Sanofi's High-Dose Flu Vaccine Delivers Superior Protection for Older Adults

Strategic Insights -

Sanofi has announced new results from the FLUNITY-HD study, confirming that its high-dose influenza vaccine, Efluelda, offers significantly greater protection against hospitalisations in adults aged 65 and older. The study, published in The Lancet, included 466,320 participants across Denmark and Spain, making it the largest influenza vaccine effectiveness trial conducted in older adults. The high-dose vaccine demonstrated a 31.9% additional reduction in laboratory-confirmed influenza hospitalisations and 8.8% greater protection against pneumonia or influenza-related hospitalisations compared to standard-dose vaccines.

Key Takeaways:

  • The FLUNITY-HD study, published in The Lancet, included 466,320 participants across Denmark and Spain, making it the largest influenza vaccine effectiveness trial conducted in older adults.
  • Efluelda, Sanofi's high-dose influenza vaccine, demonstrated a 31.9% additional reduction in laboratory-confirmed influenza hospitalisations compared to standard-dose vaccines.
  • The high-dose vaccine provided 8.8% greater protection against pneumonia or influenza-related hospitalisations versus standard-dose vaccines.
  • Efluelda also showed a 6.3% reduction in cardio-respiratory hospitalisations and 2.2% fewer all-cause hospitalisations.
  • This corresponds to one fewer hospitalisation for every 515 older adults vaccinated with Efluelda instead of standard-dose formulations.
  • Older adults account for up to 70% of flu hospitalisations, and Sanofi's high-dose vaccine could reduce healthcare costs, ease system pressures, and support independence among seniors.
  • These results build on 15 years of clinical evidence covering more than 45 million older adults.
  • Dr. Bogdana Coudsy, Sanofi's global head of Medical for Vaccines, highlighted the importance of this study in supporting independence among senior citizens.

Statistics:

  • 466,320 participants were involved in the FLUNITY-HD study.
  • 31.9% reduction in laboratory-confirmed influenza hospitalisations with Efluelda compared to standard-dose vaccines.
  • 8.8% greater protection against pneumonia or influenza-related hospitalisations with Efluelda compared to standard-dose vaccines.
  • 6.3% reduction in cardio-respiratory hospitalisations with Efluelda.
  • 2.2% fewer all-cause hospitalisations with Efluelda.
  • Every 515 older adults vaccinated with Efluelda instead of standard-dose formulations means one fewer hospitalisation.
  • 15 years of clinical evidence covering more than 45 million older adults supports Efluelda's safety and efficacy.

Sources:

  • "Sanofi reports data showing high-dose flu vaccine delivers superior protection for older adults." M2 PHARMA, October 20, 2025.
  • "FLUNITY-HD study." The Lancet.