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Health officials note increase in febrile seizures after flu vaccine
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Officials with the FDA and the CDC noted an increase in reports of febrile seizures among young children who received the trivalent inactivated influenza vaccine made by Sanofi Pasteur, Fluzone.
Fluzone is the only vaccine approved for use this influenza season among infants and children from 6 to 23 months of age, according to a statement issued by the FDA. Both health agencies are working together to investigate whether the reports are related to the vaccine or other factors.
“The FDA and CDC have seen no increase in [Vaccine Adverse Event Reporting System] 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, MedImmune),” FDA officials noted in their statement. “In the cases reported, all children recovered and no lasting effects have been seen.”
The reports were submitted to the Vaccine Adverse Event Reporting System (VAERS), which is a surveillance system for vaccine adverse events that is routinely monitored by the FDA and the CDC.
The FDA officials emphasized in their statement that the recommendation for vaccinating children against influenza remains unchanged.
Earlier this year, the CDC recommended against routine use of Afluria (CSL Biotherapeutics), for children 6 months to 8 years of age. This was due to increased reports of post-vaccination fever and febrile seizure occurrence in children 6 months to 8 years who received an antigenically equivalent product during the influenza season in Australia and New Zealand. Rates of fever and febrile seizures occurred in these children at a rate ninefold greater than expected after receipt of an antigenically similar vaccine used in these countries.
Officials from Sanofi Pasteur wrote in a statement to Infectious Diseases in Children: "We closely investigate all adverse event reports we receive and continuously monitor our safety database. Reporting rates of febrile seizure after administration of our influenza vaccine have been stable for years even as distribution of the pediatric formulation has increased. [We] are working closely with FDA in the investigation of these events and will thoroughly assess all cases of febrile seizure and any other adverse experiences reported following administration of our vaccine. "
Sanofi officials added that febrile seizures are fairly commin in children, with about 2% to 5% of all children between the ages of 6 months and 5 years reporting at least one seizure.
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