Nothing has changed - government faces a stark reality

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Before last week's announcement of a 'deal with AstraZeneca, the federal government was facing the grim political prospect of some Australians living under restrictions and even lockdown while watching the vision of some other governments moving to vaccinate their populations against COVID-19.

The 'deal' has not changed this reality.

The actual delay

The federal government announced its 'COVID-19 Vaccine and Treatment Strategic Approach' on 7 August, following a meeting of the National Cabinet.

By that time, several countries had already signed formal licensing or advance supply agreements securing several billion doses of investigative COVID-19 vaccines.

This is important because the world has limited vaccine manufacturing capability - demand will massively exceed the supply of any approved vaccine in 2020 and 2021.

The US and UK started investing in vaccines and signing deals in May and June. They were quickly followed by other countries and regions - not Australia.

The Australian government has so far invested $5 million in a single vaccine.

The global push for a coordinated approach to the vaccines - through a mechanism like the COVAX facility - essentially relies on companies agreeing to set aside some of their manufacturing capability. Yet to what extent is that possible given the advance supply agreements with countries?

Australia will probably commit to COVAX but it provides a limited return - any approved vaccine for around 20 per cent of the population with no guarantee of timing.

The delay in announcing an Australian strategy is no surprise given it is understood the federal government did not formally consider and endorse the need for a national COVID-19 vaccine strategy until early July. The original plan was for its consideration by the National Cabinet in late September.

This timing is difficult to reconcile given Australia's COVID-19 'suppression' strategy is underpinned by the development of a vaccine.

The consequences of delay

The consideration and release of the 'strategic approach' was brought forward but it does highlight just how slow Australia was in recognising the extent of the global race for vaccines.

Late September is when some of the early candidates are expected to start revealing early results of late-stage trials - this has been known for some time.

In late July, a full week before the prime minister released Australia's strategy, Pfizer CEO Albert Bourla said the company will have enough "events" by the end of September to determine whether the vaccine it is developing with BioNTech works. 

“This is when we can say we have an effective vaccine and only then,” he said, adding it will be one of the first in a "wave" of pandemic vaccines.

AstraZeneca has also suggested it will be accelerating consideration of the efficacy of the vaccine it is developing in collaboration with The University of Oxford. Its global R&D head, Mene Pangalos, recently said FDA guidance allows companies to accelerate regulatory submissions by 'pooling' the results of early and late-stage trials. 

The vaccines may not work - this is reality - but many countries have 'insured' for the possibility of accelerated development and approval by acting early to secure supply.

What do they lose in the case of failure? They potentially lose financially - surely a minor consideration given the cost of the pandemic. It is obvious what they gain in the case of success.

One challenge for early approval, particularly in the US, is its politicisation. US President Donald Trump, whose re-election strategy is partly based on the successful development of a vaccine, is already accusing political opponents and even FDA officials of seeking to delay approvals.

Any approval process is likely to be highly politicised - something that will not help public confidence in any vaccine.

While the US is focussed on this issue within its borders, it seems countries like Russia and China see the vaccine in geopolitical terms. This could become a regional issue for Australia. Our failure to act early could have implications beyond the simple need to access a vaccine.

What does the PM mean by "front of the pack"?

Discussion in Australia over a potential COVID-19 vaccine has gone from virtually nothing to the events of last week during which the government simply signed a 'letter of intent' (LoI) with AstraZeneca.

Under the LoI, the government and AstraZeneca agreed to negotiate an Australian licensing and production deal for its investigative vaccine - if it is approved.

Prime Minister Scott Morrison used the LoI to claim Australia is "at the front of the pack" when it comes to access to any approved COVID-19 vaccine.

This is demonstrably wrong - even if CSL agrees to manufacture the AstraZeneca-Oxford vaccine.

CSL is already committed to the recombinant vaccine it is developing with the University of Queensland (UQ) and the Coalition for Epidemic Preparedness Innovations.

CSL has consistently said the UQ vaccine is its priority but that it is assessing the potential viability of manufacturing the AstraZeneca-Oxford vaccine.

Yet even if CSL agrees to manufacture the vaccine at a facility in Melbourne - and you must expect it will - the government faces a stark political reality.

The US and other countries, including the UK, might be considering and debating the approval of some of the leading candidates while CSL is still going through the difficult and highly complex process of repurposing a facility to manufacture the AstraZeneca-Oxford vaccine. This is a process that, with government support, could have started months ago, as it did any many other countries.

It is not just the US and UK. Companies in South Korea, India and Japan have already started the process of preparing for the production of the AstraZeneca-Oxford and other vaccines.

Is that what Mr Morrison meant by Australia at the "front of the pack"?

The stark reality of delayed action

The leading vaccine candidates may still fail. Yet, based on last week's overwrought response to an Australian LoI, imagine the public response if some start showing positive efficacy signs in late-stage trials.

The risk appetite of governments, regulators and the community will be higher than normal, not least because of the social and economic impacts of the pandemic.

Imagine the response if the discussion in other countries turns to regulatory consideration, potential approval and early distribution of a vaccine - even under highly controlled circumstances - while Australia's access to any candidates remains uncertain.

The government would and will rightly face difficult questions on what it did to secure timely supply for Australia.

Australia may have always lagged other larger and more influential markets. Yet we will never know and that defence is not available to the government because of its failure to act quickly.

This is also an issue for the Australian-based industry - it may need to prove it demonstrated a level of urgency in its approach to the government during the early stages of the pandemic.

Of course, none of these vaccines may make it through the development process, but this issue could become very real in late September and October - and that is just a few weeks away.

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