Oxford University has announced it will resume a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca after getting the green light from safety watchdogs.
Key points:Globally some 18,000 people have received the trial vaccineThe vaccine was in late-stage clinical trials in the US, Britain, Brazil and South AfricaThe US was aiming for fast-track approval of a vaccine before November’s presidential election
The late-stage trials of the experimental vaccine were suspended last week following a reported side-effect in a UK patient.
In a statement, the university confirmed the restart across all of its UK clinical trial sites.
The patient involved in the study had been reportedly suffering from neurological symptoms associated with a rare spinal inflammatory disorder called transverse myelitis.
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The vaccine being developed by Oxford and AstraZeneca has been widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.
Last month, the Australian Government signed an agreement with AstraZeneca to secure the potential COVID-19 vaccine, if its trials proved successful.
Prime Minister Scott Morrison said if the vaccine succeeded, the Government would manufacture it immediately and make it free for all Australians.
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AstraZeneca, based in Cambridge, said the September 6 shutdown had been triggered by a “standard review process” and was to allow a review of safety data by “independent committees, and international regulators”.
“The company will continue to work with health authorities across the world and be guided as to when other clinical trials can resume to provide the vaccine broadly, equitably and at no profit during this pandemic,” the company said in a statement.
British Health Secretary Matt Hancock welcomed the restart, saying in a tweet that it was “good news for everyone” that the trial is “back up and running”.
Globally some 18,000 people have received its vaccine so far in Britain, Brazil and South Africa. About 30,000 volunteers are being recruited in the US.
The vaccine was in late-stage clinical trials in the United States, Britain, Brazil and South Africa and additional trials were planned in Japan and Russia.
The Serum Institute of India said it would restart its trials once it had permission from the Drugs Controller General of India.
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Brazil’s health regulator ANVISA said it was awaiting notice from the British MHRA confirming that resumption of trials has been authorised before resuming in Brazil.
The Federal University of Sao Paulo, which is conducting the paused trials, said in a statement 4,600 of the planned 5,000 volunteers had been recruited and vaccinated without any of them reporting any serious health issues.
WHO says trial pause a ‘wake-up call’ The Oxford vaccine has been widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines.(Reuters: Amanda Perobelli)
Governments around the world are desperate for a vaccine to help end the pandemic, which has caused more than 900,000 deaths and global economic turmoil.
The pause of the trials came after reports that the United States was aiming to fast-track authorisation or approval of a vaccine before November’s presidential election.
Leading US and European vaccine developers have pledged to uphold scientific safety and efficacy standards for their experimental vaccines and not bow to political pressures to rush the process.
AstraZeneca has already agreed to supply close to 3 billion doses to governments across the globe — more than any other vaccine project.
The WHO’s chief scientist said the pause in the trials should serve as a “wake-up call” that there would be ups and downs in the development of a vaccine.
“Inevitably with such a large trial there will be times when safety issues arise,” said Peter Openshaw, professor of experimental medicine at Imperial College London.
“We must all hope that there are no future events and that the vaccine proves both safe and effective.”
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