By NewsDesk @bactiman63
Seqirus announced Friday that the U.S. Food and Drug Administration (FDA) has 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.”
FLUCELVAX QUADRIVALENT utilizes a cell-based influenza vaccine manufacturing process, an alternative to traditional egg-based manufacturing. Traditional egg-based vaccine production can cause the strain to mutate at several steps throughout the manufacturing process, which may lead to an antigenic mismatch between the circulating strains and the inactivated influenza strains contained within the seasonal influenza vaccine.
Cell-based influenza vaccines are designed to produce an exact match to WHO-selected influenza virus strains by avoiding egg-adapted changes, and therefore may have the potential for greater vaccine effectiveness. Cell-based influenza vaccine technology may offer additional advantages over the standard influenza manufacturing process, including increased scalability and production speed in the event of an influenza pandemic.
“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.”
Children younger than five years old, particularly those younger than two, are at increased risk of developing serious influenza-related complications, including pneumonia, brain dysfunction and in rare cases, even death. Children six months to five years of age who are otherwise healthy are at a high risk of influenza-related complications simply due to their lack of prior immunity. According to the U.S. Centers for Disease Control and Prevention (CDC), it is estimated that nearly 50,000 hospitalizations occurred in children younger than 18 years of age during the 2019/20 U.S. influenza season, and there were approximately over 486 influenza-related deaths in this age group. The CDC recommends everyone six months of age and older without contraindications receive an influenza vaccine annually as the best way to prevent influenza.
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