FDA Asks for Warning on Flu Vaccines About Febrile Seizure Risks in Kids

The U.S. Food and Drug Administration (FDA) wants flu vaccines to carry a warning that the shots can cause febrile seizures in young children.

The agency’s Center for Biologics Evaluation and Research (CBER) last week sent notices to several vaccine makers — including Sanofi, AstraZeneca, GSK and CSL Seqirus — asking them to add the warning.

CBER cited two postmarketing observational studies it conducted, which found that children between the ages of 6 months and 4 years faced a higher risk of febrile seizure in the day following vaccination.

The FDA proposed this wording for the vaccine labels:

“In two separate postmarketing observational studies, an increased risk of febrile seizures was observed during the first day following vaccination with standard dose trivalent (2024-2025) and quadrivalent (2023-2024) influenza vaccines in children 6 months through 4 years of age.”

The warning would be added to the labels of AstraZeneca’s FluMist, GSK’s Fluarix, ID Biomedical’s FluLaval, Sanofi Pasteur’s Fluzone, and Sequiris’ Afluria and Flucelvax vaccines.

The vaccine makers have 30 days to either agree to the proposed label update, propose changes or submit a rebuttal.