A review by the US Food and Drug Administration of the single-shot Johnson & Johnson coronavirus vaccine found it is safe and effective, concluding it has “known benefits” in reducing both symptomatic and severe illness.
It paves the way for it to become the third Covid-19 vaccine to be authorised in the US.
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.
The Belgian company Janssen, which is owned by the pharmaceutical giant, said its data showed the product was highly effective against severe disease.
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.
Notably, there were no deaths among participants who had received the vaccine and no hospital admissions after 28 days post-vaccine.