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Efluelda TIV-HD▼ Trivalent Influenza Vaccine (split virion, inactivated) High Dose, 60mcg HA/strain

Efluelda TIV-HD

Trivalent Influenza Vaccine (split virion, inactivated) High Dose, 60mcg HA/strain

Profile

Trivalent Influenza Vaccine▼ (Split Virion, Inactivated) High-Dose 60mcg HA/strain is indicated for the active immunisation against infection caused by influenza viruses in adults 60 years of age and older.1 The use of Efluelda TIV-HD should be in accordance with official recommendations on vaccination against influenza.

With Efluelda TIV-HD, you have the power to help protect beyond flu by preventing flu-related hospitalisations:1-3 

First-line Recommended

The only JCVI first-line recommended* flu vaccine to have met primary superiority efficacy outcomes for adults aged 65 and over against another flu vaccine in a randomised controlled trial.1,2,5-9

Consistent Results

  • 24% better protection against lab-confirmed influenza cases vs a standard-dose flu vaccine (24.2% relative risk reduction; 0.5% absolute risk reduction)2
  • 13% (95% CI: 7, 20) fewer pneumonia and influenza hospitalisations, 18% (95% CI: 15, 21) fewer cardiorespiratory hospitalisations, and 8% (95% CI: 5, 10) fewer all-cause hospitalisations vs standard-dose influenza vaccines in retrospective studies of 45+ million patients aged 65 and over across 12 flu seasons3

Growing Global Presence

Recommended by numerous national immunisation bodies and medical societies throughout the world4

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First-line Recommended

The only JCVI first-line recommended* flu vaccine to have met primary superiority efficacy outcomes for adults aged 65 and over against another flu vaccine in a randomised controlled trial.1,2,5-9

Consistent Results

  • 24% better protection against lab-confirmed influenza cases vs a standard-dose flu vaccine (24.2% relative risk reduction; 0.5% absolute risk reduction)2
  • 13% (95% CI: 7, 20) fewer pneumonia and influenza hospitalisations, 18% (95% CI: 15, 21) fewer cardiorespiratory hospitalisations, and 8% (95% CI: 5, 10) fewer all-cause hospitalisations vs standard-dose influenza vaccines in retrospective studies of 45+ million patients aged 65 and over across 12 flu seasons3

Growing Global Presence

Recommended by numerous national immunisation bodies and medical societies throughout the world4

*Recommended for 25/26 season

Efficacy

Efluelda TIV-HD has been shown to provide superior flu protection compared to a standard dose flu vaccine (Figure 1)

Efluelda was investigated in a multicentre double-blind efficacy trial designed to demonstrate superior efficacy conducted in the US and Canada for 2 seasons to assess the occurrence of laboratory-confirmed influenza in association with influenza-like illness (ILI) with high-dose vaccines (n=15,892) vs. standard-dose vaccine (n=15,911) as the primary endpoint, starting 2 weeks post vaccination among those ages 65 years and older.2

Figure 1:

The primary endpoint of the study was the occurence, in patients aged 65 and over, and at least 14 days after vaccincation, of laboratory-confirmed influenza*1,2

~24%

RELATIVE RISK REDUCTION AGAINST INFLUENZA INFECTION
VS. A STANDARD-DOSE FLU VACCINE1,2

(24.2% Relative risk reduction; 0.5% absolute risk reduction2†*, Primary end points: TIV-HD: 227 (1.43%), TIV-SD: 300 (1.89%).2)

*caused by influenza viral types or subtypes, in association with protocol defined influenza like illness.

†In a randomised controlled trial (RCT) of 31,803 subjects, the primary endpoint was met. HD-TIV showed 24.2% (95% CI: 9.7 to 36.5) better protection against lab-confirmed influenza cases of any circulating strain vs standard-dose influenza vaccine.

Consistent results observed across >45 million subjects and across 12 consecutive seasons of randomised and real-world evidence (Figure 2)

Efluelda is associated with a reduction in flu-related hospitalisations in people aged 65 years and older, even in mismatched years.

A meta-analysis published in 2023, including 21 publications (6 RCT and 15 observational studies) of studies conducted over 12 seasons (multiple circulating strains) and in >45 million subjects found High Dose demonstrated greater relative risk reduction against complications of influenza vs. standard-dose influenza vaccines.3

Figure 2:

HIGH DOSE POOLED RELATIVE RISK REDUCTION RESULTS:

11% REDUCTION IN
INFLUENZA HOSPITALISATIONS3
(11.2%; 95% CI: 7.4 to 14.8)

17% REDUCTION IN
CARDIORESPIRATORY HOSPITALISATIONS3
(16.7%; 95% CI: 13.8 to 19.5)

28% REDUCTION IN
PNEUMONIA HOSPITALISATIONS3
(27.8%; 95% CI: 12.5 to 40.5)

8% REDUCTION IN
ALL-CAUSE HOSPITALISATIONS3
(8.2%; 95% CI: 5.5 to 10.8)

Safety Profile

In clinical trials the safety profile of HD has been shown to be comparable to that of SD vaccines.1,10

Efluelda TIV-HD is generally well-tolerated. The most frequently reported adverse reaction after vaccination was injection site pain, reported by 42.6% of study participants, followed by myalgia (23.8%), headache (17.3%), and malaise (15.6%). Most of these reactions occurred and resolved within three days of vaccination. The intensity of most of these reactions was mild to moderate. Please refer to the TIV-HD SmPC for full list of adverse events.

Efluelda TIV-HD is identical to Quadrivalent Influenza Vaccine (Split Virion, Inactivated) High Dose (QIV-HD) with the only difference of containing antigen from one less influenza B strain.

Read more about Influenza:

Supemtek TIVr ▼

Prescribing Information UK

Learn more

Burden of Influenza

Learn more about the impact of flu.

Learn more

.

Ways to Order

You can order Sanofi Vaccines in two ways: online at VAXISHOP or through our call centre. Read more about ordering vaccines.

CALL 0800 854 430

References
  1. Efluelda TIV-HD Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/100678/smpc. Accessed July 2025
  2. DiazGranados C A et al. N Engl J Med 2014;371:635-645
  3. Lee J K H et al. Vaccine X 2023;14:100327
  4. Sanofi Data on File
  5. GOV.UK. Guidance: national flu immunisation programme 2025 to 2026 letter. Available at: http://www.gov.uk/government/publications/national-flu-immunisation-programme-plan-2025-to-2026/national-flu-immunisation-programme-2025-to-2026-letter. Accessed July 2025.
  6. Dunkle LM, et al. N Eng J Med 2017;376;2427-2436 and Supplementary Information.
  7. Beran J et al. Lancet Infect Dis 2021;21(7):1027-1037
  8. Murchu EO et al. Rev Med Virol 2023;33(3):e2329
  9. Frey S et al. Clin Infect Dis 2010;51(9)997-1004
  10. Chang LJ, Meng Y, Janosczyk H, Landolfi V, Talbot HK; QHD00013 Study Group. Safety and immunogenicity of high dose quadrivalent influenza vaccine in adults ≥65 years of age: A phase 3 randomized clinical trial. Vaccine. 2019 Sep 16;37(39):5825-5834. doi: 10.1016/j.vaccine.2019.08.016. Epub 2019 Aug 17. PMID: 31431411
     

MAT-XU-2402066 (v2.0) Date of preparation: July 2025