Seniors are better protected from flu with high-dose vaccine

August 18, 2014

A high-dose influenza vaccine protects the senior population better than the standard-dose influenza vaccine, according to a study published in the August 14 issue of the New England Journal of Medicine.

A high-dose influenza vaccine protects the senior population better than the standard-dose influenza vaccine, according to a study published in the August 14 issue of the New England Journal of Medicine.

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In response to the unmet medical need in older adults, high-dose influenza vaccine was licensed by FDA under the Agency’s accelerated approval process. As a requirement of the accelerated approval pathway, Sanofi Pasteur embarked on this large-scale, 2-season, confirmatory efficacy trial involving nearly 32,000 participants aged 65 years and older, to evaluate the clinical benefit of high-dose influenza vaccine compared to standard-dose influenza vaccine in the prevention of influenza disease. 

The large-scale, multicenter efficacy trial found that the high-dose influenza vaccine was more efficacious in preventing influenza illness in adults aged 65 years and older compared to standard-dose influenza vaccine.

The high-dose influenza vaccine was found to be 24.2% (95% CI, 9.7 to 36.5) more effective in preventing influenza relative to standard-dose influenza vaccine for the primary end point, indicating that about 1 in 4 breakthrough cases of influenza illness could be prevented if the high-dose influenza vaccine were used instead of the standard-dose influenza vaccine in the patients aged 65 years and older.

The study safety data were consistent with previous high-dose influenza vaccine studies.

People 65 years of age and older suffer disproportionately from seasonal influenza and its complications, including severe illness, hospitalization, and death,” according to David P. Greenberg, MD, vice president, scientific & medical affairs, and chief medical officer, Sanofi Pasteur US.

Approximately 60% of influenza-related hospitalizations and 90% of influenza-related deaths in the United States occur in people aged 65 years and older.

“They typically do not respond as well to influenza vaccines as younger individuals because older adults have weakened immune systems due to aging,” said Dr Greenberg. “We think [the study] results are important for hospitals and managed care organizations to consider in light of the heavy burden of influenza disease in the older population and the well-described high rates of influenza-related complications and hospitalizations that result as a consequence of this infection.”

Dr Greenberg believes that the demonstrated clinical benefit will translate into benefits to public health.

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“Influenza vaccines have been shown to offer public health benefits in preventing influenza and its complications in all age groups,” he said.

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