Seqirus, a global leader in influenza prevention, and a business of CSL Limited (ASX: CSL), announced that the FDA approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), 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 (QIV) in children six months to <four years of age during the U.S. 2019/20 influenza season. These data, presented at the Pediatric Academic Society (PAS) virtual Annual Meeting on May 1, 2021, represent the first U.S. Phase 3 study of a cell-based influenza vaccine in this population.
"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."
"Throughout our company's long history as a leader in influenza prevention, we have remained committed to delivering safe and effective vaccines to as many eligible people as possible," said Gregg Sylvester, MD, Chief Medical Officer at Seqirus. "And while we can never predict how each influenza season will unfold, we could possibly be faced with unique challenges and increased cases this upcoming season as COVID-19 mitigation tactics relax. Therefore, it is critical that all eligible people receive their annual flu vaccine."
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