(WSYR-TV) — One of the three late stage studies on a coronavirus vaccine is on pause and a safety review is underway.
This comes after learning that a participant had developed a serious neurological condition.
The Director of the national Institutes of Health testified at a Senate hearing on Wednesday saying that the step “ought to be reassuring.”
It is also a reminder of the importance of large and thorough studies to make sure that vaccines are effective and safe.
More than 10,000 adult volunteers were given two doses of AstraZeneca’s vaccine four weeks apart in the company’s trial in the United Kingdom.
One of the individuals became ill with inflammation of the spinal cord, according to an anonymous source with knowledge of the event.
The symptoms were consistent with a condition called Transverse Myelitis. AstraZeneca stopped the trial and now an independent board of experts will determine if the participant’s condition was a reaction to the vaccine.
They will create a timeline of the participant’s symptoms to see if they match up roughly with when the vaccine was administered.
Other potential causes of the symptoms will be considered in a process of elimination.
After determining whether AstraZeneca’s vaccine is the probable cause, experts will advise the company on whether to resume its trials or not.
The company has not commented on specifics of the pause.
Experts who study and produce vaccines said adverse events do occur during vaccine trials and this is a normal part of doing business.
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