Johnson & Johnson's coronavirus vaccine research is suspended after an "adversarial occasion" happens in a participant
Johnson & Johnson's late-stage coronavirus vaccine was suspended after a participant reported an "adverse event" about 36 hours earlier, the company's CFO said Tuesday.
The break will allow the Data and Security Monitoring Committee to thoroughly investigate the unexplained disease, CFO Joseph Wolk said in an interview on CNBC's Squawk Box.
"We are allowing the security protocol to proceed properly here," he said, adding that pauses in attempts are "not uncommon".
"It should also reassure the public that every scientific, medical and ethical standard is applied here," added Wolk.
J&J confirmed to STAT News Monday that a "pause rule" was being followed in the clinical trial of 60,000 patients, but declined to provide any further details about the patient.
"We have to 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 is important to know all the facts before sharing any additional information."
J&J began testing the third phase of its potential coronavirus vaccine last month, making it the fourth drug company to be supported by the Trump administration's Covid-19 vaccination program Operation Warp Speed to conduct late-stage testing .
J&J has stated that it is using the same technologies that it used to develop its experimental Ebola vaccine. Genetic material from the coronavirus is combed with a modified adenovirus, which is known to cause colds in humans. Preclinical studies have shown that the potential vaccine can produce a promising response in non-human primates and hamsters.
It is unclear whether the participant in the J&J study received the vaccine or a placebo.
Dr. Mathai Mammen, J & J's global director of Janssen Research and Development, told investors on a conference call late Tuesday that the company still has "very little information," including whether the patient has the vaccine or not received the placebo. J&J was briefed on the disease on Sunday evening and released a statement the following day, he said. Preliminary information has been sent to the data and security oversight board for review, he added.
"It will take at least a few days to gather the right information," he said.
Dr. Ezekiel Emanuel, a former health advisor in the Obama administration, said it would "raise serious questions" if the participant were given the vaccine.
"An adverse event is serious, especially when you are considering a vaccine that you will be rolling out to tens, hundreds of millions, maybe billions," he said on Squawk Box. "That is the ultimate concern."
Dr. Paul Offit, director of the Vaccine Education Center at Philadelphia Children's Hospital, said the company had "not provided any real information." Since adverse events are treated confidentially, he is not sure when the public will know more.
The pause in trials is likely to increase uncertainty as to when a safe and effective vaccine will be ready.
J&J isn't the first frontrunner in the race for a vaccine to abandon a late-stage study because of an unexplained disease.
AstraZeneca announced on Sept. 8 that the trial was on hold due to an unexplained illness in a patient in the UK. The patient is believed to have developed an inflammation of the spinal cord known as transverse myelitis. The trial has since resumed in the UK and other countries, but is still on hold in the US.
Wolk said Tuesday there is a difference between a study break and a regulatory standstill. A hold is a requirement from a health agency like the Food and Drug Administration, he said. AstraZeneca has taken its action, but the FDA has put this into regulation.
Mammen said he doesn't expect the trial break to disrupt manufacturing plans.
J&J previously said it anticipates potential batches of vaccine for a potential emergency approval that will be available in early 2021. The company said last month it was still on track to meet its goal of delivering 1 billion doses of a vaccine per year.