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What does a new Oxford COVID vaccine trial mean for Australia?


Anastasia Tsirtsakis


27/11/2020 3:44:37 PM

The decision comes after doubts emerged over recent trial results that showed greater efficacy with a lower dosage.

Lab technician comparing two vials
Australia has an agreement to purchase more than 30 million doses of the Oxford University/AstraZeneca vaccine. (Image: AAP)

Oxford University and AstraZeneca’s decision to undertake a new international trial to assess the efficacy of its COVID vaccine candidate has raised concerns over what it will mean for distribution in Australia, which has an agreement to purchase more than 30 million doses of the vaccine.
 
The announcement came amid backlash after it was revealed the preliminary finding that the vaccine is 70% effective against COVID-19 was reached by combining two trials with two different dosages – and not by study design, but a ‘difference in the manufacturing process’.
 
Those results indicated that a group of volunteers who received a lower dose appeared to be better protected (90% efficacy) than those who were administered two full doses (62% efficacy).
 
Questions have also been raised over whether the vaccine dosage with higher efficacy will protect older people, as the group of volunteers were all aged under 55.
 
However, AstraZeneca’s CEO Pascal Soriot remains optimistic and says approval for the vaccine is unlikely to be delayed.
 
‘Now that we’ve found what looks like a better efficacy we have to validate this, so we need to do an additional study,’ he told Bloomberg News.
 
‘[T]his one could be faster because we know the efficacy is high, so we need a smaller number of patients.’
 
The vaccine is among four promising candidates secured by Australia, with the Federal Government having committed to 33.8 million doses.
 
During a press conference on Friday 27 November, Federal Health Minister Greg Hunt appeared unperturbed by the news. He welcomed the new trial, calling it an ‘important part’ of the process.
 
‘Australia will not approve, unless we are absolutely convinced that a vaccine is both safe and effective,’ he said.
 
Minister Hunt said Australia’s vaccine timeframe remained unchanged and is, in fact, ahead of schedule for distribution in March 2021.
 
‘We are in a strong position,’ he said.
 
‘Australia has acquired access to four vaccines. All of those are progressing well and each day there’s news and there’s progress – and there will be ups and downs in the vaccine process.
 
‘[W]hat we’re seeing is very clear evidence that the world will have not just one, but a series of effective and safe vaccines and that’s, I think, good news for Australia, and good news for the world.’
 
Australia has also secured 51 million doses of the University of Queensland/CSL vaccine candidate. While still undergoing phase 1 clinical trials, the university has said the vaccine is ahead of schedule and, if proven effective, will be available by the end of 2021.
 
Unlike the Oxford candidate, Minister Hunt said, the University of Queensland/CSL candidate is proving particularly effective among older people.
 
‘That is an especially important outcome, given the global vulnerability to elderly around the world from COVID-19,’ he said.
 
Meanwhile, the UK Government has formally asked the Medicines and Healthcare products Regulatory Agency (MHRA) to assess whether the Oxford candidate ‘meets rigorous safety standards’ and should be authorised for use.
 
It has also requested approval for Pfizer/BioNTech’s mRNA-based vaccine, of which Australia has secured 10 million doses, which earlier this month announced it was 95% effective.
 
Despite AstraZeneca and Minister Hunt’s optimism, however, the MHRA has said it cannot give a timeframe for possible approval of the vaccines.
 
Once a vaccine is ready for distribution, Minister Hunt reaffirmed the central role that GPs will play.
 
‘[G]eneral practice will be the cornerstone of delivery for most Australians for the vaccine. But we’ll work through a variety of different distribution mechanisms,’ he said.
 
The Federal Health Minister added that older people and frontline healthcare workers, including aged care workers and other critical workers, as defined by the medical expert panel, will be prioritised to receive the vaccine.
 
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