Sat. Nov 19th, 2022

Vaccine experts have cautioned against the Federal Government’s plan to have a COVID-19 vaccine ready by January next year, saying the “surprising” and “optimistic” time frame means safety measures will be “short-circuited”.
Key points:

  • Experts say any expectations a COVID-19 vaccine will be available in early 2021 are ‘optimistic’
  • The comments come after the Federal Government announced a deal that would guarantee supply of both the Oxford and University of Queensland vaccine candidates
  • As part of the deal, some Australians could get early access to the Oxford vaccine, according to the Government

In a deal labelled as a sign of “hope” by Prime Minister Scott Morrison, more than 84 million doses of potential coronavirus vaccines from both Australia’s University of Queensland (UQ) and Oxford University would be rolled out to Australians in stages across next year if the “promising” drug trials prove successful.
But in a statement that has some experts worried, the Morrison Government also claimed early access to the Oxford vaccine, which is currently in phase 3 trials, could see some Australians being vaccinated “as soon as January”, with 3.8 million doses expected in the first two months of 2021.
Jane Halton, former Health Department chief and the Australia representative for the Coalition for Epidemic Preparedness Innovations, told the ABC the time frame was “ambitious”.
Westmead Institute founding director and vaccine expert Tony Cunningham said he was “surprised” by the announcement.
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The Oxford vaccine candidate started its phase 3 trials on July 27, and Professor Cunningham said completing a phase 3 trial in “six to seven” months, which usually tests 30,000 people, meant regulators would have to “short circuit” safety assessments.
“Most companies are thinking one to two years [for a phase 3 trial],” he said.
“So I’m surprised that they are thinking January would be the optimum time.
“It would mean it would be an ‘unconventional’ approach to looking at efficacy and safety, less than a year.
“I think it is unusual, and one would have to be very sure of one’s figures, to actually move from phase 3 into supply.”
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What is the Government saying?
The Government has said it hoped the UQ vaccine will be available in mid-2021, given it was earlier in the earlier phase 1 trials, compared to the Oxford vaccine, which is in phase 3.
Experts say there is potential for the two vaccines to be combined in what is known as “prime boosting”.
The Prime Minister said the inclusion of the UQ vaccine candidate and Melbourne-based firm CSL as manufacturing partner was a key part of its “sovereign vaccine plan”.
“Because this vaccine plan and the agreements that are supporting it [are] giving us the capacity to not just produce the vaccine here in Australia [with the AstraZeneca vaccine, through CSL], but also to develop and produce the UQ vaccine,” he said.
“So that is giving us a sovereign capacity to get Australians what they will need should both of those vaccines prove successful as they go through their trials.”
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Health Department Secretary Brendan Murphy said the Oxford-AstraZeneca vaccine was “clearly the most advanced” in terms of its scientific evidence.
“And it is looking pretty good,” he said.
“We’re still waiting for the phase 3 trials, but this gives us very quick access to an onshore product,” he said.
Once vaccines have received regulatory approval, the Government hopes to see batches of vaccines produced in Australia monthly.
Health Minister Greg Hunt said TGA approval would be “fundamental” for both vaccines.
Labor shadow health spokesman Chris Bowen said the vaccine deal was “welcome” but it was something the Federal Government “should have done a long time ago”.
“The Government would have our support entering into more agreements,” he said.
Tony Cunningham says properly run trials are essential to prove a vaccine’s safety.(ABC News: Chris Taylor)
But Professor Cunningham, a renowned global vaccine expert and lead author of the Australian Academy of Science’s advice to the Federal Government, said the fast-tracking of the trials would have to be monitored “very carefully”.
“My view is this, and I’m sure every other vaccine specialist would say the same thing, one thing you don’t want to do is rock public confidence by finding out that one of these vaccines has side effects that are not properly tested out in phase 3 trials,” he said.
“That’s why we do them, and that’s why we look at 30,000 people.
“And even Putin, in Russia, has decided to do this.
“And you have to monitor this very carefully. The confidence of the community can be persuaded very easily by the anti-vaccination people out there.”
Global political pressure
The Federal Government’s announcement comes just days after a group of global drug companies competing with one another to be among the first to develop COVID-19 vaccines revealed a pledge to not release any vaccines that do not follow rigorous efficacy and safety standards.
As reported by the Wall Street Journal, manufacturers Pfizer, Moderna, Johnson & Johnson, GlaxoSmithKline and Sanofi have reportedly signed the letter following perceived political pressure from the Trump Administration.
President Trump has pushed for a vaccine to be available by October just before the November presidential election and the New York Times reported its campaign advisers have privately called a pre-election vaccine “the holy grail”.
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