An Australian company is set to start producing doses of the Covid-19 vaccine by mid-next year, despite not yet passing last stage of approval.
The CSL Limited company started manufacturing the University of Oxford/AstraZeneca coronavirus vaccine in Victoria on Monday, Australian media report.
CSL is making about 30 million doses of the Oxford-AstraZeneca vaccine despite it still going through phase-three clinical trials. The results from these trials won't be known until the end of the year.
While there's still a way to go, CSL's chief scientific officer Andrew Nash said the company is "hopeful" the gamble will pay off.
"We're making this ahead of time so should the clinical trial be positive with the outcome that we're looking for … the vaccine will be available in the short term to distribute to the population," he said.
"We've seen that the vaccines can induce the immune response that we would hope to see.
"Then we have to test in large numbers of people to see if that immune response prevents them from being infected." Dr Nash likens this vaccine to a "delivery truck".
"So it will deliver and manufacture the vaccine antigen to the person that's been vaccinated, as distinct from some of the other vaccine technologies where we actually make the vaccine antigen known as the spike protein … outside the body, then we administer that to the recipient of the vaccine."
Sydney bio-ethicist Angus Dawson says starting production early is a calculated risk.
"It is extremely unusual to do so," Professor Dawson said.
"Normally you would conduct the trials and know that it is effective and safe and then go ahead and start manufacturing," he said.
"But we are in unusual times, there is a pandemic going on."
Why are they producing a vaccine when it has not been approved yet?
The gamble by the Federal Government and CSL means Australia has a chance to roll out the vaccine as soon as it becomes approved — assuming it gets past phase three trials and the TGA's scrutiny.
Professor Dawson says it is a high-risk strategy that could cost billions of dollars if it fails, but its success could save hundreds of thousands of lives.
"A vaccine would take at least six months to produce but by actually manufacturing and then stockpiling those vaccines now, we can get ahead," he said.
Will a Covid-19 vaccine bring an end to the pandemic?
Even if the vaccine gets approval, it's unlikely to mean the end of the pandemic.
"Covid-19 vaccines will be approved if they are 50 per cent effective at preventing the Covid-19 disease, not necessarily the infection," ABC Coronacast presenter Norman Swan said.
"So the first round of vaccines may be not as effective as the community expects."
What other vaccine candidates are in the mix?
The Federal Government has backed the University of Queensland's protein-based vaccine as the home- grown trial of choice. It is also being supported by the international Coalition for Epidemic Preparedness Innovation (CEPI).
UQ's vaccine is undergoing stage one clinical trials. Should it be approved for use, it will also be manufactured by CSL.
The Government has also secured 50 million potential vaccine doses through new agreements with companies Novavax and Pfizer/BioNTech, both of which are currently in stage three trials.
Like UQ, Novavax is trialling a protein-based vaccine, using technology that has been used for decades.
The Pfizer/BioNTech vaccine contains genetic material called mRNA — these vaccines effectively carry the molecular instructions to make the protein, so a person's body can produce it, treat it as a foreign material and mount an immune response.
Australia has also handed over $123 million to join the global vaccines facility known as COVAX, a World Health Organization (WHO) initiative allowing all countries to share not only the costs of vaccine development, but also the benefits.
The money paid acts as a down payment, meaning if COVAX — which is working with CEPI, among others — develops a successful vaccine, Australia has a $123 million credit to spend on vaccine doses.
How realistic is it to expect a coronavirus vaccine so soon?
While the Government's deals to secure four potential vaccines have been hailed by experts as "smart", there remain several concerns over the purported timelines for their rollout.
There is still no concrete timetable on when the Oxford-AstraZeneca vaccine will roll out, if approved, with Federal Budget papers earlier this month indicating a rollout from July 1 next year as an "earlier" time frame.
Industry Minister Karen Andrews has said if the UQ or Oxford vaccines are not approved, other global frontrunners in the race may take "nine to 12 months" to deliver in Australia, after approval.
There are also logistical concerns over the Pfizer/BioNTech mRNA vaccine, which one expert describes as a "dicey molecule" that needs to be frozen at about -70 degrees Celsius before a human vaccination.
The Westmead Institute's Tony Cunningham says it will be interesting to see how the Government delivers such a vaccine to remote areas, adding: "This mass-scale transportation has not been seen before."
But even once an approved vaccine becomes available, there will still be a period before the majority of Australians can receive it.
Paul Griffin, the principal investigator of the UQ trial, estimates it will be months and maybe even a year before the wider public can get inoculated.
"The vaccine being 'available' isn't going to look like the flu vaccine program where we get shipments and Chemist Warehouse advertise it for $14.95 and everyone can get it. That level of availability is a fair way down the track," he said.
But he says this isn't as bleak as it seems.
"Because even if a proportion of people have had this vaccine, a modest rollout will still have a significant contribution," he said.
Prime Minister Scott Morrison has indicated the Government will target a 95 per cent vaccination rate and the vaccine will be free for all Australians.