Late trials of the flagship Coronavirus vaccine were suspended after one of the study participants suffered from a “potentially unexplained disease. AstraZeneca has halted phase 3 trials of a vaccine being developed in cooperation with the University of Oxford.
Last month, if trials were successful, the Australian Government signed an agreement with a UK-based company to secure a potential COVID-19 vaccine.
In a statement, AstraZeneca said it had “voluntarily discontinued” the third phase of the clinical trial – which began in July – to allow for a “single event” review by an independent panel.
This is a routine procedure that should occur whenever there is an unexplained potential disease in an experiment while investigating it, to ensure that the integrity of the trials is preserved,” the statement said.
Diseases will happen by chance in large trials, but they need to be independently reviewed to carefully check that out.
The Australian Government has secured 33.8 million doses of the local manufacturing Oxford vaccine. 51 million doses of a potential vaccine being developed by the University of Queensland and CSL have also been seized.
A total of 84 million potential doses will be released for free in phases over the next year, pending successful trials, with the government indicating that 3.8 million doses of the Oxford vaccine could be released as early as January.
However, on Monday, vaccine experts warned that the federal government’s timeframe was “ambitious” and “optimistic,” with most phase III trials taking at least a year to complete.
50,000 participants in the Oxford trials
The Oxford vaccine produced an immune response in its first human trials, confirming its position as one of the main candidates in the anti-virus race that has resulted in hundreds of thousands of deaths and paralyzed the global economy.
Late last month, AstraZeneca began recruiting 30,000 people in the United States for its largest study of the vaccine.
And Andrew Pollard, chief scientist of the experiment, said earlier, that experimental data for a potential vaccine could be given to regulators this year. It’s unclear if today’s announcement will affect the schedule if it will at all.
Australian company CSL said it plans to start manufacturing the Oxford Candidate vaccine early next month in preparation for its rollout in Australia.
Australian vaccine expert Tony Cunningham, who has run multiple Phase 3 trials around the world, said that these types of “severe adverse events” are relatively common.
He said that vaccine trials generally saw half of them get the vaccine and the other half receive a placebo, yet it is not clear which group the unexplained disease came from.
They will have a data-monitoring safety board, he said. People who are at a distance from the trials will evaluate these events to determine what happened.
But it only shows that things have to be done correctly. You are probably dealing with the health of hundreds of millions of people and that is why these experiments take time. We can not have them rushed.
Nick Coatsworth, Australia’s deputy chief medical officer, said the move “doesn’t put the vaccine on the table in any way”.
He said the government is investing in “multiple technologies and potentially multiple vaccines” to compensate for the setbacks that any single vaccine faces.