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SWIFTWATER, Pa. — The Food and Drug Administration has approved updated prescribing information for Sanofi Pasteur’s Fluzone High-Dose influenza vaccine for seniors.
The Sanofi vaccines division said this week that the FDA gave the OK to the supplemental biologics license application (sBLA) for Fluzone High-Dose to include efficacy data in the prescribing information. The data show that the vaccine provided improved protection against flu compared with the standard-dose Fluzone vaccine (trivalent intramuscular formulation) in adults 65 years of age and older.
According to the company, the prescribing information for Fluzone HD now includes data from a large-scale, multi-center efficacy and safety trial published in the Aug. 14 issue of The New England Journal of Medicine. The study found Fluzone HD vaccine was 24.2% more effective than standard-dose Fluzone vaccine in preventing laboratory-confirmed influenza caused by any influenza viral type or subtype in association with flu-like illness. This indicates that about one in four breakthrough cases of flu could be prevented if Fluzone HD were used instead of the standard-dose Fluzone vaccine in the 65 and older population.
"Inclusion of these efficacy data in the Fluzone High-Dose vaccine prescribing information validates the importance of this vaccine for people 65 years of age and older," stated David Greenberg, vice president of scientific and medical affairs and chief medical officer at Sanofi Pasteur U.S. "We are fully committed to helping protect patients from influenza, and we urge everyone eligible — especially older adults — to get vaccinated as soon as possible if they have not already done so."
Fluzone High-Dose vaccine is an inactivated influenza vaccine that contains four times the amount of antigen (60 mcg hemagglutinin [HA] per strain) than in standard-dose Fluzone vaccine (15 mcg HA per strain).
Sanofi reported that seniors typically account for 60% of flu-related hospitalizations and 90% of flu-related deaths. The company said studies have shown people ages 65 years and older do not respond to standard-dose influenza vaccine as well as younger adults and may be left without sufficient protection.
"We look forward to further discussing these data with the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and other health policy-makers," commented Phil Hosbach, vice president of new products and immunization policy at Sanofi Pasteur. "Given the significance of these results, we believe that Fluzone High-Dose vaccine fills a vital public health need as the only influenza vaccine shown specifically to address the age-related decline of the immune system. Compared to younger adults, people 65 years of age and older suffer disproportionately from seasonal influenza and its complications, including severe illness leading to hospitalization and death."
