In just a few short weeks the Trump administration has halted, overturned, defunded or revised vaccine-related research programs, approvals processes and public health guidance, with steps underway to downgrade or even eliminate independent expert advice. The predictable result is chaos in health agencies and confusion among the public — all at a time when measles outbreaks are spreading and a H5N1 bird flu pandemic is feared.
Trump’s decisions have far-reaching international consequences. American leadership of vaccination efforts in developing countries has evaporated, along with USAid funding for the programs. New Covid-19 variants are being discovered monthly and an array of other viruses are threatening — among them Marburg, Ebola and other haemorrhagic infections in Africa, Hendra and Nipah viruses in Southeast Asia, Japanese encephalitis in Australia and Asia, and mpox internationally. Many countries, Australia included, purchase essential vaccines from the United States, but its traditional primacy in developing and manufacturing new vaccines is threatened by major cuts to research funding.
On top of all this, misinformation about vaccine safety is pervasive, as is the growing vaccine hesitancy that has led to outbreaks of preventable diseases such as measles, polio, pertussis and hepatitis in many countries. And Trump’s withdrawal of the United States from the World Health Organization has undermined the ability to detect threats abroad and endangered negotiations over a pandemic treaty.
Public health experts in both the United States and Australians are watching with dismay as decades of global progress are put at risk. It seems pointless to expect Trump, his health secretary Robert Kennedy Jr, or his chief staff-slasher Elon Musk to reverse course. But can Australia avoid America’s backwards slide and even become a world leader in vaccines?
One clue lies in what’s happening on the ground in the United States, where the measles outbreak has spread to at least fifteen states. Despite Kennedy’s obfuscation — he has blamed poor diet for the outbreak, pushed vitamin A and other questionable treatments, and insinuated that measles infection confers a lifetime immunity that vaccination does not — many Americans, even vaccine sceptics, now realise they must get vaccinated. Shortages of the measles, mumps and rubella vaccine, or MMR, have been the inevitable result, especially in Texas.
Australians, meanwhile, have grown complacent about diseases, like measles, that are no longer common. (In recent years the only cases reported have been brought in by international visitors). The average immunisation rate among young children in Australia comes close to the goal of 95 per cent (and it’s pleasing to see that immunisation rates for Aboriginal and Torres Strait Islander five-year-olds are higher than that). But rates have been falling overall, and parts of Australia are now vulnerable to disease outbreaks. Vaccination rates for children in the Richmond Valley, on the Gold Coast Hinterland and in Noosa, for example, are as low as 75 per cent and many adults are not fully immunised.
Australian authorities should also be cognisant of the vulnerability of Australian supplies of the MMR vaccine. The Merck and GSK vaccines approved for use in the United States are also approved in many other countries, including Australia, and shipments meant for export could be diverted for American use. The vaccine is made in Australia by Sequirus (part of CSL) but it’s not clear how much of the market they represent. An audit of local (and maybe Pacific Island) MMR vaccine supplies and potential demand would seem to be in order.
Although Kennedy has called the measles outbreak “a call to action for all of us” he has failed to make a strong case for vaccination. Whatever value might be attributed to his statement that “MMR vaccine is crucial to avoiding potentially deadly disease,” it was immediately undermined by the announcement that the Centers for Disease Control and Prevention is planning a large study looking into potential connections between vaccines and autism, despite all the research showing they are not linked.
The waste inherent in this ideologically driven exercise seems to have escaped Elon Musk’s cost-cutters. But it will revitalise the anti-vaxxers and worry vaccine sceptics globally. Already a newly elected Western Australian crossbencher, Legalise Cannabis WA leader Brian Walker, has suggested that childhood MMR vaccinations may cause autism and should be delayed.
As concerns rise about the potential for an H5N1 pandemic in humans in North America, Kennedy has interrupted efforts to increase the development and availability of bird flu vaccines, directing his department to re-evaluate a US$590 million contract with vaccine developer–manufacturer Moderna. Signed in the final days of the Biden administration, the contract would have helped Moderna develop and test mRNA vaccines, which are designed to protect against five subtypes of influenza, including H5N1, that could prompt pandemics.
The official rationale for the re-evaluation is that “four years of the Biden Administration’s failed oversight have made it necessary to review agreements for vaccine production.” But experts worry the decision could be a prelude to cancelling a contract they believe is critical to the country’s efforts to be ready for a bird flu pandemic.
