Ask Dr. Nandi: AstraZeneca pauses coronavirus vaccine trial after unexplained illness in volunteer

Posted at 7:05 PM, Sep 09, 2020
and last updated 2020-09-09 19:05:00-04

A coronavirus vaccine trial has been paused due to a "potentially unexplained illness” that developed in a study participant.

Drugmaker AstraZeneca reports that its clinical trials are on hold while an independent committee investigates.

First of all, this is the Oxford Vaccine that’s being developed in partnership with Britain's University of Oxford. And so far, AstraZeneca hasn’t revealed much information - they’re only saying that one of their volunteers has a "potentially unexplained illness”.

Now stage 3 trials are taking place in several countries, the United Kingdom, Brazil, South Africa, and here in the US. And while I’m sure we’ll learn more in the coming days, the New York Times reports that they’ve spoken to an anonymous source close to the trial. And it’s been revealed that the participant with this illness is in a UK trial. And it’s suspected they have transverse myelitis - an inflammatory syndrome that affects the spinal cord.

There are thousands of people involved with clinical trials, especially in Phase 3. And health issues can pop up that are unrelated to a vaccine. So it is possible that this unexplained illness is just a coincidence and happened by chance.

But that’s the job of the independent committee to determine. They’ll investigate and review the data to see if the illness is a direct cause of the vaccine.

Now as for transverse myelitis, it can be serious. It can cause pain, muscle weakness, and paralysis. It’s often triggered by viral infections but immune system disorders can also cause this neurological disorder.

Most people recover at least partially but some end up with major disabilities.

This is a normal part of the process and a standard precaution. Anytime there is an unexplained illness, it gets investigated and scrutinized.

That’s the reason why we do trials. We want to see how effective a vaccine is, and we want to make sure it’s safe and that there are no serious reactions before it’s released to the general public.

As for the possibility of the vaccine being delayed, AstraZeneca says they’re “working to expedite the review of the single event to minimize any potential impact on the trial timeline."

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