The late phase of Johnson & Johnson’s coronavirus vaccine has been put on hold after a participant reported an “adverse event” about 36 hours earlier, the company’s chief financial officer said on Tuesday.
The pause will allow the data and safety monitoring board to investigate the unexplained disease in depth, CFO Joseph Walk said in an interview with CNBC’s Squawk Box.
“We leave the safety protocol to follow the correct procedure here,”
“What he also needs to do is reassure the public that all scientific, medical and ethical standards apply here,” Walk added.
J&J confirmed to STAT News on Monday that a “pause rule” had been followed in a clinical trial of 60,000 patients, but declined to provide further details about the patient.
“We must respect the privacy of this participant,” the company said in a statement late Monday. “We also learn more about this participant’s illness, and it’s important to have all the facts before sharing any additional information.”
J&J began trial phase 3 testing of its potential coronavirus vaccine last month, becoming the fourth drugmaker to be supported by the Trump administration’s Covid-19 vaccine program, Operation Warp Speed, which entered late testing.
J&J said it uses the same technology it uses to develop its experimental Ebola vaccine. It involves combining genetic material from the coronavirus with a modified adenovirus that is known to cause the common cold in humans. Preclinical studies indicate that the potential vaccine may generate a promising response in non-human primates and hamsters.
J&J is not the first favorite in the vaccine race to stop testing at a late stage due to an unexplained illness.
AstraZeneca announced on September 8 that its trial had been suspended due to an unexplained illness of a patient in the United Kingdom. The patient is thought to have developed an inflammation of the spinal cord known as transverse myelitis. The process has since resumed in Britain and other countries, but is still pending in the United States.
Walk said Tuesday that there is a difference between a study break and regulatory detention, such as AstraZeneca. Detention is a requirement of a health authority, such as the Food and Drug Administration, he said.