Sanofi launches high-dose egg-based quadrivalent influenza vaccine (QIV-HD) in the UK

Sanofi launches high-dose egg-based quadrivalent influenza vaccine (QIV-HD) in the UK

·       Developed with a higher antigen content to increase protection in older adults, a population at greater risk of severe complications from infection.

·       Now available and can be pre-ordered for the first time for the 2025/26 flu season.

Reading, UK – 15 October 2024 – Sanofi has today announced the launch of high-dose egg-based quadrivalent influenza vaccine (QIV-HD) in the UK for people aged 65 years or older, and clinically at-risk individuals aged 60 to 64 years. QIV-HD has been recommended by the Joint Committee on Vaccination and Immunisation (JCVI) and is reimbursed by the National Health Service (NHS).[i] QIV-HD is now available and can be pre-ordered for the first time for the 2025/2026 flu season in the UK.

Dr Yassir Javaid

General Practioner with a Special Interest (GPwSI) in Cardiology

“Flu can be a potentially devastating multi-system disease. The elderly are at greatest risk of severe complications, associated with high rates of hospitalisation and mortality. We are practicing in an evidence based world where, as far as possible, our treatment decisions should be based  on high quality evidence and data. It is exciting to see the introduction of vaccines designed to address immunosenescence in older adults, irrespective of the season and circulating strain.”

The increased protective effect of high-dose influenza vaccine versus standard-dose in older adults is supported by more than a decade of data, including randomised studies in clinical and real-world settings.[ii] Sanofi manufactures and distributes over 250 million doses of influenza vaccines globally each year.[iii]

QIV-HD is the quadrivalent version of high-dose trivalent influenza vaccine (HD-TIV). In a randomised clinical trial comprising 31,989 people aged over 65, across 2 flu seasons, HD-TIV met the pre-specified superiority criteria, demonstrating it was 24.2% (95% CI: 9.7 to 36.5) more efficacious than standard-dose influenza vaccine in protecting older adults from lab-confirmed influenza of any circulating strain.[iv] The HD-TIV results from this landmark head-to-head trial have been inferred to QIV-HD, via an immunobridging approach often used when changing valences for vaccines.[v]

Furthermore, in a meta-analysis of 21 publications of randomised and observational studies comprising over 45 million people aged 65 and over, across 12 flu seasons, high-dose inactivated influenza vaccine (HD-IIV) has been proven to reduce serious complications related to influenza infection compared to standard-dose.² HD-IIV was seen to reduce pneumonia hospitalisations by 27.8% (95% CI: 12.5 to 40.5), cardiorespiratory hospitalisations by 16.7% (95% CI: 13.8 to 19.5), influenza hospitalisations by 11.2% (95% CI: 7.4 to 14.8) and all-cause hospitalisations by 8.2% (95% CI: 5.5 to 10.8), versus standard-dose influenza vaccine.² The meta-analysis included studies performed on both quadrivalent and trivalent HD formulations.²

In order to investigate the protective effect of QIV-HD versus QIV-SD (standard dose) on influenza infection and pneumonia hospitalisation, DANFLU-1, a pioneering pragmatic study combining individual randomisation to real-world settings, was conducted on over 12,400 subjects aged 65 to 79 years, over 1 flu season in Denmark. The feasibility study indicated a trend showing that QIV-HD was associated with 64.4% (95% CI: 24.4 to 84.6) lower rates of flu and pneumonia hospitalisations than standard-dose.[vi]

Rebecca Catterick

Vaccines General Manager, UK and Ireland, Sanofi 

“We are delighted that older adults in the UK can now receive QIV-HD, helping to answer the medical and public health burden of flu. The launch of this high-dose vaccine may represent a step-change for protection of the most vulnerable in our society and is testament to our commitment to working alongside the NHS in safeguarding patients from virus infection and its complications.” 

The safety profile of high-dose influenza vaccine in adults 60 years of age and older was considered acceptable, with no safety concerns identified.[vii]^,[viii],[ix] Independent assessment from the European Centre for Disease Prevention and Control (ECDC) noted high-dose influenza vaccines are likely associated with a higher frequency of local and systemic reactions, with symptoms reported as ‘mild’ and ‘transient’ in nature.⁹ No new or unexpected safety concerns have been identified among individuals aged 65 and over.⁹

[i] Gov.uk. Flu vaccination programme 2024 to 2025: information for healthcare practitioners. Available at: https://www.gov.uk/government/publications/flu-vaccination-programme-information-for-healthcare-practitioners/flu-vaccination-programme-2023-to-2024-information-for-healthcare-practitioners. Last accessed: October 2024

[ii] Lee J, et al. Vaccine: X. 2023 doi:10.1016/j.jvacx.2023.100327

[iii] Sanofi. 2023. Sanofi Breaks Ground on State-of-the-Art Facility in Swiftwater for Sustainable Production of Pandemic Flu Vaccine. Available at: https://www.prnewswire.com/news-releases/sanofi-breaks-ground-on-state-of-the-art-facility-in-swiftwater-for-sustainable-production-of-pandemic-flu-vaccines-301789776.html Last accessed: October 2024.

[iv] DiazGranados CA, et al. N Engl J Med. 2014; 371:635-45. doi: 10.1056/nejmoa1315727

[v] Chang LJ et al. Vaccine. 2019;37:5825-34. doi: 10.1016/j.vaccine.2019.08.016

[vi] Johansen ND, et al. NEJM Evid 2023;2. doi: 10.1056/EVIDoa2200206

[vii] Moro PL et al. Infect Dis. 2012; 54:1608-14. doi: 10.1093/cid/cis256

[viii] Moro PL et al. Vaccine. 2020; 38:5923-26. doi: /10.1016/j.vaccine.2020.07.007

[ix] ECDC. Seasonal influenza vaccines systematic review. Available at: https://www.ecdc.europa.eu/sites/default/files/documents/seasonal-influenza-vaccines-systematic-review-efficacy.pdf Accessed: October 2024.