This weekend, scores of staff at Australia’s drug regulator are poring over last-batch data from manufacturer Pfizer. It is expected they will approve the pharmaceutical company’s coronavirus vaccine this week. The clearance will be welcomed, but there is growing angst within state and territory governments about how the rollout will be handled and whether Scott Morrison has thrown premiers a hospital pass.
“It feels like a theme is developing,” a senior Victorian government official tells The Saturday Paper, “where the feds get to make the shiny announcement and disappear when things get tough.”
While vaccination of front-line workers, quarantine employees and aged and disability care staff and residents is due to begin in mid- to late February, precious little detail has been given to premiers and state health ministers who will be largely responsible for the logistics.
In addition to Victoria’s concerns, ministers in Queensland and New South Wales have shared misgivings about the arrangements.
“I do sense anxiety about vaccine choice, supply and rollout,” one Queensland minister said.
In that state, for example, decisions about precisely which hospital workers will receive the vaccine in the first round have been left to local health districts.
“I know there are tensions within hospitals about which clinicians will get it. Anaesthetists may not,” a Queensland government source says.
Other officials noted that ear, nose and throat doctors are also likely to miss out in the first round. Those who do get vaccinated first will mostly be receiving the AstraZeneca vaccine, which interim studies show has an efficacy of 70 per cent after two doses.
Some clinicians want the Pfizer shot, which has been observed to be 95 per cent effective in research trials, but which Australia cannot get access to in significant quantities.
“These are really knowledgeable and smart people,” a source in the Queensland government says. “They’re doctors, and they tend to be very loud about it and they’ve read the studies for themselves and are asking why they aren’t being given the Pfizer vaccine.
“Obviously, when we thought the coronavirus was going to be all death and destruction like it is in the United Kingdom and the USA, that might have been really important. But we are now in a position, because we’ve managed it so well, that AstraZeneca’s product will be okay.”
Australia announced its deal with AstraZeneca in August, before the vaccine’s effectiveness was known. Deals with Pfizer and a smaller firm, Novavax, were announced in November. A deal with the University of Queensland and CSL had to be abandoned when trials produced false positives for HIV.
Australia’s deal with AstraZeneca is for 53.8 million doses of the recombinant adenovirus-vectored vaccine. Novavax, which is producing a vaccine on a tried-and-true “subunit” platform, has agreed to supply Australia with 51 million doses during this year. The announcement of first results from its phase 2b trial is imminent.
But the apparent frontrunner worldwide, the Pfizer vaccine, was largely subscribed by the time Australia sought access to it. And the Australian government was only able to lock in 10 million doses, which will vaccinate five million people.
These Pfizer doses are not even in the country, and it will be some time before there is scope to secure more. The Department of Health puts it like this: “Australia will have the option to purchase additional doses where supply is available.”
Another vaccine from Moderna, which uses the same mRNA platform as Pfizer and has achieved 94 per cent efficacy, is also fully subscribed. There is no hope Australia will secure any of its product until 2022.
It is the nature of a crisis for people to ask whether things could’ve been handled better. But that question has grown louder this month: Has the federal government botched the Covid-19 vaccine program?
The answer is not simple. Labor says yes. Epidemiologist Professor Allen Cheng says no.
Cheng, who co-chairs the Australian Technical Advisory Group on Immunisation and chairs the Advisory Committee on Vaccines, along with his duties as deputy chief health officer in Victoria, tells The Saturday Paper that Australia “could easily have been in a position” where none of its vaccine deals were for a product that worked.
“If you’d asked me a year ago if we would have two vaccines to choose from right now, I would not have said no,” he says. “You have to remember, very few vaccines in development actually ever make it to market. The proportion of those that do is very low.”
Still, he says, entering into any vaccine supply agreement in the throes of a fast-evolving pandemic is a gamble. “It’s a bet you make with different deals and different companies,” he says. “You can always be smarter in retrospect.”
Labor’s Health spokesman, Chris Bowen, says the Coalition was late to the table and did not sufficiently hedge those bets. The outcomes of those decisions are playing out now. “The first deal around the world was done in March,” Bowen says. “We didn’t get a deal until September and now it is very difficult for the government to catch up because these companies are very strongly committed around the world to other deals that they already have.
“The government said we were first in the queue. It was nonsense then and it is nonsense now. Many countries have five or even six vaccine deals. Very few countries have as few deals as we do.”
Even with widespread domestic vaccination, Australia’s international borders are unlikely to reopen before the end of this year. That is because this is a global problem and, ultimately, we need to vaccinate the world.
There is another unanswered question with each of these vaccines: Can they do more than just prevent a person getting Covid-19?
Professor Cheng says nobody yet knows if any vaccine can stop transmission of the SARS-CoV-2 virus from one person to another. There are doubts, too, about whether the drugs can prevent asymptomatic infections – that is, cases where the virus is spread by people who do not show signs of the illness.
