Oxford Trial resumes

As I mentioned in my recent post the case of transverse myelitis in Oxford Vaccine trial would be reviewed by the trial’s Data Safety and Monitoring Board and the UK regulator. The case has now been considered and both bodies have given the green light for the vaccine trials to proceed.

A press release announced:

“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 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.

We cannot disclose medical information about the illness for reasons of participant confidentiality.We are committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.“

Comment

• This is not unexpected nor unreasonable given there was only a single case of this complication among all the people in the trial, although the authorities have responded very rapidly.
• I had also made the assumption that the complication occurred in a volunteer from the group who had received the active vaccine of the trial but this may not have been the case
• Indeed the trial group of the affected individual had not been disclosed
• Possibly that person could have been in the inactive vaccine group – which might explain the rapid response to lift the pause
• Hopefully there will be no further cases of transverse myelitis!

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