FDA Approves First Cell-Based Influenza Vaccine for Everyone Aged 6 Months or Older
The US Food and Drug Administration has approved the Flucelvax® Quadrivalent influenza vaccine for individuals as young as 6 months. It is the first and only cell-based quadrivalent influenza vaccine in the United States and is an alternative for individuals allergic to the egg-based vaccines.
Approval comes after the results of a phase 3 clinical trial showed that Flucelvax® Quadrivalent was as safe and immunogenic as a standard quadrivalent seasonal influenza vaccine in children aged 6 months to younger than 4 years during the US 2019-2020 influenza 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.”
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 December 2, 2021. https://www.multivu.com/players/English/8933751-seqirus-fda-approval-of-cell-based-quadrivalent-influenza-vaccine-for-people-six-months-and-older/