Sanofi: FDA Approves Use of 0.5 mL Dose of Influenza Vaccine in Children as Young as 6 Months of Age

Originally Published by Sanofi.

The U.S. Food and Drug Administration 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.


“Offering pediatricians the convenience of the same 0.5 mL dose option for children, may help streamline immunization efforts,” said Dr. David P. Greenberg, Regional Medical Head North America, Sanofi Pasteur. “The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering. We commit ourselves every day to bring solutions to help meet ongoing public health needs related to influenza, especially among vulnerable groups such as young children.”

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 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. In these same trials, the most common local and systemic adverse reactions to Flublok Quadrivalent and Fluzone High-Dose vaccines include pain at the injection site, headache and myalgia.

Health care providers can place 2019-20 reservations for all Sanofi Pasteur 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.

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