On Monday, Johnson & Johnson halted its coronavirus vaccine trial as one of the participants became even more ill.
The company stated that there is a temporary pause in proceeding further with the COVID-19 clinical trials, which also includes the Phase 3 ENSEMBLE trial as there has been an unexplained illness in one of the participants.
The halt also includes the online enrollment system for 60 thousand patients, which has a clinical trial as the independent patient safety committee has convened.
The drugmaker did not disclose further details about the illness, indicating the participant’s privacy. It also said that this is a learning experience for all of them as the virus is new and so is its vaccine and consequences. It said, everything is under observation, and once some clarity is there, it will be shared accordingly.
Johnson & Johnson announced that serious adverse events are part of such clinical tests and study, especially when extensive studies like this are involved. Company guidelines supported them to halt the study to resolve if the SAE (serious adverse events) was related to the medication or drug in question and whether to recommence the study.
The Johnson & Johnson Phase 3 experiments had commenced enlisting participants in the late week of September, intending to enroll up to 60,000 volunteers over 200 sites in the U.S. and throughout the globe.
The other nations where the trials and analyses were taking place are Brazil, Argentina, Chile, Mexico, Colombia, South Africa and Peru.
This is one of six coronavirus vaccines that are under trial in the U.S., including 1 of 4 in the most venerable Phase 3 stage. It is a single-shot vaccine that, if declared competent, could explain the distribution of millions of doses corresponded with preceding rivals claiming two shots.