# Lancet Publication Marks Important Advance in Influenza Prevention for Older Adults

- Link: https://www.thailand-business-news.com/pr-news/lancet-publication-marks-important-advance-in-influenza-prevention-for-older-adults
- Published: 2026-09-11T05:51:00+07:00
- Author: PR Newswire

**Phase 3 study demonstrates benefits of the first influenza vaccine to combine 
three proven approaches to enhancing protection for older adults in a single vaccine.**

MAIDENHEAD, United Kingdom, Sept. 11, 2026 /PRNewswire/ — CSL Seqirus, a business
of CSL (ASX: CSL; USOTC: CSLLY), today announced publication of pivotal Phase 3 
study results for its MF59^(®)-adjuvanted cell-based higher-dose quadrivalent influenza
vaccine (aQIVc) in _The Lancet Infectious Diseases_, marking an important milestone
in the evolution of influenza prevention for older adults.^(1)

The publication follows approval of the trivalent formulation of aQIVc by the Medicines
and Healthcare products Regulatory Agency (MHRA) in the United Kingdom earlier this
year for adults aged 50 years and older.^(2) The vaccine, marketed as AUJEMFLU^(
®), has also been approved by the European Commission for adults aged 50 years and
above.

The peer-reviewed publication reports findings from a large-scale study of the first
influenza vaccine to combine three proven approaches to enhancing protection in 
older adults: MF59^(®) adjuvant, cell-based manufacturing, and a higher dose formulation
compared to standard influenza vaccines.^(1)^(,)^(3)

Each of these approaches has been used separately in influenza vaccines for many
years and is supported by extensive clinical and real-world evidence. This publication
provides the first large-scale evaluation of their combination within a single vaccine.
^(1)^(,)^(2)

Influenza remains a significant public health challenge, causing substantial illness,
hospitalisations and deaths each year despite widespread vaccination programmes.
^(4) 

Older adults are particularly vulnerable because the immune system becomes less 
responsive with age, reducing its ability to mount a strong protective response 
following vaccination.^(5) 

aQIVc combines three proven approaches to enhancing vaccine protection in older 
adults, with each playing a distinct and complementary role. Cell-based manufacturing
helps preserve a closer match to circulating influenza strains, MF59® adjuvant strengthens,
broadens and lengthens the immune response and a higher dose formulation further
optimises that response.^(2)^(,)^(6)^(,)^(7)^(,)^(8)

The Phase 3 randomised immunogenicity and safety study enrolled 7,699 adults aged
50 years and older across eight countries and compared aQIVc with two enhanced influenza
vaccines. The study met its primary objectives and demonstrated:^(1)

 ◦ Superiority versus the adjuvanted egg-based influenza vaccine comparator across
   all four influenza strains and age groups assessed.
 ◦ Non-inferiority versus a recombinant influenza vaccine for three out of four 
   strains in the 50+ age group and four out of four strains in those aged 65+.
 ◦ Immune responses that persisted throughout the influenza season.
 ◦ A well-tolerated safety profile. Most reactions were mild or moderate and resolved
   within three days.^(1)  

The publication also reported exploratory findings of enhanced neuraminidase antibody
responses versus comparators. The role of neuraminidase antibodies is an emerging
area of influenza research that may contribute to reduced disease severity and broader
protection beyond traditional measures of vaccine response.^(9)

The study authors concluded that the findings support further evaluation of the 
vaccine and provide evidence for National Immunisation Technical Advisory Groups
considering enhanced influenza vaccination strategies for older adults.^(1)

Regulatory submissions for the trivalent formulation of aQIVc have been made in 
multiple markets, with introductions expected to occur through a phased approach
aligned to local regulatory, policy and access pathways.

**Gregg Sylvester, Chief Medical Officer and Head of Research & Development, CSL
Seqirus, said:_"Publication in The Lancet Infectious Diseases is a significant milestone
for CSL Seqirus and reflects decades of investment in influenza vaccine innovation."_

_"These findings provide important new evidence for healthcare professionals, policy
makers and immunisation advisory groups considering future influenza vaccination
strategies for older adults."_

**Professor Colin Russell, Chair of the European Scientific Working Group on Influenza(
ESWI) and Professor of Applied Evolutionary Biology at Amsterdam University Medical
Center, said:_"Influenza vaccine innovation has historically progressed through 
incremental advances in technology and manufacturing. What makes this study noteworthy
is that it shows the potential benefit of bringing multiple proven approaches together
in a single vaccine."_

_"Given the continued burden of influenza-related illness, hospitalisation and death
among older adults despite widespread vaccination, these findings represent an important
contribution to ongoing efforts to improve protection in this vulnerable population."_

**About the Phase 3 StudyThe randomised, observer-blind Phase 3 immunogenicity study
enrolled 7,699 adults aged 50 years and older across Canada, Denmark, Estonia, Germany,
Pakistan, the Philippines, the United Kingdom and the United States. Participants
received either the MF59-adjuvanted cell-derived higher dose quadrivalent vaccine,
an MF59-adjuvanted egg-based quadrivalent influenza vaccine or a recombinant quadrivalent
influenza vaccine. The study evaluated immunogenicity, safety and manufacturing 
consistency.

