Cell-based influenza vaccine approved for kids 2+

Seqirus’s cell-based seasonal influenza vaccine, Flucelvax Quad (quadrivalent influenza vaccine — surface antigen, inactivated, prepared in cell cultures), has been approved for Australian children aged two years and older.

The four-strain vaccine is said to be 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.¹ The vaccine is available now as a private prescription.

Data from seven major Australian hospitals from 2017 and 2018 found 10–15% of children admitted with confirmed influenza needed intensive care across these seasons and that, of all hospitalised children, up to 84% were unvaccinated.⁴

During three influenza seasons, participants from eight countries, including Australia, were enrolled in an observer-blinded, randomised clinical trial comparing Flucelvax Quad with a non-influenza vaccine. This study confirmed that Flucelvax Quad led to a robust immune response in children aged two to 18 years.³

Infectious diseases paediatrician Professor Robert Booy said, “Cell-based influenza vaccine production is an alternative to traditional egg-based manufacturing where reference influenza viruses are grown inside fertilised hens’ eggs. Egg-based manufacturing can result in mutation of the influenza virus leading to a mismatch between the World Health Organization’s (WHO) selected influenza strains and the strains contained within the seasonal influenza vaccine.^5–7

“Cell-based flu vaccines, grown in mammalian (animal) cells, are designed to produce a closer match by avoiding egg-adapted mutations, which may result in greater effectiveness in some seasons.”^{2, 5–8}

Professor Booy said cell-based vaccine technology may also offer additional advantages, including increased scalability and production speed in the event of an influenza pandemic.²

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

“With our healthcare system facing pressure from COVID-19, 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 patients and healthcare professionals additional options,” said Dr Anderson.

Availability of Flucelvax Quad in Australia follows Seqirus’s $800 million investment in a cell-based influenza vaccine manufacturing facility in Australia, to be located in Melbourne.

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 (erythema).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 (eg, anaphylaxis) to any component of the vaccine or to a previous dose of any influenza vaccine.¹

References

<sup>1. FLUCELVAX® QUAD Approved Product Information
2. Rajaram S et al. Ther Adv Vaccines Immunother. 2020;8:1-10.
3. Nolan, et al. N Engl J Med 2021; 385:1485-1495.
4. McRae JE et al. Commun Dis Intell (2018). 2020;44.
5. Wu NC et al. PLoS Pathog. 2017;13(10):e1006682.
6. Skowronski DM et al. PLoS One. 2014;9(3):e92153.
7. CDC. Cell-based flu vaccines. Available from: www.cdc.gov/flu/prevent/cell-based.htm. Accessed November 2021.
8. Paules CI et al. N Engl J Med. 2018;378(1):7-9.</sup>

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