But FDA Says Early Reports of Seizures Does Not Mean Vaccine is Unsafe
By Daniel J. DeNoon, WebMD Health News
Jan. 20, 2011 — The FDA and CDC are investigating reports linking febrile seizure in infants to the Sanofi Fluzone flu vaccine.
The reports come from the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). It’s the early-warning system designed to give the first signal of vaccine safety issues. But a VAERS signal does not necessarily mean that a vaccine is unsafe.
Febrile seizure is relatively common. About one in 25 kids under age 5 will have at least one febrile seizure, usually triggered by illnesses associated with a fever such as an ear infection, a cold, the flu, or measles. Febrile seizures triggered by vaccination are uncommon.
However, reports to the VAERs system by parents and doctors suggest that there have been more febrile seizures than usual among kids getting the Fluzone vaccine. Fluzone is the only vaccine approved for kids ages 6 to 23 months.
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