Johnson & Johnson announced Monday they are suspending their coronavirus vaccine trial after a participant came down with a mystery illness.
“There is no greater priority than the safety and well being of the people we serve every day around the world,” Johnson & Johnson said in a statement. “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 illnesses are expected in large studies, and that they “can reasonably” expect more participants to show illness symptoms. The trial was paused after the patient’s condition was evaluated by the ENSEMBLE independent Data Safety Monitoring Board. It’s unclear what symptoms the participant showed.
A staff member works during a media tour of a new factory built to produce a COVID-19 coronavirus vaccine at Sinovac, one of 11 Chinese companies approved to carry out clinical trials of potential coronavirus vaccines, in Beijing on September 24, 2020. (Photo by WANG ZHAO/AFP via Getty Images)
Johnson & Johnson emphasized that the vaccine is not under a regulatory hold, which they described as a formal regulatory requirement by the Food and Drug Administration (FDA) and can last much longer. (RELATED: Over 60 Percent Of Americans Say They Will Not Get A 1st Generation Coronavirus Vaccine)
Johnson & Johnson began enrolling participants in its Phase 3 trial on Sept. 23, with researchers having planned to enroll 60,000 participants in the U.S. and throughout the world, according to CNBC.
The news comes after AstraZeneca paused their vaccine study after a participant in the United Kingdom experienced a serious adverse reaction. AstraZeneca has since resumed their clinical trials.
