Licensure of a High-Dose Inactivated Influenza Vaccine for Persons Aged ≥65 Years (Fluzone High-Dose) and Guidance for Use

Persons aged ≥65 years are at greater risk for hospitalization and death from seasonal influenza compared with other age groups (1,2), and they respond to vaccination with lower antibody titers to influenza hemagglutinin (an established correlate of protection against influenza) compared with younger adults (3). On December 23, 2009, the Food and Drug Administration (FDA) licensed an injectable inactivated trivalent influenza vaccine (Fluzone High-Dose, Sanofi-Pasteur) that contains an increased amount of influenza virus hemagglutinin antigen compared with other inactivated influenza vaccines such as Fluzone. Fluzone High-Dose is licensed as a single dose for use among persons aged ≥65 years and will be available beginning with the 2010--11 influenza season. The Advisory Committee on Immunization Practices (ACIP) reviewed data from prelicensure clinical trials on the safety and immunogenicity of Fluzone High-Dose and expressed no preference for the new vaccine over other inactivated trivalent influenza vaccines (4). This report summarizes the FDA-approved indications for Fluzone High-Dose and provides guidance from ACIP for its use.