It’s unit Jannsen, plans to submit an emergency use authorisation software to the U.S. Meals and Drug Administration (FDA) in February
Johnson & Johnson mentioned on Thursday it has absolutely enrolled contributors for the primary late-stage trial of its COVID-19 single-dose vaccine candidate.
The research, named Ensemble, has enrolled about 45,000 contributors and is being performed by its unit Janssen, J&J mentioned in a press release, including that it expects interim knowledge from the trial by the top of January 2021.
J&J additionally mentioned it plans to submit an emergency use authorisation software to the U.S. Meals and Drug Administration (FDA) in February if the information from the research is protected and efficient.
A separate late-stage scientific trial of an investigational COVID-19 vaccine candidate by Janssen to discover a two-dose routine was ongoing, J&J mentioned.
The Ensemble trial was paused for over every week in October after a affected person developed an “unexplained illness” in the course of the research. The corporate later mentioned it will resume the trial after an analysis discovered no clear trigger for the sickness.