Johnson & Johnson‘s late-stage coronavirus vaccine was paused after a participant reported an “adverse event” about 36 hours earlier, the corporate’s chief monetary officer stated Tuesday.
The pause will permit the info and security monitoring board to totally examine the unexplained sickness, CFO Joseph Wolk stated in an interview on CNBC’s “Squawk Box.”
“We’re letting safety protocol follow proper procedure here,” he stated, including that pauses in trials are “not uncommon.”
“What it should also do is reassure the public that every scientific, medical and ethical standard is being applied here,” Wolk added.
J&J confirmed to STAT News on Monday that a “pausing rule” in the 60,000-patient scientific trial had been met, however declined to supply additional particulars on the affected person.
“We must respect this participant’s privacy,” the corporate stated in a assertion late Monday. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
J&J started its part three trial testing of its potential coronavirus vaccine final month, turning into the fourth drugmaker backed by the Trump administration’s Covid-19 vaccine program Operation Warp Speed to enter late-stage testing.
J&J has stated it is utilizing the identical applied sciences it used to develop its experimental Ebola vaccine. It includes combing genetic materials from the coronavirus with a modified adenovirus that is identified to trigger frequent colds in people. Preclinical research have proven the potential vaccine can generate a promising response in nonhuman primates and hamsters.
J&J is not the primary frontrunner in the race for a vaccine to halt a late-stage trial as a result of an unexplained sickness.
AstraZeneca announced on Sept. 8 that its trial had been placed on maintain as a result of an unexplained sickness in a affected person in the United Kingdom. The affected person is believed to have developed irritation of the spinal twine, often called transverse myelitis. The trial has since resumed in the U.Okay. and different international locations, however is nonetheless on maintain in the United States.
Wolk stated Tuesday there’s a distinction between a examine pause and a regulatory maintain, like AstraZeneca. A maintain is a requirement by a well being authority, just like the Food and Drug Administration, he stated.