The late-stage trial of the Oxford University COVID-19 vaccine is on hold after a study participant suffered a suspected serious adverse reaction.
On Monday, Prime Minister Scott Morrison announced that the government had secured deals for the local manufacture of the Oxford University vaccine and for another being developed at the University of Queensland. He said Australia would buy 84.8 million doses at a cost of $1.7 billion.
The Oxford vaccine trial was halted by drug maker AstraZeneca in what it said was a “routine” action due to a potentially unexplained illness among participants.
In a statement, AstraZeneca said it had “voluntarily paused” the trial 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.”
Earlier in the week, AstraZeneca and CSL, the Australian company that would make the vaccine, said doses of the product could be ready in Australia early in 2021.
“We are working to expedite the review of the single event to minimise any potential impact on the trial timeline,” an AstraZeneca spokesperson said.
The Age reports that the nature of the safety issue and when it happened were not immediately known, although the participant is expected to recover.
Speaking on ABC radio on Wednesday morning, world-leading immunologist Professor Peter Doherty said it was not uncommon for vaccine trials to be halted due to an adverse health reaction.
It was “pretty much expected” for a trial member to develop a health problem while testing the vaccine, he said, adding that it was too early to judge the seriousness of the reaction because details had not been shared.
“I don’t think it’ll slow it down much … unless there’s a real indication there’s a safety issue,” he said.
“I don’t think we’re anything near that stage.”
The Conversation reports that of the hundreds of potential COVID-19 vaccines in development, six are in the final phase three stage of testing.
Rebecca Ashfield, a senior project manager at the University of Oxford, and Pedro Folegatti, a clinical research fellow at the university, explain the research and approval process.
“To be approved, vaccines need to go through multiple rounds of testing to show that they’re safe and effective. A combined phase one and phase two trial of the Oxford vaccine has demonstrated that it is safe – with only short-term side-effects and no serious unexpected events reported – and that it elicits an immune response.
“The purpose of a phase three trial is to assess whether this vaccine-induced immune response is strong enough to actually protect people from COVID-19. Proving this would pave the way for the vaccine to become publicly available.”
They said trial volunteers were located in the UK, Brazil, South Africa, the US and India in order to evaluate its capabilities across different regions and populations.
The ABC reports that two vaccines are in final stage tests in the US – one made by Moderna Inc and the other by Pfizer and Germany’s BioNTech.
In other news, nine leading US and European vaccine developers have publicly pledged to uphold scientific safety and efficacy standards, despite the urgency to develop a vaccine.
The companies – AstraZeneca, Pfizer, GlaxoSmithKline, Johnson & Johnson, Merck & Co, Moderna, Novavax, Sanofi and BioNTech – issued a “historic pledge” in the wake of widespread concern that safety standards might be compromised due to the urgency for 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”.
Do you believe a vaccine is the only ‘safe’ way forward? Are you confident that all the usual safety measures will be followed?
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