AstraZeneca has put a hold on the late-stage trial of the highly-anticipated COVID-19 vaccine candidate being developed with Oxford University after a suspected serious adverse reaction in a study participant, though the company says this is a "routine action."
The vaccine being trialled is the same product that biotechnology giant CSL has committed to making 30 million doses of for Australians if the product passes regulatory approvals.
AstraZeneca has not said what the serious adverse reaction was.
Independent scientists monitoring the trial will now try to determine whether the reaction was caused by the vaccine.
Clinical trial experts emphasised that pauses are a common part of the vaccine-development process.
An AstraZeneca spokeswoman told The Age and The Sydney Morning Herald that the "standard review process triggered a pause to vaccination to allow review of safety data."
An AstraZeneca spokeswoman said the pausing of a trial was "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."Credit:Bloomberg
"As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee," the spokeswoman said.
"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. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully."
The study is testing the COVID-19 vaccine being developed by AstraZeneca and University of Oxford researchers at sites including the US and Britain, where the adverse event was reported.
The nature of the safety issue and when it happened were not immediately known, although the participant is expected to recover, according to Stat News.
AstraZeneca declined to comment on whether the pause would cause any delays on when the product would be available for distribution, or whether Australia would have to wait longer for its doses.
Earlier this week AstraZeneca and CSL both said doses of the product could be ready in Australia in the early part of 2021.
"We are working to expedite the review of the single event to minimise any potential impact on the trial timeline," the AstraZeneca spokeswoman said.
Professor Adrian Esterman, chair of biostatistics at the University of South Australia, said trial pauses were "absolutely common".
"It would happen in every single clinical trial. It is extremely common. There is nearly always someone who dies or has a stroke during a clinical trial."
Serious adverse events can include a range of illnesses, including serious allergic reactions, strokes, and death.
An independent monitoring committee will now scrutinise the trial to determine if the event was caused by the vaccine itself.
"Someone could have a stroke but it could have nothing to do with the vaccine altogether," said Professor Esterman.
How clinical trials work
Phase 1: The vaccine is tested on a small group of healthy volunteers. Scientists look for serious safety concerns
Phase 2: these trials are also small. They test different doses of vaccine and look for early evidence the drug or vaccine is effective
Phase 3: these trials often involve tens of thousands of people. They test a drug or vaccine's safety and effectiveness in people of different ages and with different health conditions
Approval: A regulator looks at all the data and decides whether to approve the vaccine
Associate Professor Darren Saunders, a cancer biologist at the University of NSW, said trial pauses would not normally attract attention – but the pandemic has turned science into a spectator sport.
"This is the way it works. It always works like this. It’s just that most people normally don’t get to see it.
"People should not be too despondent. This is not an unusual thing to happen in a clinical trial. Research does not work on a linear path. There are hiccups, there are hurdles, and sometimes we have to backtrack"
The Stat report said suspension of the trial was having an impact on other AstraZeneca vaccine trials – as well as on clinical trials being conducted by other vaccine makers.
Nine leading US and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines despite the urgency to contain the coronavirus pandemic.
The companies, including AstraZeneca, Pfizer and GlaxoSmithKline, issued what they called a "historic pledge" after a rise in concerns that safety standards might slip in the face of political pressure to rush out a vaccine.
The companies said they would "uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines".
The other signatories were Johnson & Johnson, Merck & Co, Moderna, Novavax, Sanofi and BioNTech.
with Reuters
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Emma reports on healthcare companies for The Age and Sydney Morning Herald. She is based in Melbourne.
Liam is The Age and Sydney Morning Herald's science reporter
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