Sanofi Pasteur Posts Positive Results For Flu Vaccine
Sanofi vaccines division Sanofi Pasteur reported positive results from its efficacy trial of Fluzone High-Dose (Influenza Vaccine) showing that it is more effective than standard-dose Fluzone in preventing the flu in adults aged 65 years old and above.
Fluzone High-Dose is an inactivated influenza vaccine that carries four times the amount of antigen than that of standard-dose Fluzone. High-Dose induces a higher antibody response than that of its predecessor. According to the company, Fluzone High-Dose registered 24.2 percent greater efficacy over the standard-dose Fluzone vaccine as the primary endpoint.
John Shiver, SVP of R&D at Sanofi Pasteur, said, “Adults age 65 years and older typically account for more than half of influenza-related hospitalizations and about 90 percent of influenza-related deaths. We are fully committed to helping to offer protection against influenza by delivering a more effective vaccine option designed specifically to address the needs of people aged 65 years and older.”
Influenza affects up to 20 percent of the U.S. population every year or around 15 to 60 million cases annually. Adults aged 65 years old and above are at high risk for flu, especially the A/H3N2 strain. Older people also do not respond as well to standard-dose flu vaccines compared to younger people.
David P. Greenberg, VP of Scientific & Medical Affairs, and Chief Medical Officer of Sanofi Pasteur US, said, “We are thrilled that the results of this trial… Fluzone High-Dose vaccine is the only influenza vaccine in the U.S. that is designed specifically to address the age-related decline of the immune system in older adults.”
The company submitted an application for approval to the U.S. Food and Drug Administration (FDA) based on trial results gathered last year that sought to change Fluzone High-Dose’s label to include data announcing the drug’s improved efficacy in adults 65 years of age and older. Sanofi said it expects a decision from the agency this year.