Johnson & Johnson has paused its COVID-19 vaccine clinical trial following an “unexplained illness” in a study participant.
The company said it had voluntarily put its ENSEMBLE trial, currently in its 3rd phase of testing, on hold after the incident, the details of which are being kept under wraps.
The pharmaceutical giant is not saying whether the patient was given a placebo or the experimental vaccine, which is being developed by the company’s Janssen pharma unit.
The vaccine uses a non-replicating virus to prime the body against the SARS-CoV-2 coronavirus that causes COVID-19, and is one of the front-runners in the race to a working vaccine against the disease.
This is the second COVID-19 vaccine trial to hit trouble – AstraZeneca’s study of its rival vaccine is still on hold in the US after a safety issue, although trials have restarted in other territories.
As is always the case in these situations, an independent committee is reviewing the medical information before deciding whether the trial should restart.
J&J’s vaccine is one of 42 in clinical development, according to a regularly updated list from the World Health Organization.
The company is not giving any further details about the illness away to protect the privacy of the person involved.
With two of the most advanced vaccine trials affected by safety issues, the chances of developing a viable vaccine approved by the FDA in time for the 3rd November elections have diminished.
J&J’s vaccine is closely watched because it requires just one dose, making a mass vaccination easier to institute when compared to potential vaccines from Moderna and Pfizer, which require two injections.