Loading ...FDA Asks for Warning on Flu Vaccines About Febrile Seizure Risks in Kids
The FDA’s Center for Biologics Evaluation and Research last month sent notices to several vaccine makers — including Sanofi, AstraZeneca, GSK and CSL Seqirus — asking them to add the warning. The agency cited studies showing an increased risk of febrile seizures in the day following vaccination.
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.