(Adds commentary from companies on trial; adds bylines)
By Julie Steenhuysen and Carl O'Donnell
Oct 23 (Reuters) - AstraZeneca Plc has resumed the
U.S. trial of its experimental COVID-19 vaccine after approval
by regulators, and Johnson & Johnson is preparing to
resume its trial as early as next week, the companies said on
Friday.
AstraZeneca's U.S. trial was paused on Sept. 6 after a
report of a serious neurological illness, believed to be
transverse myelitis, in a participant in the company's UK trial.
J&J paused its large, late-stage trial last week after a study
participant became ill and the company said an independent
safety panel was investigating.
J&J said on Friday that the safety panel, called a Data and
Safety Monitoring Board, has recommended that the drugmaker
resume trial recruitment after finding no evidence that the
vaccine caused the volunteer to fall ill.
J&J expects to resume its trial in the U.S. on Monday or
Tuesday of next week and remains on track to produce data from
the trial on the vaccines' effectiveness by the end of 2020 or
early 2021, J&J's chief scientific officer Paul Stoffels said.
J&J is also in discussions with other regulators to resume a
trial outside of the United States, the company said.
So far, the medical board has not identified a clear cause
for the patients' illness. J&J cannot reveal any details about
the patient's sickness because of patient privacy rules,
Stoffels said.
AstraZeneca said that it is not unusual for some trial
participants to fall ill during large scale vaccine trials but
that the U.S. Food and Drug Administration has reviewed all
safety data from the trials globally and deemed it safe to
continue testing the vaccine.
AstraZeneca trials in the United Kingdom, Brazil and South
Africa resumed last month even as the U.S. Food and Drug
Administration continued its investigation into the case.
Reuters earlier this week reported that the FDA had
completed its review and that the AstraZeneca U.S. trial was set
to resume as early as this week, citing four sources familiar
with the situation.
AstraZeneca's vaccine is being developed along with
researchers at Oxford University.
(Reporting by Munsif Vengattil and Carl O'Donnell; Editing by
Anil D'Silva, Rosalba O'Brien and Grant McCool)
Astrazeneca (AZN)
