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Johnson and Johnson vaccine: FDA finds the single-shot jab safe
A review by US regulators of the single-shot Johnson & Johnson coronavirus vaccine finds it is safe, especially against severe cases.
It paves the way for a third Covid-19 vaccine to be authorised in the US, possibly as early as this weekend.
The vaccine could be a cost-effective alternative to Pfizer and Moderna, as it can be stored in a refrigerator instead of a freezer.
The review was largely positive but more nuanced than for the other two.
The Food and Drug Administration found the Johnson & Johnson vaccine has "known benefits" in reducing both symptomatic and severe illness.
Results from vaccine trials conducted in the US, South Africa and Brazil found its efficacy against the worst outcomes of the virus was "similarly high" but overall protection was lower in South Africa and Brazil, where virus variants have become dominant.
Data showed it was more than 85% effective at preventing serious illness, but only 66% effective overall, when moderate cases were included.
Notably, there were no deaths among participants that received the vaccine and no hospital admissions after 28 days post-vaccine.
An external committee of experts will meet on Friday to recommend whether the FDA should authorise the vaccine, possibly adding to a coming surge in vaccine availability in the US.
On Tuesday, Johnson & Johnson said it could hand over four million doses upon approval of the vaccine.
The company plans to deliver 20 million doses in total by late March, in line with an agreement to supply the US with 100m doses by the end of June.
www.bbc.com
A review by US regulators of the single-shot Johnson & Johnson coronavirus vaccine finds it is safe, especially against severe cases.
It paves the way for a third Covid-19 vaccine to be authorised in the US, possibly as early as this weekend.
The vaccine could be a cost-effective alternative to Pfizer and Moderna, as it can be stored in a refrigerator instead of a freezer.
The review was largely positive but more nuanced than for the other two.
The Food and Drug Administration found the Johnson & Johnson vaccine has "known benefits" in reducing both symptomatic and severe illness.
Results from vaccine trials conducted in the US, South Africa and Brazil found its efficacy against the worst outcomes of the virus was "similarly high" but overall protection was lower in South Africa and Brazil, where virus variants have become dominant.
Data showed it was more than 85% effective at preventing serious illness, but only 66% effective overall, when moderate cases were included.
Notably, there were no deaths among participants that received the vaccine and no hospital admissions after 28 days post-vaccine.
An external committee of experts will meet on Friday to recommend whether the FDA should authorise the vaccine, possibly adding to a coming surge in vaccine availability in the US.
On Tuesday, Johnson & Johnson said it could hand over four million doses upon approval of the vaccine.
The company plans to deliver 20 million doses in total by late March, in line with an agreement to supply the US with 100m doses by the end of June.
Johnson and Johnson vaccine: FDA finds the single-shot jab safe
US regulators say Johnson and Johnson's single-shot vaccine is safe, and could be approved in days.
www.bbc.com
