Questions remain surrounding Oxford vaccine trial pause

Scientists around the globe celebrated news the University of Oxford would restart the trial for its COVID-19 vaccine candidate, but some called for more transparency surrounding the pause while others backed the decision to not detail the illness that prompted it.

The university over the weekend announced it was resuming its trial, just under a week after it was suspended due to a reported side-effect in a UK patient.

In a statement issued on Saturday, Oxford 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.

“On Sunday our standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators.

“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.”

The university said it could not disclose medical information about the participant’s illness “for reasons of participant confidentiality”.

Per an article by Nature, Paul Komesaroff, a physician and bioethicist at Monash University, questioned that claim.

Komesaroff said it was possible to provide information in a way that avoids identifying an individual but still provides a summary of the clinical issues that arose. “It is of concern that they sought to avoid doing so,” he said.

But Paul Griffin, an infectious-diseases researcher who is involved in the University of Queensland’s vaccine candidate trial, said releasing information about the trial prematurely could present a bias to the clinicians involved. He said the integrity of the trial was on the line.

Globally, some 18,000 individuals have received study vaccines as part of the trial.

In an article written for The Conversation prior to the pause, Oxford researchers said there was a good chance they will know whether their vaccine is effective before the end of 2020.

"After the successful completion of phase 3 trials, regulatory bodies in each country will need to review the available data before approving the vaccine for general use."

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