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Cell-based Flucelvax® Quad influenza vaccine now approved for Australian children aged two years and older

• Flucelvax® Quad, Australia’s first and only cell-based influenza vaccine is now approved for children aged two years and older.1
• Flucelvax® Quad was first available in Australia in 2021 and now the TGA has approved its extended use in children down to two years for the 2022 influenza season.1
• Cell-based technology represents a significant innovation in influenza vaccine manufacturing.2
• More than 100 million doses of Flucelvax Quad® have been distributed worldwide.3

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Seqirus today confirmed that its cell-based seasonal influenza vaccine, Flucelvax® Quad [quadrivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures)] has been approved by the Therapeutic Goods Administration (TGA) for children aged two years and older. 

The four-strain vaccine is the first and only cell-based influenza vaccine available in Australia, approved by the TGA for use in adults and children two years of age and older. Flucelvax® Quad is available now for purchase via GP clinics, pharmacies, and other immunisation providers – it will not be funded on the National Immunisation Program in 2022.

Prior to 2020, there would typically be more Australian children aged under five hospitalised with influenza than any other vaccine preventable disease.4   

Data from seven major Australian hospitals from 2017 and 2018 found between 10-15% of children admitted with confirmed influenza needed intensive care and of all hospitalised children up to 84% were unvaccinated.4

“Young children and older adults are at a higher risk for serious influenza-related complications than the rest of the population, so this approval by the TGA is welcome news,” said Professor Robert Booy, leading infectious diseases paediatrician. “This offers an additional option to health care providers, parents and children and will be an important tool in the fight against influenza.”

Ahead of each flu season, the World Health Organisation (WHO) issues recommendations on which influenza strains should be included in the vaccines. These recommendations are based on which strains are predicted to be most problematic.5 

The production of Flucelvax® Quad using cell-based technology results in a close match to the WHO-selected strains.2,5-8

Dr Jonathan Anderson, Seqirus Head of Medical Affairs Asia Pacific, said there has been a major focus on the importance of vaccine science and technology in improving the health of all Australians in recent years. 

“We want to make sure Australians have access to cell-based influenza vaccine technology. Flucelvax Quad offers a choice when it comes to flu vaccination and it is important for patients to discuss options with their healthcare provider before a decision is made.”

“With our healthcare system facing pressure from COVID-19 and influenza this winter, achieving high influenza vaccination coverage is crucial in ensuring we help to reduce the strain on hospitals. This is even more important this year, and the expanded approval of Flucelvax® Quad will be timely to give more patients and health care professionals additional options”, confirmed Dr Anderson.

There were some adverse events recorded in clinical trials in children and adults but they were generally mild to moderate in nature.1 The most commonly reported were local injection site reactions - these being pain and redness.1 In addition, the most common systemic adverse events reported were headache, fatigue and irritability (in children aged 2-6 years). 

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following vaccination.1 Additionally, immunisation should be postponed in patients with febrile illness or acute infection.1 Flucelvax® Quad should not be used in individuals with a history of severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine.1

Please speak with your healthcare professional if you have any questions about flu vaccination, including which vaccine is suitable for you.
For over 100 years Seqirus – a CSL company – has been on the front line in the fight against influenza in Australia, and in 2022 we continue to build on this history of innovation by delivering this Australian-first vaccine to patients.

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MEDIA CONTACT

For further information or to request an interview, please contact:

Hamish Walsh

Account Manager
Palin Communications

hamish@palin.com.au

0422 424 338

Ruth Heenan

Senior Manager – Asia Pacific Communications, Seqirus

Ruth.Heenan@seqirus.com

0416 565 332

 

PBS Information: This product is not funded on the National Immunisation Program.

Consumer Medical Information available at www.seqirus.com.au/products

About Seqirus

Seqirus, a CSL company, is a leading provider of essential vaccines and pharmaceuticals. We have served Australia’s healthcare needs for over a century and today we develop, manufacture and source medicines that support the health and wellbeing of many thousands of people around the world.
SeqirusTM (Australia) Pty Ltd Melbourne, Victoria. ABN: 66 120 398 067 www.seqirus.com.au Seqirus Medical Information: 1800 642 865. Flucelvax® is a registered trademark of Seqirus UK or its affiliates. SeqirusTM is a trademark of Seqirus UK Limited or its affiliates. 

Date of Preparation: March 2022. ANZ-IV-22-0002

References

  1. FLUCELVAX® QUAD Approved Product Information
  2.  Rajaram S et al. Ther Adv Vaccines Immunother. 2020;8:1-10.
  3.  Seqirus data on file.
  4.  McRae JE et al. Commun Dis Intell (2018). 2020;44.
  5.  WHO. Recommended composition of influenza virus vaccines for use in the 2022 SH influenza season; Available from:https://www.who.int/publications/m/item/recommended-composition-of-influenza-virus-vaccines-for-use-in-the-2022-southern-hemisphere-influenza-season Accessed February 2022.
  6.  Barr et al. Vaccine. 2014 Aug 20;32(37):4713-25.
  7.  Mabrouk T et al. Dev Biol (Basel). 2002;110:125–134.
  8.  WHO. Influenza A(H3N2) lineage cell culture-derived CVVs for development and production of vaccines for use in the 2022 SH influenza season; Available from: https://www.who.int/publications/m/item/influenza-a(h3n2)-lineage-cell-culture-derived-candidate-vaccine-viruses-or-recombinant-vaccine-antigen(s)-for-development-and-production-of-vaccines-for-use-in-the-2022-southern-hemisphere-influenza-season Accessed February 2022.