FDA Investigating Reports of Febrile Seizures with Fluzone Vaccine

Washington, DC: The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have recently detected an increase in the number of reports to Vaccine Adverse Event Reporting System (VAERS), of febrile seizures following vaccination with Fluzone (trivalent inactivated influenza vaccine or TIV, manufactured by Sanofi Pasteur, Inc).

Fluzone is the only influenza vaccine recommended for use for the 2010-2011 flu season in infants and children 6-23 months of age. These reported febrile seizures have primarily been seen in children younger than 2 years of age.

Data from VAERS are preliminary and serve as a sign or indication that further investigation is warranted. Further investigations are under way to assess whether there could be an association between influenza vaccination and febrile seizures, or if other factors could be involved.

FDA and CDC have seen no increase in VAERS reports of febrile seizures in people older than 2 years of age following vaccination with TIV, and no increase after live attenuated influenza vaccine (FluMist, the nasal spray vaccine). In the cases reported, all children recovered and no lasting effects have been seen. Recommendations for the use of flu vaccine in children have not changed.

Information on Febrile Seizures
Febrile means "relating to a fever" or an unusually high body temperature. In some children, having a fever can cause a seizure. Although febrile seizures can be frightening for the child's caregivers, nearly all children who have a febrile seizure recover quickly and have no long term effects. Febrile seizures may occur with any common childhood illnesses that may cause fever, such as ear infections, colds, influenza and other viral infections, and they sometimes happen after vaccination. With regard to influenza infection, one study estimated that seizures occur in 1 percent of children under 5 years of age with laboratory-confirmed influenza and 9 percent of children who are hospitalized due to influenza virus infection

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Published on Jan-21-11