Australia’s first cell-based influenza vaccine hits the market
A new flu vaccine technology is now available to Australian pharmacies and general practices for the first time, with Seqirus announcing availability of its cell-based seasonal influenza vaccine, Flucelvax Quad.
The product is a quadrivalent influenza vaccine (surface antigen, inactivated, prepared in cell cultures) for use in the 2021 influenza season.
It is the first and only cell-based influenza vaccine available in Australia, approved by the TGA for use in adults and children nine years of age and older.
Cell-based technology is one of the most significant changes in the development of influenza vaccines for 70 years – a transition away from traditional manufacturing methods which have largely stayed the same since the 1930s.
Until now, all influenza vaccines supplied in Australia were made from viruses grown in hens’ eggs, but Flucelvax Quad is made from viruses grown in an advanced mammalian cell-culture system.
Growing influenza viruses in eggs may introduce changes called egg-adaptation, which can cause differences between the viruses in the vaccine and the WHO-selected strains, explains Seqirus.1,2,3
Flucelvax Quad was licensed based on results of two large randomised controlled trials (RCTs) conducted in children and adults that demonstrated the vaccine was generally well tolerated and elicited a protective antibody response to all four vaccine influenza strains.
The benefit-risk profile of Flucelvax Quad was considered favourable for the therapeutic use approved, stated the TGA.
Professor Robert Booy, an infectious diseases paediatrician from the University of Sydney, welcomed the arrival of a cell-based influenza vaccine in Australia.
“With Flucelvax in use overseas for almost a decade, it’s great to see the technology now available in Australia,” he said.
“This offers an additional option to health care providers and consumers and will be an important tool in the fight against influenza for many years to come.”
Flucelvax Quad will be available via pharmacies, GP clinics and other immunisation providers through the private market, as it will not be funded on the National Immunisation Program in 2021.
Availability of the vaccine in Australia comes off the back of Seqirus’ $800 million investment in a cell-based influenza vaccine manufacturing facility in Australia – to be located in Melbourne.
This means that in future years, Flucelvax Quad will be manufactured in Australia.
Official advice from the Federal Department of Health is that all Australians from six months of age should be vaccinated against influenza, with the Australian Technical Advisory Group on Immunisation advising a 14-day window between currently available COVID-19 and influenza vaccines.
The Australian Public Assessment Report for Quadrivalent Influenza Vaccine is available here
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- Paules CI et al. N Engl J Med. 2018; 378(1):7–9.
- Zost SJ et al. Proc Natl Acad Sci USA. 2017; 114(47):12578–12583.