After a week on Clinical Hold, the large UK trial of the Oxford SARS-CoV-2 vaccine has resumed.
The late-stage trials were paused due to a reported side effect in a patient in the UK.
www.bbc.com
No further comments were available about any relationship between the case of transverse myelitis and the vaccine. I don't know details of how serious adverse events are handled in the UK, but in the US, this would require a formal assessment on a 5-point scale:
- Definitely Related
- Probably Related
- Possibly Related, possibly unrelated, but unable to rule out
- Probably Unrelated
- Definitely Unrelated
It's my guess that this case might be assessed as a 3 Possibly Related. Apparently, transverse myelitis is rare, often has an unknown cause, and is usually treatable (with cortico-steroids?). It's easy to guess that this case involved a person who received the experimental vaccine, and not the placebo vaccine.
If it happens again on the experimental arm of this trial, it could be given a higher assessment of 2 Probably Related. If so, that might be cause to stop the trial. I hope not. We'll see.
In the meantime, all the other SARS-CoV-2 vaccines are now alerted to look for transverse myelitis on their clinical trials. It could be a false alarm, but no one can afford to ignore it.