Johnson & Johnson (NYSE:JNJ) has said that it enrolled around 45,000 participants for its late stage study of its single-dose COVID-19 vaccine candidate and anticipates interim data at the end of January 2021.
ENSEMBLE Study enrolls 45,000 participants
The pharmaceutical company seems to lag rivals such as Moderna Inc. (NASDAQ:MRNA) and Pfizer Inc. (NYSE:PFE) in the race to deliver a COVID-19 vaccine. Already Pfizer’s vaccine candidate has received approval in seven countries while Moderna’s vaccine is set for regulatory approval in the US this week.
In a statement, JNJ said that its unit Janssen is conducting the late-stage study named ENSEMBLE. The company said that the 45,000 participants enrolled in the trial will be adequate to generate the required data to determine the safety and efficacy of the vaccine candidate. Results will be available towards the end of January but since the study is reliant on disease events this is an approximate timing. The company initiated the ENSEMBLE study in collaboration with the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases.
Johnson & Johnson to file EUA in February
JNJ said that it will submit an Emergency Use Authorization to the FDA by February if study results demonstrate the effectiveness and safety of the vaccine. Also, the company will make other regulatory applications globally in parallel with the EUA. The drugmaker had at the beginning of this month cut enrolment for the study from the planned 60,000 due to the increase in the number of COVID-19 cases.The increase in infection means that the company can generate necessary data from just a few subjects.
It is important to note that the company had temporarily halted the ENSEMBLE study in October after a subject had developed an “unexplained illness.” JNJ later stated that they will go on with the study after an assessment failed to established a clear cause of illness. The company said that Janssen is conducting a separate third phase clinical study of the experimental COVID-19 exploring a two-dose regimen.