FDA Approves Cell-Based Flu Vaccine for Children as Young as 6 Months

The US Food and Drug Administration (FDA) has approved Seqirus’ quadrivalent influenza vaccine (FLUCELVAX QUADRIVALENT) for an expanded indication in children as young as 6 months old.

The indication now makes the vaccine the first cell-based vaccine available for every patient age eligible for flu vaccination in the US.

Seqirus’ application for expanded age indication was supported by phase 3 data published earlier this year demonstrating the cell-based vaccine matched the safety and immunogenicity of standard quadrivalent seasonal flu vaccine in US children aged 6 months to <4 years old during the 2019-20 influenza season.

Cell-based vaccines such as FLUCELVAX are considered to have greater likelihood of vaccine effectiveness due to their design, which produces an exact match to World Health Organization (WHO)-selected flu virus strains without risk of strain mutation during manufacturing—such as with standard egg-based vaccines.

Seqirus remains committed to the delivery of “safe and effective vaccines to as many eligible people as possible,” Gregg Sylvester, MD, Chief Medical Officer at Seqirus, said in a statement.

“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,” Sylvester said. “Therefore, it is critical that all eligible people receive their annual flu vaccine.”

As Seqirus noted, children aged 6 months to 5 years old could be at greater risk of flu-related complications due to lack of prior immunity; approximately 50,000 hospitalizations and 486 deaths during the 2019-20 flu season occurred in US children younger than 18 years old.