Fluzone Quadrivalent 0.5 mL Dose Approval Submitted for Children 6-35 months

FDA application to expand the indication of the 0.5 mL dose of Fluzone Quadrivalent to include children 6 through 35 months of age
toddler sitting on ground with Teddy bear

The seasonal flu is a serious risk for infants and young children, says the Centers for Disease Control and Prevention (CDC).

The CDC continues to recommended for persons 6 months of age and older the annual influenza vaccination.

A previous CDC study shows just how vulnerable U.S. children are to the flu each year.

This study’s results showed that half of child flu-related deaths occurred in otherwise healthy children, 22% of whom were fully vaccinated.

To address this serious health issue, the U.S. Food and Drug Administration (FDA) continues to evaluate additional flu vaccines.

The FDA just accepted for review a supplemental Biologics License Application to expand the age indication of the 0.5 mL dose of Fluzone® Quadrivalent to include children 6 through 35 months of age.

"If this dose increase is approved by the FDA, it will provide children 6-35 months old with more protection against the flu, hopefully lessening the burden the illness can cause on this patient population,” said Alexandria Duffield, Pharm.D. MTM Clinical Pharmacist at Brookshire Grocery Company.

If this Fluzone request is approved, it would become available for the 2019–2020 flu season.Fluzone Quadrivalent influenza vaccine is designed to help protect people 6 months of age and older against the four flu viruses that cause the most disease:

  • two influenza A subtypes, A(H1N1) and A(H3N2), and
  • two influenza B lineages, Victoria and Yamagata.

A 0.25-mL dose of Fluzone Quadrivalent vaccine is currently approved for use in children 6 through 35 months of age; a 0.5-mL dose is approved for people 36 months of age and older.

This FDA application is supported by clinical data from a Phase IV randomized, observer-blinded, controlled, multicenter, safety and immunogenicity study conducted in nearly 2,000 children.

Dr. David P. Greenberg, Associate Vice President and Regional Medical Head of North America, Sanofi Pasteur said, "We are one step closer to potentially offering clinicians the option to use 0.5 mL dose of Fluzone Quadrivalent vaccine with all of their eligible pediatric patients 6 months of age and older."

According to Sanofi, Fluzone Quadrivalent vaccine should not be administered to anyone who has had a severe allergic reaction to any vaccine component, including egg protein or thimerosal, or to a previous dose of any influenza vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent vaccine should be based on careful consideration by a healthcare provider of the potential benefits and risks.

Most pharmacies offer flu shot services for adults, and pediatrics generally administer vaccines for infants.

The CDC Vaccine Price List provides the private sector prices for general information.

Flu vaccine discounts can be found here.

Vaccines, like any medicine, can have side effects, says the CDC. You are encouraged to report negative side effects of vaccines to the FDA or CDC.

Providers can find CDC distributed flu shot information at this link