A recent FDA study found no statistical connection between a specific flu vaccine and an increased number of febrile seizures during the 2010-2011 influenza season.
The FDA initiated the study through its Mini-Sentinel Postlicensure Rapid Immunization Safety Monitoring program after recording a higher amount of fever-related seizures than average among patients who were treated with the Fluzone vaccine, manufactured by French pharmaceutical company Sanofi Pasteur, Inc.
The study examined 842,325 children who met specific criteria and had accurate vaccination records from the 2010-2011 flu season. Of those in the study, only 68 cases of febrile seizures were recorded within 20 days of receiving flu vaccines, including Fluzone.
The FDA did not recommend any changes to the administration of Fluzone as a result of the study. Fluzone is the most widely-used flu vaccine in the U.S.
The risk of influenza is increased for young children, with nine out of 10,000 children between 6-24 months of age requiring hospitalization each flu season in the U.S.
Febrile seizures can occur with many childhood illnesses that cause fever, including ear infections, influenza and other viruses. Approximately 4 percent of all children will have a febrile seizure in their lifetime, and most of them fully recover.
Sanofi Pasteur offers 20 vaccines for a range of infectious diseases.