The tense present and future of vaccines in Australia

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Australia’s framework for procurement and delivery of vaccines is about 15 years old. While it’s a reliable and cost-effective program, the coronavirus pandemic exposed the tired bits and changed our expectations about how vaccines are developed, regulated and valued.

The National Immunisation Program (NIP) was established in 1997 as the solution to low rates of vaccination and disparity among the states who were, until then, solely responsible for immunising the population. 

The NIP centralised decisions on which vaccines should be provided routinely and free of charge, it also eventually became a single-purchaser system with the Commonwealth responsible for negotiating the price and procurement of vaccines for the states to distribute.

The NIP protects Australians from 17 diseases and costs about $464 million each year, a mere fraction of the health budget, which includes the Medicare Benefits Scheme ($37 billion), National Disability Insurance Scheme ($24.6 billion) and the Pharmaceutical Benefits Scheme ($13.9 billion). 

Most vaccines aim to prevent morbidity from acute disease via personal protection and herd immunity. Some vaccines prevent longer-term complications of infection, such the human papillomavirus (HPV) which, combined with regular cervical screening, may nearly eliminate cervical cancer in Australia this decade.

The process of listing a vaccine on the NIP occurs in four stages:

• Therapeutic Goods Administration (TGA) approval
• The Australian Technical Advisory Group on Immunisation (ATAGI) considers efficacy and safety and recommends vaccines for use in general or specific populations
• The Pharmaceutical Benefits Advisory Committee (PBAC) considers efficacy and cost-effectiveness and recommends vaccine for the NIP
• The government makes final decision and begins procurement

That sounds super safe, affordable and effective so what’s the problem?

Difficulties begin with the slow and cumbersome NIP listing process. Once a vaccine is approved by the TGA, it takes an average of 1,375 days to be listed on the NIP. That’s close to four years. This time range can be quite variable too. It takes an average of 190 days to list a new influenza vaccine and 6,400 days for a new diphtheria/tetanus/pertussis vaccine.

What is clear is that the NIP process tends to be much slower than the PBS, which lists new medicines an average of 750 days after TGA approval.

Another frustration is the mixed messaging to clinicians and patients when a vaccine is recommended (ATAGI) but not NIP listed (PBAC), such as the meningococcal B vaccine. Given that ATAGI and PBAC overlap in advisory roles, they are ripe and reasonable targets for reform to streamline the assessment and approval process.

Won’t somebody think of the GDP?

On the most recent figures (2017-18), private industry in Australia spent $1.9 billion on medical research and development. Over the same period the university sector invested $3.7 billion and the government $640 million.

Appropriately, health benefits are the primary measure of a vaccine’s value and the headline figure considered is the incremental cost-effectiveness ratio (ICER). While an official cost-benefit threshold does not exist in Australia, vaccines are generally listed on the NIP if their ICER is less than $15,000 and are unlikely to be listed above $45,000. This cost comfort zone is comparable to the UK but tighter than Canada and Japan.

A 2021 report from Shawview Consulting, commissioned by Sanofi Australia, is critical of the approach taken by PBAC for calculating the economic value of vaccines. The report argues that increased participation from herd immunity, reduced sick and carer’s leave, post-market data and year-on-year benefits are undervalued at the point of PBAC assessment.

These arguments are industry-friendly, though there is a compelling example that suggests vaccines are indeed undervalued. in 2006, PBAC initially rejected the aforementioned HPV vaccine Gardasil for NIP listing despite an ICER < $44,000. 

A contemporary case is the use of nirsevimab for respiratory syncytial virus (RSV), a mostly seasonal infection that hospitalises about 7000 children under the age of five each year in Australia. 

Having been approved by the TGA in November 2023, nirsevimab is a monoclonal antibody, not a vaccine, but is a pre-emptive treatment that could reduce hospitalisation of infants by 80%. The Western Australian government has committed to funding a single dose for infants this year, and at the time of writing Queensland and NSW had announced similar intent, but with an ICER of US$100,000 it is unlikely to make it onto the NIP.

Epistemic pandemic

When COVID was no longer just an “Oh, it’s only over there” problem, an unprecedented collective global effort yielded effective vaccines, including the first mRNA vaccines, manufactured by the end of 2020. 

With swathes of the country confined to their homes and the economy battered to the tune of hundreds of billions of dollars, the economic argument for rapid vaccination was front and centre. 

Australia manufactured the AstraZeneca vaccine locally, though once that was abandoned we were, and still are, reliant on private sector relationships and international supply chains for mRNA vaccine supply (the Moderna mRNA manufacturing facility in Melbourne is on schedule for completion this year). 

The exact cost of the COVID vaccines remains confidential, though if just half of the cited $18 billion spent on prevention and treatment was directed to vaccines it would be enough to fund the entire NIP for 20 years.

The COVID pandemic, like many emergencies, demonstrated what is possible in a pinch. The lessons are simply that the economic benefits of vaccines matter, clear messaging is essential, the timeline from approval to delivery can be slashed, and that it is possible to rapidly develop and locally manufacture novel vaccines.

It just depends on what we’re willing to spend.

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