J&J pauses coronavirus vaccine trials due to unexplained illness
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[October 13, 2020]
(Reuters) - Johnson & Johnson <JNJ.N>
has paused clinical trials of its coronavirus vaccine candidate due to
an unexplained illness in a study participant, delaying one of the
highest profile efforts to contain the global pandemic.
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.
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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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The company logo for Johnson & Johnson is displayed to celebrate the
75th anniversary of the company's listing at the New York Stock
Exchange (NYSE) in New York, U.S., September 17, 2019.
REUTERS/Brendan McDermid/File Photo
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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 _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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