Update: Recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding use of CSL seasonal influenza vaccine (Afluria) in the United States during 2010-11

Abstract

During the 2010 influenza season in Australia, administration of a 2010 Southern Hemisphere seasonal influenza trivalent inactivated vaccine (TIV) (Fluvax Junior and Fluvax) manufactured by CSL Biotherapies was associated with increased frequency of fever and febrile seizures in children aged 6 months through 4 years. Postmarketing surveillance indicated increased reports of fever in children aged 5-8 years after vaccination with Fluvax compared to previous seasons. An antigenically equivalent 2010-11 Northern Hemisphere seasonal influenza TIV (Afluria) manufactured by CSL Biotherapies is approved by the Food and Drug Administration (FDA) for persons aged >or=6 months in the United States. Prescribing information for the 2010-11 Afluria formulation includes a warning that "Administration of CSL's Southern Hemisphere influenza vaccine has been associated with increased postmarketing reports of fever and febrile seizures in children predominantly below the age of 5 years as compared to previous years". In the United States, annual influenza vaccination is recommended for all persons aged >or=6 months. On August 5, 2010, the Advisory Committee on Immunization Practices (ACIP) recommended that the 2010-11 Afluria vaccine not be administered to children aged 6 months through 8 years. Other age-appropriate, licensed seasonal influenza vaccine formulations should be used for prevention of influenza in these children. If no other age-appropriate, licensed inactivated seasonal influenza vaccine is available for a child aged 5-8 years who has a medical condition that increases their risk for influenza complications, Afluria can be used; however, providers should discuss with the parents or caregivers the benefits and risks of Afluria use before administering this vaccine to children aged 5-8 years.