FDA Approves Fluzone Quadrivalent Vaccine For Children 6-35 Months

The US Food and Drug Administration (FDA) has approved the extended use of the Fluzone quadrivalent vaccine to include children age 6 through 35 months, Sanofi Pasteur has announced.

The approval grants authorization of use of the 0.5mL dose of the vaccine in young children. The dose will be available alongside the 0.25 mL dose for the 2019-2020 season for the young children included in this indication.

The approval was granted based on data from a Phase IV safety and immunogenicity study which demonstrated that 1 or 2 doses of 0.5 mL of the vaccine in children 6-35 months of age had a safety profile that was comparable to 1 or 2 doses of 0.25 mL of vaccine.

Additionally, no new safety concerns were observed, and investigators noticed the dose 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.

"Offering pediatricians the convenience of the same 0.5 mL dose option for children, may help streamline immunization efforts," David P. Greenberg, MD, Regional Medical Head North America, Sanofi Pasteur said 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."

In children, the most common side effects to Fluzone Quadrivalent included pain, redness, and swelling at the injection site, as well as muscle aches, fatigue, and headache (irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever in young children). Other adverse reactions to these vaccines may occur, the company reports.

In addition to Fluzone Quadrivalent vaccine, Sanofi produces Flublok Quadrivalent and Fluzone High-Dose.

Flublok Quadrivalent, Fluzone Quadrivalent, and Fluzone High-Dose influenza vaccines are indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B virus(es) contained in each vaccine.

Flublok Quadrivalent vaccine is approved for use in persons 18 years of age and older. Fluzone Quadrivalent vaccine is approved for use in persons 6 months of age and older. Fluzone High-Dose vaccine is approved for use in persons 65 years of age and older.