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

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By : dLife Editors

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,” Greenberg said in a statement.

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 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.


  1. FDA approves use of 0.5 mL dose of Fluzone® Quadrivalent (influenza vaccine) in children as young as 6 months of age. (2019, Jan. 23) Retrieved 2019, Jan. 24 from https://www.prnewswire.com/news-releases/fda-approves-use-of-0-5-ml-dose-of-fluzone-quadrivalent-influenza-vaccine-in-children-as-young-as-6-months-of-age-300783151.html