Sanofi's High-Dose Influenza Vaccine Provides Superior Protection for Older Adults

Strategic Insights -

The largest study of its kind, FLUNITY-HD, has demonstrated that Sanofi's high-dose influenza vaccine, Efluelda/Fluzone High-Dose, provides superior protection for older adults against hospitalization compared to standard-dose vaccines. The study, published in The Lancet, involved nearly half a million participants across several seasons and two geographic areas, showing that Efluelda/Fluzone High-Dose reduced the risk of hospitalization in adults 65 years and older by up to 31.9% compared to standard-dose vaccines. This finding has significant implications for public health and clinical guidelines, particularly in vulnerable populations.

Key Takeaways:

  • Efluelda/Fluzone High-Dose demonstrated a reduction in laboratory-confirmed influenza hospitalizations by an additional 31.9% (95% CI, 19.7 to 42.2; p < 0.001) compared to standard-dose influenza vaccines.
  • The vaccine provided superior protection against hospitalizations due to pneumonia or influenza, cardio-respiratory events, and all-cause hospitalizations in older adults.
  • The study, FLUNITY-HD, is the largest and most rigorous individual randomized trial of its kind, involving nearly half a million participants across several seasons and two geographic areas.
  • Efluelda/Fluzone High-Dose is the first vaccine to demonstrate superior protection against both influenza infection and hospitalizations in individually randomized studies in adults 65 years and over.
  • The vaccine provided 8.8% (95% CI, 1.7 to 15.5; one-sided p=0.008) additional protection against pneumonia/influenza hospitalizations.
  • The vaccine also provided 6.3% (95% CI, 2.5 to 10.0; p <0.001) additional protection against all-cause hospitalizations.
  • By vaccinating with Efluelda instead of standard-dose, one all-cause hospitalization could be averted for every 515 (95% CI, 278 to 3,929) individuals vaccinated.
  • The FLUNITY-HD study paves the way for potential public health and societal benefits, such as lower healthcare costs, less pressure on medical systems, and reduced burden on caregivers.

Statistics:

  • 466,320 participants involved in the FLUNITY-HD study, the largest influenza vaccine effectiveness study of its kind.
  • 332,000 participants aged 65 and above in Denmark for the DANFLU-2 trial.
  • 134,000 participants aged 65 to 79 in the region of Galicia in Spain for the GALFLU trial.
  • 31.9% reduction in laboratory-confirmed influenza hospitalizations (95% CI, 19.7 to 42.2; p < 0.001) with Efluelda/Fluzone High-Dose compared to standard-dose influenza vaccines.
  • 8.8% additional protection against pneumonia/influenza hospitalizations (95% CI, 1.7 to 15.5; one-sided p=0.008).
  • 6.3% additional protection against all-cause hospitalizations (95% CI, 2.5 to 10.0; p < 0.001).
  • One all-cause hospitalization could be averted for every 515 (95% CI, 278 to 3,929) individuals vaccinated with Efluelda instead of standard-dose.
  • 15 years of clinical evidence spanning over 45 million older adults on Efluelda/Fluzone High-Dose.

Sources:

  • Sanofi Press Release, "Sanofi's high-dose influenza vaccine demonstrates superior protection for older adults," October 20.
  • The Lancet, "Effectiveness of high-dose influenza vaccine in adults aged 65 years and older," October 17.
  • Sanofi's FLUNITY-HD study, "Evaluating the effectiveness of high-dose influenza vaccine in adults aged 65 years and older."
  • Sanofi website, "About Efluelda/Fluzone High-Dose."