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Global trials of the leading vaccine were put on hold last month after a British study participant fell ill with what was believed to be a rare spinal inflammatory disorder.
(Reuters)
Clinical trials of AstraZeneca and
Oxford University’s experimental Covid-19 vaccine has resumed
in five countries almost a month after being put on hold due to an
illness of a British volunteer, while discussions with US authorities continue.
Trials in Japan, UK, Brazil, South Africa and India resumed, but US trials remain paused as regulators widened their probe on Wednesday.
In a statement on Friday, the pharmaceutical giant stressed that safety of the participants was of “paramount importance” and that it was applying the highest standards of conduct in trials.
Global trials of the vaccine, called AZD1222 or ChAdOx1
nCoV-19, were put on hold on September 6 after a study participant
fell ill with what was believed to be a rare spinal inflammatory
disorder called transverse myelitis.
READ MORE:
AstraZeneca’s Covid-19 vaccine trial suspended after volunteer falls ill
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Investigation of the halt
AstraZeneca has called the halt a standard review procedure,
and a document posted online by Oxford university last month
stated the illness may not have been associated with the
vaccine.
However, the incident has drawn focus on the safety of
candidates being developed in the race for a successful vaccine
against the illness caused by the novel coronavirus which has
claimed more than a million lives globally.
The US Food and Drug Administration (FDA) broadened its
investigation of the illness in the volunteer, and would look at
data from earlier trials of similar vaccines developed by the
same scientists.
READ MORE: AstraZeneca says it will know by year-end if its vaccine is safe to use
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Sources had told Reuters that the data requested by the FDA
for one of the most advanced Covid-19 vaccine candidates in
development was expected this week.
READ MORE: What you need to know about Covid-19 vaccines in the works
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Source: Reuters












