JNJ’s coronavirus vaccine trial halted after ‘adverse event’

The company’s chief financial officer reported on Tuesday that Johnson & Johnson’s late-stage coronavirus vaccine was halted 36 hours earlier after a participant reported an “adverse event”.

The pause will allow the Data and Safety Monitoring Board to conduct a thorough investigation of the unexplained disease, CFO Joseph Walk said in an interview on CNBC’s “Squawk Box”.

“We are letting security protocols follow due process here,” he said, adding that stagnation in tests “is not uncommon.”

“Should it also do this, the public is confident that every scientific, medical and ethical standard is being implemented here,” Walk said.

J&J confirmed to STAT News on Monday that a “stagnation rule” had been found in the 60,000-patient clinical trial, but declined to provide more details on the patient.

“We must respect the privacy of this participant,” the company said in a statement on Monday. “We are learning more about this participant’s illness, and it is important to have all the facts before sharing additional information.”

J&J began a three-phase trial of its potential coronavirus vaccine last month, entering the late-stage trial as the fourth drugmaker supported by the Trump administration’s Kovid-19 vaccine program Operation War Speed.

J&J has stated that it is using the same technologies that it used to develop its experimental Ebola vaccine. This involves combating genetic material with adenovirus modified from coronovirus known to cause the common cold in humans. Preclinical studies have shown that the potential vaccine may produce a promising response in nonhuman primates and hamsters.

J&J is not the first frontrunner in the race for a vaccine, which may prevent late-stage trials due to an unexpected disease.

AstraZeneca announced on 8 September that its testing was halted due to an unexplained disease in a patient in the United Kingdom. The patient is believed to have inflammation in the spinal cord, called transverse myelitis. Testing has resumed in Britain and other countries, but is still on hold in the United States.

Walk said Tuesday that a study is the difference between a halt and a regulatory hold. He said that like the Food and Drug Administration, a health authority needs it. AstraZeneca initiated its action, but the FDA kept a regulatory hold on it.


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