The work on mRNA vaccines is especially important for bird flu. Most flu vaccines are currently made using a decades-old approach whereby viruses are grown in hen’s eggs and then inactivated. Production is slow and reliant on huge quantities of eggs, the supply of which is now threatened by outbreaks of H5N1 and other bird flu viruses.
H5N1 hasn’t so far been found in Australia, but it is already in Antarctica, where it is killing seabirds (many of which are migratory) and seals. Australian authorities need to be prepared for its arrival.
The other clue lies in Australia’s capacity to rise to the challenge. The good news is that Australia has a sterling reputation in vaccine research and development and has benefited significantly from the vaccine manufacturing capacity of CSL (once the government-owned Commonwealth Serum Laboratories), which has expanded internationally in recent years. Lessons learned from the Covid-19 pandemic and highlighted in the Halton report to the Australian government have underlined how important forward planning, vaccine readiness and self-sufficiency are in times of crisis.
The bad news is that Australia seems not to be taking an efficient, team-based approach to the threats. As the world marks the five-year anniversary of Covid-19 emergence, public health experts warn that Australia remains “grossly unprepared” for a future pandemic.
Last November Australian National Audit Office announced that it was looking into “the effectiveness of the procurement and contract management of onshore-manufactured antivenoms and vaccines” during 2020–22. This evaluation appears also to be looking at the Australian government’s $2 billion agreement with the US pharmaceutical firm Moderna to set up vaccine manufacturing in Australia. The deal was done with an overseas firm despite the fact that Seqirus, the CSL vaccine business based in Melbourne, had offered to make vaccines here more cheaply.
Using publicly available resources, it’s possible to trace how Australia’s shambolic efforts to secure adequate quantities of Covid-vaccine unfolded after health minister Greg Hunt responded to intense pressure by announcing on 13 May 2021 that the Morrison government would test the market for local manufacture. Hunt acknowledged that the government was already negotiating with Moderna about a new local facility, a fact that the company had disclosed to investors the previous day.
Despite a cheaper proposal from CSL, which already had facilities being built but didn’t yet have an approved COVID mRNA vaccine, the government announced in December 2021 that Moderna would build a manufacturing plant at Monash University capable of producing up to 100 million doses of vaccine a year. Commonwealth funding of $2 billion was included in the government’s 2022–23 Mid-Year Economic and Fiscal Outlook.
A media release from Monash University, dated 21 April 2021, had previously announced that the Victorian government would invest $50 million in mRNA Covid-vaccine manufacturing at the university. It noted that a team of Monash University researchers had developed Australia’s first COVID-19 mRNA vaccine candidates the previous year, and had received a Medical Research Future Fund, or MRFF, grant in collaboration with the Doherty Institute to develop the vaccine. Further MRFF funding would finance a Phase 1 clinical trial.
The Department of Health and Aged Care announced the deal in these terms: “The Australian government has entered into a ten-year partnership with Moderna and the Victorian government that will see Moderna build an mRNA vaccine manufacturing facility at Monash University Victoria.” Interestingly, the statement links to a media release from prime minister Anthony Albanese, dated 14 August 2022. Labor appears to have concluded the deal initiated under Morrison.
In a 28 September 2022 interview with health minister Mark Butler, Radio National’s Patricia Karvelas enquired about vaccine contracts and negotiations underway with Moderna and Pfizer at that time. Intriguingly, Butler made no mention of the government’s efforts to develop onshore vaccine manufacture for COVID vaccines — although he did say he had met with the global head of Moderna just that week.
Making the dates align here is a challenge. My guess is that, at the height of the Coalition government’s failure to secure an adequate and timely supply of Covid-19 vaccines for Australia, Morrison and Hunt looked to link up with what Victoria was doing with Monash University and the Doherty Institute, and then Moderna was somehow invited in, pushing CSL aside. The final deal was presumably struck under the Albanese government, which came to power in May 2022.
Unknown at this point is whether Moderna stood to gain any mRNA intellectual property from ground-breaking work funded by the federal and Victorian Governments, and if so, what was paid for this. Also unknown (although this is likely to be investigated by the Audit Office) is whether the deal won the Morrison government better prices on their Moderna vaccine purchases.
