Sanofi has received approval from the US Food and Drug Administration (FDA) for 0.5ml Fluzone Quadrivalent vaccine to treat influenza in children aged between six and 35 months.
Sanofi Pasteur is set to provide both 0.5ml and 0.25ml dose for the expanded age group.
Fluzone Quadrivalent is designed for active immunisation to prevent flu caused by influenza A subtype and type B viruses. The vaccine already holds approval for use beyond this age range.
The latest approval is based on results from a Phase IV clinical trial conducted to assess the safety and immunogenicity of 0.5ml dose in approximately 2,000 children aged 6-35 months.
One or two 0.5ml doses of the vaccine demonstrated a safety profile comparable to one or two doses of 0.25ml. The 0.5ml also did not cause any new safety concerns, and trigged a strong immune response, the company said.
Sanofi Pasteur North America regional medical head David Greenberg said: “Offering paediatricians the convenience of the same 0.5ml dose option for children, may help streamline immunisation efforts.
“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.”
The company’s flu vaccine portfolio also includes Flublok Quadrivalent and Fluzone High-Dose.
Flublok Quadrivalent is indicated for people aged 18 years and older while Fluzone High-Dose vaccine holds approval for use in individuals aged 65 years and above.
The most common adverse reactions to Flublok Quadrivalent and Fluzone High-Dose vaccines were observed to be pain at the injection site, headache and myalgia.