Sitting in his New York home, Geoff Porges is away from his family in Orange, in the New South Wales area.
In fact, during 2020, it has never felt far away for Dr Porges, a vaccine expert for 25 years and director of therapeutic research at one of the world’s leading health care investment banks.
And although he may still be a long way off, this week Dr Porges made comments that resonate back to his home country.
On Monday evening Australian time, the candidate for the AstraZeneca-University of Oxford vaccine, one of the COVID-19 vaccines the Australian Government has committed to a multi-billion dollar deal, released the first interim results from the phase 3 trial.
The results have been praised at first glance, with the company claiming a single dose option provides 90 percent protection against COVID-19.
The Australian Government stated it a a “very good result” that will help create a “completely safe Australia”.
But Dr Porges isn’t sure.
“We called him first,” he told the ABC.
“We said, ‘we think the company is [AstraZeneca] has decorated the data ‘.
“And we said we didn’t think it would be approved in the US.
“People were angry with our first statement, but I think the more information that comes out, the more people agree with us.”
As the week rolls around, Dr Porges’ comments have proven correct.
Pressure has been building on the company throughout the week, with a worldwide flow of scientists and researchers joining Dr Porges’ initial assessment.
Some label it “shaky science”, while others questioned the validity of the data released by the company.
Now, critically, regulators are involved.
And the problem, it seems, all boils down to a strange error.
Interim results from the phase 3 trial found the Oxford-AstraZeneca vaccine 62 percent effective in people who received two doses.
But when volunteers were given half a dose followed by a full dose, that efficacy jumped to 90 percent.
The company later admitted that half the dose was a “production problem” and was given to test participants by mistake.
He also revealed that only 2,741 people had been given half a dose while 8,895 people received two full doses.
Facing increasing pressure to clarify the data, AstraZeneca chief executive Pascal Soriot said on Friday it was likely to conduct a new global clinical trial to assess the vaccine’s efficacy.
However, he said he did not expect it to delay regulatory approval in the UK or the European Union, although British authorities on Friday publicly questioned whether the vaccine met “stringent safety standards”.
In the US, the Food and Drug Administration is another story.
Experts say the agency may take longer to approve the Oxford-AstraZeneca vaccine – if there is one – given that there are questions about results, and parts of the trials are being carried out in different countries.
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Experts say the Government’s move to lock in four different types of COVID-19 vaccines is “smart”, but warns of significant hurdles that must be overcome before they can be distributed across the country.
In Australia, the Therapeutic Goods Administration makes decisions about the safety and efficacy of vaccines to be released to the public.
These are often guided by international agreements in the US and UK and are currently assessing the Oxford-AstraZeneca vaccine – which the Government has committed to purchasing 33.8 million doses if approved – through what is known as a “provisional determination”.
The TGA did not answer the ABC’s specific questions about whether the two doses shown in the data would influence the approval process.
Health Secretary Greg Hunt also did not answer specific questions from the ABC about the development of the Oxford-AstraZeneca vaccine this week.
However, speaking at a press conference on Friday, he said he expected “ups and downs” in the process.
He described TGA as “the best regulator in the world” and said the timeline for the Australian vaccine – scheduled for first launch in March – was “unchanged”.
However it is still unclear which one from four vaccines that have been invested by the Government will be the ones that launch in March.
“Australia will not agree [a vaccine] unless we really believe that the vaccine is safe and effective, “said Hunt.
“The data on all the major vaccines is already good, and I look forward to more positive news about other vaccines in the coming weeks about the introductory briefs we have.”
But some vaccine experts are less sure.
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“[AstraZeneca] hasn’t handled it very well, “said RMIT immunologist and vaccine expert Kylie Quinn.
“The dosing error is disappointing, it is disappointing to hear that it will happen at this particular point in time.
“But this whole situation highlights the importance of clear communication about what is actually being done.
“And I hope in a way the reaction [across the world] reassure the community how much surveillance there is, and that once approved by regulatory agencies, we can be assured that their vaccine has undergone a high level of surveillance: “
Vaccine expert and virologist Tony Cunningham said it was too early to say how the dosing problem with the Oxford-AstraZeneca vaccine could affect approval in Australia until all the results of the Phase 3 trial were known.
The results, which assess 40,000 people, are expected before Christmas.
Professor Cunningham said he had never seen a “tainted” experiment like this before.
“But I have looked at what are known as ‘adaptive experiments’,” said Professor Cunningham.
“This is where a change can build up and you can change the dosage during a trial.
“So maybe they are [AstraZeneca] plans to do that and allow them to focus half the dose on countries where trials are still ongoing.
“That might be what they are suggesting they do, or they might start a ‘new experiment’.”
Professor Cunningham said it was unlikely, however, that safety would be affected by the two dosing regimes.
And, he said, even the 62 percent efficacy reported by companies in the two regimes was above the 50 percent required by most authorities – that’s just far below the “outstanding” 95 percent efficacy previously reported by Moderna and Pfizer. this month.
“This is a fairly important vaccine for Australia, and we are waiting with great interest to see the properly peer-reviewed report.”
Vaccine development still ‘excellent’
Back in New York, Dr Porges said he was worried about how “consumer confidence” in vaccines would be affected after AstraZeneca’s reporting this week.
“Confidence comes from communication transparency and clarity of communication,” said Dr Porges.
“You have to be completely honest about what you share and really clear about the information.
“And I think AstraZeneca, at least, violates both principles.”
However, he said, there is still time for the company to recover.
And, like most people, he waited patiently and eagerly for the vaccine to arrive.
“I usually come back to Australia three or four times a year,” he said. “But not this year, obviously.
“And despite the problems this week, if you think about it, what we achieved after nine months was incredible.