(Reuters) – Johnson & Johnson said on Thursday it has registered some 45,000 participants for the first final trial of its single-dose vaccine candidate COVID-19 and expects provisional data by the end of January.
The company, however, lags behind rivals Pfizer Inc. and Moderna Inc. in the race for a vaccine to fight the COVID-19 pandemic that has infected some 75 million people worldwide.
J&J’s study, called Ensemble, is being conducted by its Janssen unit, the drug maker said in a statement.
Although seven countries have already authorized the emergency use of candidates from Pfizer and German company BioNTech, Moderna’s rival vaccine has been set for regulatory clearance this week in the United States.
J&J also said it plans to file an application for emergency use authorization with the U.S. Food and Drug Administration (FDA) in February if the study data is safe and effective.
The company had announced earlier this month cuts in enrollment for the vaccine trial for its original 60,000 plan, as higher rates of COVID-19 infections amid a worsening pandemic should generate the data you need with fewer study subjects.
The Ensemble trial stopped 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 of the disease.
J&J continued a separate final-phase clinical trial of a COVID-19 vaccine candidate investigated by Janssen to explore a two-dose regimen.