UK to Become First Country to Deploy CSL Seqirus Adjuvanted Cell-Based Flu Vaccine Aujemflu in 2027/28
核心洞察
The UK will become the first country worldwide to introduce Aujemflu (搜索) (aTIVc (搜索)), CSL Seqirus (搜索)' adjuvanted cell-based higher-dose influenza (搜索) vaccine, from the 2027/28 season.
Aujemflu (搜索) combines MF59 adjuvant, cell-based manufacturing and a higher dose formulation, the first flu vaccine to bring all three approaches together in one product.
The JCVI recommended the vaccine for adults aged 65 and over and at-risk adults aged 50 to 64, with MHRA approval granted in June based on a 7,699-participant Phase 3 study.
The United Kingdom will become the first country in the world to introduce AUJEMFLU (搜索) (aTIVc (搜索)), CSL Seqirus (搜索)' adjuvanted cell-based seasonal influenza (搜索) vaccine, from the 2027/28 influenza season under a strengthened partnership with the UK Government. The vaccine, approved by the MHRA in June for use in people aged 50 and over, was recommended by the Joint Committee on Vaccination and Immunisation (搜索) (JCVI) in July for adults aged 65 years and over as well as at-risk adults aged 50 to 64 who are more vulnerable to influenza complications.
Aujemflu (搜索) is the first influenza (搜索) vaccine to combine three proven approaches to enhancing protection for older adults in a single product: the MF59 adjuvant, cell-based manufacturing, and a higher dose formulation compared with standard influenza vaccines. Each approach has been used separately in influenza vaccines for many years with extensive clinical and real-world evidence behind it; the Phase 3 publication provides the first large-scale evaluation of their combination within a single vaccine.
Phase 3 Data Supporting Approval
Regulatory approval was supported by a pivotal, peer-reviewed Phase 3 randomised immunogenicity and safety study published in The Lancet Infectious Diseases. The randomised, observer-blind 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 (搜索) vaccine, or a recombinant quadrivalent influenza vaccine. The study evaluated immunogenicity, safety and manufacturing consistency.
The trial demonstrated superiority versus the adjuvanted egg-based influenza (搜索) vaccine comparator across all four influenza strains and age groups assessed, and non-inferiority versus a recombinant influenza vaccine for three out of four strains in the 50-and-over age group and four out of four strains in those aged 65 and over. Immune responses persisted throughout the influenza season, and the vaccine showed a well-tolerated safety profile, with most reactions mild or moderate and resolving within three days.
Each dose contains 45 micrograms of haemagglutinin per influenza (搜索) strain and 19.5 mg of MF59 adjuvant. Aujemflu (搜索) is administered as a single-dose injection into the upper arm by a doctor, nurse or pharmacist.
Mechanism of the Three-Part Formulation
The three components play distinct roles in older adults, whose immune systems become less responsive with age and less able to mount a strong protective response after vaccination. Cell-based manufacturing helps preserve a closer match to circulating influenza (搜索) strains, while the MF59 adjuvant strengthens, broadens and lengthens the immune response, and the higher dose formulation further enhances that response.
"This significant milestone builds on our decades of influenza (搜索) vaccine innovation and reflects our ongoing commitment to advancing influenza prevention," said Gregg Sylvester, Chief Medical Officer and Head of Research & Development at CSL Seqirus (搜索). "By bringing together our proven MF59 adjuvant and cell-based technologies in a higher-dose formulation, this new enhanced vaccine represents a significant advance in our portfolio of differentiated influenza vaccines."
Professor Adam Finn, an international vaccine expert from the University of Bristol, described the combination as "an obvious next step in the development pathway," adding that it "provides an opportunity to optimise the doses of both flu antigens and adjuvant to maximise protection while having an acceptable safety profile."
Influenza Burden in England
Influenza (搜索) continues to cause substantial illness, hospitalisations and deaths each year despite widespread vaccination programmes. The annual UK vaccination programme is estimated to have prevented 104,000 hospital admissions and 7,100 deaths in England during winter 2025/26. According to UK Health Security Agency (搜索) figures, there were an estimated 3,798 excess deaths associated with influenza in England during the 2025/26 season, with most of those deaths (3,442) occurring in the 65-and-over age bracket.
"Every winter, flu affects millions of families across the country, with older people among those particularly at risk," said Dame Diana Johnson, Minister of State for Public Health and Patient Safety. "That's why I'm proud that the UK is due to be the first country in the world to roll out a new vaccine next year targeted at older age groups along with existing vaccines."
Pandemic Preparedness Agreement Extended to 2031
Alongside the vaccine introduction, the UK Health Security Agency (搜索) has extended its pandemic Advance Purchase Agreement (APA) with CSL Seqirus (搜索) for a further four years through to 2031. Under the renewed agreement, the UK Government would have the option to purchase more than 100 million doses of pandemic influenza (搜索) vaccine from CSL Seqirus should a WHO-declared influenza pandemic occur, with manufacturing based entirely at the company's Liverpool facility.
The Liverpool site is the only injectable influenza (搜索) vaccine manufacturing facility in the UK and one of the largest biotechnology sites in Europe, employing more than 1,000 production workers. It combines seasonal influenza vaccine supply with pandemic and outbreak preparedness capability. Aujemflu (搜索) will be manufactured through CSL Seqirus (搜索)' global influenza vaccine network, with final production stages taking place at Liverpool.
"This strengthened partnership with the UK Government brings together a world-first vaccine introduction and a unique pandemic preparedness offering rooted in world-class manufacturing in northern England," said Marc Lacey, Global Executive Director at CSL Seqirus (搜索).
Supply Transition and Ordering
CSL Seqirus (搜索)' adjuvanted egg-based vaccine (aTIV) will continue to be available for the upcoming 2026/27 UK influenza (搜索) season. The announcement enables healthcare providers to begin ordering aTIVc (搜索) for the 2027/28 season, with planning and pre-ordering activities now underway. The trivalent formulation has been licensed for use in people aged 50 and above in the UK and by the European Commission, where it is marketed as AUJEMFLU (搜索).