Johnson & Johnson expects coronavirus vaccine to be ready for approval by February, report says

 Alexandria Hein

Johnson & Johnson’s lead scientist said the company expects to have all data needed to file for authorization for its single-shot coronavirus vaccine candidate by February, according to a report.

Dr Paul Stoffels, Johnson & Johnson’s chief scientific officer, reportedly told Reuters that the company expects to have 60,000 people enrolled in a late-stage trial, dubbed ENSEMBLE, by year’s end.

“And efficacy endpoint should be there in the first few weeks or months, January of February of the new year,” he told the news outlet.

Johnson & Johnson is several weeks behind competitors Moderna and Pfizer, with the latter announcing Wednesday that it would be filing for emergency use authorization “within days.” However, both Moderna and Pfizer are built on a two-dose model, whereas Johnson & Johnson’s JNJ-78436735 requires a single jab.

“In a pandemic, a single shot is definitely important globally,” Stoffels told Reuters. “(A two-shot vaccine) is a very significant operational challenge. More so in health care systems which are less well organized.

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However, Johnson & Johnson’s vaccine had snafus of its own, including a pause in the phase 3 trial that 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 that the vaccine caused the event.

In a press release posted 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 be run parallel to ENSEMBLE.

On Wednesday, the company’s CEO, Alex Gorsky, said during the Washington Economic Club event that until vaccines and therapeutics can be widely distributed, the public would have to rely on public health measures to control the spread of coronavirus, especially as people battle restriction fatigue and head back indoors

“And look, I guess the positive news is that in terms of the correlation that we’re seeing directly with mortality and fatalities, it has not manifested itself at quite the same level – but I think it’s way too early to read too much into that because I think the next three to four to five months are going to be challenging,” he said. “We’re going to have to navigate our way through. We’re going to have to again, use all the things that we know such as masking, social distancing, contract tracing and do everything we can to control the virus until we’re able to get more therapeutics and some of these vaccines out and widely available to get to the other side.”-SOURCE

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