The FDA has approved a label update for Seqirus’s Flucelvax and Flucelvax Quadrivalent to include a warning about febrile seizures in young children.
The new warning applies to children ages 6 months through 4 years old, according to the Flucelvax package insert that was updated March 20. It was added following the FDA’s review of two post marketing observational studies that identified an increased risk of febrile seizures on the day following vaccination with standard-dose influenza vaccines. The agency characterized the association as suggestive of a causal relationship.
Flucelvax, first approved in 2012, is indicated for individuals 6 months and older. It was the first flu vaccine made using cultured animal cells rather than fertilized chicken eggs and received pediatric expansion in 2021.
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