Johnson & Johnson Pauses Covid-19 Vaccine Trials Due to Sick Subject -- 2nd Update
October 12 2020 - 11:58PM
Dow Jones News
By Peter Loftus
Johnson & Johnson said it has paused further dosing in all
clinical trials of its experimental Covid-19 vaccine because a
study volunteer had an unexplained illness.
The pause announced Monday affects all trials of J&J's
vaccine, including a large Phase 3 trial that began in September
and aimed to enroll as many as 60,000 people in the U.S. and
several other countries.
An independent data-safety monitoring board is reviewing the
study subject's illness, the company said. The company didn't
immediately disclose more information about the illness, and said
it needed to respect the subject's privacy.
This is the second time trials for a Covid-19 vaccine trial have
been paused over a safety concern. Last month, AstraZeneca PLC
paused clinical trials of an experimental Covid-19 vaccine after a
participant in a U.K. study had an unexplained illness. The U.K.
study resumed, but a large U.S. study is still on hold.
J&J, of New Brunswick, N.J., said illnesses and other side
effects are an expected part of any clinical study, and it has
prespecified guidelines to monitor for the events.
The guidelines "ensure our studies may be paused if an
unexpected serious adverse event that might be related to a vaccine
or study drug is reported, so there can be a careful review of all
of the medical information before deciding whether to restart the
study," the company said.
The pause was earlier reported by Stat News.
J&J's vaccine is one of the most advanced Covid-19 shots in
development, among just a handful that had entered the last stage
of testing in the U.S., after entrants from AstraZeneca, Moderna
Inc. and Pfizer Inc.
Company officials had estimated the Phase 3 trial could begin
providing results either by the end of the year or in early 2021,
and the shots could be authorized for use in early 2021.
Drugmakers including J&J have developed their Covid-19 shots
remarkably quickly. Vaccines typically take years to bring to
market, and many often don't make it because they fail to work
safely during testing.
Side effects often turn up during clinical trials. Sometimes,
they don't turn out to have a link to the vaccine. But if the
independent experts monitoring the safety of the trial find a link,
the safety issue can derail the experimental shot.
The safety board needs to assess whether the subject's illness
was related to the vaccine or not, a person familiar with the
matter said.
J&J's plan for its Phase 3 study sets out criteria for
pausing the testing, including if a subject has a serious adverse
event that is determined to be related to the vaccine, or if
someone has a severe allergic reaction, known as anaphylaxis, or
hives, that can't be attributed to something other than the
vaccine.
The company's shot uses a weakened version of a common cold
virus, which is engineered to deliver genetic instructions teaching
the body's cells to make a protein resembling one found on the
surface of the coronavirus. This, in turn, induces the body's
immune system to build up defenses against the coronavirus if a
person subsequently is exposed to it.
The common cold virus used in the vaccine is modified so that it
can't replicate and cause disease.
J&J co-developed the vaccine with Beth Israel Deaconess
Medical Center in Boston.
AstraZeneca's trials were paused after a woman in a U.K. study
of their vaccine had an unexplained illness, which a U.S. health
official described as a spinal-cord problem. This followed an
earlier pause in July to the U.K. study after another subject had
symptoms that researchers later concluded was multiple sclerosis
and unrelated to the vaccine.
U.K. authorities allowed the U.K. trial to resume in September
after concluding it was safe to do so. Trials have resumed in
several other countries including Japan and Brazil, but the U.S.
trial remains paused while AstraZeneca works with the Food and Drug
Administration in reviewing the information needed to make a
decision regarding resumption of the trial.
AstraZeneca's vaccine also uses a weakened version of a common
cold virus, but one from chimpanzees instead of humans.
Write to Peter Loftus at peter.loftus@wsj.com
(END) Dow Jones Newswires
October 12, 2020 23:43 ET (03:43 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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