JNJ Johnson and Johnson

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)

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