Its Jannsen unit plans to file an emergency use authorization application with the U.S. Food and Drug Administration (FDA) in February
Johnson & Johnson said Thursday that it has fully enrolled participants for the first advanced stage study of its COVID-19 single-dose vaccine candidate.
The study, called Ensemble, has enrolled about 45,000 participants and is led by its Janssen unit, J&J said in a statement, adding that it expects provisional data from the study by the end of January 2021.
J&J also said it plans to file an emergency use authorization application with the U.S. Food and Drug Administration (FDA) in February if the study data is safe and effective.
A separate late-stage clinical trial of an experimental COVID-19 vaccine candidate from Janssen to explore a two-dose regimen was underway, J&J said.
The Ensemble study was suspended for over a week in October after a patient developed an “unexplained illness” during the study. The company later said it would resume the process after an evaluation found no clear cause of the disease.