Cell-based flu vaccine manufacturing facility opens in Australia as flu season spikes early in Northern Hemisphere

CSL Seqirus has recently opened its new high-tech cell-based influenza vaccine and antivenom manufacturing facility in Melbourne, Australia.

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The facility will use innovative cell technology to manufacture seasonal and pandemic flu vaccines, as well as Australian antivenoms and the world’s only human vaccine for Q-fever.

 

The facility will help expand global access to cell-based vaccines at a time when the world is facing heightened concerns about pandemic influenza and the Northern Hemisphere is facing an early and elevated start to the flu season. The facility will replace CSL Seqirus existing egg-based vaccine manufacturing facility in Melbourne, marking the end of an era spanning 80 years in manufacturing innovation.

 

Cell-based influenza vaccines are designed to be an exact match to the WHO-selected influenza strains.1,2 They can help improve vaccine effectiveness by eliminating egg-adaptive mutations that can occur in the traditional influenza vaccine manufacturing process.2,3

 

Recently published real-world data showed that cell-based influenza vaccines were nearly 20% (19.8%) more effective at preventing test-confirmed influenza relative to traditional standard-dose egg-based vaccines, during the 2023-24 United States flu season.4

 

According to the Public Health Agency of Canada’s National Advisory Committee on Immunization (NACI), cell‑based influenza vaccines avoid egg‑adapted mutations that can reduce vaccine effectiveness. The NACI review highlights evidence supporting improved strain match and potential increases in effectiveness compared with standard egg‑based vaccines.4

 

In Canada, FlucelvaxR, a cell based seasonal influenza vaccine, has been approved and used since 2020.

 

The facility will be capable of producing enough seasonal flu vaccines annually to meet demand from regions including Asia, Europe, the Middle East and the Americas.

 

Hundreds of experts in manufacturing, engineering, quality control, regulatory affairs, product release and supply chain will work year-round, ensuring essential Northern and Southern Hemisphere vaccines reach clinics for major public health programmes.

 

 

Dave Ross, CSL Seqirus Managing Director, said “Cell-based vaccines are an important innovation in the fight against flu globally and have helped transform a more than 70-year-old manufacturing process. We are seeing more and more countries challenge themselves to improve their population protection and this facility will be an important pillar in meeting that ambition.”

 

Canada has reported an early and widespread start to the 2025–26 influenza season, with activity surging across all provinces and territories. FluWatch+ data show positivity rates climbing above 27 % in mid-December5 and peaking at over 33 % by the end of the month—levels not seen in recent years. Most cases involve influenza A (H3N2)6, and hospitalizations are rising. In response, the Public Health Agency of Canada and provincial health officials have urged eligible Canadians to get vaccinated without delay, warning that flu activity is accelerating weeks earlier than in previous seasons.10

 

Australia experienced an early and prolonged season in 2025 with its highest recorded lab-confirmed cases (439,000, 20% increase on previous record) and nearly 7,000 hospitalisations across 15 sentinel hospitals.11,12 The duration and severity of the flu season in Southern Hemisphere countries like Australia is one of the factors that can help to predict the upcoming Northern Hemisphere season.13, 14

 

Globally, the WHO estimates that flu infects 1 billion people annually, causing 3 to 5 million cases of severe illness and between 290 000 to 650 000 respiratory deaths.15

 

Dr Gregg Sylvester, CSL Seqirus Chief Health Officer, said “Influenza continues to significantly burden health systems and impact families all over the world. There is a strong body of evidence to show that differentiated, cell-based influenza vaccine technology is as an effective means of improving influenza protection. This is even more important as we look towards a potentially significant Northern Hemisphere flu season.”

 

Cell-based technology is also well suited to pandemic preparedness as it reduces reliance on large volumes of critical materials and is a modern, fast and highly scalable manufacturing method.16-18

 

In the event of an influenza pandemic, the facility and associated network will have the capability to rapidly produce over 150 million vaccines in the first wave of manufacturing to help protect many countries around the world, including Australia. 

