The Therapeutic Goods Administration says it could be in a position to approve vaccines for coronavirus for Australians in January next year, as authorities look to develop "sophisticated eskies" to transport one of the most promising vaccine candidates to Australia and within the country.
Subscribe now for unlimited access.
$0/
(min cost $0)
or signup to continue reading
American biotech company Pfizer released early data on its vaccine candidate this week, saying it is showing more than 90 per cent efficacy in protecting against the virus.
The vaccine, for which Australia has signed up for 10 million doses, uses cutting edge mRNA technology, needs to be stored at incredibly cold temperatures, below -70 degrees celsius.
Arrangements for it to be assessed by the medicines regulator and planning for the logistics of its rollout are being fast-tracked while clinical trials are still continuing.
Adjunct Professor John Skerritt, who leads the Therapeutic Goods Administration, said his agency has already started "provisional determination" with Pfizer, meaning initial clinical results and other information was already being provided by the company before the trials are finished.
Staff at the regulator were already analysing data ahead of hopefully receiving final data either later this month or early December from Pfizer, and probably in December for the AstraZeneca vaccine.
"Once we get that, we will go as fast as possible. And while many of you will be relaxing on the beach, sadly, many of my staff will be here in this building looking at that data," he said.
"But an optimistic message would be January [for approval]."
"It'll obviously also depend on how many questions there are, and issues, whether there's issues that we and, say, other regulators in Canada and the US and England and all that raise with the data."
"While many of you will be relaxing on the beach, sadly, many of my staff will be here in this building looking at that data."
- Adjunct Professor John Skerritt
Professor Skerritt backed Health Minister Greg Hunt's prediction that wider rollout of a vaccine could start in March.
A vaccine distribution process will go to national cabinet on Friday, and Mr Hunt said plans were well-advanced, including for complete "cold-chain" transport of the Pfizer vaccine.
"We have secured already a national cold chain distribution program as part of the agreement with Pfizer," Mr Hunt said.
Professor Skerritt said Australia had started a process to ensure there would be technology that could be described as "sophisticated eskies" to ensure the cold storage and transport of the vaccines.
The portable eskies would use dry ice that would last for 14 days and have the ability to be re-filled twice, meaning they could last for a month and a half.
"And even in a country the size of Australia, you can get anywhere much quicker than that," Professor Skerritt said.
"And of course, with flights opening up as borders are coming down, it's actually easier to get urgent medical products around the country now."
Australia has signed a deal for 10 million doses of the Pfizer vaccine, as part of a portfolio of vaccine options.
Australia doesn't have the technology to manufacture the vaccine onshore, with these vaccines to be manufactured in the United States before being shipped to Australia.
Australia's initial deal with Pfizer is for 10 million doses of the vaccine, and like many of the more promising candidates, it is expected people will need two doses for the vaccine to be effective.
Mr Hunt reiterated on Wednesday that the health workers, workers in aged care and elderly Australians would be prioritised for the vaccine.
Vaccine expert at RMIT Dr Kylie Quinn said even if those 5 million people were vaccinated quickly and there was a slightly longer wait for others, unvaccinated Australians would still benefit.
"Particularly because the first rounds of the vaccine will be given to people at higher risk of exposure, those people are putting their health at risk for our collective benefit, they are the potential chinks in the armour, they are there where the virus comes from. If we protect them we protect everyone."
Immunology expert at the Australian National University David Tscharke said the early efficacy results from Pfizer were "quite exciting".
"[The 90 per cent figure] is towards the top end of what people were thinking we might be seeing," Professor Tscharke said.
He is also confident in Australia's ability to transport the vaccine at the super cold temperatures.
READ MORE:
"Dry ice is used relatively routinely [in medical research] ... It's not like we have to invent something new, we just have to do it to scale."
Professor Tscharke said the extremely cold temperatures were required because RNA is an "inherently unstable" molecule.
Vaccines using mRNA technology, which hasn't yet produced a successful vaccine, work by providing a "temporary message" to the body instructing it to create particular proteins, Professor Tascharke said.
"In the case of this vaccine the instruction is the spike of the coronavirus," he said.
"Then your immune system will have seen it before and the immune response raised against that protein can fight infection [if exposed to coronavirus]"
It was still important to wait to see later results from trials, showing how long a vaccine was effective and if it stops people from also transmitting the virus to others.
Dr Quinn said the potential success of this vaccine was also promising for other vaccine development, including for cancer. She said it would be a good investment in Australia's future pandemic preparedness to develop the technology to be able to manufacture mRNA vaccines onshore.
"The advantage of the mRNA vaccines is they can be adapted to a new virus."
Other companies are also in early talks with the Therapeutic Goods Administration, including some who have not signed deals with the government for vaccine distribution.