A review by US regulators of the single-shot Johnson & Johnson coronavirus vaccine has found it is safe and effective.
It paves the way for it to become the third Covid-19 vaccine to be authorised in the US, possibly within days.
The vaccine would be a cost-effective alternative to the Pfizer and Moderna vaccines, and can be stored in a refrigerator instead of a freezer.
Results from trials were released by Johnson & Johnson last month.
The Belgian company Janssen, which is owned by the pharmaceutical giant, said its data showed the product was highly effective against severe disease.
It comes as Ghana became the first country to receive coronavirus vaccines through the Covax vaccine-sharing initiative.
The briefing document published by the US Food and Drug Administration (FDA) gives more detail on the data submitted by Janssen to the regulator. The FDA concludes that 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, when considering cases at least 28 days after vaccination.