On Monday, Johnson & Johnson said it had temporarily halted its Covid-19 vaccine trial because one of its participants had become sick.
In a statement the company said: “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 pause means the online enrollment system has been closed for the 60,000-patient clinical trial while the independent patient safety committee is convened.
J&J said that serious adverse events (SAEs) are an expected part of any clinical study, especially large studies. 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, with a goal of enrolling up to 60,000 volunteers across more than 200 sites in the US and around the world.