FDA Approves Cell-Based Quadrivalent Influenza Vaccine, Expands Age Indication to 6 Months and Older
The approval marks the first and only cell-based influenza vaccine approved in the United States.
The cell-based quadrivalent influenza vaccine from Seqirus has been granted FDA approval as well as an expanded age indication for children as young as 6 months old, in accordance with universal age recommendations for all eligible individuals 6 months of age and older to receive annual influenza vaccination.
According to a Seqirus press release, this decision also marks the first and only cell-based influenza vaccine approved in the United States. These vaccines are designed to produce a precise match to the influenza virus strains selected by the World Health Organization.
The expanded age indication is supported by a phase 3 clinical study that found the vaccine is safe and immunogenic as a standard quadrivalent seasonal influenza vaccine in children 6 months to less than 4 years of age during the 2019 and 2020 influenza season. These findings were presented at the Pediatric Academic Society virtual annual meeting in May.
“The Flucelvax Quadrivalent expanded age indication for children as young as 6 months of age now allows all eligible people to receive a differentiated influenza vaccine option,” said Dave Ross, vice president of North America Commercial Operations at Seqirus, in the press release.
The vaccine uses a cell-based influenza vaccine manufacturing process, which is an alternative to egg-based manufacturing. Traditional processes can cause the strain to mutate throughout the manufacturing process, making it less effective against circulating strains.
Cell-based influenza vaccines, on the other hand, are designed to produce an exact match by avoiding egg-adapted changes. According to Seqirus, this technology could offer additional advantages over the standard influenza manufacturing process, including increased scalability and production speed in the event of an influenza pandemic.
“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,” said Gregg Sylvester, MD, chief medical officer at Seqirus, in the press release. “Therefore, it is critical that all eligible people receive their annual flu vaccine.”
Importantly, children younger than 5 years of age and particularly those younger than 2 are at an increased risk of developing serious influenza-related complications, including pneumonia, brain dysfunction, and death. This susceptibility is largely due to young children’s lack of prior immunity. Because of these concerns, the CDC recommends that all individuals 6 months of age and older without contraindications receive an influenza vaccine annually to prevent influenza.
Seqirus Receives FDA Approval of its Cell-Based Quadrivalent Influenza Vaccine, Expanding the Age Indication to Include Children as Young as Six Months. News release. Seqirus; October 15, 2021. Accessed October 18, 2021. https://www.multivu.com/players/English/8933751-seqirus-fda-approval-of-cell-based-quadrivalent-influenza-vaccine-for-people-six-months-and-older/