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The Johnson & Johnson principal scientist said the company expects to have all the data necessary to apply for approval of its vaccine candidate for a coronavirus vaccine by February, according to a report.
Johnson & Johnson’s chief scientific officer Dr Paul Stoffels reportedly told Reuters the company expects 60,000 people to be enrolled in an advanced-stage trial, dubbed ENSEMBLE, by the end of the year.
“And the end point of effectiveness should be there in the first few weeks or months, January to February of the new year,” he told the outlet.
Johnson & Johnson is several weeks behind its competitors Moderna and Pfizer, the latter announcing Wednesday that it would file an emergency use authorization application “within a few days”. However, Moderna and Pfizer are both built on a two-dose model, while Johnson & Johnson’s JNJ-78436735 requires a single shot.
“In a pandemic, one hit certainly matters in the world,” Stoffels told Reuters. “(A two-dose vaccine) is a very significant operational challenge. Even more so in health systems which are less well organized. “
PFIZER TO APPLY FOR AN EMERGENCY USE AUTHORIZATION OF CORONAVIRUS VACCINE “ IN THE DAY ”
However, Johnson & Johnson’s vaccine had its own snafus, including a break from the Phase 3 trial launched in late September due to a serious medical event in one of its participants. The company resumed trials in October after an independent safety review. An update said the company had no evidence the vaccine caused the event.
In a press release issued on Sunday, Johnson & Johnson announced that it would begin testing a two-dose regimen in the ENSEMBLE 2 trial, which would require 30,000 participants and run in parallel to ENSEMBLE.
Company CEO Alex Gorsky told the Washington Economic Club event on Wednesday that until vaccines and therapeutics can be widely distributed, the public should rely on health measures. public to control the spread of the coronavirus, especially as people struggle with fatigue from restrictions. and go back inside.
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“And look, I guess the good news is that in terms of the correlation that we’re seeing directly with mortality and deaths, it hasn’t manifested at the same level – but I think it’s too early to tell. read too much. because I think the next three to four to five months are going to be tough, “he said.” We’re going to have to navigate. We’re going to have to again, use all the things we know like masking , social distancing, contract tracing and doing whatever we can to control the virus until we are able to get more therapies and some of these vaccines and widely available to go to the other side .
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