The first cell-based Influenza vaccine in Australia has been approved for use in adults and children aged two years and older.
In a statement written to the Epoch Times, the Therapeutic Goods Administration (TGA) wrote that the Flucelvax Quad vaccine is the first and only cell-based flu vaccine available in Australia and approved for Australians two years of age and older.
“We want to make sure Australians have access to cell-based influenza vaccine technology,” said Jonathan Anderson, the head of the vaccine manufacturer in Medical Affairs for the Asia Pacific.
“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.”
The news comes after TGA approved the four-strained vaccine for Australians aged nine and older previously in 2020.
Seqirus UK Limited is developing the vaccine; the company has bases in UK, US and Australia and is one of the largest influenza vaccine companies globally.
The company is owned by CSL, a large biotechnology company based in Australia and responsible for manufacturing the AstraZeneca COVID-19 vaccine in Melbourne.
The four-strain vaccine contains two strains found in Singapore, one from Darwin and one from Washington, according to World Health Organisation’s recommendations in 2017.
Cell-based vaccines are different from previous Influenza vaccines in that the viral particles are produced in a mammalian cell culture rather than in chick eggs—the common method of making flu vaccines.
The benefits of cell culture vaccines are that it does not require a supply of fertilised chick eggs. Additionally, as viruses produced in eggs must undertake biochemical processes in the egg, there are concerns that the viruses will have variants introduced that are commonly found in birds rather than humans.
Whereas mammals are more closely related to humans, therefore variants introduced will be closer to those found in humans, and therefore believed to be more effective.
However, mammalian cell culture is around 40 percent more expensive than vaccines produced in eggs, and therefore will affect the global distribution of Influenza vaccines if cell-based flu vaccines become the mainstream.
Recent studies have shown that cell-based vaccines are generally more effective than egg-based flu vaccines.
Nevertheless, no clinical studies have revealed the actual efficacy of the Flucelvax Quad vaccine apart from the TGA review stating that the vaccine works just as well as other influenza vaccines in the market.
The vaccines are currently both approved by the TGA and the FDA in the US.
Common adverse effects (pdf) experienced by participants in the TGA clinical trials included pain and redness at injection site as well as headaches and fatigue.
Common unsolicited adverse effects included upper respiratory tract infection which affect around 3.5 percent of the sample and 3 percent reported symptoms of the common cold.
Post-marketing adverse reactions however included extensive swelling of the injected limb, allergic or immediate allergic responses including anaphylactic shock, prickly skin (pins and needles) and skin reactions such as itchiness, hives, and rash.
Flucelvax Quad will not be covered by the National Immunisation Program in 2022, though the company hopes it will be in future years.