(Reuters) – Johnson & Johnson said on Thursday it had enrolled about 45,000 participants in the first study in the late stage of its single-dose COVID-19 vaccine candidate and was waiting for interim data by the end of January.
However, the company remains in competition with rivals Pfizer Inc. and Moderna Inc. in the race for a vaccine to fight the COVID-19 pandemic that has infected about 75 million people globally.
J & J’s study, called the Ensemble, is led by his Janssen unit, the doctor said in a statement.
While seven countries have already authorized the emergency use of Pfizer and German firm BioNTech, Modern’s rival vaccine was set for regulatory approval this week in the United States.
J&J also said it intends to apply for emergency use authorization with the US Food and Drug Administration (FDA) in February if the study data is safe and effective.
The company announced earlier this month enrollment reductions for the initial 60,000 vaccine study because higher rates of COVID-19 infection amid a worsening pandemic should generate the data it needs with fewer study subjects.
The Ensemble trial was discontinued 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 process after an assessment did not find a clear cause of the disease.
A separate late-stage clinical trial of a COVID-19 vaccine candidate under investigation by Janssen to explore a two-dose regimen was underway, J&J said.