A billion-dollar deal for the Morrison government to buy more than 50 million doses of the University of Queensland’s potential coronavirus vaccine has been abruptly terminated after several trial participants returned false positive HIV test results.
UQ, working in partnership with Australian global biotech company CSL, will abandon its current clinical trials following the discovery. It informed the federal government of the initial data on Monday, which was then referred to health authorities for urgent medical advice.
Sources with knowledge of the current trials said pathology tests had in the past weeks confirmed the positives were in fact false and the health of the participants has not been put at risk.
The National Security Committee of Cabinet agreed to terminate the purchasing agreement on Thursday, following expert health advice and fears the revelation would severely damage the Australian public’s confidence in the COVID-19 vaccination program, which is expected to begin early next year.
A health official, not authorised to speak publicly, told The Age and The Sydney Morning Herald on Thursday night the government had moved swiftly in the past 48 hours to secure tens of millions more doses of candidate vaccines, including from Oxford University-AstraZeneca, to cover for the 51 million doses the home-grown product was to supply.
The UQ vaccine candidate uses a protein and adjuvant platform, containing the COVID-19 spike protein and a "molecular clamp". A small component is derived from the human immunodeficiency virus, known as HIV, that is not able to infect people or replicate.
CSL had a deal with the University of Queensland to produce its candidate vaccine.Credit:Getty Images
A source with knowledge of the clinical results said although the HIV protein fragment posed "absolutely no health risk to people", they had identified that some trial participants who received the vaccine produced a partial antibody response to it.
The partial antibody response had the potential to interfere with some HIV screening tests that look for the antibodies – leading to a false positive test result. It is unclear how long participants would continue to return false positive results.
The source said although all participants had been told there was a remote possibility HIV markers could be found in tests during the trial, medical researchers had not expected it to occur.
More than 200 volunteers in two groups – aged 18 to 55, and 56 and over – were involved in the phase one trial with a proportion of the participants receiving a placebo.
Evidence publicly released so far from the clinical trials found the vaccine to be safe and said it produced a strong immune response able to neutralise the COVID-19 virus in laboratory based tests.
A government source said the Australian government’s Science and Industry Technical Advisory Group, headed by Health Department secretary Brendan Murphy and acting Chief Medical Officer Paul Kelly, had reviewed the findings this week and recommended ending the deal.
An industry source said CSL, Australia’s biggest company, will make a statement to the ASX 200 on Friday before the market opens. Both UQ and CSL will continue their research in the hope of creating a successful vaccine in coming months.
Neither CSL, the University of Queensland nor the Morrison government would comment when contacted by this masthead.
Vaccines typically require years of research and testing before reaching the clinic, but scientists around the world are racing to produce a safe and effective coronavirus vaccine by next year.
Prime Minister Scott Morrison said on Thursday the government would "just follow the medical advice" and of the four purchased vaccines he knew "not all of those would ... necessarily get there".
Although the deal with CSL was expected to be worth up to $1 billion, the federal government was not required to pay unless the vaccine had received the green light from health authorities and large-scale production occurred. It means the funding commitment can be diverted to securing doses from other candidate vaccines.
Before the UQ-CSL termination, the Morrison government had signed five agreements securing potential access to 134 million doses from different vaccines at a total cost of $3.2 billion.
Researchers are testing 58 vaccines in clinical trials on humans, and at least 86 preclinical vaccines are under active investigation in animals.
Rob Harris is the National Affairs Editor for The Sydney Morning Herald and The Age, based at Parliament House in Canberra
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2020-12-10 19:00:00Z
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