The U.S. Food and Drug Administration found that a Johnson & Johnson Covid-19 single-dose vaccine was 66.1% effective in preventing moderate to severe virus disease, and that it had a “favorable safety profile.”
In the company’s clinical study of about 44,000 patients in the U.S., South Africa and other countries, the agency said, there were seven Covid-19 deaths among patients getting a placebo, and none among those who got the vaccine.
The finding appears to bolster J&J’s earlier statements that the vaccine was effective in preventing severe disease.
The federal agency’s analysis represents a key step toward a possible FDA authorization of the vaccine as early as this weekend, according to a person familiar with the matter.
A committee of outside medical specialists convenes Friday to evaluate the analyses by both the FDA and the company, as the panel did for the first two Covid-19 vaccines to be cleared for use.