FDA approves new prescribing information for Fluzone High-Dose flu vaccine

The U.S. Food and Drug Administration recently approved Sanofi Pasteur’s request to include data in the prescribing information for its Fluzone High-Dose flu vaccine that shows it is more effective in protecting older patients.

A new study, published in the Aug. 14 issue of The New England Journal of Medicine, showed that Fluzone High-Dose protects better than Fluzone’s standard dose in adults 65 and older.

"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," Dr. David P. Greenberg, vice president for Scientific & Medical Affairs and chief medical officer of Sanofi Pasteur US, said. "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."

The study found Fluzone High-Dose vaccine was 24.2 percent more effective than the standard-dose Fluzone vaccine when used to counteract lab-induced influenza.

"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 policymakers," Phil Hosbach, vice president of New Products and Immunization Policy at Sanofi Pasteur, said "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."

Adults 65 and older account for 60 percent of flu-related hospitalizations and 90 percent of flu-related deaths.

"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," Hosbach said.

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