“We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant,” the company said in a statement on Monday.
J&J said that such temporary halts due to “adverse events – illnesses, accidents, etc,” are very common, especially in large trials, adding that the studies conducted by the J&J subsidiary have prespecified guidelines which foresee the pause of studies “if an unexpected serious adverse event (SAE) that might be related to a vaccine or study drug is reported, so there can be a careful review of all of the medical information before deciding whether to restart the study.”
While J&J launched Phase 3 clinical trial for its COVID-19 vaccine candidate last month, with plans to enrol up to 60,000 volunteers across three continents for the study, it is unclear how long the pause will last.
Last week the European Commission announced it had signed a deal with J&J, so that its subsidiary Janssen Pharmaceutica NV could supply the EU with up to 400 million doses of its COVID-19 vaccine.
Once the vaccine gets the green-light by regulators, the American pharmaceutical could allocate 200 million doses of the potential vaccine, starting from mid-2021, with the possibility to secure an additional 200 million doses.
J&J is not the first drug maker to pause clinical trials of a potential vaccine for Coronavirus, as in September, AstraZeneca paused the global trials of the Oxford-developed vaccine candidate because of an unexplained illness in one of the volunteers.