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Study: High-Dose Fluzone Vaccine More Effective Than Standard Dose in Older Adults

Manufacturer seeks label update (August 26)

A 2-year efficacy trial involving more than 30,000 people 65 years of age and older has shown a superior clinical benefit of Fluzone High-Dose influenza virus vaccine compared with the standard dose of Fluzone vaccine in preventing influenza.

In the study, Fluzone High-Dose vaccine was 24.2% more effective in preventing influenza in adults 65 years of age and older than Fluzone vaccine. The results met the prespecified primary objective of the study, demonstrating statistically superior efficacy for Fluzone High-Dose vaccine. In addition, the study results suggested a consistent clinical benefit across the study years, influenza virus types, definitions of clinical illness, and laboratory methods of influenza confirmation.

Fluzone High-Dose vaccine was approved by the FDA in December 2009 based on the vaccine’s safety profile and superior immunogenicity compared with Fluzone vaccine. The high-dose vaccine contains 60 mcg of hemagglutinin antigen per strain of influenza virus compared with 15 mcg of influenza virus hemagglutinin antigen per strain of influenza virus in the standard-dose vaccine.

The manufacturer of Fluzone High-Dose (Sanofi Pasteur) anticipates submitting the full clinical study report to the FDA for review by early 2014 and will seek a modification to the vaccine’s label reflecting the new efficacy data in adults 65 years of age and older.

Source: Sanofi Pasteur; August 26, 2013.

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