Johnson & Johnson (NYSE: JNJ) announced Thursday it has enrolled approximately 45,000 participants for the first late-stage trial of its COVID-19 single-dose vaccine. The company anticipates provisional data by January of 2021.
Nevertheless, the multinational corporation is slightly behind competitors Pfizer and Moderna in the pursuit for a successful COVID19 vaccine that could aid in the pandemic that has infected about 75 Million people worldwide.
Emergency use for Pfizer’s and BioNTech’s candidates have already been approved in seven countries. Subsequently, Moderna’s vaccine is prepped for regulatory authorization in the United States this week.
According to J&J, the study, named Ensemble, is being administered by Janssen. The trial had previously been halted in October after a participant developed an “unexplained illness” throughout the study. The company revealed the trial would continue after concluding that the illness had no clear explanation.
The company announced it plans to apply for emergency use authorization with the U.S. Food and Drug Administration (FDA) by February if the study proves to be safe and effective.
Originally, J&J planned to integrate 60,000 participants for its trial, however it made cuts as rates of COVID-19 infections spiked, allowing them to generate necessary data with less test subjects.
Though J&J’s vaccine is a one-dose alternative, it revealed that a separate late-stage clinical trial to examine a two-dose regimen was ongoing.