New Delhi (NVI): Johnson & Johnson today said that it had temporarily paused its Covid-19 vaccine clinical trials because one of its participants had become sick.
“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.
The pause means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.
Earlier this month, Johnson & Johnson joined the short list of vaccine makers that have moved an experimental coronavirus shot into late-stage human studies in the US.
The company has since begun dosing up to 60,000 volunteers, marking the first big trial of an Covid-19 inoculation that may work after just one shot.
J&J said that serious adverse events (SAEs) are “an expected part of any clinical study, especially large studies.”
The company further said that company guidelines allowed them to pause a study to determine if the SAE was related to the drug in question and whether to resume study.
The J&J Phase 3 trial had started recruiting participants in late September, across more than 200 sites in the US and around the world.
The other countries where the trials are taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa
-CHK
