By Thomas M. Burton and Peter Loftus
Paused studies of leading Covid-19 vaccine candidates from
AstraZeneca PLC and Johnson & Johnson are resuming, the
companies said Friday.
The restarts mean testing of two of the most advanced Covid-19
vaccines in development can get back on track after their testing
had been sidetracked. The testing is crucial for regulators to
evaluate whether the vaccines safely protect against the virus and
should be given widely.
The U.S. Food and Drug Administration had wrapped up an
examination of two cases of a possible neurological side effect
that emerged in two people in studies testing AstraZeneca's shot,
and said a late-stage trial in the U.S. can resume, according to
the company.
The AstraZeneca decision, which was first reported by The Wall
Street Journal, came after the FDA didn't find the vaccine was
responsible for the two cases, though the agency couldn't rule out
a link either, a person familiar with the matter said.
The agency plans to require researchers to inform study subjects
of the cases and monitor them for any related neurological events,
such as numbness, the person said.
The move "allows us to continue our efforts to develop this
vaccine to help defeat this terrible pandemic. We should be
reassured by the care taken by independent regulators to protect
the public and ensure the vaccine is safe before it is approved for
use," AstraZeneca Chief Executive Pascal Soriot said in a
statement.
J&J said it is preparing to resume a large clinical trial of
its experimental Covid-19 vaccine, saying it has found no evidence
the vaccine caused a serious medical event in a study
volunteer.
"Based on the information gathered to date and the input of
independent experts, the Company has found no evidence that the
vaccine candidate caused the event," J&J said in a
statement.
J&J said it is taking steps to resume the late-stage trial
of its vaccine in the U.S. on the recommendation of a panel of
independent drug-research experts recommendation. The company said
it also is in discussion with regulators in other countries to
resume testing there.
Before its testing halt, J&J had said its vaccine could be
authorized early next year.
Meanwhile, AstraZeneca's vaccine, which the company is
developing with the University of Oxford, was on pace to be cleared
for wide use by the end of this year if it proves to work safely in
testing.
Last month, however, AstraZeneca paused trials testing its shot
around the world, including in the U.S., after a U.K. woman
developed a mysterious neurological illness. A U.S. health official
had said the event involved a spinal cord problem.
The illness followed a pause in testing in July after an
unexplained illness of a trial subject. Researchers initially told
subjects in the study the case involved a neurological disorder
known as transverse myelitis. AstraZeneca later said the case
turned out to be multiple sclerosis unrelated to the vaccine, and
the testing resumed.
Studies testing the vaccine around the world later resumed after
regulators outside the U.S. determined it was safe to do so.
However, a late-stage trial in the U.S. remained on hold because
the FDA was still investigating the two events.
The FDA had spent weeks exploring whether the two cases involved
transverse myelitis and whether the vaccine was responsible for the
illness, the person said.
Reuters had earlier reported the U.S. trial could resume this
week.
Transverse myelitis is a known side effect of vaccines but is
rarely linked to the shots. Other times, it is an early symptom of
the nerve-system disease multiple sclerosis, and unrelated to
getting a shot.
The condition refers to inflammation of the spinal cord
involving the destruction of a fatty white material, known as
myelin, that insulates nerve cell fibers. It impedes the ability of
nerves in the spinal cord to send messages to the rest of the
body.
Cases are rare, with only about 1,400 diagnosed annually in the
U.S. The cause is unknown. It can trigger a variety of symptoms,
including weak arms and legs, along with sharp pains, numbness and
tingling.
It can sometimes also lead to paraplegia that necessitates
wheelchair use.
Experimental vaccines undergo study in trials that progressively
test the shots in increasing numbers of volunteers both to test
effectiveness and to look for any side effects that could harm
people if regulators green light the vaccines and they are then
given widely.
To protect trial subjects, independent researchers who didn't
play a role in the vaccine's development or at the company that
would sell it look for any signs that the shot could be harmful.
This data-safety monitoring board evaluates side effects in
subjects.
Side effects often emerge in trials evaluating drugs and
vaccines, and the studies are frequently paused for researchers and
regulators to make sure it is safe to go on.
AstraZeneca and J&J were among the drugmakers that pledged
to not seek regulators' permission for widespread use of their
Covid-19 vaccines until the shots proved to work safely in
late-stage testing.
J&J, of New Brunswick, N.J., had paused trials earlier this
month, citing an unexplained illness in a person enrolled in one of
the trials. A late-stage, or Phase 3, trial began in September and
is aiming to enroll up to 60,000 people in the U.S. and several
other countries, to test whether a single dose safely protects
people from Covid-19.
J&J didn't provide further details about the nature of the
medical event in the study subject. The company said many possible
factors could have caused it, and no clear cause has been
identified.
--Joseph Walker contributed to this article.
Write to Thomas M. Burton at tom.burton@wsj.com and Peter Loftus
at peter.loftus@wsj.com
(END) Dow Jones Newswires
October 23, 2020 18:03 ET (22:03 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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