Daily Management Review

Unexplained Illness In Participant Forces J&J To Pause Its Last Phase Trials Of Its Covid-19 Vaccine


Unexplained Illness In Participant Forces J&J To Pause Its Last Phase Trials Of Its Covid-19 Vaccine
Clinical trials for its Covid-19 vaccine candidate had been temporarily stopped after one of the volunteers participating in the trial complained of unexplained illness, Johnson & Johnson said on Monday. This move now puts on hold the final phase of trials for one of the highest profile efforts to develop a vaccine against the novel coronavirus pandemic that had originated in China and allowed to spread from there to the rest of the world.
The company said in a statement that an independent data and safety monitoring board as well as clinical and safety physicians of the company are reviewing and evaluating the participant's illness.
In big vaccine trials, such pauses are common since the trials include thousands of people, J&J said. This pause in the trials for the vaccine candidate was different from a “regulatory hold” required by health authorities, the company said and described the current case as only a small pause.
This move by J&J to pause the study follows a similar one that was made for its Cvoid-19 vaccine candidate by AstraZeneca Plc. The late-stage trials of its experimental coronavirus vaccine were paused by AstraZeneca in September because of an unexplained illness being reported in a participant in the United Kingdom. AstraZeneca is developing the vaccine in partnership with the University of Oxford.
While AstraZeneca has resumed its stage three trials for the vaccine in the UK, Brazil, South Africa and India, its trials in the United States are yet to begin as a regulatory review is still pending there.
“Everybody is on the alert because of what happened with AstraZeneca,” said Dr. William Schaffner, a professor of infectious diseases at the Vanderbilt University School of Medicine, in an email to a media, and added that information gathering could take a week.
“It would have to be a serious adverse event. If it was something like prostate cancer, uncontrolled diabetes or a heart attack - they wouldn’t stop it for any of those reasons. This is likely to be a neurological event,” he said.
In an early-to-mid stage clinical trial, a strong immune response against the novel coronavirus by its experimental Covid-19 vaccine candidate was reported by J&J last month. After this success, a final phase trial that included a total of more than 60,000 participants was started by the company with reault6s of the trial expected to be announced by the end of the current year or early next year.
No details about the illness were provided by Johnson & Johnson because of privacy concerns. The company however did say that in such studies, some participants get placebos and it is not always possible to determine clearly at least initially whether participant suffering a serious adverse event in a clinical trial had been administered with a placebo or the treatment.