After confirming 36 reports of seizures in children who received Fluzone vaccination, U.S. officials said they are investigating if there is any connection between the vaccination and the seizures.
For the investigation, a national reporting system is being used to monitor possible side-effects following the vaccination. All medical practitioners and even vaccine manufacturers can now file their reports.
U.S. Food and Drug Administration spokeswoman Shelly Burgess told CBC that the reporting system is “meant to cast a wide net” to look for problems but is only regarded as preliminary information that must be checked out.
In the confirmed reports, seizures occurred within one day after the children ages 6 months through 2 years were vaccinated with Fluzone. Fluzone, manufactured by Sanofi Pasteur, is the only flu shot recommended in the U.S. for infants and very young children.
Moreover, FDA officials added that they have been paying special attention to seizure reports after an unexplainable higher rate of fevers and seizures in young children in Australia and New Zealand who got a specific flu vaccine earlier this year.
The fever-related seizures, called febrile seizures, are convulsions brought on by a fever in infants or small children. Most seizures last a minute or two wherein the child often loses consciousness and shakes, and often children quickly recover.
Since it is not clear yet whether the seizures are connected to the vaccine or whether they were caused by something else, the FDA’s recommendations for using the vaccine has not changed. Presently, there’s also no change in flu vaccine guidance.
Meanwhile, Sanofi Pasteur, the vaccine’s manufacturer has issued a statement stressing that no clear link has been confirmed between its drug and the seizures and that the reported cases may be coincidental.
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For more blog entries on drug safety, check out our post on the effects of acetaminophen overdose to your liver, the safety of mercury dental fillings, and the safety and reliability of mammograms.
Info source: CBC Canada
