Australian medical facilities will begin producing COVID vaccines from next week, even before being officially approved by authorities, but there’s still hurdles to clear before widespread inoculations can occur.
Prime Minister Scott Morrison announced deals for two new types of potential COVID vaccines on Thursday, unveiling details of agreements with international pharma firms Pfizer and Novavax.
He also dropped a surprising tidbit, that local manufacture of the University of Oxford and AstraZeneca vaccine candidate would begin next week – a development the PM called “very important”.
‘At risk’ vaccine manufacture
The production of the Oxford vaccine comes before it has been approved by the Therapeutic Goods Administration (TGA).
“We start manufacturing the AstraZeneca vaccine in Australia next week, which is another exciting milestone,” Mr Morrison said on Thursday.
“[It] has to meet TGA approval, it also has to go through the final stage trials, all of those things. But we’re making sure that should these approvals be given, that we’ll be able to move as quickly as possible.”
This is not the standard sequence of events for a vaccine, with production usually coming after approval.
But in the rush to get a COVID vaccine as soon as possible, many nations and pharmaceutical companies worldwide are manufacturing supplies early, in anticipation of possible approval.
This is called manufacturing “at risk”, with producers accepting that supplies may not be approved or found successful.
The vaccines wouldn’t be distributed until meeting the necessary health and safety approvals, but beginning the production early means getting a head start on stockpiling supply in the event of approval.
The Australian Government has secured a further 50 million doses of COVID-19 vaccine.
Our Government’s COVID-19 Vaccine and Treatment Strategy has now secured access to four COVID-19 vaccines & over 134 million doses.
— Greg Hunt (@GregHuntMP) November 5, 2020
AstraZeneca and Australian vaccine manufacturer CSL, which will produce the Oxford vaccine and also the University of Queensland candidate, confirmed the PM’s timeline.
The New Daily understands the UQ vaccine is also already in production by CSL.
The Oxford candidate is in stage three trials, while the UQ vaccine is currently in stage one.
Australia had previously confirmed an order for 51 million doses of the UQ vaccine and 34 million of the Oxford model.
Thursday’s announcements bring Australia’s vaccine “portfolio” to four – Oxford, UQ, Novavax and Pfizer.
The government hopes all four will be ready, approved, and available for administering from “early 2021”.
Health Minister Greg Hunt said the mix of two protein vaccines – one mRNA and one viral vector-type vaccine – put Australia in a strong position, pending the outcome of further testing and approvals.
But his Labor counterpart, shadow health minister Chris Bowen, cast scorn on the latest deal by saying the Pfizer vaccine presented a problem.
It is known as an mRNA type – standing for messenger ribonucleic acid.
These are synthetic vaccines created in test tubes, compared to protein-based ones that are cultivated in cells or eggs.
The mRNA vaccines are a newer type, never before produced at large scale for human use.
The technology also requires the vials to be kept at incredibly low temperatures, a capability Mr Bowen claimed Australia doesn’t have.
“It needs to be stored and distributed at temperatures as low as -80 degrees. We currently have no capacity to do this,” Mr Bowen claimed.
“So even if it was ready tomorrow, we couldn’t use it. That’s a big problem.”
Mr Hunt responded by saying Australia was currently working to secure technology to deal with the issue.
“The Australian government continues to prepare for the temperature requirement scenarios for all candidates, including 2-8 degrees, -20 degrees and -70 degrees,” he said.
“Tenders are being issued today to co-ordinate the distribution of the vaccines across the country to deliver on those requirements.”
New vaccine deal details
Novavax confirmed that it hoped to deliver supplies to Australia in coming months.
A company spokesperson told The New Daily that could be “as early as the first half of 2021, subject to the successful completion of Phase 3 clinical development and approval” by the TGA.
“The vaccine regimen is expected to require two doses per individual, administered 21 days apart,” Novavax said.
Pfizer did not commit to as concrete a timeline, saying in a statement that “deliveries are planned in 2021”, but “as quickly as possible”.
The company said that “assuming positive data, Pfizer and BioNTech plan to initiate rolling applications in the fourth quarter of 2020.”
Australia now has four vaccine deals, with the first supplies of the Oxford model hoped to be available for priority vaccine recipients “in the first quarter of 2021” according to Mr Hunt.
“Health and aged-care workers and the elderly and vulnerable will be the first to gain access to a vaccine that’s deemed safe and effective,” he said.