The Australian government has cancelled further development of a COVID-19 vaccine after several participants in the vaccine trial tested false positive for HIV. The vaccine was developed by the University of Queensland, with which CSL Limited, an Australian biotechnology company, has signed a contract to provide 51 million doses. The vaccine was originally scheduled for launch in mid-2021, with phase II and Phase III clinical trials scheduled to begin in December.
However, The Australian prime Minister, Scott Morrison, announced on Friday: “Based on scientific advice, vaccine development at the University of Queensland cannot continue and will no longer be part of Australia’s vaccine programme.” “I think the decision that we have taken today is a great reassurance to the Australian people that we are proceeding cautiously, that we are acting expeditiously, and that we are not acting rashly here,” Morrison added.
Morrison added: “We are not going to budge on the approval process. Eventually, as with any vaccine in Australia, the Medical Supplies Authority will have to make their approval. No vaccine can be used in this country without approval. This is true for the COVID-19 vaccine, and it is true for any other vaccine used in Australia.”
The vaccine is one of four guaranteed by the Australian government, which is now shifting its focus to Astrazeneca and Pfizer.
The vaccine does not cause infection and, after a false positive, tests have shown that there is no HIV in the body. The government is now seeking to give Astrazeneca’s vaccine to Australians.
CSL said in a statement on Friday: “Following consultation with the Australian government, CSL will not be conducting phase II or III clinical trials of vaccine candidates.”
According to Ten Australia, the decision to drop the University of Queensland vaccine was driven by fears that a false positive would cause Australians to refuse the vaccine, despite the fact that the patient did not have the disease.
The now-canceled vaccine uses “molecular pinching” to lock COVID-19 “spike proteins” into a shape that can be recognized and neutralized by the human immune system. To ensure an immune response, the clamps chosen to induce an attack by the immune system include two fragments of a protein found in HIV that do not pose a threat in themselves.
This was unexpected, although participants were told in advance that it was possible to detect vaccine-induced HIV antibodies. Subsequent HIV tests provided positive negative results for trial participants.
Although false positive HIV tests pose no risk to trial participants, major changes to well-developed HIV testing procedures are needed to make the vaccine suitable for launch, researchers said. Phase I trials will continue and further data analysis will show how long the antibodies persist. “– The Guardian
Professor Paul Young, co-lead researcher on the vaccine, said it could be redesigned to avoid false positives, but there was not enough time. “Doing so will delay development by another 12 months or so,” he said. “While this is a difficult decision, the urgent need for a vaccine is everyone’s top priority.”
Greg Hunt, the health minister, said that while the HIV test results were false positive, the scientific advice was that “the risk of confidence in the vaccine is the main issue here”.
Meanwhile, Australia has been awarded a contract for 140 million doses of vaccine, “one of the highest proportions of vaccine purchased and available to the population in the world,” hunt said. “What we can do is vaccinate our people twice,” he added.
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