Year-End Still Target For Oxford Drug Data -- WSJ
September 11 2020 - 2:02AM
Dow Jones News
By Jenny Strasburg
This article is being republished as part of our daily
reproduction of WSJ.com articles that also appeared in the U.S.
print edition of The Wall Street Journal (September 11, 2020).
LONDON -- AstraZeneca PLC's chief executive said a Covid-19
vaccine it is developing with the University of Oxford could still
be ready by the end of the year, despite the company pausing
late-stage trials after a participant in the U.K. developed an
unexplained illness.
Chief Executive Pascal Soriot said the progress of a safety
review into the trial subject will determine the timetable for
vaccine progress. He said, though, that he still expects a set of
data from the trials that can be presented to regulators for
approval by the end of the year.
"We could still have a vaccine by the end of this year, early
next year, " he told reporters during an online conference Thursday
morning.
Mr. Soriot said manufacturing capacity for the global
distribution of the vaccine should be ready by early next year, and
the company intends to make the vaccine available to all regions of
the world at the same time. AstraZeneca has signed deals with
several governments, manufacturers and other institutions around
the world to help it make and distribute its vaccine
world-wide.
An independent committee is reviewing potential safety concerns
related to the sick U.K. trial participant, which led to the trial
pause. The vaccine, which AstraZeneca has licensed from Oxford, is
one of the most advanced efforts in the West. Before the pause, the
company said it might have enough data by next month to submit the
vaccine to regulators for approval.
Mr. Soriot said the company doesn't have a diagnosis for the
trial subject who fell ill. "More tests are being done on the
patient, the person, who developed the symptoms...You have to do a
number of tests, and you have to take time."
The U.K. study of the vaccine was paused once before, in July,
according to an Oxford spokesman. The university declined to
discuss specifics, other than that there were no ongoing concerns
as a result of the event. Material sent to study subjects in July
indicated the pause was triggered by symptoms of a neurological
disorder known as transverse myelitis in a volunteer. But
AstraZeneca said Wednesday the case turned out to be multiple
sclerosis unrelated to the vaccine, and the testing resumed.
AstraZeneca had been conducting a large trial in the U.K., and
had just started another large, late-stage trial in the U.S., which
aims to enroll up to 30,000 people. Both trials were aimed at
determining whether the vaccine safely protects people from
Covid-19. AstraZeneca also had been testing the vaccine in
countries including South Africa and Brazil.
Write to Jenny Strasburg at jenny.strasburg@wsj.com
(END) Dow Jones Newswires
September 11, 2020 02:47 ET (06:47 GMT)
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