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OCTOBER 15, 2021

FDA Expands Indication for Flucelvax Quadrivalent to as Young as Children 6 Months Old

By IDSE News Staff

The FDA expanded the indication for a cell-based quadrivalent influenza vaccination (QIVc; Flucelvax Quadrivalent, Seqirus) for children as young as 6 months old.

The expanded age indication is supported by a phase 3 clinical study demonstrating that QIVc was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine (QIV) in children 6 months to younger than 4 years of age during the U.S. 2019-2020 influenza season, according to data presented at the