Johnson & Johnson said on Monday it had temporarily halted the Covid 19 vaccine clinical trials including the Phase 3 ENSEMBLE trial due to an unexplained illness in one of its study participants.The company said the participant is being evaluated by a safety monitoring panel and its physicians to determine the cause of the illness.
Such pauses are an expected part of any clinical study, especially large studies which includes thousands of people, said the company which is conducting highest profile efforts to contain the global pandemic. It said the company guidelines have allowed them to pause the study and it is different from a regulatory hold. Citing the participants’ privacy, the company has refused to disclose any more details about the illness.
As per reports of Stat News, a document was sent to outside researchers which stated a “pausing rule” had been met.
In an early-to-mid stage clinical trial, J&J’s experimental Covid-19 vaccine produced strong immune response.Following which, last month it had started enrolling upto 60,000 volunteers for Phase 3 clinical trials.
Due to pause, the online enrollment system had been closed and the independent patients safety committee would be convened, reported Stat News.
Meanwhile,the late stage trials of a Covid-19 vaccine developed by AstraZeneca and Oxford University in the US remains on hold pending a regulatory review. In September, the company had paused the clinical trials due to similar challenges as faced by Johnson & Johnson. The trial was stopped when a UK study participant developed severe neurological symptoms and a rare inflammation of the spinal cord.
The trials in South Africa, UK, Brazil, and India have resumed.The other countries where the trials were taking place are Chile, Colombia, Argentina, Brazil, Mexico, Peru and South Africa.