FDA Approves Cell-Based Quadrivalent Influenza Vaccine Including Children at Six Months
New Jersey-based Seqirus announced that the U.S. Food and Drug Administration (FDA) had 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 FDA 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.
A Phase 3 clinical study supported the expanded age indication demonstrating that FLUCELVAX QUADRIVALENT was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine 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 virtual Annual Meeting on May 1, 2021, represent the first U.S. Phase 3 study of a cell-based influenza vaccine in this population.
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," stated Gregg Sylvester, MD, Chief Medical Officer at Seqirus, in a press release.
"And while we can never predict how each influenza season will unfold, we could 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, mainly 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.
The CDC recommends everyone six months of age and older without contraindications receive an influenza vaccine annually as the best way to prevent influenza.
In the U.S., Seqirus operates a state-of-the-art cell-based manufacturing facility in North Carolina, purpose-built in partnership with the Biomedical Advanced Research and Development Authority, a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, to increase cell-based vaccine manufacturing capacity and combat pandemic influenza threats.