FDA Approves Fluzone Quadrivalent .5 mL for Children 6-35 Months


This expands the indication of the flu vaccine’s .5 mL dose to this younger age group.


The US Food and Drug Administration (FDA) has approved the use of the .5 mL dose of Fluzone Quadrivalent, an influenza vaccine, for children 6-35 months of age.

Previously, a .25 mL dose of Fluzone Quadrivalent was approved for children 6-35 months of age, while the .5 mL dose was approved for adults and children 36 months of age and older.

"Offering pediatricians the convenience of the same .5 mL dose option for children may help streamline immunization efforts," said David P. Greenberg, MD, Regional Medical Head North America, Sanofi Pasteur, in a statement.

The Fluzone Quadrivalent vaccine was originally approved by the FDA in 2013. The FDA approved a supplemental Biologics Licensing Application for the expanded indication of the .5 mL dose in April 2018.

The FDA’s decision to approve was supported by results from a phase 4 safety and immunogenicity study. The study included 1950 healthy participants aged 6 to 35 months. The study found that the safety profile of 1 or 2 doses of .5 mL of vaccine was comparable to 1 or 2 doses of .25 mL of the vaccine.

The most common adverse injection site reactions reported in children 6-35 months of age (≥10%) were pain (57%) or tenderness (47%—54%), erythema (23%–37%), and swelling (13%–22%). The most common systemic adverse reactions reported were irritability (47%– 54%), abnormal crying (33%–41%), malaise (38%), drowsiness (31%– 38%), appetite loss (27%–32%), myalgia (27%), vomiting (10%–15%), and fever (11%–14%).

"The potentially life-threatening effects of influenza in children reported during the 2017-18 season, especially among those who were not vaccinated, is sobering,” said Greenberg. “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."

The company intends to have both the .5 mL and .25 mL doses of Fluzone Quadrivalent available for the 2019-2020 flu season.

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