FDA expands approval of cell-based flu vaccine down to age 6 months

The FDA expanded the age indication of the only cell-based inactivated influenza vaccine approved for use in the United States to include children as young as age 6 months, the vaccine’s manufacturer announced Friday.

The expanded age indication means that Flucelvax Quadrivalent (IIV4c, Seqirus) is available as an alternative to traditional egg-based vaccines for anyone in the U.S. who is eligible to receive an influenza vaccine. Previously, the vaccine was available for people as young as age 2 years.

“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,” Dave Ross, vice president of North America commercial operations at Seqirus, said in a news release.

IIV4c remains the only cell-based influenza vaccine approved for use in the U.S. A study published in The New England Journal of Medicine just this week demonstrated its effectiveness among children during three recent influenza seasons.

Friday’s FDA approval was supported by positive phase 3 data presented earlier this year that showed the vaccine performed well in children aged 6 to 47 months.

Most influenza vaccines — including approximately 82% of this year’s U.S. supply — are still manufactured using egg-based technology. These vaccines prevent disease, but their effectiveness can be negatively impacted by adaptations resulting from the production method.

Reference:

Nolan T, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2024848.