Late-stage trials for a leading coronavirus vaccine have been suspended after a study participant suffered a “potentially unexplained illness”.
AstraZeneca has put on hold phase three trials of a vaccine being developed in collaboration with the University of Oxford.
The Australian Government last month signed an agreement with the UK-based company to secure the potential COVID-19 vaccine, if its trials prove successful.
In a statement, AstraZeneca said it “voluntarily paused” the phase 3 clinical trial — which kicked off in July — to allow a review of the “single event” by an independent committee.
“This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials,” the statement said.
“In large trials illnesses will happen by chance but must be independently reviewed to check this carefully.”
The Australian Government had secured 33.8 million doses of the Oxford vaccine for local manufacturing. It also locked in 51 million doses of a potential vaccine being developed by the University of Queensland and CSL.
The potential total 84 million doses would be rolled out, free of charge, in stages across next year, pending successful trials, with the Government flagging that 3.8 million doses of the Oxford vaccine could be rolled out as early as January.
However, vaccine experts on Monday cautioned that the Federal Government’s timeframe was “ambitious” and “optimistic”, with most phase 3 trials taking at least a year to complete.
In a statement, Federal Health Minister Greg Hunt said the pause showed the rigor of the trial, adding the company was working to fast-track its review.
“AstraZeneca are working to expedite the review of the single event to minimise any potential impact on the trial timeline,” Mr Hunt said.
He said Australia was pursuing a “diversified COVID-19 vaccine strategy” which included the UQ vaccine trial and government talks with the manufacturers of other promising vaccines.
50,000 participating in Oxford’s trials
The Oxford vaccine produced an immune response in its first human trials, underlining its position as one of the leading candidates in the race to combat a virus that has led to hundreds of thousands of deaths and crippled the global economy.
Late last month, AstraZeneca began recruiting 30,000 people in the United States for its largest study of the vaccine.
It also is testing the vaccine in thousands of people in Britain, and in smaller studies in Brazil and South Africa.
The trial’s lead scientist, Andrew Pollard, previously said trial data for the possible vaccine could potentially be given to regulators this year. It is unclear whether today’s announcement will affect the timeline, if at all.
Australian company CSL said it planned to start the manufacturing process for the Oxford vaccine candidate as early as next month in preparation for its potential rollout in Australia.
In statement this morning, the company said it did not expect the pause in the trial — which it described as a “routine action” — to impact that plan.
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