by Michael Nevradakis, Ph.D., Childrens Health Defense:
The U.S. Food and Drug Administration (FDA) wants flu vaccines to carry a warning that the shots can cause febrile seizures in young children.
The agency’s Center for Biologics Evaluation and Research (CBER) last week sent notices to several vaccine makers — including Sanofi, AstraZeneca, GSK and CSL Seqirus — asking them to add the warning.
CBER cited two postmarketing observational studies it conducted, which found that children between the ages of 6 months and 4 years faced a higher risk of febrile seizure in the day following vaccination.
TRUTH LIVES on at https://sgtreport.tv/
The FDA proposed this wording for the vaccine labels:
“In two separate postmarketing observational studies, an increased risk of febrile seizures was observed during the first day following vaccination with standard dose trivalent (2024-2025) and quadrivalent (2023-2024) influenza vaccines in children 6 months through 4 years of age.”
The warning would be added to the labels of AstraZeneca’s FluMist, GSK’s Fluarix, ID Biomedical’s FluLaval, Sanofi Pasteur’s Fluzone, and Sequiris’ Afluria and Flucelvax vaccines.
The vaccine makers have 30 days to either agree to the proposed label update, propose changes or submit a rebuttal.
A spokesperson for Sanofi told Fierce Pharma that febrile seizures have occurred only in a “limited subset of patients” and that the company already includes information about such seizures in Fluzone’s label.
GSK told Fierce Pharma the company is reviewing the FDA’s request and that the company is “confident” in the “safety and efficacy profile” of its flu shots.
‘Any seizure is bad, period’
Febrile seizures are convulsions most often caused by fevers triggered by infections related to common childhood illnesses. The seizures typically occur in children 6 months to 5 years old when they have a fever over 100.4 F.
Most febrile seizures last less than 15 minutes and are not life-threatening. According to Medpage Today, they “do not cause any permanent harm and do not have any lasting effects.”
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense (CHD), disagreed. “Any seizure is bad, period,” he said.
“‘Mild’ febrile seizures can double a child’s chance of an epilepsy diagnosis and ‘complex’ febrile seizures — lasting more than 15 minutes — can increase that risk up to 10 times,” Hooker said.
Read More @ ChildrensHealthDefense.org
