A top Johnson & Johnson executive said Tuesday pausing its coronavirus vaccine trials was “not at all unusual” for these massive studies.
On Monday, J&J confirmed it had paused its ongoing trials after a participant developed an unexplained illness.
It’s the second major vaccine program to halt its trial due to potential safety concerns.
J&J provided few details around this case. Mathai Mammen, the global head of Janssen research and development at J&J, said it will require “a few days at a minimum” to gather and assess the information.
The pause, first reported by Stat News, came just weeks after the pharma giant launched the massive study to evaluate whether the vaccine could prevent COVID-19.
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A top Johnson & Johnson executive provided few new details on Tuesday about the decision to pause its coronavirus vaccine trials, but called the halt “not at all unusual.”
On Monday, J&J confirmed it had temporarily halted its vaccine studies after a participant experienced an unexplained illness, the second major setback to hit a late-stage test of an immunization for the novel coronavirus. J&J’s stock dropped about 2% on Tuesday.
The pharma giant said it paused all further dosing in the trials after a participant fell ill. The pause in the trial, which is aiming to enroll 60,000 people to determine whether the vaccine is safe and effective, was first reported by Stat News’ Matthew Herper.
J&J said the participant’s illness was being reviewed by an independent board as well as by company doctors.
“It’s not at all unusual for unexpected illnesses that occur in large studies over their duration,” Mathai Mammen, the global head of Janssen research and development at J&J, said on a Tuesday earnings call.
Mammen said J&J is committed to being transparent through the process but also needs to learn more about this incident. He estimated it will be “a few days at a minimum” to gather and evaluate the information. The company does not yet know if the person who fell ill received the experimental vaccine or a placebo, Mammen added.
The company didn’t share more information about the nature of the illness, citing patient privacy.
“We must respect this participant’s privacy,” J&J said in a Monday statement. “We’re also learning more about this participant’s illness, and it’s important to have all the facts before we share additional information.”
A coronavirus vaccine trial from the British drugmaker AstraZeneca is facing a similar setback. In September, AstraZeneca paused its trial over concerns that a participant might’ve had an adverse reaction. The UK arm of the trial has resumed, though the US portion of the trial is still paused while being investigated further by the US Food and Drug Administration.
Other late-stage vaccine trials from Pfizer and Moderna are underway, and they could yield results this year.
J&J, the world’s largest healthcare company, started its late-stage trial in September to determine whether the shot could prevent COVID-19. The trial is also designed to provide information about whether the vaccine is safe to administer to millions of people.
The trial had initially expected to yield early results in late-2020 or early 2021. Depending on how long the trial is paused, the findings could be delayed. J&J didn’t provide any information about the length of the pause.
Read more: Pharma giant J&J just launched a pivotal 60,000-person coronavirus vaccine trial, and we could learn if the shot works by the end of 2020
This story was originally published on October 12 and was updated on October 13 to include comments from Johnson & Johnson’s third-quarter earnings call.
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