US Food and Drug Administration (FDA) reviewed the single-shot Johnson & Johnson (J&J) coronavirus vaccine and found it to be safe and effective.
With this, J&J becomes the third Covid-19 vaccine to receive authorization in the US in a short time span.
Alternative to the Pfizer and Moderna vaccines, J&J has made the vaccine cost-effective which can be easily stored in a refrigerator instead of a freezer. The pharmaceutical giant released its results from the trials last month.
The Belgian company Janssen, which is a part of J&J, said that its data revealed the product was highly effective against severe disease.
Through the Covax vaccine-sharing initiative, Ghana became the first country to receive coronavirus vaccines.
FDA published a briefing document that provides detail on the data submitted by Janssen to the regulator where it concludes that the under consideration 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.
Notably, there were no deaths among participants who had received the vaccine and no hospital admissions after 28 days post-vaccine.
Further recommendation and authorization of the vaccine by the FDA will be discussed by an external committee of experts on Friday, possibly adding to a coming surge in vaccine availability in the US.
A White House official said the administration anticipated distributing at least three million doses of the Johnson & Johnson vaccine next week, should it receive emergency authorization from the FDA.
The company says it 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.
