Thread: Covid 19 C&P

An adverse reaction brings the Oxford coronavirus trial to a halt. The trial has just been put on hold to investigate the reaction, which is normal practise.

National deputy chief medical officer Nick Coatsworth said the delay did not necessarily mean the vaccine deal was dead, but the adverse reaction needed to be investigated.
Dr Coatsworth said he was not worried about the trial being put on hold and praised the transparency of those testing the vaccine.

'Adverse reaction' brings Oxford coronavirus vaccine trial to a halt

From the New York Times.

A vaccine front-runner hits the brakes

AstraZeneca yesterday paused the late-stage trials for its coronavirus vaccine because of a suspected adverse reaction in a participant. Now it will investigate whether the vaccine caused the illness, which several people familiar with the situation said was transverse myelitis — an inflammation of the spinal cord that is often prompted by viral infections.

This is the second time that AstraZeneca, which is developing its vaccine with the University of Oxford, has put its trials on hold. Another participant developed symptoms of transverse myelitis, researchers reported in July, but it was later attributed to an “unrelated neurological illness.”

AstraZeneca’s vaccine has garnered attention as one of the most promising and advanced candidates. To understand what the pause may mean in the race for a vaccine, we spoke with our colleague Katherine Wu, a science reporter. Our conversation has been lightly edited and condensed.

What does pausing the vaccine trials mean?

AstraZeneca is not giving the vaccine to any more people until they can determine whether the person’s sickness was directly linked to the vaccine.

How is AstraZeneca’s vaccine different from the other coronavirus vaccines in development?

AstraZeneca’s vaccine is based on what’s called a viral vector. You want to produce an immune response to the coronavirus, but instead of using the coronavirus itself, they use what’s called an adenovirus that they took from a chimpanzee.

This is meant to be a modified virus that they have genetically altered to be harmless to humans, but they’ve also modified it to express some genes from the coronavirus. The idea is that this virus is like a chauffeur that can bring coronavirus genes into the body and then will allow the body to mount a response to the products of those coronavirus genes, but the body will not be infected with the coronavirus.

What happens now with the trial?

The U.S. vaccine trials were not in full swing yet. AstraZeneca was planning to enroll 30,000 people at 80 sites. They’ve enrolled at only 62 sites, so this may mess up their timeline.

AstraZeneca has previously said they were hoping to roll something out early next year. That could still be possible. It really depends on what other data emerges from the Phase 3 trials. But if this hold takes awhile to investigate, it could be longer than that.

It is also possible that if they notice more of these adverse events or if the event is bad enough, the trial could be stopped. In that case the researchers have to be pretty sure they are seeing something that resulted from the vaccine. That’s a big question mark right now. We don’t know whether this person was in the placebo group or the vaccine group.

How long could the investigation take?

That is totally unclear at this point. AstraZeneca released statements yesterday saying they were going to expedite the process as much as possible so that their plans for the Phase 3 trial weren’t going to be derailed.

But obviously the most important thing here is to make sure that the participant is safe and being followed up on. They’ve made it sound as if they’re not going to cut corners.

How should people think about this pause?

One of the most important things is that people should not be worried. I see this as an optimistic development. If the researchers notice an adverse effect, the right thing to do is to pause the trial and figure out what’s going on.

The other upshot is that if adverse events happen and they have a relationship to any of the vaccine candidates, this is what Phase 3 trials are for. This is why it’s so important to see the data through and to really monitor these patients. We wouldn’t know that this is happening if we were rushing through these trials, so this is science working as it should.

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