The labeling for one vaccine, CSL Limited's Afluria, has undergone changes this season to inform health care providers about an increased incidence of fever and febrile seizure, which was seen in young children, mainly those younger than 5 years, following administration of the 2010 Southern Hemisphere formulation of CSL's influenza vaccine. The Southern Hemisphere influenza season occurs prior to that of the Northern 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.
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.
The Centers for Disease Control and Prevention has published recommendations for annual influenza vaccination to include all people aged 6 months and older. The expanded recommendation is to take effect in the 2010-2011 influenza season. The Advisory Committee on Immunization Practices (ACIP), which advises the CDC on vaccine issues, voted on the new recommendation during its February 24, 2010 meeting in Atlanta. Prior recommendations for seasonal influenza vaccination focused on vaccination of persons at increased risk for complications from influenza including people with underlying health conditions, children 6 months through 18 years of age, and close contacts of high risk persons among others. The new recommendations can be found at cdc/mmwr/preview/mmwrhtml/rr59e0729a1.htm.
For more information:
FDA Web Page on Influenza Vaccine Safety & Availability
fda/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm110288.htm
FDA List of Strains Included in the 2010-2011 Influenza Vaccine
fda/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Post-MarketActivities/LotReleases/ucm202750.htm
U.S. Centers for Disease Control and Prevention Web Page on Seasonal Influenza
cdc/flu/
SOURCE U.S. Food and Drug Administration