In a large-scale trial, Sanofi's Fluzone High-Dose vaccine demonstrated efficacy in preventing influenza specifically in adults aged 65 years or older.
In a large-scale trial, Sanofi’s Fluzone High-Dose vaccine demonstrated efficacy in preventing influenza specifically in adults aged 65 years or older.
According to a statement from Sanofi Pasteur, the vaccines division of Sanofi, the High-Dose version of the shot contains 4 times the amount of antigen than its standard-dose predecessor. As a result, there is a higher antibody response within the recipient of Fluzone High-Dose, the manufacturer noted.
“Fluzone High-Dose vaccine is the only influenza vaccine in the (United States) that is designed specifically to address the age-related decline of the immune system in older adults,” said David Greenberg, MD, Vice President of Scientific & Medical Affairs and Chief Medical Officer at Sanofi Pasteur US. “We are thrilled that the results of this trial have shown that Fluzone High-Dose vaccine is significantly more effective than standard-dose Fluzone vaccine in providing protection against influenza in the 65 and over population.”
The trial, published in the New England Journal of Medicine on August 11, 2014, was conducted during the 2011-2012 and 2012-2013 influenza seasons and involved 32,000 participants aged 65 years or older. At the conclusion of the study, Fluzone High-Dose was shown to be 24.2% more effective in keeping influenza at bay than the standard-dose vaccine.
Following the trial, the full results were submitted to the FDA to modify the prescribing instructions for Fluzone High-Dose to reflect the vaccine’s improved efficacy compared to the standard-dose version. Sanofi anticipates that the FDA will deliver a decision on the matter later this year.
“Considering the burden of influenza in older adults, it is encouraging to see that this trial demonstrated the ability of Fluzone High-Dose vaccine to provide better protection in this high-risk population,” said Keipp Talbot, MD, a coordinating investigator of the trial.