Global Vaccine Safety

Statement on Fluzone and febrile seizures

24 January 2011

The U.S. Food and Drug Administration and Centers for Disease Control and Prevention have recently detected an increase in the number of reports to the Vaccine Adverse Event Reporting System (VAERS) of febrile seizures following vaccination with the trivalent inactivated influenza vaccine, Fluzone. The reported febrile seizures have mainly been seen in children younger than 2 years of age.

GACVS has been informed about this finding and notes that in the cases reported, all children recovered with no lasting effects seen. It is also noted that no increase in VAERS reports of febrile seizures in people older than 2 years of age has been detected.

Based on the information presented, GACVS concurs that further investigation is needed to clarify the nature and magnitude of any increased risk, but on the basis of the data currently available does not recommend any change to the WHO recommendations for the use of seasonal influenza vaccine ( GACVS will continue reviewing data related to these reports as they become available.