 

Global experts agree the next flu pandemic is a matter of ‘when’ not ‘if’.19 Currently the 2.3.4.4b strain of H5 avian influenza is causing global concern after being detected in over 500 bird and 80 mammal species across all continents, except the Australian mainland.20,21

 

Avian influenza could cause a pandemic if it adapted to be able to spread rapidly from person to person. Influenza pandemics can have a significant impact as people have little to no immunity against the virus that causes the outbreak.22

 

- ENDS -

 

Site facts and figures

  • The site near Melbourne Airport will have a gross floor area of 28,400m2, larger than the Melbourne Cricket Ground (MCG) playing surface. The site features three key buildings, which will be used for:
    • Seasonal and pandemic cell-based influenza vaccine manufacturing
    • Antivenoms and Q-Fever vaccine manufacturing, and
    • Administration and laboratories
  • The facility has been electrified and incorporates on-site solar energy generation, heat and water recovery to preserve a healthier environment.
  • The new site features a digitally connected manufacturing environment, deploying advanced analytics that will drive innovation and optimise our manufacturing operations.
  • This includes a fully automated and paperless manufacturing execution system that will support our highly skilled workforce to optimise production, conduct predictive maintenance, improve quality control and reduce downtime.
  • Over 320 million doses of cell-based flu vaccines have been distributed worldwide from the Melbourne site’s sister facility in Holly Springs, North Carolina.


MEDIA CONTACT
Melanie Kerin
+44 7345 433260
Melanie.Kerin@Seqirus.com

 

About CSL Seqirus

CSL Seqirus is part of CSL Limited (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. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

 

About CSL

CSL (ASX: CSL; USOTC: CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses, CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 30,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.


References

  1. Rockman S, et al. Vaccines (Basel). 2023;11(1):52.
  2. Rajaram S, et al. Ther Adv Vaccines Immunother. 2020;8:2515135520908121.
  3. CDC. Cell-based flu vaccines. .cdc.gov/flu/vaccine-types/cell-based.html. Accessed December 2025.
  4. NACI Supplemental Statement – Mammalian Cell Culture-Based Influenza Vaccines https://www.canada.ca/en/public-health/services/immunization/national-advisory-committee-on-immunization-naci/mammalian-cell-culture-based-influenza-vaccines.html#:~:text=Supplemental%20Statement%20%E2%80%93%20Mammalian%20Cell%20Culture%2DBased%20Influenza%20Vaccines
  5. Influenza: Canadian respiratory virus surveillance report (FluWatch+) — Canada.ca
  6. 2026-jan-9-phe-epi-alert-influenza-rsven.pdf
  7. The Guardian. UK hospitals bracing for once-in-a-decade flu surge this winter. Available from: https://www.theguardian.com/society/2025/nov/14/flu-mutated-strain-uk-hospitals-winter-surge
  8. EuroNews. Experts warn: Spain faces severe flu after virus mutates. Available from: https://euroweeklynews.com/2025/11/10/experts-warn-spain-faces-severe-flu
  9. Influenza Pocket Guide 2025-2026
  10. Flu hospitalizations expected to 'increase sharply,' officials warn, as cases surge and vaccinations lag
  11. Australian Government. National Notifiable Disease Surveillance System. Available from: nindss.health.gov.au/pbi-dashboard/
  12. Australian Government. 2025. Australian Respiratory Surveillance Report. Available from: health.gov.au/sites/default/files/2025-11/australian-respiratory-surveillance-report-20-october-to-2-november-2025.pdf
  13. Chan et al. 2023. Can Commun Dis Rep. 49(11-12):494–500. doi: 0.14745/ccdr.v49i1112a05
  14. Zhang et al. 2019. Sci Rep 9, 3262. https://doi.org/10.1038/s41598-019-39871-2
  15. WHO. Influenza Burden. who.int/news-room/feature-stories/detail/the-burden-of-influenza. Accessed December 2025.
  16. CDC. Cell-based flu vaccines. .cdc.gov/flu/vaccine-types/cell-based.html. Accessed December 2025.
  17. Wright PF. N Engl J Med. 2008;358(24):2540-2543.
  18. Doroshenko A, et al. Expert Rev Vaccines. 2009;8(6):679-688
  19. WHO. The next flu pandemic: a matter of ‘when’, not ‘if’. emro.who.int/pandemic-epidemic-diseases/news/the-next-flu-pandemic-a-matter-of-when-not-if.html. Accessed December 2025.
  20. Wildlife Health Australia, Technical Update: Global High Pathogenicity Avian Influenza in Wildlife. wildlifehealthaustralia.com.au/Portals/0/Incidents/HPAI_Technical_Update.pdf. Accessed December 2025.
  21. Department of Agriculture, Fisheries and Forestry. Avian influenza (bird flu). agriculture.gov.au/biosecurity-trade/pests-diseases-weeds/animal/avian-influenza. Accessed December 2025.
  22. CDC. Types of Influenza Viruses. cdc.gov/flu/about/viruses-types.html. Accessed December 2025.

 

 

Intended Audience

This press release is issued from CSL Seqirus in Montreal, Canada and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products.