FDA approves Sanofi’s flu vaccine in children as young as 6 months

Anthony Vecchione//January 24, 2019//

FDA approves Sanofi’s flu vaccine in children as young as 6 months

Anthony Vecchione//January 24, 2019//

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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 months through 35 months.

Sanofi Pasteur, the vaccine division of Sanofi based in Bridgewater, will have the 0.5 mL dose, in addition to the 0.25 mL dose, available for the upcoming 2019-2020 season.

“Offering pediatricians the convenience of the same 0.5 mL dose option for children, may help streamline immunization efforts,” said Dr. David Greenberg, regional medical head North America, Sanofi Pasteur, in a statement.

“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,” Greenberg said.

Sanofi said that the 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 months 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 from the study 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.

Health care providers can place 2019-2020 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 2019-2020 reservations.