When I first heard that the Oxford/Astra-Zeneca vaccine trial was on hold, I admit it spiked my depression.
I have high risk relatives in the UK and I would like them to be able to go outside again. Then I thought about it some more.
A UK participant in the trial came down with symptoms consistent with transverse myelitis. This is an inflammatory disorder that can, rarely, be caused by viral infection (including COVID-19) and, even more rarely, by vaccination. The diagnosis has not been confirmed and the volunteer is recovering.
The company has put the trial on pause while experts establish whether the adverse event, as it’s called, was caused by the trial or whether it was a coincidence.
Is this Normal?
Yes! It’s normal for phase 3 clinical trials, particularly vaccine trials, to be paused after a severe adverse event. Any unexplained illness in any participant has to be investigated, and when you’re running a trial with, say, 30,000 people in it, there’s almost certainly going to be at least one such incident.
This is simply part of the trial process. Note that to trigger a pause, an adverse event has to be pretty serious. Many people getting the experimental vaccines are experiencing side effects such as injection site soreness, muscle aches and mild fever.
Does this Mean the Astra-Zeneca Vaccine is a Non-Starter?
Possibly. Due to the severity of the reaction, it is possible the trials will be halted and the manufacturer will have to start over.
However, it’s statistically more likely that they will establish what happened and the trial will continue.
Even if this particular vaccine isn’t safe, this doesn’t affect any of the other vaccines in development.
So, About that Good News Thing?
But good news? Surely this is bad news (and it certainly is for the volunteer).
It’s good news because it demonstrates that we are still taking safety seriously. There’s a lot of concern about rushed vaccine development resulting in the wide distribution of a vaccine that is unsafe and/or ineffective.
The fact that standard safety protocols are still working in at least one of these trials demonstrates that the scientific community is taking safety seriously.
If we were as bad off politically as some think, it would have been easy enough to conceal this one illness and keep going. Harder than it was before social media, but they could still have done it.
This makes me more inclined to trust whatever vaccine is eventually released, not less. I would have been very worried if vaccine trials had appeared to go on with absolutely no problems.
We will probably have a vaccine. It might even be this one. But we need to make sure that it’s not one that puts people in the hospital.