and systemic adverse reactions included injection site pain, headache, and myalgia. (Bioon.com)

Original Source:FDA approves use of 0.5 mL dose of Fluzone® Quadrivalent (influenza vaccine) in children as young as 6 months of age