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A player in the company’s complex coronavirus vaccine trial reportedly developed severe neurological symptoms and experts now want to assess whether the vaccine is responsible.
By Katherine J. Wu
On Wednesday, scientists welcomed AstraZeneca’s resolution to suspend its testing of a complex coronavirus vaccine and begin a protection review after a player has developed a serious neurological disease. Dr. Francis Collins, director of the National Institutes of Health, testified at a Senate hearing on Wednesday. , saying the move “should be reassuring. “
The effects of the protection review, which will be carried out through an independent panel of experts, will help if the participant’s condition was a reaction to the candidate vaccine or simply a coincidence, and deserve a great influence if and when trials can resume.
But many of the main points about the rest of the trial and the occasion that triggered it remain unclear: researchers still don’t know what caused the volunteer’s symptoms, how long the evaluation procedure will take, or what the consequences will be.
Part of the review will come with the generation of a timeline of the participant’s symptoms to see if they correspond to the time the vaccine was administered. The committee will also discuss other possible causes of symptoms in an elimination procedure.
After finding out if the AstraZeneca vaccine is the most likely cause, experts will tell the company if it resumes testing.
Regulatory agencies such as the Food and Drug Administration are likely to collect knowledge and make more contributions along the way, said Dr. Mark Goldberger, an infectious disease expert at Global Antibiotic Research and Development Partnership and a former FDA official.
In the meantime, no doses of the vaccine will be administered.
In initial trials, the AstraZeneca candidate vaccine, built from an innocent virus known to cause colds in chimpanzees, which was designed to bring coronavirus genes, provided promising protection knowledge in humans, several participants experienced mild or moderate side effects, adding fever and pain and effort.
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