J&J’s one shot vaccine proves safe and effective, says FDA

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, paving the way for its US approval for emergency use.

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.

J&J’s vaccine effectiveness varied from 72% in the United States to 66% in Latin America and 57% in South Africa, where a new variant has spread, though the vaccine was 85% effective overall in stopping severe cases of the disease, the federal regulator said.

It was 66% effective in preventing Covid-19 against multiple variants, results that came out of a global trial involving nearly 44,000 people, the company said last month.

The vaccine was effective in reducing the risk of Covid-19 and preventing PCR test-confirmed Covid-19 at least 14 days after vaccination, the FDA said in its briefing documents.

Three vaccine recipients had severe side effects in the trial, but the FDA said that its analysis did not raise any specific safety concerns that would preclude the issuance of an emergency use authorization. J&J had not previously released details of its clinical trial data beyond efficacy rates.