FDA approve license addition for Fluzone High-Dose for Influenza-Sanofi

The FDA has approved the supplemental biologics license application (sBLA) for Fluzone High-Dose (vaccine), from Sanofi, to include efficacy data in the Prescribing Information for Influenza. These data demonstrate that Fluzone High-Dose vaccine provided improved protection against influenza compared to standard-dose Fluzone vaccine (trivalent intramuscular formulation) in adults 65 years of age and older. Fluzone High-Dose vaccine was licensed by the FDA in December 2009 under the agency's accelerated approval process. The Prescribing Information for Fluzone High-Dose vaccine now includes data from a large-scale, multi-center efficacy and safety trial published in the August 14, 2014, issue of The New England Journal of Medicine (DOI: 10.1056/NEJMoa1315727).

The study found Fluzone High-Dose vaccine was 24.2 percent (95% CI, 9.7 to 36.5) more effective than standard-dose Fluzone vaccine in preventing laboratory-confirmed Influenza caused by any influenza viral type or subtype in association with Influenza-like illness, the primary endpoint. This indicates that about one in four breakthrough cases of Influenza could be prevented if Fluzone High-Dose vaccine were used instead of the standard-dose Fluzone vaccine in the 65 and older population.