New findings from the FLUNITY-HD study, published today in The Lancet, reveal that Sanofi’s Fluzone High-Dose influenza vaccine significantly reduces the risk of hospitalization in adults aged 65 years and older compared to standard-dose influenza vaccines.
As the largest study of its kind, conducted across multiple influenza seasons, FLUNITY-HD provides compelling real-world evidence that the high-dose influenza vaccine delivers superior protection for older adults — a population at increased risk of serious flu-related complications.
The study findings include:
8.8% (95% CI, 1.7 to 15.5; one-sided p=0.008) additional protection against pneumonia/influenza hospitalizations
6.3% (95% CI, 2.5 to 10.0; p<0.001) additional reduction in hospitalizations for cardio-respiratory events
31.9% (95% CI, 19.7 to 42.2; p<0.001) additional reduction in lab-confirmed influenza hospitalizations
2.2% (95% CI, 0.3 to 4.1; p=0.012) additional protection against all-cause hospitalizations, translating to one additional hospitalization prevented for every 515 (95% CI, 278 to 3,929) individuals vaccinated with Fluzone High-Dose instead of standard-dose influenza vaccine.
"The FLUNITY-HD study, unparalleled in its design and scale, harnesses the power and scientific rigor of individual randomization in real-world settings," shared Professor Tor Biering-Sørensen, Cardiologist, Chief Investigator, and sponsor of the FLUNITY-HD study. "This first-of-its-kind study assessed the benefits of the high-dose influenza vaccine against severe outcomes compared to standard-dose, including against cardio-respiratory hospitalizations, in a randomized setting, covering two geographic areas. The results provide critical evidence, potentially reshaping public health strategies and clinical guidelines."
Professor Federico Martinon-Torres, Co-Principal Investigator of the FLUNITY-HD study, added, "This new evidence reinforces the clinical confidence healthcare professionals have that the high-dose influenza vaccine achieves superior protection over standard-dose against severe outcomes in older adults, a group considered vulnerable due to having a weakened immune system and a higher risk of developing serious complications after flu infection."
Beyond clinical outcomes, the findings also underscore significant public health and societal benefits.
"Adults 65 and older represent up to 70% of flu hospitalizations. The FLUNITY-HD data confirm that our high-dose flu vaccine provides superior protection against hospitalizations compared to standard-dose vaccines in older adults," said Dr. Bogdana Coudsy, Global Head of Medical, Sanofi Vaccines. "For every 515 older adults who receive our high-dose flu vaccine instead of standard-dose vaccines, one all-cause hospitalization is prevented. This can mean a lot, especially for vulnerable seniors, decreasing the burden on their quality of life and helping them to maintain their autonomy for longer. Additionally, preventing influenza hospitalizations may bring societal benefits such as lower healthcare costs, less pressure on medical systems, and reduced burden on caregivers."
With these new findings, Sanofi’s high-dose influenza vaccine now boasts 15 years of clinical evidence, spanning more than 45 million older adults worldwide.
The standard-dose influenza vaccines used in the FLUNITY-HD study were VaxigripTetra (Sanofi) and InfluvacTetra (Viatris), both commonly employed as primary influenza prevention options for the general population.
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