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

If this indication is approved, physicians will be able to reserve the vaccine for young children to protect them against the 2019-2020 flu season.

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

The target action date is January 28, 2019, per the Prescription Drug User Fee Act.

“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.

This especially hits home as the United States begins to recover from a particularly harsh flu season, where many pediatric flu deaths had been reported. A total of 156 flu-related pediatric deaths have been reported for the 2017-2018 season, 5 of them having been reported to the Centers for Disease Control and Prevention during week 15. If this indication is approved, physicians will be able to reserve the vaccine for young children to protect them against the 2019-2020 flu season.

The application is backed by clinical data from a phase 4 safety and immunogenicity study that had been conducted in nearly 2000 children; according to Sanofi Pasteur, data pertaining to this study will be presented at several medical meetings this year.

The vaccine was developed 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 who has ever experienced a severe allergic reaction to eggs or egg products or after receiving any flu 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).

A previous version of this article was published on MDMagazine.com.