CSL’s ‘super flu jab’, Flucelvax Quad, gets green light for use on toddlers

Australia’s health regulator has given CSL approval to inject its new generation of influenza vaccine on children as young as two years old.

Flucelvax Quad is a new type of cell-based influenza vaccine, which CSL says is significantly more effective than conventional protein-based shots grown in eggs.

CSL’s new generation of influenza vaccine — dubbed its ‘super jab’ — has won regulatory approval for use on toddlers ahead of the winter cold season and amid record demand for its flu shots.

Flucelvax Quad is a new type of cell-based influenza vaccine, which CSL says is significantly more effective than conventional protein-based shots grown in eggs. It also allows the company to produce higher volumes at shorter notice.

CSL’s vaccine division Seqirus has sold more than 100 million doses since the Therapeutic Goods Administration approved its general use last March. Sales are expected to soar higher after the regulator extended that approval this week to children as young as two years old.

It comes as health experts warn that this year’s flu season will be the worst since the Covid-19 pandemic began, following the reopening of the international border and Australians move about more freely.

Seqirus head of medical affairs Asia Pacific, Jonathan Anderson, said the new influenza jab aimed to help take pressure off the health system.

“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,” Dr Anderson said.

“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.”

Children younger than five, as well as the elderly, are at a higher risk of severe influenza infections, with about 10 per cent who go to hospital needing intensive care treatment, according to NSW Health.

Seqirus head of medical affairs for Asia Pacific Jonathan Anderson says ‘achieving high influenza vaccination coverage is crucial in ensuring we help to reduce the strain on hospitals’.

But Flucelvax Quad — which costs $40 a shot — is not yet available on the government-funded National Immunisation Program. Only a handful of brands are available for free on the program and are all protein-based vaccines.

Children as six months old can be vaccinated against influenza but only via conventional protein-based jabs.

Although available only for private purchase, infectious diseases paediatrician Professor Robert Booy, said Flucelvax Quad “offers an additional option to health care providers, parents and children and will be an important tool in the fight against influenza”.

“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,” Professor Booy said.

It comes as CSL has withdrawn its research on Covid-19 vaccines, focusing more on cell-based jabs for influenza and bird flu. The company is currently building an $800m cell-based influenza factory in Melbourne that is scheduled to open in 2026.

Seqirus’s revenue surged 17 per cent to $US1.69bn ($2.28bn) in the six months to December 31. It sold a record 110m doses of seasonal influenza vaccine during the period. CSL’s overall revenue firmed 5 per cent to $US6.04bn.

Morgan Stanley analyst Sean Laaman said: “CSL‘s flu vaccine business Seqirus continues to surprise on the upside” and should give investors hope about its $16.4bn takeover of European renal treatments company, Vifor Pharma.

“CSL’s ongoing outperformance in vaccine execution should provide investor confidence regarding the proposed acquisition & integration of the other “non-plasma” business of

Vifor,” Mr Laaman wrote in a note to investors.

Seqirus advised of “some adverse events” for Flucelvax Quad recorded in children and adults during clinical trials.

“But they were generally mild to moderate in nature,” the company said.

“The most commonly reported were local injection site reactions — these being pain and redness. In addition, the most common systemic adverse events reported were headache, fatigue and irritability (in children aged two to six years).”