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Related: Editorials & Other Articles, Issue Forums, Alliance Forums, Region ForumsAstraZeneca vaccine trial paused to investigate 'a potentially unexplained illness'
https://thehill.com/policy/healthcare/515558-astrazeneca-vaccine-trial-paused-to-investigate-a-potentially-unexplainedOne 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.
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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
(42,550 posts)SouthernCal_Dem
(852 posts)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
(19,844 posts)BannonsLiver
(16,369 posts)He is required to report any illness of any kind during the trial period. Its quite exhaustive. Hes now received both of his scheduled injections. Anecdotal of course but figured Id mention it.
iluvtennis
(19,844 posts)Iliyah
(25,111 posts)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
(3,635 posts)and we shouldn't allow Trump and his FDA to fasttrack a vaccine for political purposes.
underpants
(182,763 posts)Is it a potential illness?
Is it unexplained or what would it being potentially unexplained even occur?
DrToast
(6,414 posts)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
(34,060 posts)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.
and that
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/