By Peter Loftus
Johnson & Johnson hopes to know within days whether it can
resume testing its Covid-19 vaccine, as the giant health-products
company battles the virus on several fronts.
An independent committee is investigating the unexplained
illness of a study volunteer that prompted a pause in clinical
trials of the company's experimental Covid-19 vaccine, J&J
Chief Financial Officer Joseph Wolk said in an interview
Tuesday.
The illness is "still under investigation and we're going to let
that process play out," Mr. Wolk said. The company is hopeful that
the pause will only last a few days, he said.
The pause, announced on the eve of J&J earnings that showed
an uptick in business hurt by the pandemic, is the second for
leading coronavirus vaccines in development. The halts illustrate
the ups and downs that typically characterize the testing of
promising but unproven therapies and vaccines.
Researchers have made relatively rapid progress developing
vaccines that could protect against the new coronavirus, but the
shots still face a last phase of testing that is designed to test
whether they protect people and to further suss out any safety
issues beyond the injection-site pain and flulike symptoms seen in
some of the earlier studies.
Subjects in vaccine trials often have side effects that require
further evaluation and sometimes a pause in the study, according to
industry officials.
J&J paused all trials of its vaccine, including a
60,000-subject late-stage trial that began last month, due to the
unexplained illness. The Phase 3 trial is testing whether the
company's vaccine safely protects against symptomatic Covid-19
disease compared with a placebo.
J&J executives said they know very little about the event
that prompted the company to call for a pause.
The company doesn't know whether the volunteer who fell ill got
the experimental shot or a placebo, Mr. Wolk said. Mathai Mammen,
who heads J&J's pharmaceutical research and development, said
the company has very little information about the case.
Dr. Mammen said J&J was informed of the study subject's
illness on Sunday evening and then notified a board of outside
experts monitoring the safety of the trial. Dr. Mammen said the
board asked for more information.
"As soon as we overcome this temporary pause, our plan is to
continue the 60,000-person study that we're en route to," Dr.
Mammen said on a conference call with analysts. He expects the
company to complete enrollment in two to three months.
Despite the study pause, J&J continues to expand its
manufacturing capacity for the shots, Mr. Wolk said. The company
hopes to make the vaccine available by early 2021, and to produce
more than one billion doses by the end of next year.
"This is the largest vaccine study that's out there," Mr. Wolk
said. "It's endeavoring to study 60,000 patients. When you have a
study of that size, it's not uncommon to see unexpected illnesses
within the population. That's for any drug across any therapeutic
area. This is something that's not foreign in the development
process."
He said enrollment for the study was in the "early days" at the
time of the pause, but didn't say how many people had enrolled.
J&J's vaccine is one of several in late-stage clinical tests
that could yield results in the coming weeks and months. Pfizer
Inc., Moderna Inc. and AstraZeneca PLC also are testing vaccines,
though AstraZeneca's U.S. trial is halted while it and U.S.
regulators investigate a woman's illness in a U.K. study of the
shot.
J&J executives discussed the vaccine as they reported
third-quarter financial results that showed signs of an upturn in
its business, after the pandemic and associated lockdowns weighed
on sales earlier in the year.
J&J said its net earnings more than doubled to $3.55
billion, or $1.33 a share, from $1.75 billion, or 66 cents a share,
a year earlier. Sales rose 1.7% to $21.08 billion. Excluding
certain items, J&J's third-quarter adjusted earnings were $2.20
a share. Analysts surveyed by FactSet were expecting earnings of
$1.98 a share on sales of $20.2 billion.
Pharmaceutical sales rose 5% and consumer-health sales rose
1.3%. J&J's medical-device sales declined 3.6%, but that was an
improvement from a sharper decline earlier in the year.
Earlier in the year, the pandemic delayed certain medical
procedures, such as knee replacements, which hurt its
medical-device sales. Mr. Wolk said procedures have picked up as
hospitals and other health-care providers took steps to assure
patients that they could safely come in for them.
J&J boosted its forecast of full-year sales and
earnings.
J&J also disclosed that it will add $1 billion to its
proposed contribution to a settlement to resolve lawsuits filed by
states, cities and other entities against the company alleging its
marketing practices fueled the opioid epidemic.
This is on top of the $4 billion that J&J said last year it
would contribute when it first reached an agreement in principle
with a committee of state attorneys general. J&J said it is not
admitting liability or wrongdoing.
J&J shares declined 2% to $148.74 in midday trading.
(END) Dow Jones Newswires
October 13, 2020 13:52 ET (17:52 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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