Covid-19 vaccine just what the doctor ordered
News of successful trials of a potential COVID vaccine has lifted spirits worldwide but Australia will have to wait in line.
The prospect of an effective COVID-19 vaccine just received an almighty booster shot, with Pfizer’s clinical trials revealing its candidate was more than 90 per cent effective in preventing the coronavirus in people who had never been infected. The news fired up financial markets and provided hope to people the world over.
Pfizer chairman Albert Bourla declared it was “a great day for science and humanity”. US infectious diseases chief Anthony Fauci said the results were extraordinary: “It’s going to have a major impact on everything we do with respect to COVID.”
What felt like a game-changing moment was celebrated in Australia as an early lead. “I don’t want to overstate it, but that is welcome news,” Scott Morrison said on Tuesday. “It is one of four vaccines that Australia is involved in and these results are very promising and I am optimistic and hopeful about next year, about the rollout of those vaccine programs.”
But temper the joy. Australians won’t be the first in the world to be immunised, because the Morrison government was slow to back a horse in the vaccine stakes. Keeping our options open, while watching the form of unproven runners, means taxpayers will pay a premium, perhaps hundreds of millions of dollars more, to get “free” access to a suite of vaccines.
Caution, complacency, limited manufacturing capacity, geography, scale of our market, and the scramble to lock in supplies by other rich countries, more damaged by the pandemic than our own, are behind it. Secrecy surrounds most aspects of our vaccine program: contract prices, indemnities, prioritisation and distribution. Canberra’s approach has been “trust us, we’ve got this, our experts are guiding us through”.
According to a person familiar with aspects of the program, the paucity of detail suggests our experts for vaccine purchase, distribution and immunisation record-keeping are behind the play. “Building community confidence for the vaccine rollout is fundamental,” a key source told The Australian. “I’m worried that any impression that Australians will be one of the first to receive an approved vaccine is ambitious.”
What’s also not clear is who in the community will have first, second and third access to the four vaccines Australia has pre-purchased, and how willing Australians will be to be injected with medicines that have been delivered to market in world-record time.
“The pre-purchase of a COVID-19 vaccine is basically an insurance policy that you will have more rapid access if trials demonstrate the vaccine is successful,” says Philip Clarke, director of the Health Economics Research Centre at Oxford University. “If pre-purchase of a vaccine means the economy can return to more normal conditions faster, even by a few weeks, the benefits will exceed the costs. While it is theoretically possible to overspend, we are most likely a long way from that point.”
Last Thursday, the Prime Minister announced advance purchase agreements with Pfizer and Novavax to buy 10 million and 40 million doses respectively of their vaccine candidates, at a cost of $1.5bn. It adds to agreements worth $1.7bn to buy 33.8 million doses of Oxford/AstraZeneca’s AZD1222 and 51 million doses of the University of Queensland-CSL candidate, V451. Australia has also pledged $203m towards a global syndicate known as the COVAX facility, which hopes to accelerate development, production and delivery of a vaccine for equitable access, especially to poorer nations.
So far Canberra’s outlay of $3.5bn for vaccines, needles, syringes and research appears modest, given the potential pay-off. Underpinning the federal budget is an assumption that a population-wide COVID-19 vaccination program will be “fully in place by late 2021”.
According to Health Department secretary Brendan Murphy, who is overseeing the expert working groups on vaccination, we have a diversified array of vaccines. For instance, two are protein sub-unit vaccines (the UQ-CSL and Novavax), which are established technologies. Oxford’s AZD1222 is an adenovirus vector vaccine. Murphy says Pfizer’s mRNA vaccine is a “very exciting new technology” but has never been registered for human use.
Buried deep in last month’s budget papers was notice Canberra has provided an indemnity to the suppliers of the first two vaccines, “covering certain liabilities that could result from the use of the vaccine”. Asked whether Novavax and Pfizer had been provided with an indemnity, a Health spokesman said: “The government acknowledges the need to appropriately share risks associated with achieving early access to a successful vaccine, and is engaging on indemnity positions with a number of potential COVID-19 vaccine suppliers.”
So that’s a yes, no and maybe.
What we do know is Australia took its time to assess untried vaccines. Yet this caution risked failing to secure limited early supplies of the leading candidates. In early May, in answer to a request by the government for a rapid response to the question of what were the most promising COVID-19 vaccines, Chief Scientist Alan Finkel was watchful.
“It is too early to select the ‘most promising’ vaccine candidate as we do not yet know their safety or efficacy, or our capability to manufacture them at large scale under Good Manufacturing Practice conditions. Furthermore, it is not a given that vaccines licensed first will be the most effective,” Finkel wrote to Industry Minister Karen Andrews and Health Minister Greg Hunt.
Finkel also said it was important that in the rush to develop a vaccine, international regulatory and safety protocols not be weakened. “The risk is deployment of a vaccine that is not fully evaluated for safety or efficacy and, worse still, exacerbates the potential of immune-mediated disease,” he wrote.
But the quest for a vaccine was changing by the day; the US, European and Asian countries were placing large bets, locking in supplies as clinical testing progressed. In a ministerial submission on joining COVAX to Hunt on June 29, Health officials said: “Once a safe and effective vaccine or vaccines are developed there will be global competition from high- and middle-income countries to ensure early access for their populations. Already countries, both as individuals and groups, are entering into advance purchasing agreements with vaccine manufacturers to ensure allocation.”
Not that Hunt needed to be told, officials added “the mainstream media continues to report on vaccine development and public expectations of early access to any vaccine will be high”. Over coming weeks, as Victoria’s second wave rose with a vengeance and more countries announced vaccine pre-purchases in July, it became clear Australia was leaving it late to lock in a deal. Industry sources detected a “desperation” among officials and ministers amid growing public disquiet.
