Johnson & Johnson Might Apply For EUA In Feb.
December 21, 2020 -- Johnson & Johnson has totally registered 45,000 participants in phase III clinical trial of its clinical trials for a coronavirus immunogen Associate in Nursingd hopes to use for an emergency use authorization of the Food and Drug Administration in Feb, the corporate says in a piece of very news unleash.
Data from phase III clinical trial is anticipated to be out there by the tip of a Gregorian calendar month, the corporate says. “If the information indicates the immunogen is safe and effective, the corporate expects to submit Associate in Nursing emergency use authorization application to the U.S. Food and Drug Administration in Feb. different health regulative applications around the world are going to be created in parallel,” the news unleash says.
Johnson & Johnson trails Pfizer-BioNTech and Moderna within the race to place a COVID-19 immunogen on the market. Pfizer’s immunogen got Associate in Nursing emergency use authorization (EUA) on Dec. eleven and was injected into the arms of yank health care employees.
The FDA granted a EUA to Moderna on Friday, every day when the Associate in Nursing consultative panel suggested its use. The Johnson & Johnson immunogen differs from the Pfizer and Moderna ones in this it doesn’t ought to be frozen and needs just one dose, not two.
Johnson & Johnson paused clinical trials within the fall as a result of a participant developed Associate in Nursing “unexplained malady.” Trials were restarted two weeks later. The company's same “no clear cause” was known. “There square measure several doable factors that would have caused the event,” it same in a very statement.
Johnson & Johnson same earlier this month that it might scale back the quantity of phase III clinical trial participants from its original goal of 60,000, Reuters reportable.
“Given the high incidence of COVID-19 among the final population within the countries wherever the trial is being conducted, this variety of participants are going to be sufficient to come up with the information required to see the effectivity and safety of the company’s investigational COVID-19 immunogen candidate,” Johnson & Johnson same in its news unleash.