FDA approves cell-based flu vaccine for kids as young as 6 months

Seqirus’s FLUCELVAX® cell-based quadrivalent influenza vaccine has been approved to expand the age indication to children as young as 6 months of age by the US Food and Drug Administration.

The US Food and Drug Administration has approved the FLUCELVAX® cell-based quadrivalent influenza vaccine for an expanded age indication for children as young as 6 months of age.1 The vaccine is now indicated for any patient who is eligible to receive an influenza vaccine in the United States.

The approval was based on phase 3 clinical trial data that showed the vaccine was as immunogenic and safe as the standard quadrivalent seasonal influenza vaccine in children 6 months of age to <4 years during the 2019 to 2020 annual influenza season. In the trial 2414 children were randomized to receive either FLUCELVAX® or the standard quadrivalent vaccine. Depending on vaccination history, a child received either 1 or 2 vaccine doses. Following immunization, participants received at least 180 days of follow-up and noninferiority of FLUCELVAX® was determined. The safety of the FLUCELVAX® vaccine was comparable to the standard vaccine and common adverse events included tenderness, irritability, and erythema at the site of injection. Complete data from the clinical trial was presented at the Pediatric Academic Society virtual Annual Meeting earlier in 2021.

Cell-based vaccines are meant to exactly replicate the influenza virus strains chosen by the World Health Organization. Because they avoid egg-adapted changes, they may potentially have greater effectiveness than other vaccine forms.


1. Seqirus. Seqirus receives FDA approval of its cell-based quadrivalent influenza vaccine, expanding the age indication to include children as young as six months. Published 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/