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Johnson & Johnson's Late-Stage Trial Of Single Dose COVID-19 Vaccine Fully Enrolled

Johnson & Johnson's Late-Stage Trial Of Single Dose COVID-19 Vaccine Fully Enrolled

Johnson & Johnson (NYSE: JNJ) has completed the participant enrollment for the Phase 3 trials of its single-dose COVID-19 vaccine, the company said in a statement Thursday.

What Happened: JNJ has enrolled roughly 45,000 participants in the "Ensemble" trial, which is being conducted by its Janssen unit.

The pharma company expects interim data from the trial by the end of January. It anticipates applying for emergency use authorization with the U.S. Food and Drug Administration in February if the study shows the vaccine to be effective.

JNJ said that a separate Phase 3 trial for its investigational Janssen COVID-19 vaccine candidate by Jansen is ongoing to explore a two-dose regimen. 

Based on an earlier report, the "Ensemble 2" trial will complete the participants’ recruitment by March.

Why It Matters: The "Ensemble" trial was paused for a week in October when a participant developed an unexplained illness. JNJ resumed the trial after no clear cause of the illness was found.

JNJ vaccine is one of the six vaccines expected to get a regulatory nod by the first quarter, according to Bill Gates. U.S. health officials are also offering logistical support to vaccine makers for the speedy delivery and efficient supply chain as the demand rises.

Moderna Inc (NASDAQ: MRNAsecured the nod of the FDA advisory panel for its experimental COVID-19 vaccine on Thursday. The FDA typically concurs with the advisory panel's recommendations and EUA could arrive on Friday. 

Moderna’s COVID-19 vaccine would the second such to be available in the United States after Pfizer Inc. (NYSE: PFE) and BioNTech SE's (NASDAQ: BNTX).

Price Action: JNJ shares closed 2.64% higher at $153.62 on Thursday.


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Posted-In: COVID-19 VaccineBiotech News FDA Media General Best of Benzinga

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