AstraZeneca tested for this and found asymptomatic cases could be prevented in 59 per cent of people in the trial, but only for those who received a low dose first and a standard-strength second dose. For those who received standard doses at both intervals, efficacy plunged to just under 4 per cent.
Pfizer, on the other hand, did not initially test for this but says its trial was designed to collect data on asymptomatic cases and that it is currently analysing its results. Moderna may offer better protection against severe infections and there are early signs it has some effect on reducing asymptomatic cases.
The National Institutes of Health in the United States says, “Additional analyses are underway of the incidence of asymptomatic infection and viral shedding post-infection to understand the vaccine’s impact on infectiousness.”
What this means, Professor Cheng says, is that we need to look beyond the headline efficacy figures of Covid-19 vaccinations. If they prevent transmission – and stopping asymptomatic carriers is a key plank in this strategy – then that is a huge deal, one that may upend Australia’s entire vaccination strategy.
“If we knew that the vaccinations could control transmission, then in theory you might actually give them first to the most socially active people,” Cheng told The Saturday Paper.
Just two days after our interview, reports emerged that the British government was preparing to pivot its vaccine rollout to office workers using public transport, school students, teachers and police – among others – as soon as clear evidence emerged that transmission could be curtailed.
National Centre for Immunisation Research and Surveillance director Professor Kristine Macartney told the ABC’s 7.30 on Tuesday that herd immunity data is not yet available in detail and needs to be analysed “in very big numbers”.
“We’ll probably learn the most about the transmission impacts once we see countries starting to have significant numbers of people vaccinated,” she said.
“One country that is starting to get there is Israel and they’ve almost vaccinated a quarter of their population. Their epidemic curve is on the way down. It’s too early to say whether it is all the vaccine, but we’ll learn more from Israel soon.”
In Australia, some 680,000 people are included in the first wave of vaccinations, with a further 6.1 million people in the second. These nearly seven million people will include the general elderly population aged 70 and over, other healthcare workers, Aboriginal and Torres Strait Islander people aged 55 and over, priority workers such as emergency services personnel, meat processing employees and young people with underlying medical conditions.
One thing is clear, however: there are not enough doses of the more effective Pfizer vaccine to inoculate all these people. With a two-dose schedule, Australia has enough of Pfizer to cover just five million people before exhausting its supply.
The country’s greatest hope, at this point, is the domestic manufacture of the AstraZeneca vaccine – and the chance that it might be more effective at stopping transmission, even as it shows lesser efficacy in resisting infection.
Towards the end of last year, Melbourne-based vaccine manufacturer CSL received an inch-thick vial of the biological material that would produce the AstraZeneca vaccine.
CSL, formerly the Commonwealth Serum Laboratories but now a private company, retooled its Broadmeadows facility in order to manufacture the vaccine. This could not have been done for the next-generation mRNA vaccine platforms, and as such the cost per unit for this vaccine is just over $3 compared with $26 for the Pfizer drug.
CSL says it remains on track to deliver the first locally made batches of the AstraZeneca shot by April, and will ultimately produce 30 million doses. Astoundingly, it has maintained production of the seasonal influenza vaccine for the southern hemisphere as well as other products used to fight rare diseases.
“Through 24/7 scheduling, we have accelerated the normal production time lines of seasonal influenza vaccines in preparation for the upcoming Australian influenza season, as well as bringing forward scheduled production of antivenoms so that the facility is available as soon as possible to complete the fill and finish process for the AZD1222 vaccine,” a spokeswoman for CSL said in a statement.
“All of this work has resulted in the completion of the first batches of bulk drug substance (the active ingredient used to make drug product) at our Broadmeadows biotech manufacturing facility, which are now subject to extensive quality control tests to confirm that the technical processes delivered to us by AstraZeneca are performing as expected.
“The quality review process will take approximately four weeks before proceeding to the fill and finish step, and finished product will be then subject to regulatory approvals.”
It is an astounding feat of engineering and global co-operation that has enabled Australia, and the world, to come this far. Yet, as the virus mutates, the clock is ticking.
On Monday, officials from South Africa’s National Institute for Communicable Diseases released a communique that revealed the spike protein of the SARS-CoV-2 virus has mutated in two variants. The protein, which gives the virus its distinctive crown of thorns appearance, is also the feature of the molecule that triggers neutralising antibodies in the human body once infected.
“These antibodies bind to specific parts of the spike protein that have mutated in the new variant (K417N and E484K). We now know that these mutations have allowed the virus to become resistant to antibody neutralization,” South Africa’s NICD said in the January 18 update.
“The blood samples from half the people we tested showed that all neutralizing activity was lost. This suggests that they may no longer be protected from re-infection. In the other half, the levels of antibodies were reduced and so the risk of re-infection is not known.”
Nobody really knows how the current crop of vaccines will handle significant mutations in the coronavirus. It is better not to find out the hard way.
This article was first published in the print edition of The Saturday Paper on January 23, 2021 as "Did Australia put its money on the wrong vaccines?".
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