The U.S. Food and Drug Administration (FDA) just updated the Warnings and Precautions sections of the Prescribing Information for the Afluria influenza vaccine. The update was made to inform healthcare professionals that the Afluria vaccine has been associated with an increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those children who are less than five years of age.
The FDA announced the approved vaccines for the 2010-2011 influenza season in the United States. The brand names and manufacturers for the upcoming season’s vaccines are:
Afluria, CSL Limited
Agriflu, Novartis Vaccines and Diagnostics
Fluarix, GlaxoSmithKline Biologicals
FluLaval, ID Biomedical Corporation
FluMist, MedImmune Vaccines Inc.
Fluvirin, Novartis Vaccines and Diagnostics Limited
Fluzone and Fluzone High-Dose, Sanofi Pasteur Inc.
Available data suggest that increased rates of fever and febrile seizure are only associated with the Southern Hemisphere formulation of CSLâ€™s vaccine. Available data regarding the safety of other influenza vaccines for children used in the Southern Hemisphere does not suggest an increased rate of fever or febrile seizure.
The FDA is requiring CSL Limited to conduct a study of Afluria in children to obtain additional information regarding the febrile events that were seen in the Southern Hemisphere. CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children; the 0.5 milliliter single-dose, prefilled syringes and 5 milliliter multi-dose vials will be distributed.
Vaccines for the 2010-2011 influenza season are approved by the FDA for the prevention of influenza in children, adolescents, and adults, including the elderly. There are several vaccines approved by FDA available in both nasal spray and injectableâ€”â€œshotâ€â€”forms. Because the influenza viruses that cause people to get sick can change, each year’s vaccine may be different from the previous year, therefore, it is important to get the influenza vaccine every year.
Various investigations into the cause(s) of the febrile seizures seen with Afluria vaccine are still ongoing. The FDA is collaborating with Australiaâ€™s regulatory authority, other international regulatory counterparts, and CSL to obtain additional information, stay apprised of the situation, and take part in the investigations. FDA, in collaboration with the U.S. Centers for Disease Control and Prevention (CDC), will closely monitor the continued safety of all influenza vaccines.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the Vaccine Adverse Events Reporting System (VAERS), which is a national vaccine safety surveillance program co-sponsored by the CDC and the FDA. VAERS can be accessed at: http://vaers.hhs.gov/index.
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