AstraZeneca vaccine trial paused to investigate 'a potentially unexplained illness'

[iluvtennis]

https://thehill.com/policy/healthcare/515558-astrazeneca-vaccine-trial-paused-to-investigate-a-potentially-unexplained

One of the leading coronavirus vaccine clinical trials, from AstraZeneca, has been paused to investigate a “potentially unexplained illness” in one of the participants, the company said Tuesday.

The announcement could lead to a concerning setback to a high profile coronavirus vaccine clinical trial, though much remains unknown, and it is not clear how much of an impediment the development will be.

“As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process triggered a pause to vaccination to allow review of safety data,” AstraZeneca said in a statement. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”

The statement said it is possible the illness in one of the participants in the trial is not even caused by the vaccine. “In large trials illnesses will happen by chance but must be independently reviewed to check this carefully,” the company said. “We are working to expedite the review of the single event to minimise any potential impact on the trial timeline.”

Stat, which first reported the pause in the trial, reported that the participant who had the “suspected serious adverse reaction” is in the United Kingdom.

AstraZeneca is one of three companies that have Phase 3 coronavirus vaccine trials ongoing in the United States. Two other trials are being conducted for potential vaccines from Pfizer and Moderna.

....continued at link

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This was the most promising of all of the vaccine trials. Let'skeep out fingers crossed that the unexplianed illness in unelated to the CV-19 vaccine.

[tanyev]

1. Let's keep our fingers crossed that they haven't created something worse.

[SouthernCal_Dem]

3. The movie "I am Legend" comes to mind

They created a vaccine to fight cancer and it ended up killing most of the population and the small number of survivors essentially became zombies.

[iluvtennis]

4. + agree. nt

[BannonsLiver]

2. I have a friend in the Moderna trial

He is required to report any illness of any kind during the trial period. It’s quite exhaustive. He’s now received both of his scheduled injections. Anecdotal of course but figured I’d mention it.

[iluvtennis]

6. Good to actually have info from someone involved in the trial. thanks for sharing. nt

[Iliyah]

5. Skipping pertinent trials, at least 3 stages . . .

that this administration is trying to do would lead to problems.

As experts have repeatedly said, trials are very important. But alas, the administration wants Americans to be guinea pigs.

[radius777]

7. This is why doing full testing is important

and we shouldn't allow Trump and his FDA to fasttrack a vaccine for political purposes.

[underpants]

8. What does "potentially unexplained illness" mean?

Is it a potential illness?
Is it unexplained or what would it being potentially unexplained even occur?

[DrToast]

9. All we know so far is someone got sick

However, when you have a trial with thousands of participants, people could get sick for many reasons. It could be the vaccine, or it could be something completely unrelated.

All they know is someone got sick, so the next step is to investigate why they got sick.

[Ms. Toad]

10. The illness was described as potentially being a serious adverse reaction

There are a number of different reactions that can qualify as suspected serious adverse reactions, symptoms that require hospitalization, life-threatening illness and even death.

So the illness is serious. Wheyher it is related to the vaccine is what is currently under investigation.

As an aside - this discovery not only impacted this phase 3 study, but other vaccine trials, as well.

An individual familiar with the development said researchers had been told the hold was placed on the trial out of “an abundance of caution.” A second individual familiar with the matter, who also spoke on condition of anonymity, said the finding is having an impact on other AstraZeneca vaccine trials underway — as well as on the clinical trials being conducted by other vaccine manufacturers.

and that

Researchers running other trials are now looking for similar cases of adverse reactions by combing through databases reviewed by a so-called Data and Safety Monitoring Board, the second person said.

https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/