Work on the vaccine manufacturing facility at Monash began in December 2022. Two years later, on 4 December last year, Butler issued a media release announcing that “the Southern Hemisphere’s only mRNA manufacturing facility has opened in Victoria.” The facility will have the capacity to produce up to 100 million vaccine doses each year for a range of respiratory diseases including Covid, influenza, and respiratory syncytial virus.
Moderna says it will supply vaccines for the Australian winter respiratory season in 2025. But one important milestone is still to be met: the facility must gain regulatory approvals from the Australia’s Therapeutic Goods Administration — and from authorities in countries like the United States if there are plans to export its vaccines overseas.
The Moderna partnership will face some serious local competition. Despite failing to win the federal–state mRNA contract, CSL/Seqirus has affirmed its commitment to accelerating its proprietary self-amplifying mRNAx vaccine program. These sa-mRNA vaccines have better immunogenicity than conventional mRNA vaccines. A sa-mRNA vaccine against the JN-1 Covid variant produced by CSL with Arcturus Therapeutics is approved in Japan for immunisation in adults eighteen years and older.
The Victorian government also has a strategic partnership with BioNTech, announced in December 2023, that will see the company establish a clinical-scale mRNA manufacturing facility and an mRNA Innovation Centre in Melbourne. BioNTech partnered with Pfizer to develop the mRNA vaccine licensed as Comirnaty, which was the first Covid vaccine to receive regulatory approval in Australia. The company is also working on mRNA platforms for cancer drugs, and this may be its major focus in Victoria.
In New South Wales the Perrottet government announced in September 2021 that it would make a $96 million investment in a pilot facility to spearhead a local RNA and mRNA manufacturing industry. The facility, in partnership with all NSW universities, will include laboratories and pre-clinical trial spaces that will enable early-stage mRNA-based drug development. Progress towards this goal has been slow: construction of the site at Macquarie University only commenced in September last year.
Universities and research institutions in other states are also moving ahead with research, testing and manufacture of mRNA vaccines and medicines. The University of Queensland and the Brisbane-based biotechnology company Vaxxas are developing a microneedle patch-based mRNA vaccine for Covid. Moderna is also a partner in this effort. (The patches deliver the vaccine to immune cells below the skin’s surface without the need for needles or a cold-chain.) Some small-scale manufacture of these patches appears to have taken place, but where will future large-scale manufacture occur? The chances are it will be one more Australian biomedical success story that moves offshore. Or will Moderna come to the rescue with their new facility in Victoria?
There is much to celebrate in this explosion of effort. The key story here is the strength of Australia research and development in this important and burgeoning new area of mRNA-based medicines and vaccines. These efforts are an important aspect of preparedness and self-sufficiency for any future pandemic. Relying on a single manufacturer and/or supplier would have its dangers, and competition might help with keeping vaccine prices low. A strong capacity could also enable Australia to help with vaccine supplies to developing nations, especially in the South Pacific.
But Australia has too often failed when it comes to commercialising research. That summary of vaccine-related research and development efforts reveals insufficient coordination and cooperation in the expensive business of scaling up manufacturing.
True, a $10 million April 2023 grant from the Albanese and Malinauskas governments will help the South Australian firm BioCina scale-up and produce mRNA vaccines in quantities sufficient for clinical trials (though not for mass production.) And the NSW government is building a large-scale manufacturing facility for mRNA vaccines targeted at animals, but vital for controlling outbreaks, because it turns out that all the other facilities being built in Australia are only for human vaccines. (It’s pertinent to note here that CSL used to make vaccines for livestock and domestic animals but sold its Animal Health business to Pfizer in a deal finalised last year.)
And you do have to ask how much vaccine capacity a nation of twenty-seven million people needs and how much it can afford. Just as there are dangers in putting all our manufacturing eggs in one basket there is also a danger of being seduced into financing state rivalries and spending valuable government funds on duplicative efforts. A national, team-based approach is needed. Is this a task for the new Australian Centre for Disease Control?
Finally, as Australian journalist Natasha Robinson points out, Australia is building an impressive vaccine capacity at a time when vaccine hesitancy is growing. Developing new vaccines for emerging infectious diseases and achieving vaccine self-sufficiency must be accompanied by transparency about how these vaccine have been tested and approved and public education programs about why they are so important. •
