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 The U.S. trial of AstraZeneca's COVID-19 vaccine candidate,
initially developed by the University of Oxford, remains on hold
while regulators investigate an illness in one of the participants,
even after a British study and other programmes outside of the
United States have resumed.
"We are the sponsor of the U.S. study. We then provided all this
information to the FDA (U.S. Food and Drug Administration) and we
are waiting to hear their decision," Soriot told a virtual World
Economic Forum discussion.
U.S. Health and Human Services Secretary Alex Azar said on Wednesday
the continued suspension showed the FDA was taking vaccine safety
seriously.
A document posted online by Oxford university last week stated the
illness in a British participant that triggered the pause on Sept. 6
may not have been associated with the vaccine.
Asked why the company had not disclosed details about the nature of
the illness, Soriot said clinical trial regulators and independent
supervisors were guarding participants' privacy.
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Still, the company would look into increasing transparency without compromising
individual rights and while also preventing the public and volunteers from
drawing wrong conclusions, which could endanger trial enrollment.
"We are discussing with other companies as an industry what information we can
offer without compromising patient privacy but also without compromising the
trial itself," said the CEO.
Soriot also said that tests of the vaccine prototype on children had not started
yet.
The British trial (https://clinicaltrials.gov/ct2/
show/NCT04400838), launched in May seeking more than 12,000 volunteers, will
have one out of 11 subgroups with children 5 to 12 years of age.
(Editing by Mark Potter and Jane Merriman)
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