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Coronavirus vaccine: Oxford, AstraZeneca resume trial after patient’s serious side-effect

Oxford University has announced it is resuming a trial for a coronavirus vaccine it is developing with pharmaceutical company AstraZeneca, a move that comes days after the study was suspended following a reported side-effect in a UK patient.

In a statement on Saturday, the university confirmed the restart across all of its UK clinical trial sites after regulators gave the go-ahead following the pause on Sunday.

“The independent review process has concluded and following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, the trials will recommence in the UK,” it said.

The vaccine being developed by Oxford and AstraZeneca is widely perceived to be one of the strongest contenders among the dozens of coronavirus vaccines in various stages of testing around the world.

The university said in large trials such as this “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety”.
Camera IconThe university said in large trials such as this “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety”. Credit: Alastair Grant/AP

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.”

The university said in large trials such as this “it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety.”

It said globally some 18,000 people have received its vaccine so far. Volunteers from some of the worst affected countries – Britain, Brazil, South Africa and the US – are taking part in the trial.

Although Oxford would not disclose information about the patient’s illness due to participant confidentiality, an AstraZeneca spokesman said earlier this week that a woman had developed severe neurological symptoms that prompted the pause.

Specifically, the woman is said to have developed symptoms consistent with transverse myelitis, a rare inflammation of the spinal cord.

The university insisted that it is “committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”

Health Minister Greg Hunt says the Oxford vaccine is still on schedule despite trials being halted.
Camera IconHealth Minister Greg Hunt says the Oxford vaccine is still on schedule despite trials being halted. Credit: AAP/James Ross

Pauses in drug trials are commonplace and the temporary hold led to a sharp fall in AstraZeneca’s share price following the announcement on Tuesday.

The Oxford-AstraZeneca study had been previously stopped in July for several days after a participant developed neurological symptoms that turned out to be an undiagnosed case of multiple sclerosis that researchers said was unrelated to the vaccine.

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