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FDA Approves New Influenza Vaccine Designed Specifically for Older Adults NEW YORK -- December 23, 2009 -- The US Food and Drug Administration (FDA) has approved a high-dose influenza vaccine (FluzoneR High-Dose) for adults aged 65 years and older for the upcoming 2010-2011 influenza season. The high-dose vaccine is an inactivated vaccine indicated for active immunization caused by influenza virus subtypes A and type B. The vaccine contains 60 mcg of hemagglutinin per strain of influenza virus in the vaccine. In a phase 3 study of 3,876 adults aged 65 years and older, the high-dose vaccine was compared with the standard-dose influenza vaccine. The key finding was that the new high-dose vaccine induced statistically significant increases in immune responses compared with the standard-dose vaccine in the study population. After 28 days following immunisation, investigators assessed serum hemagglutination inhibition (HAI) titers in study participants and higher HAI titers were reported in those who received the high-dose vaccine compared with those who received the standard-dose vaccine. Immunogenicity results met pre-defined criteria for superiority of the high-dose vaccine. There are no data demonstrating clinically relevant prevention of culture confirmed influenza or its complications after vaccination with the high-dose vaccine compared with the standard-dose vaccine in elders. In the study, the high-dose vaccine was shown to have a clinically comparable safety profile to the standard-dose vaccine. Solicited local adverse events and solicited systemic adverse events were more frequent after vaccination with the high-dose vaccine compared with the standard-dose vaccine. More frequent mild to moderate local reactions were observed at the injection site as would be expected with increased antigen. The most common injection site reactions (.10%) were injection site pain and redness. The most common systemic adverse events (.10%) were malaise, headache, and myalgia. SOURCE: Sanofi-aventis E-mail this page to a friend or colleague! To print, use this version