[dabigv13]

Some details from the NYTimes:

“A person familiar with the situation, and who spoke on the condition of anonymity, said that the participant had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is unclear.”

What does this mean? What are the implications?

If they think the vaccine caused someone to get transverse myelitis, that would be bad news. Neurological complications like Guillain-Barre and transverse myelitis are rare events generally, and may be associated with vaccinations. If they can't find any other reason for it.....hard to say. N of 1. But worth pausing. If one in 30,000 gets transverse myelitis, that vaccine is definitely getting pulled. If one in 300,000 does, probably the same.
- EDIT -
Just realized I got my math wrong here. Should have said 15,000, since half the trial is getting placebo.
- EDIT -
During a pandemic, safety should be paramount. You're ideally injecting most of your populace in a short period of time. If a small fraction end up paralyzed or dead or in constant pain or ....., that could be a lot of people. Especially for a virus that kills less than a half percent of the people that get it, and a significantly lower percentage than that for younger and healthier people who will still need to be vaccinated.

[dabigv13]

Some details from the NYTimes:

“A person familiar with the situation, and who spoke on the condition of anonymity, said that the participant had been enrolled in a Phase 2/3 trial based in the United Kingdom. The individual also said that a volunteer in the U.K. trial had been found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections. However, the timing of this diagnosis, and whether it was directly linked to AstraZeneca’s vaccine, is unclear.”

What does this mean? What are the implications?

If they think the vaccine caused someone to get transverse myelitis, that would be bad news. Neurological complications like Guillain-Barre and transverse myelitis are rare events generally, and may be associated with vaccinations. If they can't find any other reason for it.....hard to say. N of 1. But worth pausing. If one in 30,000 gets transverse myelitis, that vaccine is definitely getting pulled. If one in 300,000 does, probably the same.
- EDIT -
Just realized I got my math wrong here. Should have said 15,000, since half the trial is getting placebo.
- EDIT -
During a pandemic, safety should be paramount. You're ideally injecting most of your populace in a short period of time. If a small fraction end up paralyzed or dead or in constant pain or ....., that could be a lot of people. Especially for a virus that kills less than a half percent of the people that get it, and a significantly lower percentage than that for younger and healthier people who will still need to be vaccinated.