The move comes around a month after AstraZeneca <AZN.L> also
suspended trials of its experimental coronavirus vaccine - which
uses a similar technology - due to a participant falling ill.
J&J said on Monday the illness was being reviewed by an independent
data and safety monitoring board as well as the U.S. group's
clinical and safety physicians.
The company, which reports quarterly financial results on Tuesday
morning, said such pauses are normal in big trials, which can
include tens of thousands of people.
It added the voluntary "study pause" in giving doses of the vaccine
candidate was different from a "regulatory hold" imposed by health
authorities.
AstraZeneca last month paused late-stage trials of its experimental
coronavirus vaccine developed with the University of Oxford due to
an unexplained illness in a British study participant.
While AstraZeneca's trials in Britain, Brazil, South Africa and
India have since resumed, its U.S. trial is still on hold, pending a
regulatory review.
The J&J and AstraZeneca vaccines are both based on a so-called
adenovirus, a harmless modified virus that instructs human cells to
produce vaccine proteins.
They are both also part of the U.S. government's Operation Warp
Speed programme to support vaccine development.
"This could be a second case of adenoviral vaccine to spur safety
concerns," said Bryan Garnier analyst Olga Smolentseva.
AstraZeneca and medical experts say trial suspensions to look into
the cause of a participant's illness are not uncommon. Underwriters
of clinical trial insurance have said premiums for coronavirus
vaccines studies are only marginally higher than for pre-pandemic
vaccines.
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J&J on Sept. 22 became the fourth Warp-Speed participant to enter the final
stage of testing on humans, with the aim of enrolling 60,000 volunteers in the
United States and abroad."Everybody is on the alert because of what happened
with AstraZeneca," Dr. William Schaffner, a professor of infectious diseases at
the Vanderbilt University School of Medicine, said by email, adding it could
take a week to gather information.
"This is likely to be a neurological event," he said. Last month, J&J said its
vaccine candidate produced a strong immune response in an early-to-mid stage
clinical trial. This prompted the company to start the large scale trial, with
results expected by the end of this year or early 2021.
J&J declined to elaborate on the illness due to privacy concerns. It did say
some participants in studies get placebos, and it was not always clear whether a
person suffering a serious adverse event in a trial received a placebo or the
treatment.
Stat News reported
https://www.statnews.com/2020/10/12/
johnson-johnson-covid-19-vaccine-study-paused-due-to-unexplained-illness-in-participant/?utm_content=buffer37312&utm_
medium=social&utm_source=
twitter&utm_campaign=twitter_organic the pause earlier, citing a document sent
to outside researchers, which stated that a "pausing rule" had been met, the
online system used to enroll patients in the study had been closed and the data
and safety monitoring board would be convened.
(Reporting by Ayanti Bera in Bengaluru, Deena Beasley in Los Angeles, Peter
Henderson in Oakland, Ludwig Burger in Frankfurt; Editing by Rashmi Aich, Louise
Heavens and Mark Potter)
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