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VACCINE TRIAL STOPPED AFTER NEUROLOGICAL SYMPTOMS DETECTED

A drugmaker says it halted a coronavirus vaccine study because a woman who
received the experimental shot developed severe neurological symptoms

By MARIA CHENG AP Medical Writer
10 September 2020, 17:54
• 2 min read
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The Associated Press
FILE - This Saturday, July 18, 2020 file photo shows a general view of
AstraZeneca office...Read MoreRead More

LONDON -- A woman who received an experimental coronavirus vaccine developed
severe neurological symptoms that prompted a pause in testing, a spokesman for
drugmaker AstraZeneca said Thursday.

The study participant in late-stage testing reported symptoms consistent with
transverse myelitis, a rare inflammation of the spinal cord, said company
spokesman Matthew Kent.



“We don't know if it is (transverse myelitis)," Kent said. “More tests are being
done now as part of the follow-up.”

On Tuesday, AstraZeneca said its “standard review process triggered a pause to
vaccination to allow review of safety data." It did not provide any details
other than to say a single participant had an “unexplained illness.” The vaccine
was initially developed by Oxford University after the coronavirus pandemic
began this year.

Kent said an independent committee was reviewing the study's safety data before
deciding if and when the research could continue.

The study was previously stopped in July for several days after a participant
who got the vaccine developed neurological symptoms; it turned out to be an
undiagnosed case of multiple sclerosis that was unrelated to the vaccine.

Late last month, AstraZeneca began recruiting 30,000 people in the U.S. for its
largest study of the vaccine. It also is testing the vaccine in thousands of
people in Britain, and in smaller studies in Brazil and South Africa. Several
other COVID-19 vaccine candidates are in development.

Dr. Soumya Swaminathan, the World Health Organization's chief scientist, said
the U.N. health agency wasn't overly concerned by the pause in the Oxford and
AstraZeneca vaccine trial, describing it as “a wake-up call” to the global
community about the inevitable ups and downs of medical research.



Temporary holds of large medical studies aren’t unusual, and investigating any
serious or unexpected reaction is a mandatory part of safety testing.
AstraZeneca pointed out that it’s possible the problem could be a coincidence;
illnesses of all sorts could arise in studies of thousands of people.

———

The Associated Press Health and Science Department receives support from the
Howard Hughes Medical Institute’s Department of Science Education. The AP is
solely responsible for all content.

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