Sanofi ($SNY) began its appeal to the FDA late last year to change the labeling of its high-dose Fluzone vaccine to reflect superior efficacy data in people aged over 65, and now it has fresh trial results to back up its case.
According to Phase III trial data published Aug. 14 in the New England Journal of Medicine, Fluzone High-Dose provides better protection in individuals in this age group compared to traditional flu jabs. The study, which involved nearly 32,000 people at 126 research centers in the U.S. and Canada, found that Fluzone High-Dose also induces significantly higher antibody responses in seniors compared with the standard-dose Fluzone vaccine.
Researchers found that Fluzone High-Dose vaccine was 24.2% more effective in preventing flu when stacked up against standard-dose Fluzone vaccine, suggesting that about one in four cases of flu in people older than 65 could be prevented if Fluzone High-Dose vaccine were used instead of the standard-dose Fluzone vaccine.
Dr. David Greenberg, vice president of scientific and medical affairs and chief medical officer at Sanofi Pasteur, told FierceVaccines that the study is good news for seniors, who are hit harder by seasonal flu than other age groups.
"People 65 years of age and older suffer disproportionately from seasonal influenza and its complications, including severe illness, hospitalization, and death. They typically do not respond as well to influenza vaccines as younger individuals because older adults have weakened immune systems due to aging," Greenberg said.
Based on early data from the trial, Sanofi asked the FDA late last year for regulatory approval to modify its prescribing information for Fluzone High-Dose vaccine. In a company statement, Sanofi said it anticipates a decision later this year.
An FDA sanction plus backing from the Advisory Committee on Immunization Practices--a panel that helps the Centers for Disease Control and Prevention (CDC) devise vaccine recommendations--should help Sanofi boost sales of Fluzone.
The FDA first approved the vaccine back in 2009, but it has yet to catch on as the vaccine of choice among seniors. Four out of 5 seniors who got vaccinated in 2012 received a different product. Though Fluzone costs more than standard vaccines, Sanofi thinks the reason it hasn't caught on yet is because of limited data, not cost.
- read the press release from Sanofi
- get the study abstract
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