FDA OKs expanded indication for Flucelvax Quadrivalent flu vaccine

Seqirus has received the Food and Drug Administration’s blessing for Flucelvax 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 United States, is now indicated for everyone eligible to receive an influenza vaccine in the United States.

[Read more: Seqirus starts shipping influenza vaccines for 2021-2022 flu season]

“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, Seqirus chief medical officer. “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.”