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.”
, 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.