One-shot Covid vaccine 'is safe and effective and could be available in weeks'

A new one-off Covid vaccine is safe and could be launched by March, according to scientists.

Johnson & Johnson expects clear data on how effective it is by the end of this month or early February, said the US healthcare company’s chief scientific officer.

Dr. Paul Stoffels also said in an interview on Tuesday that J&J expects to meet its stated goal of shipping 1 billion doses of its vaccine by the end of this year as the company ramped up production.

Dr. Stoffels said it would be premature to say how many doses would be available in March, provided the company receives emergency clearance from the U.S. Food and Drug Administration.

The New York Times previously reported that J&J was experiencing delays in manufacturing that would reduce the number of cans initially available.

“We’re aiming for a billion doses by 2021. If it is one
Single dose, that is 1 billion people. But there will be a ramp-up all year round, “said Dr Stoffels.

Johnson & Johnson’s vaccine is being manufactured in the United States, Europe, South Africa and India with the help of contract manufacturers to build capacity.

“It’s a couple of weeks early to give final figures on what we can do in the first few months,” he said.

Moncef Slaoui, chief advisor to the US vaccine development program Operation Warp Speed, said the vaccine could be 80% or more effective.

This would be below about 95% efficacy achieved in studies of Pfizer Inc’s already approved vaccines with BioNTech SE and Moderna Inc, but well above the 50% regulatory guideline for approval.

It also has the advantage of being a stand-alone vaccine, which means more people can be protected more quickly and without the cold storage requirements of the other vaccines.

Dr. Stoffels said the company has set a 60% effectiveness target, but at least 70% to 80% internally.

“We are very confident that the vaccine will be much higher than 60%,” he said, adding that “the goal is the highest values ​​and hopefully closer to what Moderna and Pfizer are doing.”

Interim results from the company’s Phase I / II study,
Information published in the New England Journal of Medicine on Wednesday helped build that confidence.

The study showed that 90% of the 805 volunteers ages 18 to 55 developed protective antibodies 29 days after a single dose, and these increased to 100% by day 57.

The study is ongoing, but protection has lasted 71 days so far.

Similar data for participants over 65 will be available by the end of January.

.

Leave a Comment