Seqirus, a business of CSL Limited (CSL.AX), Friday announced that the U.S. Food and Drug Administration approved Flucelvax Quadrivalent, the company's cell-based quadrivalent influenza vaccine, for an expanded age indication for children as young as six months old.
With this approval, Flucelvax Quadrivalent, the first and only cell-based influenza vaccine in the U.S., is now indicated for everyone eligible to receive an influenza vaccine in the U.S.
The expanded age indication is supported by a Phase 3 clinical study demonstrating that Flucelvax Quadrivalent was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine in children six months to
"As one of the world's largest influenza vaccine manufacturers, we continually seek to apply new technologies and evolve our vaccine portfolio to help address challenges associated with seasonal influenza vaccine effectiveness," said Dave Ross, Vice President, North America Commercial Operations at Seqirus. "The FLUCELVAX QUADRIVALENT expanded age indication for children as young as six months of age now allows all eligible people to receive a differentiated influenza vaccine option."
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