Johnson & Johnson (NYSE: JNJ), one of the pharmaceutical company’s striving to develop a COVID-19 vaccine, has paused it’s late-stage trial following an “adverse event” in one of its participants.
According to CFO Joseph Wolk, the recess will allow the company to investigate the matter with profundity.
“We’re letting safety protocol follow proper procedure here,” he said, reiterating that pauses in trials were “not uncommon.”
“What it should also do is reassure the public that every scientific, medical and ethical standard is being applied here,” Wolk added.
Though the company confirmed the pause in the trial, it has yet to reveal any details on the patient.
“We must respect this participant’s privacy,” the company said in a statement 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.”
Johnson & Johnson began its phase three trial in September and was supported by the Trump administration’s Covid-19 vaccine program Operation Warp Speed to enter late-stage testing.
“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians,” the company said in a statement.
Adding that “Adverse events — illnesses, accidents, etc. — even those that are serious, are an expected part of any clinical study, especially large studies.”
The company is said to be using the same technology it used to cultivate its ebola vaccine. Ultimately, genetic material from the coronavirus will be teased with a modified adenovirus, known to cause common colds within humans.