**About aQIVcaQIVc is an MF59-adjuvanted, cell-based higher-dose quadrivalent influenza
vaccine developed for adults aged 50 years and older.  The trivalent formulation
has been licensed for use in people aged 50 and above in the UK and by the European
Medicines Agency where it is marketed as AUJEMFLU.^(®)

The vaccine combines three proven approaches designed to enhance protection in older
adults:

 ◦ MF59 adjuvant technology
 ◦ Cell-based manufacturing
 ◦ A higher dose formulation versus standard dose influenza vaccines
 ◦ Each dose contains 45 micrograms of haemagglutinin per influenza strain and 19.5
   mg of MF59 adjuvant^(2)

**About CSL SeqirusCSL Seqirus is part of CSL (ASX: CSL). As one of the largest 
influenza vaccine providers in the world, CSL Seqirus is a major contributor to 
the prevention of influenza globally and a transcontinental partner in pandemic 
preparedness and response. With state-of-the-art production facilities in the US,
the UK and Australia, CSL Seqirus utilises egg, cell and adjuvant technologies to
offer a broad portfolio of differentiated influenza vaccines in more than 20 countries
around the world. For more information about CSL Seqirus, visit [www.CSL.com](https://edge.prnewswire.com/c/link/?t=0&l=en&o=4771871-1&h=750958619&u=https%3A%2F%2Fwww.csl.com%2F&a=www.CSL.com).

**Intended AudienceThis press release is issued by CSL Seqirus and is intended to
provide information about our global business. Information relating to the approval
status, product labels, recommendations and availability of CSL Seqirus products
may vary from country to country. Please consult your local regulatory authority
for information on approval status and local prescribing information.

**Forward-Looking StatementsThis press release may contain forward-looking statements,
including statements regarding future results, performance, regulatory milestones,
product availability or achievements. These statements involve known and unknown
risks, uncertainties and other factors which may cause actual results, performance
or achievements to be materially different from any future results, performance 
or achievements expressed or implied by the forward-looking statements. Given these
uncertainties, you should not place undue reliance on forward-looking statements.

**For more information, please contact:MEDIA CONTACT 
Alex Kiefer[Alex.Kiefer@Seqirus.com](https://www.thailand-business-news.com/pr-news/Alex.Kiefer@Seqirus.com)
Director International & Pandemic Communications, CSL Seqirus 

GL-aTIVc-26-0011

**References**

^(1) Essink BJ, Vermeulen W, Andrade C, Mazur M, de Rooij R, Heijnen E, et al. Immunogenicity
and safety of an MF59-adjuvanted cell-derived higher-dose quadrivalent influenza
vaccine (aQIVc) in adults aged 50 years or older: a phase 3 randomised controlled
trial. Lancet Infect Dis. In press 2026. Volume 26. September 2026.  THELANCETID-
D-26-00167R3.
^(2) Aujemflu suspension for injection in pre-filled syringe: summary
of product characteristics [Internet]. Maidenhead: Seqirus UK Limited; 4 June 2026(
PL 47991/0020). Available from: [https://www.medicines.org.uk/emc/product/102343/smpc](https://edge.prnewswire.com/c/link/?t=0&l=en&o=4771871-1&h=2922458093&u=https%3A%2F%2Fwww.medicines.org.uk%2Femc%2Fproduct%2F102343%2Fsmpc&a=https%3A%2F%2Fwww.medicines.org.uk%2Femc%2Fproduct%2F102343%2Fsmpc)
cited 2026 Aug 2.^(3) Ashraf M, Boivin W, Nguyen-Van-Tam JS, Nolan T, Stein AN, 
Russell CA. Development of an adjuvanted, higher-dose, cell-based influenza vaccine:
combining advanced technologies to improve vaccine effectiveness. Expert Rev Vaccines.
2026;25(1):2667732. doi:10.1080/14760584.2026.2667732.^(4) World Health Organization.
Influenza (seasonal): fact sheet [Internet]. Geneva: WHO; 28 February 2025. Available
from: [https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)](https://edge.prnewswire.com/c/link/?t=0&l=en&o=4771871-1&h=606757097&u=https%3A%2F%2Fwww.who.int%2Fnews-room%2Ffact-sheets%2Fdetail%2Finfluenza-(seasonal)&a=https%3A%2F%2Fwww.who.int%2Fnews-room%2Ffact-sheets%2Fdetail%2Finfluenza-(seasonal))
cited 2026 Aug 28.^(5) Cadar AN, Martin DE, Bartley JM. Targeting the hallmarks 
of aging to improve influenza vaccine responses in older adults. Immun Ageing. 2023;20:
23. doi:10.1186/s12979-023-00348-6.^(6) Essink BJ, Vermeulen W, Andrade C, de Rooij
R, Isakov L, Casula D, et al. A randomised phase 2 immunogenicity and safety study
of a MF59-adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine(
aQIVc) in adults aged 50 years and older. Vaccine. 2025;51:126791. doi:10.1016/j.
vaccine.2025.126791.^(7) de Looze F, Essink BJ, van Boxmeer J, Andrade C, de Rooij
R, Casula D, et al. Immunogenicity and safety of higher-dose cell-based adjuvanted
quadrivalent influenza vaccines: combined results of randomised, controlled dose-
finding and dose-confirmation studies. Vaccine. 2026;79:128436. doi:10.1016/j.vaccine.
2026.128436.^(8) Ashraf M, Stein AN, Youhanna J, Rockman S, McMahon M, McGovern 
I, et al. The impact of egg adaptation and immune imprinting on influenza vaccine
effectiveness. Vaccine. 2025;62:127393. doi:10.1016/j.vaccine.2025.127393.^(9) Monto
AS, Petrie JG, Cross RT, Johnson E, Liu M, Zhong W, et al. Antibody to influenza
virus neuraminidase: an independent correlate of protection. J Infect Dis. 2015;212(
8):1191-99. doi:10.1093/infdis/jiv195.

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