Sanofi Pasteur announced that the Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone High-Dose (trivalent inactivated “split virus” influenza vaccine [Types A and B]) to include new efficacy data in the drug labeling.

The updated Prescribing Information now contains data from a multi-center, double-blind safety and efficacy trial published in The New England Journal of Medicine. The post-licensure study was conducted over two influenza seasons and randomized adults to either Fluzone High-Dose (n=15,892) or Fluzone (n=15,911) vaccine.

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The new data show that Fluzone High-Dose vaccine provided 24.2% (95% CI 9.7–36.5%) more protection against influenza (caused by any influenza type or subtype in association with influenza-like illness) compared to the standard-dose Fluzone vaccine in patients aged ≥65 years.

Fluzone High-Dose (60mcg hemagglutinin per strain) contains four times the antigen that is found in the standard-dose Fluzone vaccine (15mcg hemagglutinin per strain).

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