CSL Seqirus says manufacturing setbacks have left Australia with just a few hundred doses of Q-VAX, with normal supplies unlikely to be restored until 2027.
Australia is facing a six-week stockout of its only registered Q fever vaccine, with manufacturer CSL Seqirus warning that just a few hundred doses remain nationally and no further supplies are expected to be distributed until the end of the year.
The shortage threatens access to vaccination for people working in high-risk occupations, including livestock farmers, abattoir workers, and veterinarians, particularly in Queensland, one of the country’s largest markets for the vaccine.
CSL Seqirus senior vice-president of operations Chris Larkins told The Medical Republic that a series of unrelated manufacturing problems had prevented the company from rebuilding its safety stock, leaving supplies critically low.
“We’re down to a few hundred doses at the moment, which will run out shortly, and then we won’t have material to be shipped until the end of the year,” he said.
“It’s a short-term temporary stockout, but probably about six weeks.”
Mr Larkins said the company had been attempting to recover from earlier supply problems for more than a year, but further manufacturing setbacks had affected several batches that were expected to restore inventory.
“We expected and targeted to get inventory back up above our safety stock levels, which gives us three or four months’ supply just sitting in the warehouses,” he said.
“The loss of those batches due to various different issues has meant that the safety stock inventory hasn’t been replenished.”
Mr Larkins explained that the problems began several years ago with disruptions to egg supplies used in vaccine manufacturing, followed by difficulties with filling lines at the company’s ageing Parkville facility in Melbourne.
Mr Larkins said the complexity of manufacturing Q-VAX meant even isolated production failures could have prolonged consequences.
“[The] Q fever vaccine is a very complex product to manufacture, and it takes a long time,” he said.
“It’s a nine-month process before you manufacture a single batch. We do an enormous amount of safety testing… in the order of three or four months’ worth of just testing done on each batch.
“When you do have issues with batches, especially if you have a number of them in a short period of time, it’s difficult to recover.”
He said the company could not simply manufacture replacement batches within weeks.
“You’re almost looking close to a year before you can replenish, and that’s been part of the issue,” he told TMR.
The vaccine is manufactured exclusively for the Australian market, with no comparable alternative available.
Mr Larkins said national demand was approximately 3000 doses a month, highlighting the importance of maintaining sufficient reserve inventory.
The company is now transitioning production from its legacy Parkville facility, which is due to close at the end of 2026, to new manufacturing facilities at Broadmeadows and Tullamarine.
Mr Larkins said the newer facilities, which began operating earlier this year, offered greater capacity and more automated production.
“We do think we’re past the problems of the supply issues with this product with our new facilities,” he said.
However, the lengthy production and testing process means vaccines manufactured at the new facilities were only now approaching release.
CSL Seqirus expects approximately three months’ worth of vaccine supply to become available towards the end of December, with doses likely to reach vaccination providers in January, Mr Larkins said.
Further batches are scheduled for February and April or May, with the company expecting to rebuild its normal three-to-four-month safety stock by mid-2027.
“I think by the middle of next year, we will be back to the point where we have our full amount of safety stock, you know, three or four months on the shelf that’s just being replenished every month,” Mr Larkins said.
The manufacturer has accelerated production of the next batches, which were originally scheduled for February.
“We’re working around the clock at these two facilities to get these batches out before Christmas,” Mr Larkins said.
“The original planning for them was February, and we’ve brought them forward. But that’s the best we can do.”
For GPs and occupational health providers, the shortage creates uncertainty around pre-vaccination screening and immunisation of workers at risk of exposure to Coxiella burnetii, the bacterium responsible for Q fever.
Vaccination requires assessment of previous infection or vaccination, including serological and skin testing, because people with existing immunity can experience significant adverse reactions if vaccinated.
Asked what people and businesses should do while vaccine supplies were unavailable, Mr Larkins said they should seek advice from their state workplace safety and health authorities.
“What people need to do, and what businesses need to do, is talk to their state WorkSafe and health departments to determine what the best thing for them is to do if they can’t get it,” he said.
Mr Larkins acknowledged that Queensland was one of the company’s biggest markets for Q-VAX, although the vaccine was distributed nationally.
He said CSL Seqirus had previously warned customers of constrained supply but felt it was important to communicate the impending complete stockout.
“Coming out and saying, ‘Look, we’re actually moving into a short, a full-on stockout,’ is what we felt it was our responsibility to do,” he said.
“Even though it is short, we feel it’s the right thing to do.”
Mr Larkins said restoring reliable supply was now the company’s highest priority.
“This is the number one priority for the company at the moment,” he said.
“We’ve invested an enormous amount in these new facilities, which will be much higher capacity, more robust supply coming from them.”
Related
The Therapeutic Goods Administration’s medicine shortages database lists Q-VAX as having limited availability due to manufacturing issues, with the shortage period extending from 12 January 2026 to 31 January 2027.
The regulator says CSL Seqirus is closely controlling distribution of the remaining stock.
According to latest figures from the Australian Centre for Disease Control’s National Communicable Disease Surveillance Dashboard, there have been 638 cases of Q fever in Australia so far this year (as at 12 November).
The bulk of cases of the notifiable disease have been in Queensland (301 cases), NSW (256 cases), and Victoria (58 cases).
Between 2013 and 2023, cases had hovered around 450 to 600 cases each year. But in 2024, cases increased to 881, then in 2025 Australia had the highest number of cases ever recorded at 912, according to the Australian CDC.
A TGA spokesperson told HSD that CSL had previously informed the department that supply of the vaccine would be impacted from 12 January 2026 to 31 January 2027 “due to manufacturing issues”.
“Q-vax is the only available Q fever vaccine and no other products are available globally,” he said.
“The Department of Health, Disability and Ageing recognises the concerns raised by agricultural businesses and workers about difficulties accessing Q fever vaccination, particularly in regional and remote communities.
“Health practitioners and patients should refer to their relevant state or territory health department and/or workplace safety authority for information on vaccination providers and exposure risk.”
Q fever is an infectious disease spread from animals like cattle, sheep, goats, camels, and kangaroos. People who work around animals are most at risk, but those who live nearby can also be exposed.
It causes flu-like symptoms, such as fever, sweats, and fatigue. Although most cases are mild, it can cause serious disease and long-lasting health impacts for months or even years.
The bacterium that causes Q fever can survive in the environment for a long time. It can also spread through dust and be carried over long distances by the wind.
Infection can also occur through direct contact with infected animal tissue or fluids on broken skin (e.g., through cuts with contaminated knives or needle-stick injuries when working with animals).
Consuming unpasteurised (raw) milk or milk products from infected animals may carry a risk of contracting the infection.
Tick-to-human transmission occurs infrequently, through tick bites, breathing in tick excreta or direct contact (e.g., removal of ticks from domestic animals, aerosol-generating activities such as shearing, or crushing ticks with bare hands).
Person-to-person spread of infection is rare but can occur through blood transfusion and mother to-baby transmission.
