Coronavirus clinical trials halt for safety reasons – here’s what it means

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Drug giants Johnson & Johnson and Eli Lilly’s coronavirus clinical trials ran into trouble this week after safety monitors shut them down due to poor feedback from participants.J&J said Monday it had suspended the late-stage trial of its coronavirus vaccine candidate after a participant reported an “adverse event.” Less than 24 hours later, Eli Lilly said his advanced trial of his main monoclonal antibody treatment against the coronavirus had been suspended by US health regulators due to potential safety concerns. The breaks are likely to add to concerns about the safety of potential Covid-19 vaccines or treatments.

But clinical trial breaks are not uncommon and delays should reassure the public that the systems in place to protect volunteers are working, medical experts said in telephone interviews with CNBC.

The Data and Safety Oversight Committee, an independent panel of experts who oversee clinical trials in the United States to ensure the safety of participants, recommends that a clinical trial be suspended whenever there is an “adverse event.” Said Isaac Bogoch, an infectious disease specialist and professor at the University of Toronto. The break will take as long as it takes to gather all the information and does not necessarily mean there is a problem with the vaccine or the treatment, he said.

“The DSMB will say we’re going to take a break on this,” said Bogoch, who is also a member of the group and oversees other clinical drug trials. “They’ll say, ‘we need more data and let’s see if this person was in the vaccine group or in a placebo group.’ They will say, ‘Let’s see what the real disease is and use all the data at our disposal to determine if this was a true side effect of the vaccine and if so, decide whether it is safe to continue with this. study.’ ”

Breaks happen all the time, especially in large clinical trials with older adults, according to Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Offit, a former member of the CDC’s Advisory Committee on Immunization Practices, said that “adults get sick” and sometimes “they will get sick within the same amount of time” after receiving a vaccine or treatment.

“Johnson & Johnson’s vaccine is designed to prevent Covid-19. It is not designed to prevent everything that happens in life, ”he said. “You’re always going to sort out these temporal associations. Strokes, heart attacks, neurological problems. Always. You still exercise caution and make sure it’s not a problem and then start over.

Bogoch echoed the remarks, adding that “no one before Covid-19 cared when there was a break on a clinical trial for an antibiotic or a heart medication. ”

“Never have we been in a scenario where you really have 7 billion people watching closely and following every progress under a microscope,” he said. “You know, it’s fascinating and it’s good. This creates a healthier, more educated community. There is only good that can come from it. ”

He added that a break is not the same as a regulatory suspension, sometimes called a “clinical suspension”. A clinical suspension is imposed by a health authority, such as the Food and Drug Administration, he said.

“It’s a little more serious when you get to a regulatory suspension,” he said. “That’s actually when the FDA steps in and says we’re concerned about a particular event and we’re going to stop this trial because we don’t think it’s safe to continue with the data that we are. have at this point. ”

The FDA still has an advanced stage clinical trial of AstraZeneca, one of the pioneers in the Covid-19 vaccine race, pending in the United States. This means the company is unable to deliver second doses of its two-dose vaccine schedule to US participants.

The company announced on September 8 that its trial had been put on hold due to an unexplained illness in a patient in the UK. The patient is believed to have developed inflammation of the spinal cord known as transverse myelitis. The trial has since resumed in the UK and other countries but is still suspended in the US

It is not known what the reactions of participants to the J&J and Eli Lilly trials were.

Offit said companies would sometimes claim to protect patient privacy, but he disagreed with the behavior. “As long as you can’t identify the person, they can give you a fair amount of information about the person, but they don’t,” he said.

Dr Mathai Mammen, global head of Janssen’s research and development division at J&J, told investors on Tuesday in a conference call that the company still had “very little information” on the reason for the lockdown, including understood whether the patient had received the vaccine or the placebo. “It will take at least a few days for the right information to be collected,” he added.

Dr Ezekiel Emanuel, a former Obama administration health adviser, said it would “raise serious questions” if the participant received the vaccine.

“An adverse event is serious, especially when you are considering a vaccine that you are going to deploy to tens, hundreds of millions of people, or even billions,” he said Tuesday on CNBC’s “Squawk Box”. “This is the ultimate concern. ”

Eli Lilly and the National Institutes of Health also did not disclose what the “safety” issue was, but Eli Lilly said it “supports the independent DSMB’s decision to prudently ensure the safety of participating patients. this study”.

“Safety is of the utmost importance to Lilly. We are aware that, out of caution, the Independent Data Security Oversight Board (DSMB) ACTIV-3 has recommended a pause in registration, ”spokesperson Molly McCully told CNBC.

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