(Reuters) – Johnson & Johnson said Thursday that it has enrolled approximately 45,000 participants in the first late phase of its single-dose COVID-19 vaccine trial and expects interim data by the end of January.
However, the company is lagging behind rivals Pfizer Inc and Moderna Inc in the race for a vaccine to combat the COVID-19 pandemic that has infected approximately 75 million people worldwide.
J & J’s study, called Ensemble, is being conducted by the Janssen unit, the drugmaker said in a statement.
While seven countries have already approved the emergency use of Pfizer and the candidates of the German company BioNTech, Moderna’s rival vaccine was approved in the United States this week.
J&J also said it plans to file an emergency use permit with the U.S. Food and Drug Administration (FDA) in February if the data from the study is safe and effective.
The company announced earlier this month that the number of enrollments for the vaccine trial would be reduced from the original plan to 60,000, as higher rates of COVID-19 infections during a worsening pandemic should provide the necessary data with fewer subjects.
The Ensemble study was interrupted for more than a week in October after a patient developed an “unexplained illness” during the study. The company later said it would resume the trial after an evaluation found no clear cause for the disease.
A separate late-stage clinical trial of a COVID-19 vaccine candidate by Janssen to investigate a two-dose regimen was underway, J&J said.