The immune system weakens with age, hence Sanofi Pasteur has two influenza vaccines under the popular Fluzone brand – standard Fluzone, and a beefed-up Fluzone High-Dose version for adults over the age of 65. While a demonstration of superior immune response helped Fluzone High-Dose gain a US license through the FDA's accelerated approval pathway in 2009, Sanofi has been required to evaluate the actual clinical benefit of Fluzone High-Dose compared to standard Fluzone.
Now, through a 30,000 patient, two-season, confirmatory efficacy trial, Sanofi has done just that. The company demonstrated that the high-dose vaccine was 24.2% more effective in preventing influenza in adults 65 years of age and older than regular Fluzone vaccine.
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"This efficacy trial complements the previous evidence of superior immune responses for Fluzone High-Dose vaccine compared to Fluzone vaccine and reaffirms the Phase III safety data in this population that were the basis for FDA licensure of Fluzone High-Dose vaccine in 2009," said David Greenberg, M.D., Sanofi Pasteur.
Sanofi plans to submit the full clinical study report to the FDA with a view to adding the superiority claim to the Fluzone High-Dose label. High-Dose contains 60 mcg of haemagglutinin antigen per strain of influenza virus as opposed to 15 mcg per strain in the standard trivalent Fluzone vaccine.
Also under the Fluzone umbrella is Sanofi's Fluzone Quadrivalent vaccine, which the French company began shipping recently for use in the 2013-2014 season in the US.
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