On August 16, Murphy’s vaccine advisory group met for the first time and decided to immediately recommend the government sign a letter of intent with AstraZeneca. According to another brief to Hunt, the expert group noted while there were still questions over AZD1222 as clinical trials progressed, including in relation to eventual effectiveness and storage requirements, “this was the leading candidate and it was timely to make an investment”.
“While AstraZeneca’s total manufacturing capacity currently stands at two billion doses, there is already significant global demand, with a number of countries and organisations investing in AZD1222, including the UK and US governments, the Coalition for Epidemic Preparedness (CEPI) and Gavi the Vaccine Alliance,” the brief said.
On August 19, Morrison summoned the media to AstraZeneca’s facility in Macquarie Park, in Sydney’s north, to announce the government had signed a “letter of intent” with the UK-based company. But this wasn’t a legally binding agreement, merely the first step in a long process.
“The next steps, of course, are getting down into the details of contractual agreements,” AstraZeneca’s country president, Liz Chatwin, said at the press conference. “The numbers, the timelines, the doses, the pricing, and securing an agreement with our selected Australian manufacturers so we can manufacture the vaccine here locally, should it prove successful.”
The queue for a leading vaccine was getting longer and global production capacity was almost exhausted. But after high-level representations, the government snatched an initial batch of 3.8 million doses of AZD1222, a tiny allocation among the 1.1 billion doses committed by the company at the time to Europe, the UK, US and COVAX.
In early September, Morrison announced the first two advance purchase agreements. “It’s a sovereign vaccine plan,” he said, with biotech CSL producing 81 million doses at home. It would take another month to secure final agreement, which includes upfront payment to support the clinical and technical development of the so-called “molecular clamp” technology. As well, in late September, Canberra announced it had joined COVAX, providing access to a wide portfolio of vaccine candidates; if required, we could access vaccine for up to 50 per cent of our population under a two-dose treatment.
The Prime Minister has often claimed we are at the front of the queue. Murphy was asked at Senate estimates last month if Australia could be stuck in a line behind other countries, including at least seven that have advance deals for the Pfizer candidate at the time. “This is not how these agreements work,” Murphy said, noting vaccine delivery is determined by dose numbers and supply dates.
So how many candidates does a country of 25.6 million need? “A good analogy is betting on a horse race when you don’t have a form guide,” says Oxford’s Clarke, who is also professor of health economics at the University of Melbourne. “The only way to ensure you back a winner is to bet on every horse in the race, but then you also lose a lot of money backing horses that don’t win.”
Value for money is not front of mind for the Prime Minister, officials or maybe even taxpayers: efficacy, safety and production quality are more pressing issues.
Still, it appears Australia has paid a premium of around $350m for just the latest two purchases, based on deals struck by the companies elsewhere and much earlier.
In July, the US set the global benchmark price when it purchased 100 million doses of the Pfizer BioNTech vaccine for $US1.95bn ($2.7bn) or $27 per dose in our currency; it paid $2.2bn for 100 million doses of the Novavax vaccine or $22 per dose. We paid $1.5bn for 10 million and 40 million doses, respectively, of those two potential vaccines; four months ago, or at American mates rates, we may have been able to get them for $1.15bn.
Neither company would comment on contract prices, nor whether the government had granted them indemnities. Asked whether Australia had paid too much for the Pfizer and Novavax deals, a spokesman for the Health Department said: “The specific details of the agreements are commercial in confidence. The department is not able to comment on the details of agreements in place in other jurisdictions as such details are not public.
“The Australian government is focused on securing early access to safe and effective COVID-19 vaccines. Each agreement takes into account a range of commercial considerations, including 2021 volume, delivery schedule and distribution.” According to the Health Department, only detailed phase three clinical data will be able to inform prioritisation decisions. “It is likely the first vaccine doses will be given to frontline healthcare workers, carers of vulnerable people and, if safety data supports, vulnerable people,” a spokesman said.
In Britain, vaccination will be by age group, with older people first. In the US, a broader range of factors will come into play, with priority for essential workers like first responders and teachers, and the homeless and prisoners.
Murphy says we have never faced a logistics challenge like this. For instance, the Pfizer candidate requires cold storage at ultra-low temperature. While Canberra purchases the vaccines and provides transport and the storage, Morrison says it is the states and territories that play a critical role in the actual administering of that vaccine across the population.
On Monday, CSL began thawing vials of frozen cells of Oxford’s AZD1222 at its Broadmeadows plant in Melbourne.
Over the next few months the cells will be replicated in a bioreactor, the vaccine will be filtered and purified, leaving just the antigen.
Thirty million doses of AZD1222 will be filled and finished. Hunt says if the vaccine passes clinical tests and clears regulatory hurdles, it will be distributed in March, through GPs, respiratory clinics, state and territory vaccination sites and workplaces such as aged-care facilities.
The Prime Minister maintains Australians are at the head of the queue. Morrison said national vaccine policy has had its first pass by his cabinet; it will go back there after further consultation with the states and territories, and then go to the national cabinet for confirmation before dissemination.
“We’ve got notional distribution plans,” Murphy told reporters last Thursday, before Pfizer’s spectacular results were revealed. “The first doses of AstraZeneca vaccine are actually coming from overseas early next year and that will give us an early approach to using the highest-priority populations. And then all of the four vaccines are planned to have scheduled delivery during the course of next year so that the plan is to have all of our 134 (million)-plus doses delivered about by the end of 2021.”
As vaccine demand is likely to outstrip supply, prioritisation has the potential to cause trouble. Oxford’s Clarke says Canberra should be more transparent on its thinking, while conducting a public consultation process about what a vaccination program is actually trying to achieve.
