CSL Seqirus has announced publication of pivotal phase 3 results for its MF59‑adjuvanted cell‑based higher‑dose quadrivalent influenza vaccine in The Lancet Infectious Diseases, marking what the company describes as an important milestone in influenza prevention for older adults. The trivalent formulation of the vaccine, marketed as AUJEMFLU, was approved earlier this year by the MHRA for adults aged 50 and above, and has also received European Commission approval.
The study is the first large‑scale evaluation of an influenza vaccine that combines three established approaches to enhancing protection in older adults: MF59 adjuvant, cell‑based manufacturing and a higher‑dose formulation. Each has been used separately for many years, but this is the first time they have been assessed together within a single vaccine.
Influenza continues to cause substantial illness, hospitalisations and deaths each year, with older adults particularly vulnerable due to age‑related decline in immune responsiveness.
Gregg Sylvester, Chief Medical Officer and Head of Research & Development at 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.” He added: “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 ESWI, said: “Influenza vaccine innovation has historically progressed through incremental advances in technology and manufacturing.” He added: “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.”
The phase 3 randomised, observer‑blind study enrolled 7,699 adults aged 50 and above across eight countries. It demonstrated superiority versus an adjuvanted egg‑based comparator across all four strains, non‑inferiority versus a recombinant vaccine for most strains, persistent immune responses throughout the season and a well‑tolerated safety profile.
