Johnson & Johnson’s single-dose COVID-19 vaccine trial reaches full enrollment


Johnson & Johnson announced it reached full enrollment for its late-stage single-dose coronavirus vaccine trial with about 45,000 participants. 

In a company statement, the health care giant said there is a high incidence of the virus circulating among the general populations where the U.S.-based study trials (called Ensemble) are underway, which will allow the company the data it needs. In general, when the rate of illness falls in a population, it can slow the enrollment process.

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Company officials said interim data, or data released before the trial is over, is expected by the end of January 2021. Though this news lags behind other companies on the COVID-19 vaccine front, like Pfizer and Moderna, officials welcome as many vaccine candidates as possible in order to meet global demand and ultimately conquer the ongoing health crisis.

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If data suggests the vaccine is safe and effective, Johnson & Johnson said it expects to file for an emergency approval from the U.S. Food and Drug Administration in February. The company said a second trial is working to explore another COVID-19 vaccine candidate with a two-dose regimen.

The company had paused its trial for over a week in mid-October upon an “unexplained illness” in a trial participant but resumed trials after an evaluation didn’t identify a clear cause. The company later announced it “found no evidence that the vaccine candidate caused the event.”



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