US drug regulator said Wednesday that Johnson & Johnson’s single-dose coronavirus vaccine is safe and effective.
A report by the US Food and Drug Administration (FDA) was released ahead of a meeting Friday where experts will discuss the sufficiency of the American drugmaker’s vaccine for emergency use authorization.
The international study, which was conducted in the US, Latin America, and South Africa with 40,000 people, found the company’s vaccine to be 66.9% effective in preventing moderate to severe coronavirus symptoms. The efficiency in the US trials was 72%.
“The most common solicited adverse reactions were injection site pain (48.6%), headache (38.9%), fatigue (38.2%),” according to the report.
Johnson & Johnson is also working on a two-dose regimen that might prove more effective.
If the agency authorizes the vaccine, it will be the third shot available in the US after Pfizer-BioNTech and Moderna and become the first global single-shot coronavirus vaccine. All others require two shots at least two weeks apart.
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