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


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.

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