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The Australian government has terminated its agreement with Australian biotechnology company CSL Limited to supply 51 million doses of a Covid-19 vaccine being developed by the University of Queensland, after participants in the vaccine trial yielded false positive results in HIV testing.
Australia had expected the protein vaccine to be available by mid-2021. Phase one clinical trials in humans began in July in Brisbane, and phase two and three clinical trials are due to begin in December. It is one of four vaccines insured by the Australian government.
But on Friday, Australian Prime Minister Scott Morrison said: “The University of Queensland vaccine cannot continue to be based on scientific advice, and that will no longer be part of Australia’s vaccination plan.
“I think the decision we have made today should give Australians great reassurance that we are proceeding with care, we are moving quickly, but not in undue haste,” he said.
“Our processes will not be compromised. At the end of the day, the Therapeutic Goods Administration, as with any vaccine in Australia, must give its approval. Without the tick, there is no problem when it comes to vaccines in this country. That is true for the Covid-19 vaccine, as it is true for any other vaccine that is administered here in Australia. “
In a statement issued Friday morning, CSL said that “after consultation with the Australian government, CSL will not advance the candidate vaccine to phase 2/3 clinical trials.”
The Covid-19 “spike protein” has been the focus of the University of Queensland vaccine, using molecular clamp technology to block the protein in a way that allows the immune system to recognize and then neutralize the virus.
Covid spike proteins, like most viral surface proteins, are quite unstable. To ensure that the vaccine elicited the correct immune response, the clip chosen comprises two fragments of a protein found in HIV, as those fragments provided the greatest stability to the vaccine. Adding those fragments to the spike protein is completely harmless.
Trial participants were informed about the possibility that vaccine-induced antibodies to HIV could be detected as a result, but this was nonetheless unexpected. Subsequent HIV tests provided definitive negative results in the trial participants.
While the HIV tests were false positives and there was no risk to trial participants, significant changes to well-established HIV testing procedures would be needed to accommodate the launch of this vaccine, the researchers said. The Phase 1 assay will continue, where a more detailed analysis of the data will show how long the antibodies persist.
The Vice Chancellor of the University of Queensland, Professor Deborah Terry, said that while the result was disappointing, she was proud of the research team. “I also want to thank our many partners, our donors, including the Queensland and federal government, and of course the 216 Queenslanders who volunteered for Phase 1 trials,” he said.
The vaccine’s co-leader, Professor Paul Young, said that while the vaccine could be redesigned, the team did not have the time. “If I did, it would delay development for another 12 months or more, and while it is a difficult decision to make, the urgent need for a vaccine should be everyone’s priority,” he said.
Health Minister Greg Hunt said the announcement showed that “the scientific process was working.” He said that while the HIV results were false, “the scientific advice is that the risk to confidence from the vaccine was the main problem here.”
The national security committee and the scientific committee were “unanimous” in not proceeding with the CSL agreement, Hunt said.
Morrison said Australians should not worry that there are not enough vaccines as a result of the elimination of the vaccine from the University of Queensland. Australia has entered into enough different vaccine agreements to cover the Australian population, even if one or two candidate vaccines were unsuccessful.
With the suspension of the candidate from the University of Queensland, Australia still has 140 million units of vaccine available to Australia, which Hunt said is “one of the highest rates of vaccine purchase and availability to the population in the world.” All vaccine candidates require two doses.
“What we can do is vaccinate our population twice,” Morrison said. “And we have one of the highest dose availability rates of any country in the world. So this is a demonstration of the success of the vaccination policy and approach that we have been following. ” He said 31 million doses of two other candidate vaccines had been secured in light of the news from the University of Queensland.
Professor Brendan Murphy, secretary of the federal department of health, said he was confident that the other three candidate vaccines would not have similar problems, as two had already published promising data from phase 3 trials. Murphy said the reason why the The government invested in four candidates was because they expected that not all of them would materialize.
“We are very confident that we will not see this problem with the other vaccines,” Murphy said.
