Johnson & Johnson, which is one of the many companies working to develop a vaccine for COVID-19, has temporarily halted its vaccine trial after a participant had an “unexplained illness”. The news was confirmed by health website STAT news, which has accessed a document sent to outside researchers running the 60,000-patient clinical trial, stating that a “pausing rule” has been met. It also stated that the online system, used to enrol patients in the study, has been closed, and the data and safety monitoring board would be convened.
Following the news, Johnson & Johnson in a press statement 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 company, when contacted by STAT news, said that they are not disclosing further information regarding the illness of the participant, as they want to shield the privacy of the volunteer and that they are still “learning about the participant’s illness.”
Johnson & Johnson began enrolling volunteers in its Phase 3 study on September 23. Researchers had planned to enrol over 60,000 volunteers from the US and other countries.
The company 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.
Besides the US, the other countries where the trials were taking place are Argentina, Brazil, Chile, Colombia, Mexico, Peru and South Africa.
Johnson & Johnson intended to develop a vaccine for COVID-19 by 2021. “We’re committed to bringing a safe and effective vaccine to the public on a not-for-profit basis for emergency pandemic use. Through our collaborations with health leaders around the world, we are engaging diverse scientists from inside and outside our company with the goal of delivering large volumes of a safe and effective vaccine as soon as early 2021,” the company had announced.
On September 6, the vaccine trial by AstraZeneca, which is developing a COVID-19 vaccine along with the University of Oxford, too was halted around the world, after a participant in the United Kingdom fell ill. The trial was later resumed.