FDA Accepts Supplemental Biologics License Application for .5 mL Influenza Vaccine in Children 6-35 Months

The US Food and Drug Administration accepted for review a supplemental Biologics License Application to expand the indication of the 0.5 mL dose of the influenza vaccine (Fluzone Quadrivalent) to include children 6 through 35 months of age, announced Sanofi Pasteur.

As per the Prescription Drug User Fee Act, the target action date is January 28, 2019, and if this new indication is approved, physicians will be able to reserve the vaccine for young children for the 2019—2020 flu season.

“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,” David Greenberg, MD, associate vice president and regional medical head of North American, Sanofi Pasteur, said in a statement.

The application is backed by clinical data from a phase 4 safety and immunogenicity study that was conducted in nearly 2000 children.

Details from the phase 4 study will be presented at medical meetings later this year.

The vaccine is designed to protect those 6 months of age and older against 4 flu viruses: 2 influenza subtypes, A(H1N1) and A(H3N2) and 2 influenza B lineages, Victoria and Yamagata.

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

Fluzone Quadrivalent should not be administered to anyone with a severe allergic reaction to any vaccine component including egg protein or thimerosal, or to a previous dose of an influenza vaccine.

The most common adverse effects include pain at injection site (all ages) and erythema and swelling at the injection site (children). Common systemic reactions include myalgia, malaise and headache (irritability, abnormal crying, drowsiness, appetite loss, vomiting and fever in young children).